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FDA Releases Draft Guidance on NDIN Master Files for Dietary Supplements
April 4: The FDA issued a draft guidance document to help industry comply more easily with the new dietary ingredient notification (NDIN) requirement by providing recommendations on the submission and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 Written comments on the draft guidance are due by June 3, 2024. More information, as well as a link to the draft guidance document can be found here.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.
A database of warning letters can be found here.
USDA Updates
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.