More than 400 forklift drivers are newly certified and ready to work safely, and member Engauge Workforce Solutions is to thank.
Engauge, based in Menomonee Falls, WI, has been offering weekly comprehensive forklift training in its warehouse facility in its mission to increase workplace safety and OSHA compliance. Participants – 50% of which have come from underserved populations – have the opportunity to become certified on sit-down forklifts, stand-up reach trucks, and cherry pickers.
“There is no better way to ensure employee loyalty than to provide them the skills they need to increase their overall earning potential,” says Katie Malnight, Engauge’s chief operating officer. “We recognize that there is a significant shortage of skilled forklift drivers in the greater Milwaukee area and understand that many companies simply do not have the time or resources to train inexperienced associates themselves.”
Milwaukee-based frozen pizza manufacturer Palermo’s Pizza has seen great success since the beginning of their partnership. Since May 2023, 73 individuals have passed Engauge’s forklift certification class seeking Palermo’s opportunities, with 60 of these individuals passing Palermo’s final on-site evaluation with offers to start at Palermo’s, 52 ultimately starting at Palermo’s in forklift positions, and 14 having been officially hired after completing their Contract to Hire period.
“We saw an opportunity to partner with a great local company like Palermo’s to expand the opportunities given to associates with strong soft skills. The result was a company and employee ‘win win’ in terms of significantly higher retention rates coupled with higher employee satisfaction,” explains Malnight.
The training provides participants with pre-assessment drug screening, a classroom session with videos, presentations, and a written exam, more than four hours of hands-on training in Engauge’s production facility, and a final assessment and compliance – a format that has worked wonders for Palermo’s.
“Thanks to Engauge, we were able to establish training classes that helped us revamp our onboarding process for temporary employees,” shared an HR Generalist at Palermo’s. “This helped us improve our staffing numbers in the warehouse and allowed the team to work on implementation of new processes. Associates coming out of the class were grateful for the opportunity and appreciate the work they are doing for the company. We are looking forward to having them become part of the family.”
Learn more about Engauge’s forklift certification program here.
Just four years after purchasing their production facility, Milwaukee Pretzel Company is feeling the pinch and expanding their production site footprint.
The expansion will more than double the size of the their facility, located at 8050 N. Granville Woods Road in Milwaukee, from 22,000 square feet to 50,000 square feet. Increased production floor space, warehouse space, freezer storage, and docks are planned to accommodate the growing demand for their renowned soft Bavarian pretzels.
Matt Wessel, owner and president of Milwaukee Pretzel Company, knows Keller, a leading design-build contractor and fellow FaB member, is up for the challenge.
“Keller appeared on our radar after meeting one of their project managers at a FaB event,” says Wessel. “We had met with and talked with a handful of similar companies around that time because we were getting ready to need to make a facility move. When we got serious about looking at new spaces, we gravitated toward Keller because of their customer service and reputation. They did a really great job meeting us where we were and helping us navigate the complex decision of a facility move.”
And as the project progresses, Wessel calls working with Keller, who is 100% employee-owned, with 275 employee-owners and design and build experts with offices throughout the state, “easy.”
“They’re very accessible. They’re very fair,” he explains. “They try to be as transparent as possible. And their business model, which puts all of the services under one roof, makes it really convenient for us as busy business owners.”
Nathan Laurent, southeast region vice president and co-owner of Keller, is excited for the continued partnership with the Wessels and Milwaukee Pretzel Company.
“Matt and Katie are just incredible business owners to work with. They come off as someone you’ve known your whole life and are just down to earth,” says Laurent. “They’re a delight to work with from a business stance too. They value our Keller master planning approach and it has been a pleasure working on this expansion for them. Plus, their pretzels are the best and that is a direct reflection of the work and passion Matt and Katie have put into the business.”
This update includes FDA and USDA updates, FDA warning letters, lawsuits, and other articles of interest, including an update on the safety of the country’s commercial milk supply, reports of adulterated and misbranded food, and new technology to help Prepare for FDA’s traceability rule.
FDA Updates
FDA Collecting Information on Food Calorie and Nutritional Labeling Requirements April 11: FDA announced a proposed collection of information pertaining to calorie labeling of food items in vending machines and nutrition labeling of standard menu items in restaurants and similar retail food establishments. This information collection supports statutory and regulatory requirements that govern food labeling, and information collection recommendations discussed in associated Agency guidance. Respondents to the collection of information are manufacturers, packers, and distributors of food products, as well as certain food retailers such as supermarkets, vending machine operators and restaurants, subject to food labeling requirements. Comments on this information collection are due May 13, 2024. More information can be found here.
FDA Announces Information Collection for Food Allergen Labeling and Reporting April 11: FDA announced a proposed collection of information to ensure accurate labeling of ingredients derived from major food allergens. Respondents to this information collection are manufacturers and packers of packaged foods sold in the U.S. subject to the labeling requirements and prohibitions found in section 403 of the federal Food, Drug, and Cosmetic Act. Comments on this information collection are due May 13, 2024. More information can be found here.
FDA Releases Draft Guidance on NDIN Master Files for Dietary Supplements April 4: The FDA issued a draft guidance document to help industry comply more easily with the new dietary ingredient notification (NDIN) requirement by providing recommendations on the submission and use of Master Files which contain identity, manufacturing, or safety data that can be used to support a NDIN. New dietary ingredient Master Files are submitted solely at the discretion of the Master File owner and are not required by statute or regulation. Written comments on the draft guidance are due by June 3, 2024. More information, as well as a link to the draft guidance document can be found here.
Update on FDA PFAS Investigation in Food Supply Reveals Low Dietary Risk April 18: The FDA released an update that outlines its recent activities and approach to managing PFAS-related risks. The FDA has been testing exposure to PFAS substances in the general food supply since 2019. To date, the FDA tested nearly 1,300 samples from a wide range of foods, as part of the Total Diet Study (TDS), to assess dietary exposure to PFAS. Recent test results reveal that out of 95 samples from a regional TDS collection, PFAS was detected in 8 beef and seafood samples. Overall, the rate of detection has been low, with PFAS found in less than 3% of TDS samples tested so far. The FDA concluded that the PFAS levels detected are not likely to be a health concern for either young children or the broader population. More information can be found here.
FDA Reports Improvement in Honey Adulteration Rates Following Recent Import Tests April 8: The FDA released data from a sampling assignment carried out in 20223 and 2023 to test imported honey for adulteration aimed at economic gain. FDA sampled imported honey for the presence of cheaper sweeteners not declared on the label, a practice known as economically motivated adulteration (EMA). Out of 107 honey samples, 3% were found to be non-compliant. This is a decrease from the previous year’s violation rate. When violations were detected, the FDA denied entry of the products into the U.S. and placed the associated company and product on Import Alert. More information can be found here.
FDA Finalizes Guidance on Veterinary Feed Directive April 29: The FDA announced that is has finalized Guidance for Industry (GFI) #120: Veterinary Feed Directive Regulation Questions and Answers, to provide guidance to industry on the requirements of the veterinary feed regulations (i.e., the Veterinary Feed Directive (VFD) final rule). The VFD final rule outlines the process for authorizing the use of approved animal drugs intended for use in or on the feed of food-producing animals that require veterinary oversight, including medically important antimicrobials when needed for specific animal health purposes. This final guidance also serves as a Small Entity Compliance Guide to aid industry in complying with the requirements of the VFD final rule. More information can be found here.
FDA Releases Guidance on Revocation of Partially Hydrogenated Oils in Foods April 29: The FDA announced the availability of a guidance for industry entitled “Revocation of Uses of Partially Hydrogenated Oils in Foods: Guidance for Industry; Small Entity Compliance Guide”. The compliance guide is intended to help small entities comply with FDA regulations after the FDA revoked specific requirements pertaining to the use of partially hydrogenated oils in certain foods or as a direct or indirect food substance. More information can be found here.
FDA Files Food Additive Petition from Environmental Defense Fund, et al. April 26: The FDA announced that it filed a food additive petition, submitted by Environmental Defense Fund, et al., proposing that the food additive regulations be amended to remove fluorinated polyethylene. The petitioners state that the fluorinated polyethylene manufactured consistent with § 177.1615 can produce polymeric per- and poly-fluorinated alkyl substances that can migrate to food and are not safe pursuant to section 409(c)(5) of the Food Drug &Cosmetic Act. The FDA is seeking comments, additional scientific data, and other information related to the issues raised by this petition. Comments must be submitted by June 25, 2024. More information can be found here.
FDA Considering Warning Labels on Foods April 30: The FDA is considering requiring food manufacturers to put new labels on the front of packages to flag certain health risks, such as high levels of salt, sugar or saturated fat. It may be some time before such labels appear in stores, as the FDA is still determining the best approach. However, the food industry disputes the effectiveness of such labels in altering consumer behavior and argues that some proposed label designs are confusing. More information can be found here.
FDA Warning Letters
Misbranded Food: FDA issued a warning letter to Lipari Foods Operating Company alleging that its walnuts, filberts, and cashews labels did not declare a major food allergen.
Adulterated Seafood: Upon inspection of Euro USA’s seafood processing facility, FDA issued a warning letter for violations of the seafood Hazard Analysis and Critical Control Point regulation involving packaging products under insanitary conditions.
Imported Food: FDA issued warning letters to two California companies for failure to develop, maintain and follow a Foreign Supplier Verification Program for imported produce and snacks.
Adulterated Animal Feed: FDA issued a warning letter to Appleton City Feed Service LLC for violations of Veterinary Feed Directive requirements and for using a new animal drug that is adulterated. FDA also issued a warning letter to Hi-Pro Feeds for adulterated goat feed.
Adulterated Soybean Sprouts: FDA issued a warning letter Korean Food, Inc. for violations of the sprouts and the food labeling regulations alleging that the company’s soybean sprouts products are adulterated because they were prepared, packed, or held under insanitary conditions.
USDA Issues Order Requiring Mandatory Testing and Reporting Requirements for Livestock April 25: The U.S. Department of Agriculture is implementing new measures to safeguard the U.S. livestock industry from the highly pathogenic H5N1 avian influenza. As of April 29, 2024, the Animal and Plant Health Inspection Service (APHIS) will enforce a Federal Order with requirements for mandatory testing for interstate movement of dairy cattle and mandatory reporting. The Federal Order aims to widen the understanding of H5N1’s behavior, particularly its movement between wild birds and dairy cows, and to control its spread by mandating reporting of positive tests. More information can be found here.
Other Articles of Interest
Potential Snack and Candy Ban Due to Cancer Concerns April 18: Several states are considering or have enacted laws to ban common snacks and candies because they contain ingredients that could cause cancer. The list of potentially banned products includes cereals like Lucky Charms and Fruit Loops, various candies such as Skittles and M&M’s, and snacks like Flamin’ Hot Cheetos and Doritos. This move is due to concerns about certain food and color additives, which, while preserving food, may pose health risks. Supporters of the legislation argue that these ingredients are harmful and should be eliminated. Meanwhile, some states have refused to pass similar bans, citing a lack of “scientific basis”. More information can be found here.
Shareholder Criticizes General Mills Over Use of Plastic Packaging April 16: General Mills Inc. is under scrutiny from Green Century Funds (Green Century), a shareholder, for not adequately addressing sustainable packaging, despite a resolution passed two years ago with majority support from shareholders for the company to establish plastic waste reduction goals and provide progress reports. Green Century has filed a new plastics-focused resolution for General Mills’ annual meeting later this year. Although General Mills claims significant progress towards making packaging recyclable or reusable by 2030, with a current rate of 93% recyclable packaging by weight, Green Century remains skeptical and critical of the pace of change. Problems have arisen with the shuttering of Myplas, a Minnesota-based plastic facility backed by General Mills, which was part of the company’s plastic strategy.
FDA Commissioner Wants Congressional Action on Hemp-Derived CBD April 11: During a U.S. House of Representatives Oversight Committee hearing, FDA Commissioner, Dr. Robert Califf, expressed that the FDA did not consider hemp-derived CBD safe for legal sale as a dietary supplement. He advocated for Congress to establish a regulatory framework for CBD. The FDA has consistently maintained that it would not develop rules to allow CBD to be sold in dietary supplements or foods. Califf said that CBD does not fall under the FDA’s regulatory scheme. According to Califf, the existing policies in place governing food and dietary supplements are insufficient to manage the risks associated with CBD. Califf was also concerned about the potential harms of CBD exposure that could cause liver damage over time. Read Califf’s testimony here.
Get Ready: New Technology Available to Help Prepare for FDA’s Traceability Rule April 12: The new traceability rule (Rule 204 under the Food Modernization Act) finalized in November 2022 will be enforced beginning January 20, 2026, with routine inspections anticipated to start in 2027. Frank Yiannas, a former FDA official involved in drafting the rule, advises companies to start preparing now. He cautions against the use of Advanced Shipping Notices (ASNs) as a compliance shortcut, suggesting that ASNs are insufficient for the specific food safety traceability intended by Rule 204. Yiannas suggests that companies should instead concentrate on improving the tracking of shipping and receiving records through the use of technology that can track shipments more accurately without manual scanning, providing instant and retrievable data for compliance with Rule 204’s requirements. More information about technology available to prepare for the new traceability rule can be found here. More information about the new traceability rule and how businesses can prepare for it can be found here.
Surge in Food Recalls Since Before Pandemic April 25: Last year saw food recalls reach the highest levels since the pre-pandemic period, with significant outbreaks causing illness in 1,100 people and resulting in six deaths, according to a report by the Public Interest Research Group (PIRG). Recalls rose by 8% in 2023, with dangerous bacteria like Listeria, Salmonella, and E. coli causing a quarter of these incidents. 49% of the recalls stemmed from undeclared allergens, partly due to new requirements for manufacturers to list sesame as an ingredient. More information can be found here.
FDA Says U.S. Commercial Milk Supply is Safe April 24: Recent cases of highly pathogenic avian influenza (HPAI) in U.S. dairy herds have prompted the FDA and USDA to reassert that the nation’s commercial milk supply remains safe. This assurance is based on two critical components of the federal-state milk safety system: the pasteurization process, which eliminates pathogens, and protocols to either divert or destroy milk from cows that are ill. More information can be found here.
FDA Calls on Congress to Establish National Food Lead Testing Requirements April 23: Due to concerns about toxic heavy metals in baby food and related products, FDA Commissioner Robert Califf went before Congress to request new laws for lead testing in food, emphasizing the need to protect young children and babies from lead poisoning. This action follows incidents like the Wanabana applesauce pouch recall in October, which contained high lead levels and has since been connected to numerous poisoning cases across the U.S. Califf argued for increased FDA authority to test food for lead and set heavy metal limits, citing the lack of federal requirements for such testing beyond a few exceptions. More information can be found here.
Lawsuits
$5 Million Missouri Raisin Packaging Class Action Certified April 19: A federal judge in Missouri has granted class certification to consumers suing Mariani Packing Company Inc. for allegedly deceptive packaging of vanilla yogurt raisins. The lawsuit, led by Kimberly Diesel, alleges that Mariani sold its raisins in packaging that contained only 42% of raisins, with the remainder being empty space, known as slack-fill. The Plaintiffs claim this is a violation of the Missouri Merchandising Practices Act (MMPA), as it deceives consumers about the quantity of the product. A copy of the Court’s Order can be found here.
Kraft Sued Over Lead in Lunchables April 18: A lawsuit was filed against Kraft Heinz Co. in the US District Court for the Eastern District of New York, by Vince Palmeri, alleging deceptive advertising of Lunchables products. The complaint alleges that Lunchables packaging, which promises “100% Freshness Guaranteed,” is misleading because it suggests the products are safe for consumption. Palmeri claims that Kraft Heinz Co. failed to disclose the presence of lead, thus making the value of Lunchables worthless. He accuses the company of negligence and violations of New York’s General Business Law and is seeking damages, as well as seeking to represent a class of purchasers nationwide. Kraft maintains that their products are safe, attributing the presence of lead to its natural occurrence in the environment, and plans to defend against the allegations. The case references a Consumer Reports article which found significant levels of lead in several lunch and snack kits, exceeding California’s regulatory limits. Similar lawsuits have been initiated against Hershey Co. and Walmart Inc. following reports of heavy metals in food. A copy of the complaint can be found here.
Bimbo Bakeries All Butter Cake Lawsuit Dismissed April 15: Bimbo Bakeries USA Inc. successfully defeated a class action lawsuit alleging deceptive advertising of its “All Butter” Entenmann brand cake, which included vanillin, a synthetic ingredient for flavoring. The US District Court for the District of Maryland ruled that federal law preempted the state-law claims of deception and warranty breach, and the complaint did not convince that a reasonable consumer would interpret “All Butter” to mean the flavoring was exclusively from natural butter. The suit, brought by Candice Bradby, argued the cake’s labeling and ingredient list failed to adequately disclose artificial flavoring, leading her to pay a premium price under a false impression. The court found the claims to be invalid under the Food Drug and Cosmetic Act (FDCA), which sets federal standards for food labeling and supersedes non-identical state regulations. The Court also noted complaint failed to allege facts showing reasonable consumers would be misled about the source of the butter flavor, particularly given the presence of “artificial flavors” on the ingredients list. More information can be found here.
Splenda Maker Faces Class Action Over “100% Natural” Claims April 12: TC Heartland LLC, the producer of Splenda Naturals Stevia, was sued over its “100% Natural” labeling, which the plaintiff claims is misleading due to the product’s synthetic ingredients. The class action filed in the US District Court for the Eastern District of New York alleges that such marketing misleads consumers who are inclined to pay extra for products deemed “natural”. The complaint claims that Splenda Naturals Stevia contains erythritol and stevia leaf extract, which are not naturally occurring substances and subjected to synthetic chemical processing. The plaintiff asserts he was deceived into buying a product that did not meet his expectations of naturalness and seeks to represent classes of consumers from across the nation who have purchased Splenda under the pretext of it being entirely natural. The lawsuit is based on allegations of deception, fraud, and breach of warranty. While a Splenda representative has stated that the disputed “100% Natural” label is discontinued, the plaintiff alleges that the product’s packaging is still widely available and advertised. More information can be found here.
Court Advances Deceptive Advertising Claims Against Coca-Cola Over “100% Recyclable” Bottles April 9: A US District Judge for the Northern District of California has allowed claims to proceed against the Coca-Cola Co. for allegedly misleading consumers with the assertion that its water bottles are “100% Recyclable.” The allegations presented in the latest complaint are that Coca-Cola’s bottles are not fully recyclable due to the plastic film material used on the product labels, which are not processed by California recycling facilities, and are consequently discarded. The complaint’s focus on the non-recyclability of the labels due to the material’s incompatibility with recycling plants led the Judge to find it plausible that the “100%” claim could be misleading and thus denied the defendants’ motion to dismiss the complaint. A copy of the Judge’s Order can be found here.
Dole’s “Healthy” Labeling Claims Remain Intact Amid Dismissal of Class Action April 9: Dole Packaged Foods LLC defeated a proposed class action that challenged the health claims on its fruit products. The lawsuit, filed in the US District Court for the Northern District of California, alleged that Dole’s labels deceptively market fruit products as “healthy and nutritious”, despite the high sugar content in products like fruit parfaits, cups, and beverages. The court dismissed the claims, citing preemption by federal law and the implausibility of consumer deception. The court noted that nutrition claims relating to vitamin C levels fall under implied nutrition standards and are subject to the Food Drug and Cosmetic Act, which mandates uniform nutrition labeling and hence preempts the plaintiffs’ state law-based claims. Furthermore, the court found that the challenged statements about “good nutrition” and “goodness and nutrition” were mingled with marketing language, such as references to sunshine and upbeat, whimsical imagery. This, the court implied, would signal to a reasonable consumer that the claims were not to be interpreted in a literal, factual way. The Judge said because the nutrition statements aren’t health representations, Dole wasn’t obligated to address the negative health effects of sugar. More information can be found here.
Licorice Maker Wins Deceptive Labeling Lawsuit April 23: KLN Enterprises Inc., the maker of Wiley Wallaby Very Berry Licorice, successfully defended against a proposed class action that claimed the company mislabeled the candy as naturally flavored while it contained synthetic malic acid. The U.S. District Court for the Southern District of California dismissed the case on the grounds that the plaintiff, Mark Trammell, did not adequately allege that the malic acid was artificial nor that it was used as a flavoring agent. Trammell alleged that labels stating the licorice was “Naturally Flavored” and free of artificial colors and flavors was deceptive. He brought consumer protection claims under California laws and additional claims for breach of warranty and unjust enrichment. The Court noted the insufficiency of Trammell’s allegations and highlighted that the product’s label did not claim to be all-natural or free of artificial ingredients. Moreover, Trammell was not considered to have standing to seek an injunction as he did not convincingly claim an intention to purchase the licorice again. Consequently, the lawsuit was dismissed in full.
This Regulatory Update covers information from April 2024. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.
MADISON — Gov. Tony Evers announced that the Board of Directors of the Wisconsin Economic Development Corporation (WEDC) today approved awarding up to $15.5 million in performance-based tax credits to assist Kikkoman Foods Inc. in expanding its operations in Wisconsin. The company plans to invest at least $800 million in expanding its brewing plant in Walworth and building a new facility in Jefferson, which is expected to will create 83 new high-paying jobs over 12 years.
“For decades, Wisconsin and Japan have built meaningful partnerships in business and in culture, from over $700 million every year in exports to Japan to the seven sister cities that Japan and Wisconsin share to the continued investment and growth of Kikkoman’s first U.S. brewing plant here in Wisconsin,” said Gov. Evers. “Whether it’s providing thousands of local jobs, bolstering our economy, or providing the state and world with phenomenal soy sauce, Kikkoman is doing good work across Wisconsin and the country, and I am grateful for their continued partnership and expansion in Wisconsin.”
Kikkoman has played a vital role in the Wisconsin economy for more than half a century. In 1973, with the opening of Kikkoman Foods Inc., in Walworth, Wisconsin, the company transformed the area into what has now become the Kikkoman Group’s highest-producing soy sauce facility in the world. The plant made history as one of the first production facilities built in the United States by a Japanese company. Since that time, Kikkoman has forged partnerships and friendships within the local community, celebrating shared cultural values like hard work, respect, cooperation, and a commitment to excellence, and contributing more than $17 million to charitable causes in the local community and beyond.
In 1998, Kikkoman opened a second production facility in Folsom, California. As demand for Kikkoman® Soy Sauce and other sauces and seasonings continues to grow in North America, the company spent the last several years conducting a nationwide search to identify the ideal location for a third manufacturing facility and ultimately selected a 100-acre site in Jefferson, Wisconsin.
“Fifty years ago, Kikkoman made history by choosing Walworth, Wisconsin, for its first international brewing plant,” said WEDC Secretary and CEO Missy Hughes. “Now Kikkoman is opening a new chapter in that history by expanding its presence in Walworth and Jefferson.”
“We have always valued Walworth for its great market access, outstanding workforce, central location for raw materials, pure water, and the open-hearted spirit of partnership of the local community,” said Mr. Yuzaburo Mogi, honorary chief executive officer and chairman of the board of Kikkoman Corp. “We chose Jefferson for those same reasons, and we look forward to expanding our footprint in Wisconsin and establishing a supply chain with increased stability in North America, Kikkoman’s largest overseas market.”
The groundbreaking for the initial phase of the Jefferson build-out—a 240,000 square-foot facility that will produce soy sauce and soy sauce–related seasonings, including teriyaki sauce—will take place in June 2024, with the first shipments of soy sauce planned for fall 2026. The next-generation production plant will combine flexibility with production efficiency and scalability. In keeping with Kikkoman’s commitment to sustainability and stewardship, the facility will aim to reduce CO2 emissions by installing energy-efficient equipment and proactively using renewable energy.
“Kikkoman’s decision to invest in Jefferson underscores the strength and appeal of our local food and beverage niche,” said Jefferson Mayor Dale Oppermann. “We appreciate the trust Kikkoman has placed in our community and look forward to a long, prosperous partnership.”
In addition to the new Enterprise Zone for Kikkoman Foods Inc., WEDC has 20 active Enterprise Zone designations throughout the state, which are expected to result in over $3.8 billion in capital investment, the retention of almost 17,000 jobs, and the creation of over 20,000 new jobs. Under state law, the Wisconsin State Legislature’s Joint Committee on Finance has 14 days to review the creation of a new Enterprise Zone. The zone will automatically be created unless the committee takes action.
An online version of this release is available here.
This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including claims about yogurt lowering diabetes risk, new rules for voluntary “Product of USA” labeling claims, and more.
FDA Updates
FDA Issues Final Guidance for New Dietary Ingredient Notification Procedures March 6: The FDA announced the availability of a final guidance for industry entitled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” The guidance focuses on frequently asked questions about the new dietary ingredient notification submission and review process. The guidance is intended to help manufacturers and distributors of new dietary ingredients and dietary supplements prepare and submit new dietary ingredient notifications to FDA. More information can be found here.
FDA Collecting Information on Foodborne Illness Risk Factors in Restaurants and Retail Food Service Facilities March 6: FDA is inviting comments on the collection of information concerning the “Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types”. The FDA conducted a study to measure trends in the occurrence of foodborne illness risk factors, preparation practices, and employee behaviors as contributing factors to foodborne illness outbreaks at retail establishments. The results of this study will be used to: develop retail food safety initiatives, policies, and targeted intervention strategies focused on controlling foodborne illness risk factors, as well as providing technical assistance to state and local regulatory professionals, identify FDA retail work plan priorities, and enhance retail food safety. Comments are due May 6, 2024. More information can be found here.
FDA Embraces the Potential of Artificial Intelligence to Revolutionize Advances in Medical Products and Food March 15: FDA Commissioner Robert M. Califf discussed how Artificial Intelligence (AI) has the potential to enable advances in the development of more effective, less risky medical products and more nutritious food. The FDA is also exploring the use of AI to facilitate internal operations and regulatory processes. The FDA issued a paper on AI and medical products, which reaffirms their commitment to promoting responsible and ethical development of AI. More information can be found here.
FDA Allows Claim that Yogurt Lowers Diabetes Risk March 1: The FDA announced that it does not intend to object to the use of certain qualified health claims regarding the consumption of yogurt and reduced risk of type 2 diabetes, provided that the qualified health claims are worded so as not to mislead consumers, and that other factors for the use of the claim are met. More information can be found here.
FDA Extends Comment Period for Draft Guidance Related to Food Allergen Program and Acidified Foods March 22: The FDA extended the comment period for two new chapters of a draft guidance entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft guidance for Industry”. The guidance aims to assist food facilities in adhering to the preventive controls for human food rule, which is part of the FDA Food Safety Modernization Act (FSMA). The new chapters available for comment are Chapter 11, which covers the Food Allergen Program, and Chapter 16, which pertains to Acidified Foods. Comments on the draft guidance must be submitted by May 24, 2024. More information, as well as the draft guidance and information for submitting comments, can be found here and here.
FDA Issues Final Rule for Determining When Food Contact Notification is No Longer Effective March 21: The FDA is revising its regulatory procedures to determine when a premarket notification for a food contact substance (FCN) is deemed no longer effective. The new rule introduces additional reasons that could form the basis for FDA to determine that an FCN is no longer effective. Furthermore, the final rule guarantees that manufacturers or suppliers are given an opportunity to provide input prior to an FDA decision that an FCN is no longer effective. These updates are being made to allow the FDA to better respond to new information on the safety and use of FCNs, adapt to changes in manufacturers’ business choices, and improve the efficiency of the premarket notification program. The rule goes into effect on May 21, 2024. More information can be found here.
FDA Hosts Virtual Public Meeting on Data-Driven Advances in Food Safety March 25: The FDA is holding a virtual public meeting on April 24, 2024 focusing on Data and Technology in the New Era of Smarter Food Safety. The event aims to explore the use of data and technology to improve food safety and health outcomes. Stemming from the 2019 New Era of Smarter Food Safety initiative, which emphasizes modernization of the food safety system, the meeting will include FDA presentations on innovative data and tech opportunities to enhance food safety. It will also hold an afternoon session for public input. The meeting is free, but registration is required. The meeting will start a 60-day comment period beginning on April 24th. More information can be found here.
FDA Issues Import Alert to Safeguard Against Chemically Contaminated Foods, including PFAS March 20: The FDA issued Import Alert 99-48, Detention without Physical Examination of Foods Due to Chemical Contamination, which allows the FDA to help prevent products entering the U.S. if they are found to be contaminated with chemical pollutants such as benzene, dioxins, PCBs, and PFAS. This measure is part of the FDA’s evolving strategy to minimize exposure to toxic chemicals and PFAS in foods. Firms with products detained under this alert must show corrective actions have been taken to re-establish compliance to have their items released. The FDA provides guidance for removal from the alert in its Regulatory Procedures Manual, Chapter 9-8. More information can be found here.
FDA Warning Letters
Misbranded Food: FDA issued a warning letter to Glister-Mary Lee Corporation alleging that its Hy-Vee brand Hamburger Chili Macaroni Skillet Meal product label did not declare a major food allergen. FDA also issued a warning letter to Regal Health Food International, Inc. alleging that its Regal Gourmet Snacks Milk Chocolate Raisins label did not declare a major food allergen.
Adulterated Seafood: Pursuant to a consumer complaint involving histamine poisoning from yellowfin tuna, FDA inspected a seafood processing facility and issued a warning letter for violations of the seafood Hazard Analysis and Critical Control Point regulation involving the packaging of tuna under insanitary conditions.
Adulterated Juice: FDA issued a warning letter to Barsotti Juice Company, Inc. for violations of the Current Good Manufacturing Practice (CGMP) and alleging that the company’s organic carrot juice is adulterated in that it was prepared, packed, or held under insanitary conditions.
Imported Food: FDA issued a warning letter to Dream Wholesale Inc. for failure to develop, maintain and follow a Foreign Supplier Verification Program for imported soda water, cooked chickpeas, grape leaves, dried apricot paste, and frozen spinach.
Dietary Supplements: FDA issued a warning letter to Healthtex Distributors, Inc. alleging that its products are misbranded and violate CGMP regulations related to adulterated dietary supplements.
Adulterated Animal Feed: FDA issued a warning letter to Woody’s Pet Food Deli after finding that its pet food was contaminated with Salmonella Reading and Listeria monocytogenes.
FSIS Releases New Rules for Voluntary “Product of USA” Labeling Claims March 18: The U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) finalized a rule amending its regulations to better define conditions under which FSIS-regulated products may bear the voluntary “Product of USA” label. The final rule allows the voluntary “Product of USA” or “Made in the USA” label claim to be used on meat, poultry, and egg products only when they are derived from animals born, raised, slaughtered, and processed in the U.S. The rule goes into effect on May 17, 2024. Establishments voluntarily using a U.S.-origin claim subject to the final rule will need to comply with the new regulatory requirements by January 1, 2026. FSIS also updated its labeling guidance document to help establishments determine whether their labels must be submitted for approval. More information can be found here.
Other Articles of Interest
Trends in FDA Warning Letters under the Food Safety Modernization Act March: Between January 2017 and December 2023, FDA issued 149 warning letters to human food facilities and 37 warning letters to animal food facilities citing violations of the applicable food current good manufacturing practice and preventive controls requirements. The most cited violations for human food facilities related to the agency’s sanitary operations, preventive controls, and hazard analysis requirements. The most cited violations for animal food facilities related to plant operations, hazard analysis, and sanitation. Warning letters reference hazard analysis and other requirements that were introduced as part of the Food Safety Modernization Act (FSMA). More information, along with best practice recommendations for food facilities to ensure the success of their next FDA inspection and reduce the risk of government scrutiny, can be found here.
Second Human Case of Bird Flu Confirmed: CDC Continues Monitoring and Emphasizes Low Public Risk April 2: A second case of the avian influenza virus (H5N1) has been confirmed in a person in the U.S. following exposure to dairy cattle in Texas. The individual has mild symptoms, specifically eye redness, and is on antiviral treatment. The CDC assesses the risk to the general U.S. population as low but acknowledges higher risk for those with close contact with infected animals or contaminated environments. This is the second U.S. case after one reported in 2022. Despite this case, no changes in the human health risk assessment for bird flu are suggested. The CDC is overseeing preventative measures and working with the FDA and USDA to monitor for animal and human infection. The virus was confirmed by testing of unpasteurized milk and cattle throat swabs in Texas and Kansas, with cases also identified in Michigan. The CDC recommends avoiding exposure to sick or dead animals and their products, including raw milk from infected animals. The FDA confirms that the commercial milk supply remains safe due to pasteurization, which inactivates viruses. More information can be found here and in this Michael Best Client Alert.
Top 5 Regulatory Challenges in the Food Industry for 2024 March 31: In 2024, food industry professionals are navigating numerous regulatory compliance issues including 1) food traceability recordkeeping, 2) major food allergen enforcement, 3) PFAS regulations and state bans on synthetic chemicals, 4) Prop 65 short form labeling, and 5) FDA’s Unified Human Foods Program. These topics will be discussed at the American Conference Institute Food Law Summit in Chicago on April 30-May 1. More information can be found here.
Data Collection Tools and Strategies Available for Small and Midsize Food Manufacturers March 25: Generating, collecting, and utilizing process data is a daunting task for most small and midsize food and beverage manufacturers. Addressing the challenges of data collection in the food industry has become easier with advancements in sensor technology. These improvements allow for non-invasive, accurate measurement of product characteristics. Low-cost tools are available that can make collection and utilization of data attainable for smaller businesses. More information can be found here.
AGs Urge Congress to Address Intoxicating Hemp Products in Farm Bill March 21: A bipartisan coalition of 21 attorneys general is urging Congress to address the issue of hemp intoxicants in the upcoming reauthorization of the 2018 Farm Bill. The AGs argue that the 2018 Farm Bill created a loophole that allows for hemp-derived intoxicating products to be sold legally, which they believe poses a public health and safety crisis. The AGs want the definition of hemp to be amended to clarify that intoxicating products derived from hemp extracts are not legal under federal law. The AGs also want Congress to reaffirm that states are not limited in their ability to regulate or restrict cannabinoids or other derivatives of hemp. More information can be found here.
Lawsuits
Nestle Faces Lawsuit for Allegedly Impure Perrier Mineral Water March 5: A proposed false advertising class action lawsuit was filed in the U.S. District Court for the Eastern District of New York alleging that Nestle USA Inc. misbranded Perrier products as “natural mineral water” from a spring in France when the company began blending water from multiple sources, as well as tap water. The French spring is contaminated and must be treated and filtered which is in violation of U.S. regulations governing mineral water. More information can be found here.
This Regulatory Update covers information from March 2024. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.
This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including the end of PFAS sales in food packaging, misbranded hot dog buns, an online system for identifying foodborne illness outbreaks, and more.
FDA Updates
FDA Announces the End the Sale of PFAS in Food Packaging February 28: The FDA announced that grease-proofing materials containing per- and polyfluoroalkyl substances (PFAS) are no longer being sold for use in food packaging in the U.S. The announcement marks the fulfillment of a voluntary commitment by manufacturers to not sell food contact substances containing certain PFAS intended for use as grease-proofing agents in the U.S. More information can be found here.
FDA Updates Ingredient Directory for Dietary Supplements February 21: FDA updated its Dietary Supplement Ingredient Directory, a webpage where the public can look up ingredients used in products marketed as dietary supplements to find what the FDA has said about that ingredient and whether the agency has taken any action regarding the ingredient. The updated Dietary Supplement Ingredient Directory can be found here.
FDA Warning Letters
Imported Food: FDA issued a warning letter to Indian Groceries and Spices, Inc. of Chicago, IL for failure to develop, maintain and follow a Foreign Supplier Verification Program (FSVP) for imported spices.
Dietary Supplements: FDA issued a warning letter to Pacific BioLogic Co. alleging that its products are misbranded and unapproved new drugs and they violate Current Good Manufacturing Practice (CGMP) regulations related to adulterated dietary supplements.
Misbranded Hot Dog Buns: FDA issued a warning letter to Aunt Millie’s Bakeries alleging that its hot dog buns are misbranded because the label did not declare that it contains sesame which is a major food allergen.
Adulterated Food: FDA issued a warning letter to Lucky L.T. Co., Inc. alleging that its noodle products were prepared, packed, or held under insanitary conditions.
Adulterated Animal Feed: Pursuant to a complaint involving the death of cattle from consuming non-medicated animal feed, FDA inspected and issued a warning letter to Progressive Nutrition after finding that its product contained excessive levels of non-protein nitrogen.
FSIS Releases 2023 Foodborne Illness Outbreak Investigations Report February 23: The U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) released a summary of outbreaks investigated during FY 2023. This report summarizes outbreaks investigated by FSIS during FY 2023 and includes information on pathogens, implicated sources, illnesses, and lessons learned from outbreak investigation after-action reviews. More information about outbreaks investigated by FSIS, previous annual summary reports and resources can be found on the FSIS website.
Other Articles of Interest
Wisconsin Launches Online System for Identifying Foodborne Illness Outbreaks February 2: The Wisconsin Department of Health launched a system to help people report foodborne illnesses to identify outbreaks more quickly. Through an online survey, the system allows people who suspect their illness might be from eating or drinking something contaminated to report symptoms, recent food items eaten, and places visited before becoming sick. The online survey can help officials identify a source of contamination and learn more about water and food-related illnesses. More information can be found here.
USDA Strengthening Organic Enforcement Rule to go into Effect February 20: The USDA Strengthening Organic Enforcement (SOE) Rule goes into effect on March 19, 2024. The rule is meant to fortify the integrity of USDA organic products. Businesses across the supply chain, including manufacturers and retailers, must adjust their procedures and practices to comply with the updated rule. The SOE Rule calls for more rigorous certification practices for various types of businesses, such as importers, exporters, brokers, traders, and storage facilities. Businesses that aggregate, cull, package, repackage, or store USDA organic products must now obtain certified organic status. The certification process involves completing an application, submitting documentation, an on-site inspection, and technical review. The SOE Rule also calls for a mandatory electronic National Organic Program (NOP) Import Certificate for any organic product entering the US. Businesses must create or update an Organic Systems Plan (OSP) to comply with the rule. More information can be found here.
Family Dollar to Pay Millions of Dollars for Rodent Infestation February 27: Family Dollar Stores LLC was fined $41.675 million for holding food, drugs, medical devices, and cosmetics under unsanitary conditions related to a rodent infestation in the largest ever monetary criminal penalty in a food safety case. The plea agreement requires Family Dollar and Dollar Tree to meet corporate compliance and reporting requirements for three years. The rodent infestation was first reported in August 2020, and by January 2021, the company was aware that the unsanitary conditions violated the Federal Food, Drug, and Cosmetic Act. The company continued to ship products from the warehouse until January 2022, when an FDA inspection revealed the extent of the infestation. More information can be found here.
This Regulatory Update covers information from February 2024. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.
This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including regulations related to color additives, undetected nanoplastics found in bottled water, proposed changes to the federal hemp policy, and more.
FDA Updates
FDA Invites Comments on Petitions Seeking to Amend Food and Color Additive Regulations January 11: FDA has filed a food additive petition and a color additive petition, submitted by Environmental Defense Fund, et al., on December 21, 2023, proposing that food and color additive regulations be amended to remove four specified solvents – Benzene, Ethylene Dichloride, Methylene Chloride, and Trichloroethylene. The Petitioners claim that these substances have been found to induce cancer in humans or animals and are not safe pursuant to the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. Comments must be submitted by March 11, 2024. More information about the color additive petition can be found here and more information about the food additive petition can be found here.
FDA Seeks Applications for Kratom HAP Study January 16: The FDA announced a grant opportunity for applications to support the development, implementation, and evaluation of a human abuse potential (HAP) study on the use of botanical kratom. Addressing the use of botanical Kratom is a priority as the FDA works to characterize its abuse potential and subjective effects, given the absence of published literature and clinical evaluations despite increased human use. This HAP study will generate important findings related to the safety of kratom that will help researchers, scientists, and individuals using or considering the use of kratom. The deadline for submitting applications is March 18, 2024. More information can be found here.
FDA Considers Change of Final Guidance Comment Period; Issues Draft Report on Best Practices for Guidance January 5: The FDA is seeking comments on whether to issue more guidance as final for immediate implementation without first undergoing a formal notice and comment period. The FDA announced the availability of a draft report entitled “Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance.” This draft report responds to the Consolidated Appropriations Act of 2023, which directed FDA to update its 2011 guide on best guidance practices and issue a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents, as well as a plan for implementing such best practices. Written comments on the draft report and plan must be submitted by March 4, 2024. More information can be found here and here.
Revised Draft Guidance Published on Hazard Analysis and Preventive Controls for Human Food January 30: The FDA announced the availability of a revised draft guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry”. This guidance, when finalized, will explain FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under the rule entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” The FDA revised the draft Introduction and draft Appendix 1 “Known or Reasonably Foreseeable Hazards” to address comments submitted on drafts that were made available in 2016. Comments on the draft Guidance will be accepted until June 3, 2024. More information can be found here.
Amended Color Additive Regulations for Jagua Blue Go into Effect January 23: The FDA amended the color additive regulations to provide for the safe use of jagua (genipin-glycine) blue as a color additive in various food categories at levels consistent with good manufacturing practice. The final rule went into effect on December 4, 2023. More information can be found here.
FSIS Highlights Key Achievements in 2023 February 2: The U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) released its key accomplishments for 2023 that protected public health through food safety. Among the accomplishments are meeting consumer expectations on labeling claims, strengthening the food supply chain, raising consumer awareness of food safety, and developing a new strategy to target salmonella in poultry. FSIS continues to modernize inspection systems and operations to enhance efficiencies without compromising food safety. More information can be found here.
Other Articles of Interest
FDA CORE Network Releases Annual Report on Foodborne Outbreaks January 8: The FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network released its first annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated human foods for the 2022 calendar year. In 2022, CORE evaluated 65 incidents of foodborne outbreaks, responded to 28 incidents, and issued advisories for 11 incidents. The 2022 numbers were up slightly from 2021. More information can be found here.
California Widens the Gap between State and Federal Food Regulations January 12: California Governor Newsome signed House Bill 418 into law in October 2023, Potassium Bromate, Propylparaben, and Red Dye No. 3. The bill has met resistance from federal regulators and industry trade groups. Manufacturers and industry trade associations are concerned that the law moves food regulations in the U.S. further away from a uniform regulatory framework under the FDA, and toward a fragmented model of contrasting state regulations. States are taking an increasingly active role in food safety regulations ahead of federal regulators, as seen by not only with the passage of HB 418, but also with state regulation of PFAS substances in food. More information can be found here.
Undetected Nanoplastics Found in Bottled Water January 19: A peer-reviewed study, published in the journal Proceedings of the National Academy of Sciences, is the first to evaluate bottled water for the presence of “nanoplastics” — plastic particles under 1 micrometer in length, or one-seventieth the width of a human hair. The findings show that bottled water could contain up to 100 times more plastic particles than previously estimated. Earlier studies only accounted for microplastics, or pieces between 1 and 5,000 micrometers. According to the study, a one-liter bottle of water contains about 240,000 plastic fragments on average and many of those fragments have historically gone undetected, suggesting that health concerns linked to plastic pollution may be underestimated. Nanoplastics pose a greater risk to human health than microplastics because they are small enough to penetrate human cells. The study’s co-authors invented a new microscopy technique to identify individual nanoparticles. They found 110,000 to 370,000 tiny plastic particles in each liter and 90% of them were nanoplastics. The International Bottled Water Association released a statement saying that the study’s methodology needs to be fully reviewed by the scientific community and that there is no scientific consensus on the potential health impacts of nanoplastic and microplastic particles.
California Proposes Changes for Chemical Warnings January 11: California may soon change the requirements for warning consumers about chemicals that may cause cancer or reproductive harm. The California Office of Environmental Health Hazard Assessment (OEHHA) held a quasi-legislative hearing on proposed rulemaking to amend the Proposition 65 short-form warning requirements. Proposition 65 requires businesses with 10 or more employees to provide a “clear and reasonable” warning before exposing individuals in California to any listed chemical that may cause cancer or reproductive harm. Companies can currently comply with Proposition 65 by warning of the potential harm without identifying a specific chemical. The proposed changes would require the listing of at least one Proposition 65 chemical for each exposure pathway. Compliance costs for the proposed regulatory changes would be significant. If OEHHA adopts the new regulatory changes, companies will have a two-year compliance period which raised concerns about insufficient time to implement compliance measures. More information can be found here.
HHS Recommends Lower Scheduling Tier for Marijuana January 12: In response to President Biden’s order to federal officials to reevaluate marijuana’s legal status, the U.S. Department of Health and Human Services (HHS) conducted a review of marijuana’s potential medical uses and public health risks. HHS concluded that marijuana has a currently accepted medical use and recommended that it be moved from Schedule I to Schedule III under the Controlled Substances Act. HHS submitted its findings and recommendations to the U.S. Drug Enforcement Administration (DEA) who will have the final say. DEA will have to consider several factors including the potential for abuse, public health risks, psychic or physiological dependence liability, and whether the U.S. can move cannabis to a lower scheduling tier and still meet international treaty obligations.
Hemp Industry Proposes Changes to Federal Hemp Policy January 3: A coalition of hemp industry organizations unveiled proposed changes to federal hemp policy they say would improve consumer safety and mitigate some of the burdensome regulations that have been in place since Congress legalized hemp in 2018. The proposal comes after Congress extended the lifespan of the 2018 Farm Bill by one year, leaving in place several policies that industry stakeholders seek to change. Among the policies supported by the coalition are bills H.R. 1629 and S. 2451 that would direct the FDA to regulate consumable products that include CBD under the Federal Food, Drug and Cosmetic Act. The group is calling on Congress to develop a framework to preempt state laws that criminalize hemp products. They also want Congress to mandate that hemp plants be deemed compliant if they contain no more than 1% total THC. The group also proposed reducing the role law enforcement plays in hemp regulations and remanent removal of a USDA rule requiring hemp processors and growers test their products at a laboratory with DEA certification.
New FDA Website for Foods Program Regulations January 26: The FDA announced a new website listing regulations it plans to publish by October 2024 and longer-term regulations it is prioritizing for publication at a later date. The FDA also updated the list of guidance topics that it is considering and expects to publish by the end of 2024. More information can be found here.
FDA Regulatory Trends for 2024 February 2: The FDA is likely to pay more attention to chemical risks, allergen thresholds and enforcement of the Food Safety Modernization Act in 2024. More information can be found here.
Raw Milk Bill Proposed in Wisconsin January 5: Senate Bill 781 was introduced in the Wisconsin legislature to reform the regulation of raw milk in the state. The bill was assigned to the Senate Committee on Agriculture and Tourism. SB 781 allows a milk producer to receive a license from DATCP to sell unpasteurized dairy products that are processed on the farm premises to consumers through delivery, at retail stores, or directly from a dairy farm. Under the bill, a milk producer who has a license to sell unpasteurized dairy products is not required to obtain a milk producer license, a grade A permit, or a butter maker or cheesemaker license if the milk producer does not send any milk to a dairy plant and sells only unpasteurized dairy products processed on farm premises. To receive a license to sell unpasteurized dairy products, a milk producer must test for several bacteria and coliform and standard plate counts, provide results from tests performed by a licensed veterinarian that show that the cows used to produce the unpasteurized dairy products do not have tuberculosis or brucellosis, and show proof of training in raw milk safety. In addition, DATCP must conduct an on-site inspection of the milk producer’s processing plant. More information can be found here.
Wisconsin Launches Online System for Identifying Foodborne Illness Outbreaks February 2: The Wisconsin Department of Health launched a system to help people report foodborne illnesses to identify outbreaks more quickly. Through an online survey, the system allows people who suspect their illness might be from eating or drinking something contaminated to report symptoms, recent food items eaten, and places visited before becoming sick. The online survey can help officials identify a source of contamination and learn more about water and food-related illnesses. More information can be found here.
FDA Withdraws Guidance on Enforcement Approach to Human Food with Chlorpyrifos Residues February 5: The FDA is withdrawing a 2022 guidance document entitled “Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues: Guidance for Industry”, following a decision by the 8th Circuit Court of Appeals to vacate an EPA final rule that revoked all tolerances for the pesticide chemical chlorpyrifos. The guidance was intended to explain FDA’s enforcement policy for foods containing chlorpyrifos residues after the tolerances expired pursuant to the EPA final rule, which is now void. More information can be found here.
Illinois Seeks to Ban Certain Food Additives in Candy and Soda January 31: SB 2637 was introduced in the Illinois State Senate that would ban food additives brominated vegetable oil, potassium bromate, Propylparaben, and red dye no. 3 in candy, soda and other foods produced or sold in Illinois. These are the same chemicals recently banned in California. It is unclear at this time whether the legislation would pass the General Assembly. If passed, the bill would go into effect on January 1, 2027. Violators could face a penalty of $5,000 to $10,000 per violation. More information can be found here.
Lawsuits
Health-Ade Sued Over Alleged PFAS in Kombucha January 11: A proposed class action lawsuit was filed in the US District Court for the Southern District of New York (Case No. 7:24-cv-00173) alleging that Health-Ade LLC deceptively markets kombucha as “health” products despite the presence of PFAS chemicals in its kombucha. The plaintiff alleges that testing by an independent laboratory revealed PFAS substances in Kombucha Ginger Pineapple Belly Reset and four other Health-Ade kombucha products.
Mondelez Faces Lawsuit Over Sustainability Labels January 30: The maker of Oreo cookies and one of the world’s largest snack and chocolate companies, Mondelez International Inc., has been accused of allegedly misleading consumers about its products being environmentally and socially responsible. A consumer filed a proposed class action lawsuit the U.S. District Court for the Northern District of California against Mondelez claiming that the company “blatantly greenwashes its products in order to increase its own sales and deceptively earn the goodwill and support of the public”. According to the complaint, Mondelez’s labels state its cocoa is 100% sustainable, certified, or supports farmers but the company allegedly pays low wages to cocoa farmers resulting in child and slave labor. The chocolate industry also contributes to deforestation in the Ivory Coast. More information can be found here.
Crystal Light “No Artificial Flavors” Label Lawsuit Dismissed January 29: A proposed class action brought by a consumer of Crystal Light, alleging Kraft Heinz Co. deceptively conceals artificial flavors in its drink mixes, has ended after the parties filed a joint stipulation for its dismissal. The plaintiff had alleged that di-malic acid acts as a flavor in the drink mixes and that the “no artificial flavors” label statements could deceive consumers. Kraft argued that the substance is a flavor enhancer and disclosure is not required.
Dancer Dies from Allergic Reaction After Eating Mislabeled Cookies January 25: A professional dancer with a peanut allergy, died when she suffered a severe allergic reaction to a Vanilla Florentine cookie from Stew Leonard’s, a grocery store chain in Connecticut. According to attorneys for the dancer’s family, the allergic reaction was so severe that an EpiPen was not effective. The cookie’s label did not disclose that the cookie contained peanuts. The grocery store chain CEO stated that the store was not informed by the cookie manufacturer that the ingredients were changed to include peanuts. The bakery that produced the cookies said it updated the grocery store chain last summer. Legal action is expected to be brought on behalf of the dancer’s estate. More information can be found here.
Mott’s Hit with Lawsuit Over Citric Acid in Bloody Mary Mix January 23: A proposed class action was filed in the U.S. District Court for the Southern District of California alleging that Mott’s LLP falsely labels its Mr. & Mrs. T Bloody Mary Mix as containing no preservatives, despite containing the additive citric acid. The lawsuit contends the product’s label claim is misleading because citric acid is a preservative regardless of whether it is added for a separate purpose. More information can be found here.
This Regulatory Update covers information from January 2024. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.
This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including draft guidance on menu labeling, PFAS found in food processing wastewater, a sustainability lawsuit for seafood, and more.
FDA Updates
FDA’s Revocation of Partially Hydrogenated Oils in Foods Goes into Effect December 14: On August 9, 2023, the FDA published a direct final rule amending regulations to no longer provide for the use of partially hydrogenated oils (PHOs) in food, due to the FDA’s conclusion that PHOs are no longer generally recognized as safe (GRAS). The rule also revokes prior sanctions for the use of PHOs in margarine, shortening, and bread, rolls, and buns. This rule went into effect on December 22, 2023. More information can be found here.
FDA Issues Draft Guidance on Menu Labeling December 14: The FDA announced the availability of a draft guidance for industry entitled “Menu Labeling: Supplemental Guidance for Industry (Edition 2).” The draft guidance, when finalized, will update existing guidelines to address the voluntary declaration of added sugars and the voluntary declaration of nutrition information for menus on third-party platforms. Comments on the draft Guidance will be accepted until February 12, 2024. More information can be found here.
FDA Information Collection Activities Announced for Food Allergen Labeling and Reporting December 8: FDA is inviting comments on food allergen labeling and reporting. This information collection solicits comments associated with statutory provisions applicable to ingredients derived from major food allergens. The respondents to this collection of information are manufacturers and packers of packaged foods sold in the U.S. subject to the labeling requirements and prohibitions found in section 403 of the Federal Food, Drug, and Cosmetic Act. Written comments on the collection of information are due by February 6, 2024. More information, and instructions on how to submit comments, can be found here.
FDA Opens Voluntary Qualified Importer Program Application Portal for FY2025 December 15: The FDA announced it will open the Voluntary Qualified Importer Program (VQIP) application portal for fiscal year (FY) 2025. VQIP is a voluntary fee-based program that provides importers, who achieve and maintain control over the safety and security of their supply chains, the benefits of expedited review and importation of human and animal foods into the U.S. To participate in VQIP, food importers must meet certain eligibility requirements, including ensuring that the facilities of their foreign suppliers are certified through the FDA’s Accredited Third-Party Certification Program. The portal will remain open through May 31, 2024. More information can be found here.
FDA Warning Letters
CBD & THC: The FDA issued a warning letter to a company in Colorado for concern that consumers may confuse their products with traditional foods, increasing the risk of unintended consumption of cannabidiol (CBD) and Delta-8 Tetrahydrocannabinol (Delta-8 THC). The FDA’s review determined that the company’s “Active CBD Oil Infused Coffee,” “Active CBD Oil Gummies,” “CBD Living Water,” and “Strain Snobs™ Delta-8 Plant-Based Gummies” products offered for sale on the company’s webpages are adulterated because they contain an unsafe food additive.
USDA Proposes Exemptions for Classifying Genetically Modified Plants December 27: The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) reopened the comment period on a proposal to add five additional exemptions to plant modifications that could be achieved through conventional breeding. According to APHIS, these types of genetic modification would be exempt from regulations concerning the movement of organisms modified or produced through genetic engineering and would reduce the regulatory burden for developers of certain plants modified using genetic engineering that are not expected to pose plant pest risks greater than the plant pest risks posed by plants modified by conventional breeding methods. The comment period runs until January 19, 2024. More information can be found here.
Other Articles of Interest
Update on FDA Reorganization Proposal December 13: As previously reported, FDA announced it would develop a proposal for a unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model. These proposed changes will strengthen the agency’s ability to oversee and protect the human food supply and other products it regulates. The proposed reorganization and modernization package includes:
Making the FDA’s HFP and product Centers solely responsible for receipt, triage and closing consumer and whistleblower complaints.
Renaming ORA as the Office of Inspections and Investigations (OII).
Establishing an Office of the Chief Medical Officer (OCMO) in the Office of the Commissioner to strengthen central coordination of cross-agency medical issues.
Merging the Office of Counterterrorism and Emerging Threats (OCET) and the Office of Regulatory Science and Innovation (ORSI) to form a new office proposed as the Office of Regulatory and Emerging Science that will strengthen support of regulatory science and preparedness research efforts.
Creating an Office of Enterprise Transformation.
The FDA completed the proposed reorganization package in December 2023, and it is currently under external review. The FDA hopes implementation will occur sometime in 2024. More information can be found here.
Agencies Propose Draft National Strategy to Reduce Food Loss and Waste December 4: The FDA, USDA and EPA collaboratively released a draft national strategy that aims to reach the national goal of reducing food loss and waste in the U.S. by 50% by 2030. The draft National Strategy for Reducing Food Loss and Waste and Recycling Organics identifies opportunities to reduce food loss and waste across the entire supply chain. The public is invited to comment on the proposed national strategy. EPA extended the original public comment period to February 3, 2024. Comments can be submitted through Regulations.gov, Docket ID No. EPA-HQ-OLEM-2022-0415. More information can be found here.
FDA Responds to Petition on Nutritional Labeling of D-tagatose December 14: The FDA issued a supplemental response to the citizen petition dated April 18, 2018, from Bonumose, Inc., regarding the percent Daily Value (%DV) declaration for added sugars for products containing D-tagatose. The FDA concluded that it is premature to finalize an overarching strategy for presenting %DV on the Nutrition Facts label for all sugars metabolized differently than traditional sugars. Many of these sugars are in the early stages of development, and FDA currently has limited information regarding the range or uniformity of the caloric values for other sugars that are metabolized differently than traditional sugar. More information can be found here.
Appeals Court Gives Nestle Glucose Control Drink False Advertising Suit a Boost December 13: A federal appeals court ruled that Nestle consumers can pursue claims that the company deceptively markets Boost Glucose Control drinks as capable to control and manage blood sugar levels. The class action suit, Horti v. Nestle Healthcare Nutrition, Inc., No. 22-16832 (9th Cir.), challenged the “Glucose Control” product name and label statements “helps manage blood sugar” and “Designed for people with diabetes.” The court said the plaintiffs sufficiently alleged that the labels and placement alongside diabetes products are likely to make consumers think Boost drinks will have a positive effect on diabetes and blood sugar level. The Court’s unpublished opinion can be found here.
PFAS and Other Contaminants Found in Food Processing Wastewater December 12: U.S. Geological Survey research revealed contaminants, including per- and polyfluoroalkyl substances (PFAS) were found in food process wastewater, raising concerns about environmental impacts. The research highlights the importance of continuous monitoring and the need for more comprehensive studies to fully understand the scale and impact of contaminants like PFAS coming from food processing facilities. More information about the study can be found here.
FDA Faces Growing Pressure to Ban Red Dye from Foods and Beverages December 7: FDA is facing growing pressure to take action against red dye in foods and beverages. Activists say red dye in foods and beverages may cause cancer and other health problems, including hyperactivity and restlessness in children. The Center for Science in the Public Interest, a non-governmental advocacy group, recently sent out a letter urging people to sign a petition to ban red dye in food, dietary supplements and medications. More information can be found here.
Kratom Industry Calls on FDA to Crack Down on Bad Actors December 28: The American Kratom Association (AKA) is calling on the FDA to properly regulate Kratom products. The regulatory status of kratom in the U.S. is currently uncertain because of the absence of laws and regulations covering its marketing and sale. However, products prepared from kratom leaves, such dietary supplements and food additives, are available in the U.S. through the Internet and at brick-and-mortar stores. Kratom has been historically used to lessen the severity of pain, coughing, anxiety and depression, opioid use disorder, and opioid withdrawal. According to the AKA, the FDA’s lack of regulation of kratom is putting consumers at risk. The AKA is concerned about the lack of prosecution by the FDA of vendors who market kratom products with illegal therapeutic claims, and the increased marketing of super-concentrated kratom products that do not provide adequate labeling for consumers. Currently the Kratom Consumer Protection Act or KCPA is pending before the U.S. Congress and the states, and is intended to resolve this issue of false labeling claims and unsafe products. More information can be foundhere.
New PFAS and Food Packaging Laws Go into Effect in Colorado December 28: On January 2024, new laws aimed at clean air, reducing water pollution , and trash, and protecting consumers went into effect in Colorado. House Bill 22-1345, passed in 2022, bans PFAS in eight product categories including food packaging by January 1, 2024. The bill also requires the state to purchase only PFAS-free products and requires companies to disclose on cookware product labels if it contains PFAS. A ban on single-use plastic bags, polystyrene cups and to-go containers enacted by HB21-1162 also goes into effect on January 1st, as well as new label standards to help consumers identify what is compostable.
Minnesota’s Ban on PFAS Chemicals in Food Packaging Begins January 1, 2024 December 14: A ban in Minnesota on PFAS chemicals in food and beverage packages goes into effect on January 1, 2024. According to the Minnesota Pollution Control Agency, Minnesota’s law is far-reaching, allowing no exemptions, no minimum limit for PFAS and no cap to potential fines. The law applies to containers used by restaurants and food service operators as well as packaged food and beverages sold at retail stores. More information can be found here.
WanaBana Faces Lawsuit Over Lead in Applesauce Pouches December 22: A consumer has filed a proposed class action lawsuit in the U.S. District Court for the Southern District of New York against WanaBana following the recall of the company’s cinnamon-flavored applesauce pouches containing high levels of lead. WanaBana also faces a proposed class suit by a North Carolina family that alleges their child was found to have significantly elevated blood lead levels. More information can be found here and here.
Red Lobster Sustainability Deception Lawsuit Advances December 20: A proposed class action lawsuit was filed against restaurant chain Red Lobster in U.S. District Court for the Central District of California alleging that it deceives customers into believing some of its seafood products are sustainable when they may be sourced from fisheries that use environmentally harmful practices. The suit challenges Red Lobster’s marketing claims, including menu statements, that its products are “seafood with standards”, “sustainable” and “sourced to the highest standards.” The Court denied Red Lobster’s motion to dismiss and ruled that the plaintiff’s evidence was sufficient for the lawsuit to proceed. More information can be found here.
This Regulatory Update covers information from December 2023. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.
This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including a proposed ban of brominated vegetable oil, new draft guidance on allergens and acidified foods, a raw milk bacteria outbreak, and more.
FDA Updates
Listing of Jagua Blue Color Additive Exempt from Certification – Final Rule November 3: FDA is amending the color additive regulations to provide for the safe use of jagua (genipin-glycine) blue as a color additive in various food categories at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) submitted by Exponent, Inc. on behalf of Ecoflora SAS (Ecoflora). The final rule is effective December 4, 2023. Objections and requests for a hearing on the final rule must be submitted by December 4, 2023. More information can be found here.
FDA Proposes to Ban Brominated Vegetable Oil in Food November 2: The FDA proposed to ban brominated vegetable oil (BVO) previously used in soft drinks. BVO was authorized for use in small amounts. However, after further study, FDA concluded that BVO use in no longer safe due to potential adverse health effects linked to thyroid, heart and liver issues. The proposed rule would revoke the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. Written comments on the proposed rule must be submitted by January 17, 2024. More information can be found here. The proposed rule and information on how to submit comments can be found here.
FDA Files Food Additive Petition from Kerry Ingredients and Flavours Ltd October 13: The FDA filed a petition submitted by Kerry Ingredients and Flavours Ltd. (“Kerry”) proposing that food additive regulations be amended to provide for the safe use of vitamin D3 as a nutrient supplement in powdered drink mixes added to water or carbonated water, excluding drinks or drink mixes that are specially formulated or processed for infants. Kerry submitted the petition on April 26, 2023. More information can be found here.
FDA Information Collection Activities Announced for Recall Regulations October 13: FDA is inviting comments on FDA Recall Regulations pertaining to the following topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA’s functions; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents. Written comments on the collection of information are due by December 12, 2023. More information can be found here.
FDA Information Collection Activities Announced for Food Canning Establishment Regulations October 12: FDA is inviting comments on registration of food processing establishments, filing of process or other data, and maintenance of processing and production records for acidified foods and thermally processed low-acid foods in hermetically sealed containers. The respondents to this information collection are commercial processors and packers of acidified foods and thermally processed low-acid foods in hermetically sealed containers. Written comments on the collection of information are due by November 13, 2023. More information can be found here.
FDA Released New Draft Guidance on Food Allergens and Acidified Foods October 3: As previously reported, FDA announced the availability of two additional draft chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, designed to help food facilities comply with the preventive controls for human food rule mandated by the FDA Food Safety Modernization Act, which could result in safer food options for people with allergies to sesame and other food allergens. The new draft chapters are Chapter 11—Food Allergen Program and Chapter 16—Acidified Foods. Chapter 11 outlines ways to ensure protection from major food allergen cross-contact and to ensure that the finished food is properly labeled with respect to the major food allergens. Chapter 11 also provides examples of ways manufacturers can significantly minimize or prevent allergen cross-contact and undeclared allergens using current good manufacturing practices. Chapter 16 applies to manufacturers of acidified foods (such as beans, cucumbers or cabbage that have an overall pH of 4.6 or below) and it explains how these manufacturers can use procedures, practices and processes that they have established to meet requirements in the acidified foods regulations. Comments on the draft guidance must be submitted by March 25, 2024. More information, as well as the draft guidance and information for submitting comments, can be found here.
FDA Updates Food Traceability FAQ October 2: The FDA has updated its Food Traceability FAQ to provide additional information about the FDA’s Product Tracing System and explain how the agency intends to conduct initial inspections beginning in 2027. The Food Traceability Final Rule was published in November 2022, establishing traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods included on the Food Traceability List. The FDA is developing additional resources and offering technical assistance to help stakeholders come into compliance. The FDA also established a compliance date of January 20, 2026 to allow those subject to the rule time to come into compliance.
FDA Warning Letters
Unapproved New Drugs: FDA issued a warning letter to Day Light Nutrition alleging that its Above the Weather, Diabetic Support Blend, Joint Well, and ViruZap products are misbranded and unapproved new drugs because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.
FSIS Examining “Raised Without Antibiotics” Marketing Claim October 9:The U.S. Food Safety Inspection Service (FSIS) and the Agricultural Research Service (ARS) are commencing a new exploratory sampling program to assess whether antibiotics residues are detected in cattle intended for the “raised without antibiotics” market. This sampling program is part of the USDA’s multi-step effort aimed at strengthening the verification of animal-raising claims. More information can be found here.
Other Articles of Interest
FDA Developing Front-of-Package Labeling System October 17: The FDA published the “Catching Up with Califf”: “Advancing Nutrition, Healthy Food Options and Front-of-Package Labeling,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. The FDA continues to work to develop a front-of-package labeling system to quickly communicate and provide certain nutrition information to consumers which “has the potential to be one of the most momentous changes to food labeling since the Nutrition Facts label.” The FDA is currently conducting consumer research to understand responses to various elements of a front-of-package labeling system. The results of this research will be used by the FDA to consider approaches to take as part of a proposed rule for public comment. On November 16, 2023, the Reagan-Udall Foundation for the FDA will host a virtual public meeting to hear directly from stakeholders. More information on the session is available on the Foundation’s web site and interested parties should register to attend. More information about front-of-package nutrition labeling can be found here.
California’s Red Dye No. 3 Food Coloring Ban Puts Pressure on FDA to get off the Sidelines October 17: There is new pressure on the FDA to take action on the synthetic food coloring, red No. 3, after California became the first state to pass a law to ban it. While public health advocates are pressuring FDA to remove red dye from the food supply nationwide, manufacturers are pushing back. According to a letter from the National Confectioners Association (“NCA”) to FDA, the California ban would create a patchwork of state requirements that could increase food costs and create confusion among consumers. Confectioners are faced with a lack of federal expertise and authority needed to dispel myths and confusion, and correct misinformation about the food ingredients and additives. NCA says “it’s time for the FDA to get off the sidelines and clear up this misinformation because California is out of its depth regarding national food safety standards and regulatory processes. That expertise and authority rests with the FDA alone.” According to an FDA spokesperson, the FDA is reviewing a petition from consumer advocacy groups to halt the use of red No. 3 in foods and will assess whether there is “sufficient data” to revoke its use. More information can be found here and here.
Raw Milk Leads to Bacteria Outbreak in Wyoming and Utah October 12: In September, one adult and four children became ill after drinking raw, unpasteurized milk in Wyoming. The patients were infected with campylobacter and E. Coli bacteria. State investigators traced the Wyoming illnesses to consuming raw milk or raw milk products but did not identify the specific seller. Meanwhile, public health official in Salt Lake County, Utah, are investigating an outbreak associated with raw, unpasteurized milk. The Salt Lake County Health Department confirmed 14 people with infections from campylobacter and all but two of the patients reported drinking raw milk before becoming sick. The source of the Utah raw milk has not been determined.
This Regulatory Update covers information from October 2023. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.
This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including information collection activities for food and color additives, the new FSIS recall API data tool, and more.
FDA Updates
FDA Issues Advisory for Listeria Outbreak in Ice Cream September 1: As previously discussed, FDA is investigating an outbreak of Listeria monocytogenes infection linked to Soft Serve On the Go ice cream cups produced by Real Kosher Ice Cream of Brooklyn, NY. Real Kosher Ice Cream and Ice Cream House of Brooklyn, NY, has voluntarily recalled all dairy and non-dairy products bearing the Ice Cream House logo that were manufactured in the Brooklyn, NY, facility. FDA is advising consumers, restaurants and retailers not to eat, sell, or serve recalled Soft Serve on the Go cups and Ice Cream House products. More information can be found here.
FDA Sponsors Workshops on the Use of Meta-Analysis in Nutrition Research and Policy September 13: FDA is sponsoring a series of three workshops to be hosted by the National Academies’ Food and Nutrition Board to discuss the usefulness of meta-analysis as a tool for nutrition research and developing nutrition policy. The expert input and recommendations from the workshop will be helpful to FDA as it develops and implements evidence-based policies and regulations related to food labeling and labeling claims. The workshops will be held on Tuesday, September 19; Monday, September 25; and Tuesday, October 3, 2023. More information can be found here.
New FDA Animal and Veterinary Innovation Agenda Released September 15: FDA announced that it is taking new steps to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products. The Animal and Veterinary Innovation Agenda released by FDA lists four objectives and details the supporting actions by the agency’s Center for Veterinary Medicine to foster product development and implement risk-based approaches to regulating modern animal and veterinary products. The new agenda applies to products like novel food ingredients that work solely in the animal’s gut to increase nutritional efficiency and production; animal biotechnology products such as animal cell- and tissue-based products and intentional genomic alterations in animals; and cell-cultured animal food ingredients. More information can be found here.
FDA Information Collection Activities Announced for Food and Color Additives September 21: FDA announced a proposed collection of information for the submission of petitions concerning food additive and color additive, including labeling. Respondents are businesses engaged in the manufacture or sale of food, food ingredients, color additives, or substances used in materials that come into contact with food. Written comments (including recommendations) on the collection of information are due by October 23, 2023. More information can be found here.
FDA Amends Yogurt Company’s Temporary Marketing Permit September 25: FDA is amending Chobani, LLC’s temporary permit to market test lower-fat yogurt products. The temporary permit is amended to allow the use of the test product as an ingredient in other non-standardized food applications including beverages, dips, and sauces. This amendment will allow the applicant to continue to test market the test product and collect data on consumer acceptance of the test product. More information can be found here.
FDA Releases New Chapters to Draft Guidance Hazard Analysis and Risk-Based Preventative Controls for Human Food September 27: FDA announced the availability of two additional draft chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, designed to help food facilities comply with the preventive controls for human food rule mandated by the FDA Food Safety Modernization Act, which could result in safer food options for people with allergies to sesame and other food allergens. The new draft chapters are Chapter 11—Food Allergen Program and Chapter 16—Acidified Foods. Chapter 11 outlines ways to ensure protection from major food allergen cross-contact and to ensure that the finished food is properly labeled with respect to the major food allergens. Chapter 11 also provides examples of ways manufacturers can significantly minimize or prevent allergen cross-contact and undeclared allergens using current good manufacturing practices. Chapter 16 applies to manufacturers of acidified foods (such as beans, cucumbers, or cabbage that have an overall pH of 4.6 or below). It explains how these manufacturers can use procedures, practices, and processes that they have established to meet requirements in the acidified foods regulations.
Comments on the draft guidance must be submitted by March 25, 2024. More information, as well as the draft guidance and information for submitting comments, can be found here.
FDA Releases Video on Importing Safe and Compliant Food into the U.S. September 29: The FDA released a video titled “Importing FDA-Regulated Products: Human Foods” that provides basic information for importers, foreign suppliers/exporters, and customs brokers on the steps they need to take to successfully import safe and compliant food into the U.S.
FDA Warning Letters
Unapproved New Drugs: FDA issued a warning letter to a Colorado company alleging that its Osmosis skin elixir products are misbranded and unapproved new drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Baby Food: FDA inspected a ready-to-eat baby food product manufacturing facility in California following a consumer complaint involving infant botulism. During the inspection, FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule) and issued a warning letter to the company.
FSIS Launches New Recall and Public Health Alert API Data Tool September 12: FSIS launched a new feature on its website that enables software developers to access data on recalls and public health alerts through an application programming interface (API) increasing the transparency and availability of critical public health information. More information about the FSIS recall API can be found here.
FSIS Implements Modernized Chemical Residue Quantitative Method September 15: The USDA Food Safety and Inspection Service (FSIS) developed an innovative method for beef muscle samples that uses modern chemistry instrumentation for quantifying chemical residues. The new quantitative method for veterinary drug residue analysis in bovine muscle samples, entitled “Quantitation of Animal Drug Residues by High-Resolution, Accurate-Mass Liquid Chromatography Mass Spectrometry (HRAM LC-MS)” (CLG-MRQ1), will be implemented on October 1, 2023 and include the ability to:
Quantitate multiple veterinary drug residue amounts simultaneously in a single analysis with high mass accuracy.
Quantitate several veterinary drugs that were previously difficult to measure.
Archive several single analyte or specific drug class quantitation methods that use older technology.
Archive traditional residue bioassay for several analytes.
Align detection limits with established drug residue tolerances.
Decrease time to result for presumptive positive residues.
FSIS also updated three methods to the new Chemical Laboratory Guidebook format: Quantitation of Salt (CLG-SLT); Quantitation of Fat (CLG-FAT); and Screening, Quantitation, and Confirmation of Beta-Agonists by UHPLC-MS-MS (CLG-AGON1). These new and updated methods can be found on the Chemical Laboratory Guidebook page of the FSIS website.
FSIS Revised Directive – Food Defense Tasks and Threat Notification Response Procedures for the Office of Field Operations September 26: FSIS issued a revised directive that provides instructions to conduct food defense activities assigned to inspection program personnel at meat and poultry establishments, Siluriformes fish and fish product establishments, egg product plants, and import inspection establishments. Food defense activities include performing food defense tasks and observing and reporting food defense vulnerabilities. This directive also outlines the internal FSIS communication protocol for addressing threats to the food and agriculture sector. More information can be found here.
FSIS Microbiological Sampling of Egg Substitutes, Freeze-Dried, and Agglomerated Egg Products September 29: FSIS issued a notice that provides instructions to inspection program personnel for the sampling of egg substitutes, freeze-dried, and agglomerated egg products. Egg substitutes, freeze-dried, and agglomerated egg products will be eligible for sampling under the current routine sampling programs starting on November 1, 2023. More information can be found here.
Other Articles of Interest
Exploratory Sampling Finds PFAS Presence in U.S. Food is Limited September 12: Government studies show that most U.S. food does not have excessive levels of per- and polyfluoroalkyl substances (PFAS) beyond food raised in certain contaminated areas. The USDA FSIS has tested for PFAS in meat, poultry and catfish since 2020. Out of 3,199 meat and poultry samples, less than 0.1% (2 bovine) had PFAS. Out of 616 catfish samples, 83 samples were positive for PFAS. FDA’s tests on food have rarely detected high levels of PFAS, except within certain seafood. More information concerning the FDA’s testing of PFAS in food can be found here. More information concerning FSIS FY 2021 and FY 2022 Exploratory PFAS Sampling Data can be found here.
Judge Pares Back Class Action Lawsuit over Heavy Metals in Hershey Chocolate September 12: A federal judge for the US District Court for the Southern District of California scaled back a putative class action against The Hershey Co. saying the plaintiff did not show lead or cadmium levels in the company’s chocolate products “create an unreasonable safety hazard”, but the judge allowed the plaintiff claims seeking an injunction for Hershey to disclose the presence of the heavy metals. The judge said the plaintiff’s suit failed to plead a duty to disclose, so the court granted Hershey’s motion to dismiss claims related to the alleged omission under California’s Consumer Legal Remedies Act. The court also concluded that the plaintiff failed to raise a viable claim for breach of implied warranty. More information can be found here.
California Senate Passes Bill to Ban Certain Food Ingredients September 13: The California Food Safety Act (AB418), which was passed by the State Assembly on May 15th, was passed by the State Senate. AB418 seeks to ban harmful food additives already prohibited in the European Union. The State Assembly version of AB418 bans Brominated vegetable oil, Potassium bromate, Propylparaben, titanium dioxide, and Red dye No. 3 from food. The State Senate bill took titanium dioxide off the banned list. The fine for a first-time violation of the new law is $5,000, with each subsequent violation going to $10,000. If the State Assembly concurs with the State Senate bill, the bill will then go to the Governor for signature. More information can be found here.
Food Recalls Triggered by Foreign Objects More Common September 17: Foreign objects in food is one of the top reasons for food recalls in the U.S. Food contaminated with foreign objects, such as metal, plastic, glass, or other “extraneous materials”, are common. The FDA acknowledged that some contamination may even be expected. In 2022, foreign objects triggered 9 recalls of more than 477,000 pounds of food regulated by the USDA FSIS. In 2019, USDA reported 34 recalls of over 16 million pounds of food, including a recall of nearly 12 million pounds of Tyson chicken strips tainted with pieces of metal. Detection of unwanted objects in food has improved over the years but some things are still missed. Companies are asked to promptly notify USDA and FDA when food is potentially contaminated with objects that may harm consumers. The agencies then determine whether recalls are necessary. Most recalls are voluntary. Recently, companies have become increasingly cautious and are recalling products more frequently than before. More information can be found here.
New FDA Administrator Gets to Work September 26: On his first day as the FDA’s Deputy Commission for Human Foods, Jim Jones sent a letter to colleagues outlining his vision for transforming the agency into a single program that embraces coordination, prevention, and response activities. He will be seeking ways to work more effectively with stakeholders to accomplish shared goals for a safer and more nutritious food supply. More information can be found here.
Country Crock Class Suit Advances September 27: A proposed class suit was filed against Upfield US Inc.’s “Country Crock Plant Butter with Almond Oil” spread alleging that the label overstates the amount of almond oil in the plant-based spread. The plaintiff alleged she was persuaded to by the product based on the almond oil representation and pictures of almonds on the container. A judge for the U.S. District Court for the Southern District of New York allowed the action to proceed saying the words and images on the front of the container tell a reasonable consumer that the plant butter is made of almond oil. The judge dismissed the plaintiff’s breach of warranty, common-law fraud, and unjust enrichment claims.
Ancient Brands Avoids False-Ad Lawsuit Over Bone Broth Protein September 27: A judge for the U.S. District Court for the Northern District of New York said that bone broth consumers can’t sue Ancient Brands LLC for allegedly overstating the protein content of the product because federal food labeling law preempts their claims. The plaintiffs alleged that the bone broth powders’ front label says “20g Protein,” and the nutrition facts panel says there are 20 grams of protein per serving. The court said the plaintiffs’ contention that Ancient Grains should have used the corrected protein calculation is beyond what is required by the FDCA, and therefore expressly preempted because the law bars state requirements that aren’t “identical” to federal ones. The plaintiffs were given 60 days to file an amended complaint. More information can be found here.
Crafted Brand Sued Over Cocktail Mixers “No Preservatives” Label September 28: A proposed class suit was filed against Crafted Brand Co. alleging it deceptively markets Mai Tai and Pina Colada cocktail mixers as having no preservatives in the U.S. District Court for Southern California. The plaintiff alleges that Crafted’s labeling is false because the products contain citric acid which is a common preservative. A copy of the complaint can be found here.
Wendy’s and McDonalds Avoid False Advertising Lawsuit October 3: Wendy’s International LLC and McDonald’s Corp avoided a lawsuit alleging their ads make burgers look bigger than they are. Lead Plaintiff, Justin Chimienti, alleged in a proposed class lawsuit that the eateries exaggerate the size of the burger patties in their ads by using uncooked meat which shrinks by about 25% when cooked. The U.S. District Court for the Eastern District of New York said the ads were not misleading. In addition, Chimienti failed to show he was financially harmed by the fast-food ads. More information can be found here.
This Regulatory Update covers information from September 2023. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit michaelbest.com.
