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Regulatory Update: August 1 – August 31, 2023

This update includes FDA updates, FDA warning letters, and other articles of interest, including an ice cream listeria outbreak, questions surrounding lab-grown meat, cannabis plain packaging rules, and more.

FDA Updates

FDA To Hold Modernizing Food and Drug Administration Recalls Listening Session
August 4: FDA will be hosting a free hybrid public meeting entitled “Modernizing Food and Drug Administration Recalls Listening Session” on September 29, 2023. The listening session will provide an opportunity for stakeholders to share information and feedback about topics related to recall modernization for FDA-regulated products. Registration is required. More information can be found here.

FDA Revokes Uses of Partially Hydrogenated Oils in Foods
August 8: FDA is issuing a direct final rule to complete administrative actions that reflect the agency’s June 2015 final determination that the use of partially hydrogenated oils (PHOs) in foods is no longer Generally Recognized as Safe (GRAS). The direct final rule removes PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna, revises the regulations affirming the use of menhaden oil and rapeseed oil as GRAS to no longer include partially hydrogenated forms of these oils, and revokes the regulation affirming hydrogenated fish oil as GRAS as an indirect food substance. FDA is also revoking prior sanctions for the use of PHOs in margarine, shortening, and bread, rolls, and buns based on their conclusion that these uses of PHOs may be injurious to health. This rule will be effective December 22, 2023.

The FDA is issuing these amendments directly as a final rule because it anticipates no significant adverse comments.  However, the agency is also issuing a companion proposed rule in case the direct final rule is withdrawn because significant adverse comments are received, and the agency needs to move forward with a proposed rule to put these changes in place. Comments on the direct final rule or its companion proposed rule must be submitted by October 23, 2023. More information and instructions for submitting comments can be found here.

FDA Investigates Ice Cream Listeria Outbreak
August 9: FDA is investigating an outbreak of Listeria monocytogenes infections linked to Soft Serve On The Go cups produced by Real Kosher Ice Cream of Brooklyn, NY. More information can be found here.

FDA’s Dietary Supplements Program Remains a Critical Priority
August 15: FDA published “Catching up with Califf: FDA’s Dietary Supplements Program Remains a Critical Priority,” by Robert M. Califf M.D., Commissioner of Food & Drugs. Under the new proposed Human Foods Program structure, the Office of Dietary Supplement Programs (ODSP) will report to the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI). This proposed structure is designed to ensure that the dietary supplements program remains a critical priority for the agency. There are currently no plans to reduce ODSP’s resources or capabilities, and it will remain the lead office responsible for executing the agency’s responsibilities under the Federal Food, Drug, and Cosmetic Act as amended by the Dietary Supplement Health and Education Act. The new OFCSDSI is expected to modernize and strengthen the assessment of food chemicals and facilitate safe and innovative ingredients for use in foods and dietary supplements. More information can be found here.

FDA to Hold Virtual Public Meeting and Listening Sessions on Strategies to Reduce Added Sugars Consumption in the U.S.
August 16: The FDA, in collaboration with other federal partners, will host a virtual public meeting followed by virtual public listening sessions to discuss strategies for reducing added sugars consumption in the United States. A virtual public meeting will be held on November 6, 2023, and virtual listening sessions will be held on November 7 & 8, 2023. More information, including meeting specifics and how to register for the virtual meeting and listening sessions, will be made available in September 2023 on the meeting page.

FDA Seeks Input on Citizen Petition to Amend Standard of Identity for Pasteurized Orange Juice
August 16: FDA announced that the Florida Citrus Processors Association (FCPA) and Florida Citrus Mutual (FCM) filed a citizen petition requesting that FDA amend the standard of identity (SOI) for pasteurized orange juice (POJ) by adjusting the minimum soluble solids content from 10.5° to 10° Brix. The agency is requesting comments, data, and information about the issues presented in the petition. Written comments and scientific data and information must be submitted by October 16, 2023. More information, including a link for submitting comments, can be found here.

FDA Commissioner Names EPA Veteran as Deputy Commission for Human Foods
August 24: James Jones was named Deputy Commissioner for Human Foods. He replaces former Deputy Commissioner for Food Policy Frank Yiannas and Susan Mayne, who headed the Office of Food Safety and Applied Nutrition. Jones is expected to begin at the FDA on September 24, 2023. While at the EPA, Jones oversaw efforts including a reduction in the impact of chemicals and pollution on the U.S. food supply. He also played a key role in the 2016 overhaul of the Toxic Substances Control Act that aimed to make it easier for the agency to regulate such compounds.

FDA Issues Proposed Rule to Amend Canned Tuna Standards
August 25: FDA is proposing to amend the standard of identity and standard of fill of container for canned tuna. This action partially responds to a citizen petition submitted by Bumble Bee Foods, LLC, StarKist Co., and Tri Union Seafoods, LLC (dba Chicken of the Sea International). If finalized, the proposed rule would:

  • Revise the weighing methods used to determine the standard fill of container;
  • Allow the use of safe and suitable flavorings and spices as optional ingredients; and
  • Clarify that the use of a packing medium is optional.

Written comments on the proposed rule must be submitted by November 24, 2023. More information, including a link for submitting comments, can be found here.

IFSAC Releases 2024-2028 Priorities
August 25: The Interagency Food Safety Analytics Collaboration (IFSAC)—a collaboration between the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and the USDA Food Safety and Inspection Service (FSIS)—has published its upcoming priorities for calendar years 2024-2028. The following four priorities will guide the IFSAC’s work for the next five years:

  • Improve foodborne illness source attribution estimates for Campylobacter;
  • Develop foodborne illness source attribution estimates for non-O157 Shiga toxin-producing Escherichia coli (STEC);
  • Finalize existing analyses; and
  • Refine foodborne illness source attribution estimates using data from non-foodborne sources of pathogens.

For more information can be found here.

FDA Warning Letters

Imported Food: FDA issued 4 warning letters to importers for failure to develop, maintain and follow a Foreign Supplier Verification Program (FSVP) for imported food and produce.

Infant Formula: FDA issued warning letters to 3 companies for violations of the Current Good Manufacturing Practice (CGMP) regulations related to adulterated infant formula.

Imported Seafood: FDA issued warning letters to 2 companies for violations of CGMP regulations and seafood Hazard Analysis and Critical Control Point (HACCP) regulations related to adulterated seafood prepared under insanitary conditions.

Dietary Supplements: FDA issued warning letters to 2 companies for violations of the Current Good Manufacturing Practice (CGMP) regulations related to adulterated dietary supplements. 

A database of warning letters can be found here.

USDA Updates

FSIS Extends Comment Period on Proposed Determination for Salmonella in Not-Ready-To-Eat Breaded Stuffed Chicken Products
August 2: On April 28, 2023, the USDA Food Safety and Inspection Service (FSIS) published a proposed determination titled Salmonella in Not-Ready-To-Eat Breaded Stuffed Chicken Products. FSIS is proposing to declare that not-ready-to-eat breaded stuffed chicken products that contain Salmonella at levels of 1 colony forming unit per gram or higher are adulterated within the meaning of the Poultry Products Inspection Act. FSIS extended the comment period for the proposed determination until August 11, 2023. More information, including a link for providing comments, can be found here.

FSIS Rescinds Regulations related to Condemnation of Poultry Carcasses affected with Avian Leukosis Complex
August 17: FSIS issued a final rule amending the poultry products inspection regulations to rescind several regulations related to the inspection and condemnation of poultry carcasses affected with any of the forms of avian leukosis complex. The final rule is effective September 18, 2023. On March 14, 2022, FSIS proposed to amend these regulations in response to a petition from the National Chicken Council which requested that the regulations be amended to designate avian leukosis as a trimmable condition rather than a condition that requires condemnation of the entire carcass. Under this final rule, carcasses affected with avian leukosis will be subject to the amended 9 CFR 381.87, which provides that any organ or other carcass part affected with tumors may be trimmed and that the unaffected parts of the carcass may be inspected and passed. More information can be found here.

Other Articles of Interest

GOP Lawmaker Criticizes FDA for Inaction on Regulating CBD
July 27: Rep. Lisa McClain, R-Mich., chair of the House Oversight Subcommittee on Health Care and Financial Services, criticized the FDA for claiming it needs further congressional action to build a regulatory pathway for CBD products and discussed curtailing the agency’s funding.  According to Rep. McClain, the pathway already exists. While the agency earlier this year said it would not regulate CBD under its existing authority, it promised to work with Congress to develop a new regulatory pathway to oversee the products. More information can be found here.

Regulatory Questions emerge as Lab-Grown Meat Hits the Market
July 31:  Earlier this summer, the U.S. became the second country in the world, after Singapore, to approve the sale of cell-cultured or lab-grown meat. As lab-grown meat hits the U.S. market, the USDA and FDA face questions about how to label it. More information can be found here.

Organic Pastures Dairy Co., LLC Enters into Consent Decree
August 1: On July 27, 2023, the U.S. District Court for the Eastern District of California entered a consent decree in United States v. Organic Pastures Dairy Co., LLC, et al., Case No. 08-cv-1786 (E.D. Cal.). Organic Pastures Dairy Co., LLC (“Organic Pastures”) is a California-based company that manufactures and sells raw milk, raw milk products, and raw cheese and is subject to a 2010 injunction. The FDA moved for contempt in March 2023, alleging that Organic Pastures: (1) distributed an unapproved new drug in interstate commerce – its raw cheddar cheese for the prevention of diseases such as heart disease, osteoporosis, and viral infections and (2) failed to affix required statements on its invoices, packaging slips and websites. In May 2023, the Court issued an order finding that Organic Pastures, its founder, and its president had violated the 2010 injunction. The Court scheduled an evidentiary hearing regarding whether their noncompliance was justified. Prior to the hearing, the parties negotiated the consent decree providing the FDA with additional oversight, enforcement, and inspection authority and imposes regular auditing requirements on Organic Pastures.

EU Food Name Rules Curdle U.S. Cheese Producer
August 8: According to a Wall Street Journal article, the European Union expanded its list of foods, wines and spirits whose names are reserved for use by traditional local producers to more than 3,500 protected items. In Europe, feta cheese must be made in Greece. Gorgonzola cheese must be from Italy. U.S. food producers have also taken steps to protect products with geographical ties, such as Idaho potatoes, Florida oranges, and Hawaiian Kona coffee. The Consortium for Common Foods Names is pushing Congress to include a provision in the upcoming Farm Bill that would secure US food producers’ rights to use common food terms. Wisconsin Senator Tammy Baldwin is backing the bill along with Senate GOP Whip John Thune.

Campbell’s V8 Juice Health Deception Suit Advances
August 8: A class action suit advanced against Campbell Soup Co. alleges that the marketing of V8 Fruit and Vegetable Blends drinks are misleading because they portray the drinks as healthful substitutes for whole fruit and vegetables. The plaintiffs claim that the V8 Juice labels are deceptive because while fruit and vegetables can protect against disease, consuming juices increases the risk of disease. 

‘All Smoke and No Fire’ – Smokehouse Almond Deception Suit Dismissed
August 8: Blue Diamond Growers won dismissal of a consumer deception case involving its Smokehouse Almonds. Three similar Smokehouse cases have been dismissed. In this latest case, a Wisconsin man alleged that he overpaid for almonds because the almonds were not made in a smokehouse but that seasoned with liquid smoke flavoring. A Wisconsin federal judge said that the plaintiff lacked standing to pursue claims for money damages because he didn’t pay a price premium. Evidence showed that Blue Diamond Growers charged the same price for Smokehouse Almonds as other varieties. The judge also ruled that the plaintiff lacked standing to seek injunctive relief.

Frozen Meat Products Recalled Due to Lack of Federal Inspection
August 10: A Paterson, NJ meat packing company, is recalling 58,721 pounds of frozen, raw halal beef tripe, beef feet, and lamb tripe products that were produced without a federal inspection, according to the FSIS. The products were produced from January 2023 through August 2023. The problem was discovered during FSIS surveillance activities. More information can be found here.

Walmart Fish Oil Supplement Buyer Can Proceed with False-Ad Suit
August 11: Walmart Inc. lost its bid to dismiss a proposed class suit alleging its “Spring Valley 1000 mg Fish Oil” dietary supplement is deceptively called fish oil. The proposed class suit alleges that the Walmart fish oil supplement is a “lab synthesized solution” in which a chemical process is used to “molecularly alter and substantially transform otherwise unmarketable fish waste into a consumable product.” According to a federal judge in California, federal labeling law does not block allegations that consumers could be misled by the fish oil label. The judge declined to dismiss claims under California consumer protection laws as well as breach of warranty claims. More information can be found here.

Kellogg and Kashi Prevail in Cereal, Burger Protein-Label Appeals
August 14: Kellogg Co. and its Kashi Co. unit defeated appeals in separate proposed class suits by consumers alleging they were misled about the protein in breakfast cereals and Morningstar veggie burgers. The US Court of Appeals for the Ninth Circuit affirmed in a combined appeal that federal food labeling regulations preempt the state-law consumer protection suits. More information can be found here.

Ice Cream Company Sued After Listeria Recall
August 15: A proposed class action was filed in New York federal district court alleging that Real Kosher Ice Cream Inc. mislead consumers by not telling them about the risk of Listeria and cost them the money they spent on the frozen food. The proposed class action follows Real Kosher Ice Cream’s recall of soft-serve desserts. The Real Kosher Ice Cream Inc. said in its recall that the “on-the-go” ice cream and sorbet cups have the potential to be contaminated with Listeria monocytogenes, noting that there had been two reports of illnesses, one each in Pennsylvania and New York. (See related FDA Update above.)

Cannabis Plain Packaging Rules
August 15: There has been a lot of attention recently on hemp-derived products marketed in packaging that mimics popular snack foods. According to the FDA and various state regulators, this type of packaging has contributed to an increase in accidental consumption of intoxicating hemp products by minors. Concerns around hemp product packaging have arisen because there is little federal and state guidance as to packaging, labeling and content. All states have some level of prohibition on packaging that is attractive to minors, but states such as Massachusetts, Connecticut, New Jersey and Missouri prohibit packaging that mimics popular candy or food, limit the use of colors and impose other restrictions. More information can be found here.

Capri Sun Customer Voluntarily Drops Kraft Heinz PFAS Suit
August 24: A proposed class suit alleging Kraft Heinz Co.’s Capri Sun juice drinks are marketed as “healthy” and “all natural” when they contain undisclosed PFAS has been voluntarily dismissed. The plaintiff sued the company in U.S. District Court for the Northern District of Illinois alleging that independent testing detected PFAS substances in Capri Sun beverages but later dropped the lawsuit.

This Regulatory Update covers information from August 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.

Regulatory Update: July 1 – July 31, 2023

This update includes FDA updates, FDA warning letters, and other articles of interest, including a bill banning chemicals in food, warnings for Delta-8 THC products, PFAS found in juice, and more.

FDA Updates

FDA Provides Update on Proposed Changes to the Human Foods Program
June 27: FDA is proposing to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA). Earlier this year, the FDA Commissioner announced a restructuring of the HFP. FDA is proposing additional changes that include establishing ORA’s core mission as conducting investigations, inspections, and laboratory testing for all FDA-regulated products, merging compliance functions currently managed within ORA into the HFP, realigning eight Human and Animal Food laboratories that are currently managed by ORA into the HFP, unifying state and local food safety partnership functions, and realignment of certain resources and personnel. More information can be found here.

Bill Banning Chemicals in Food Advances in California
June 30: The California Senate Committee on Health approved a bill (AB 418) to ban five chemicals from candy, cereals, and other processed foods. The bill, which is the first of its kind in the nation, prohibits the use of food products containing brominated vegetable oil, potassium bromate, propylparaben, red dye 3, and titanium dioxide, beginning on January 1, 2025. As discussed in our April 2023 update, several groups and trade associates oppose the bill. More information can be found here.

Companies Warned for Illegally Selling Delta-8 THC Copycat Snacks
July 5: The FDA and Federal Trade Commission (FTC) warned six companies to stop selling Delta-8 edibles that look like name-brand snacks such as Doritos, Oreos, Cheetos, Jolly Rancher, and Nerds. The warning letters were issued to the companies for illegally selling copycat food products containing Delta-8 tetrahydrocannabinol, also known as Delta-8 THC. According to the agencies, these products can easily be mistaken for traditional foods like chips, cookies, candy, gummies, or other snack food items. FDA is concerned that these products can be accidentally ingested by consumers, including children, or taken in higher doses than intended. More information can be found here.

FDA Releases Update of Priority Guidance Topics for Foods Program
July 6: FDA and the Office of Food Policy and Response (OFPR) released an updated list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during 2023. The list updates the guidance agenda released in February 2023 and focuses on Level 1 draft and final guidance.  A list of final guidance topics, as well as links to guidance documents released since February 2023, can be found here.

FDA Update on Post-Market Assessment of Certain Food Ingredients
July 12: FDA released a public inventory of certain food ingredients that the agency has determined to have unsafe uses in food because they are unapproved food additives and lists of select chemicals currently under the agency’s review.  More information, including the public inventory database and list of chemicals, can be found here.

FDA Disagrees with WHO Report about Possibly Carcinogenic Sweetener
July 13: A report released by the World Health Organization determined the sweetener aspartame may “possibly” cause cancer. This new classification is based on a review of limited evidence and does not change the recommended limit on the daily intake of artificial sweetener. The FDA has disagreed with the new classification. More information can be found here.

FDA Reissues Two Temporary COVID-19 Guidances
July 13: FDA re-issued two temporary guidance documents originally published during the COVID-19 public health emergency for certain regulatory requirements that involve onsite visits abroad under the FDA Food Safety Modernization Act (FSMA).  The two guidances extend the enforcement discretion policies issued during the public health emergency relative to supplier onsite audits for the FSMA Preventive Controls for Human and Animal Food rules and the Foreign Supplier Verification Programs rule, and onsite monitoring activities and duration of already-issued certifications for the Accredited Third-Party Certification Program, when certain circumstances are met.  More information can be found here.

Findings from Voluntary Pilot Program to Evaluate Third-Party Food Safety Standards Alignment
July 17: FDA announced the findings from the voluntary pilot program to evaluate alignment of private third-party food safety audit standards with the food safety requirements in two regulations issued to implement the FDA Food Safety Modernization Act – 1) the Preventive Controls for Human Food and 2) the Produce Safety rules.  More information can be found here.

FDA Denies Citizen Petition on Phthalates in Food Packaging and Food Contact Applications
July 24: FDA denied a petition requesting that the agency reconsider its denial of a citizen petition issued on May 19, 2022. The citizen petition requested a ban on the use of eight ortho-phthalates and revocation of the prior sanctioned uses for five ortho-phthalates in food based on alleged safety concerns.  FDA concluded that the reconsideration petition does not provide a basis for modifying the FDA’s response to the original citizen petition.  More information can be found here.

Food Safety Modernization Act 2024 User Fees Announced
July 28: FDA announced fiscal year 2024 user fee rates for the Third-Party Certification Program, the Voluntary Qualified Importer Program, and for domestic and foreign facility reinspections.   For recognized accreditation bodies and accredited certification bodies, as well as the initial and renewal fee rate for accreditation bodies applying to be recognized in the Third-Party Certification Program, the fee is effective on October 1, 2023 and will remain in effect through September 30, 2024. The 2024 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program is effective August 1, 2023 and will remain in effect through September 30, 2024. The 2024 fee rate for domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections are effective October 1, 2023 through September 30, 2024. More information about the Third-Party Certification Program 2024 user fee rates can be found here.  More information about the Voluntary Qualified Importer Program 2024 user fee rates can be found here. More information about the 2024 domestic and foreign facility reinspection fee rates can be found here. 

FDA Publishes an Update on Sesame Allergen Labeling
July 28:  FDA published “Catching Up with Califf: An Update on Sesame Allergen Labeling on Food Packages,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. Sesame was added as the ninth major food allergen earlier this year when the Food Allergy Safety, Treatment, Education, and Research Act went into effect. Sesame is now required to be listed on food labels as a major allergen. The update provides information on the work underway to help sesame-allergic consumers find safe food options.

FDA Warning Letters

Imported Food: FDA issued 6 warning letters to importers for failure to develop, maintain and follow a Foreign Supplier Verification Program (FSVP) for imported food and produce.  FDA also issued a warning letter to a California importer for FSVP violations in response to a recent recall event associated with enoki mushroom products imported from a foreign supplier that tested positive for Listeria monocytogenes.

Unapproved New Drugs: A warning letter was issued to a Missouri entity selling bee propolis and other products alleging the use of marketing claims that render the products as unapproved new drugs.

Delta-8 THC Products: FDA issued warning letters to 7 companies selling Delta-8 THC products (such as gummies, sour worms, Stoneo Oreo Cookies, Hot Cheetos, Delta 8 Rope Candy, Pot Tarts, Trips Ahoy medicated chocolate cookies, Delta 8 Nerds Candy, Dope Rope Bites, D8 chocolate bars, THC infused nacho chips, etc.) that are adulterated because they contain an unsafe food additive and may pose a serious health risk to consumers. FDA is also concerned that Delta-8 THC copycat foods may be attractive to children and mistaken for traditional foods.

Dietary Supplements: FDA issued warning letters to two companies for violations of the Current Good Manufacturing Practice (CGMP) regulations related to adulterated dietary supplements.  FDA alleged that the supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

A database of warning letters can be found here.

Other Articles of Interest

Coca-Cola Sued over PFAS-laden Simply Tropical Juice
July 17: A consumer class action lawsuit filed in U.S. District Court of the Southern District of New York alleges that Coca-Cola Company falsely advertises its “Simply Tropical” juice products as all natural, while failing to disclose that they contain high levels of per- and poly-fluoroalkyl substances known as PFAS. The complaint accuses Coca-Cola and its subsidiary the Simply Orange Juice Co. of breach of warranty, violating the Magnuson-Moss Warranty Act, breaking federal and New York deceptive trade practices, negligence and unjust enrichment. More information can be found here.

Dole Sued over Sugar in Fruit Products Marketed as Healthful
July 5: A class action suit was filed against Dole Packaged Foods LLC in the U.S. District Court for the Northern District of California alleging that it deceptively represents various fruit products as healthy, nutritious, and beneficial to the immune system despite a high sugar content that increases the risk of various illnesses. The complaint asserts that Dole markets fruit bowl snacks to children even though the snacks have 166 percent more added sugar than the American Heart Association’s recommended daily limit. More information can be found here.

USDA and Bipartisan State Attorneys General Launch Agricultural Competition Partnership to Help Reduce Anticompetitive Barriers Across Food and Agriculture Supply Chains
July 19: USDA launched a partnership with bipartisan attorneys general in 31 states and the District of Columbia to enhance competition and protect consumers in food and agricultural markets, including in grocery, meat and poultry processing. More information can be found here.

Demand for Meat in China Could Lead to Much Larger Imports
July 31: According to a recent USDA report, meat consumption in China has increased significantly since the 1970s. USDA economists said per capita meat consumption in China could increase 40% by 2031. The USDA report said: “This trend creates new opportunities for exporters in the United States and other countries, but it also poses food security challenges and environmental impacts.” A copy of the USDA report can be found here.

Lawmakers Push FDA to Regulate Cannabidiol as Dietary Supplement
July 27: Lawmakers and hemp advocates urged the FDA to regulate cannabidiol products as dietary supplements during a hearing before the House Oversight Subcommittee on Health Care and Financial Services. Advocates say consumer safeguards in the Federal Food, Drug and Cosmetic Act would apply to CBD products if regulated as dietary supplements, including good manufacturing standards, adverse event reporting, strict labeling with warnings, and potential child-proof packaging. Meanwhile, congressional leaders in both chambers are seeking public input and announced a bicameral Request for Information about FDA regulation of CBD products. More information can be found here.

This Regulatory Update covers information from July 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.

Regulatory Update: June 1 – June 30, 2023

This update includes FDA updates, USDA updates, and FDA warning letters, including guidance for inorganic arsenic in apple juice, a proposed rule for front-of-package nutrition labels in the U.S, and more.

FDA Updates

Final Guidance for Inorganic Arsenic in Apple Juice Now Available
June 1: FDA announced the availability of a final guidance for industry titled “Action Level for Inorganic Arsenic in Apple Juice.” The final guidance identifies the action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice that was issued in draft by the agency in 2013. The final guidance comes after Consumer Reports tested 21 popular fruit juices and found elevated levels of cadmium, inorganic arsenic, and/or lead in 2018. FDA expects that the 10-ppb action level, though non-binding, will help to encourage manufacturers to reduce levels of inorganic arsenic in apple juice. The agency will continue its current practice of monitoring arsenic in apple juice samples, and if testing identifies inorganic arsenic in apple juice above 10 ppb, FDA will consider this action level, in addition to other factors, to determine whether to take enforcement action. A copy of the final guidance can be found here.

FDA Launched Webpage on Equivalence and Food Safety
June 5: The FDA has published a new webpage dedicated to equivalence for food safety. Equivalence is the process of determining whether a foreign regulatory counterpart’s food safety controls achieve at least the same level of public health protection measures required by U.S. law. The webpage explains how equivalence is determined, current equivalence determinations, and how regulatory authorities can submit a formal request for equivalence for FDA-regulated food products. The Equivalence and Food Safety webpage can be found here.

Comment Period Extended for Color Additive Petition
June 28: FDA is extending the comment period for a color additive petition submitted by Environmental Defense Fund, notice of which was published in the Federal Register on May 3, 2023. The petition requests that FDA repeal the color additive regulation providing for the use of titanium dioxide in foods. The deadline to submit comments has been extended to September 1, 2023. More information and a link for submitting comments can be found here.

Comment Period Extended for Dietary Guidance Statements in Food Labeling
June 15: The FDA is extending the comment period for the draft guidance titled “Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry,” that was published on March 27, 2023. The deadline to submit comments has been extended to September 25, 2023. More information can be found here.

New FSMA Food Traceability Rule FAQs Available
June 26: The FDA published new frequently asked questions (FAQs) and additional tools to provide industry with more information about FDA’s Food Safety Modernization Act (FSMA) Food Traceability Rule. The Food Traceability Rule is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. The FAQs regarding the Food Traceability Rule can be found here and more information can be found here.

Final Guidance for Quantitative Efficacy and Risk Information in DTC Advertisements
June 27: The FDA issued a final guidance for industry entitled, “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.” The purpose of the guidance is to provide industry with recommendations for presenting quantitative efficacy and risk information in DTC promotional labeling and advertisements for prescription human drug and biological products and prescription animal drugs, as well as DTC promotional labeling for over-the-counter animal drugs. A copy of the final guidance can be found here.

FDA Testing Front of Food Package Nutrition Labels
June 14: The FDA is considering a proposed rule for front-of-package nutrition labels in the U.S.  This proposed rule would require the front of food labels to display certain nutrition information to make it easier for consumers to make more informed dietary choices, which are intended to complement the nutrition facts label on packaged foods. FDA hopes to release a proposed rule on these labels by December 2023. More information can be found here.

FDA Warning Letters

Ready-to-eat Mandarin Oranges:  A Chinese ready-to-eat (RTE) mandarin orange food manufacturing facility was issued a warning letter after FDA investigators found a serious violation of the Current Good Manufacturing Practices & Preventive Controls for Human Food Rule (“CGMP/PC Rule”). FDA determined that RTE mandarin oranges in light syrup in glass jars manufactured in the facility were adulterated because they were prepared, packed, or held under insanitary conditions.

Chewable Calcium with Vitamin D for Kids: A pharmaceutical company selling “Chewable Calcium 600 mg with Vitamin D for Kids in Orange Flavor” was issued a warning letter by FDA for misbranding of the product and selling the product, which FDA considers an unapproved new drug.

Ready to Eat Bread Rolls:  FDA issued a warning letter to a RTE bread roll facility in Ohio for serious violations of the CGMP/PC Rule.  FDA investigators determined the RTE buns processed at the facility are adulterated in that they were prepared, packed, or held under insanitary conditions. 

A database of warning letters can be found here.

USDA Updates

New Guideline for Salmonella Control in Swine Slaughter and Pork Processing
June 1: The USDA Food Safety and Inspection Service (FSIS) updated its guideline for pork producers on controlling Salmonella in swine from pre-harvest through slaughter. The guideline covers pre-harvest controls, including farm rearing, multi-hurdle interventions, transport, and lairage. It provides information on best practices that may be applied at slaughter facilities to prevent, eliminate, or reduce levels of Salmonella on swine at all stages of slaughter and dressing. It also contains best management practices for pork fabrication controls, including processing, packaging, and distribution controls for pork cuts and comminuted pork products.  A copy of the guideline can be found here.

Best Practices Guidance Available for Controlling Listeria in Delicatessens
June 20: FSIS released an updated guidance entitled “Best Practices Guidance for Controlling Listeria monocytogenes (Lm) in Retail Delicatessens.” The best-practices guidance discusses steps that retailers can take to prevent certain ready-to-eat foods that are prepared or sliced in retail delicatessens and consumed in the home from becoming contaminated with Listeria and thus a source of listeriosis. More information and a copy of the guidance can be found here.

FSIS Issues Updated Cell-Cultured Meat and Poultry Food Products Sampling Program
June 29: FSIS issued a notice of updates to the Cell-Cultured Meat and Poultry Food Products Sampling Program. The notice has been updated to reflect sampling of ready-to-eat products. The notice also provides instructions to inspection program personnel on how to collect cell-cultured meat and poultry food products and send samples to the FSIS Eastern Laboratory for microbiological, chemical residue, speciation testing, and pathology. More information can be found here.

Revised Directive for Responsibilities in Dual Jurisdiction Establishments
June 21: The directive for Responsibilities in Dual Jurisdiction Establishments provides instruction to FSIS inspection program personnel (IPP) about their roles and responsibilities regarding inspection, verification, documentation of findings, reporting and enforcement actions in establishments that operate under the jurisdiction of both FSIS and the FDA. FSIS revised this directive to reflect the updated Memorandum of Understanding between FSIS and FDA and to provide instructions to IPP in establishments that harvest cells for cell-cultured meat and poultry food products. More information can be found here.

USDA Considering Cracking Down on Animal-Raising Claims
June 14: USDA has launched a multi-step effort to strengthen standards used to substantiate animal-raising claims such as “raised without antibiotics,” “grass-fed,” and “free-range,” among others. This effort comes after petitions, comments, and letters requested USDA to reevaluate its oversight of how animal-raising claims are substantiated. To address concerns, FSIS, along with USDA’s Agricultural Research Service, will conduct a sampling project to assess antibiotic residues in cattle marketed with the “raised without antibiotics” claim. In addition, FSIS will be issuing a revised industry guideline to recommend companies strengthen the documentation they submit to substantiate animal-raising claims. More information can be found here.

This Regulatory Update covers information for June 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.

Regulatory Update: May 1 – May 31, 2023

This update includes FDA updates, USDA updates, and FDA warning letters, including a draft compliance guide for major food allergen labeling, the availability of FSIS Ready-to-Eat Fermented, Salt-cured, and Dried Products Guideline, and more.

FDA Updates

Draft Compliance Guide Available for Major Food Allergen Labeling and Cross-contact
May 16: The FDA released a draft Compliance Policy Guide (CPG) entitled “Sec. 555.250 Major Food Allergen Labeling and Cross-contact” for public comment. The CPG, when finalized, will replace existing guidance for FDA staff on FDA’s enforcement policy regarding major food allergen labeling and cross-contact. The current CPG was written before the enactment of the Food Allergen Labeling and Consumer Protection Act (2004), FDA Food Safety Modernization Act (2011), and the Food Allergy Safety, Treatment, Education and Research Act (2021). The current CPG also does not reflect requirements in FDA’s regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.”

The draft CPG describes (1) the labeling requirements for major food allergens and the proper use of the ingredient list and the “Contains” statement for major food allergen declarations; (2) requirements for firms to implement controls to prevent or significantly minimize allergen cross-contact; (3) describes additional allergen labeling violations; and (4) directs FDA staff to examine potential product adulteration due to allergen cross-contact as well as potential labeling violations. Comments on the draft CPG are due July 17, 2023. A copy of the draft CPG can be found here along with a link for submitting comments.

FDA Releases Small Entity Compliance Guide on Requirements for Additional Traceability Records for Certain Foods
May 18: The FDA published a Small Entity Compliance Guide (SECG) entitled “Requirements for Additional Traceability Records for Certain Foods: What you need to know about the FDA Regulation” to help small entities comply with the final rule. The Food Safety Modernization Act Food Traceability Rule was issued in November 2022 and the compliance date for recordkeeping requirements is January 20, 2026. The SECG can be found here.  More information about the Food Traceability Rule can be found here.

FDA Receives Color Additive Petition Regarding Use of Titanium Dioxide in Food
May 3: Earlier this year, FDA received a color additive petition from Environmental Defense Fund, et al., asking the agency to revoke the color additive listing for the use of titanium dioxide in food. On May 3, FDA published notice of the filing in the Federal Register. The petitioners assert that the intended use of this color additive no longer meets the safety standard under 21 CFR 70.3(i). A copy of the petition can be found here. Comments on the petition are due by September 1, 2023 and may be submitted using the link here.

FDA Warning Letters

In May 2023, the FDA posted nine warning letters, including the following notable letters:

FSVP: FDA issued three warning letters related to alleged violations of the Foreign Supplier Verification Program (FSVP). 

Produce Safety: A warning letter was issued to a Nebraska-based alfalfa sprouts producer for alleged violations of the Produce Safety Regulation (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption).

Unapproved New Drug: A warning letter was issued to an Oregon entity selling tea and herbal products alleging the use of marketing claims that render the products an unapproved new drug.

A database of warning letters can be found here.

USDA Updates

Availability of FSIS Ready-to-Eat Fermented, Salt-cured, and Dried Products Guideline
May 5: USDA’s Food Safety and Inspection Service (FSIS) announced the availability of a guidance document for manufacturing ready-to-eat (RTE), shelf-stable, fermented, salt-cured, and dried meat and poultry products that do not use cooking as the primary lethality step. The guideline addresses commonly asked questions concerning the food safety hazards associated with these products and the key steps in each process to ensure safety. This guideline replaces and expands upon information previously found in other guidance documents addressing the safe production of RTE fermented meat and poultry products. FSIS also published Instructions for Training associated with the guideline. The Ready-to-Eat Fermented, Salt-cured, and Dried Products Guideline can be downloaded here and Instructions for Training can be downloaded here.

This Regulatory Update covers information for May 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.

Regulatory Update: April 1 – April 30, 2023

This update includes FDA updates, USDA updates, FDA warning letters, and other developments, including a proposed rule to reduce sodium intake, new education materials on GMOs for consumers, and more.

FDA Updates

FDA Amends Yogurt Rule, Denies Request for Public Hearing
April 13: FDA modified provisions of a 2021 final rule that revoked standards of identity for lowfat and nonfat yogurt and amended the standard of identity for yogurt. Under the 2021 final rule, FDA required that yogurt have a titratable acidity of not less than 0.7 percent, expressed as lactic acid, or a pH of 4.6 or less before the addition of bulky flavorizing ingredients. After the rule was finalized, the International Dairy Foods Association (IDFA) filed a request for public hearing, objecting to these provisions of the rule. Under the modified rule, FDA will simply require products to have a pH of 4.6 or lower. Concurrent with the modification of the final rule, FDA denied IDFA’s request for a public hearing. The Federal Register notice can be found here.

FDA Issues Proposed Rule to Reduce Sodium Intake
April 10: FDA issued a proposed rule to amend standard of identity regulations that specify salt (sodium chloride) as a required or optional ingredient in standardized foods to instead allow for the use of salt substitutes, in order to reduce sodium content. FDA states that this rule, if finalized, would help support a healthier food supply by providing flexibility to facilitate industry innovation in the production of standardized foods lower in sodium while maintaining the basic nature and essential characteristics of the foods. More information can be found here. To assure consideration, comments must be submitted by August 8, 2023.

FDA Requests Information about Online Grocery Shopping Food Labeling
April 24: The FDA is requesting information on whether and how online grocery retailers, food manufacturers, and third-party online grocery providers are displaying nutrition, ingredient, and allergen information through online grocery shopping platforms. The purpose of this request is to obtain information on the content, format, and accuracy of food label information provided to consumers through online grocery shopping. Comments are due July 24, 2023.  More information can be found here.

Comment Period for Guidance on Labeling of Plant-Based Milk Alternatives Reopened
April 30: FDA reopened the comment period for the draft guidance entitled “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Guidance for Industry,” which was published on February 23, 2023. The guidance will provide industry with recommendations that will result in clear labeling to help consumers make informed decisions and understand certain nutritional differences between plant-based milk alternatives (PBMA) products and milk. The FDA also recommends that PBMA products that are labeled with the term “milk” in their names, such as “soy milk” or “almond milk,” and that have a nutrient composition that is different than milk, include a voluntary nutrient statement that conveys how the product compares with milk. A copy of the draft guidance and a link for submitting comments can be found here Comments on the draft guidance are now due July 31, 2023.

“Feed Your Mind” Education Materials on GMOs for Consumers
April 19: FDA released new materials for consumers to provide science-based information on genetically modified organisms (GMOs). “Feed Your Mind” is an educational initiative launched in 2020 to help consumers better understand GMOs. The new materials include information about genome editing, GMO benefits to the environment, farmers, and consumers, GMO regulations in the U.S., and videos from GMO growth experts. The “Feed Your Mind” materials can be found here.

FDA Warning Letters

Imported Food: Inspectors found an Illinois food importer was not in compliance with the Foreign Supplier Verification Program (FSVP) for imported food.

Quick Frozen Shrimp: A Mississippi seafood freezing and processing facility received a warning letter for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. 

A database of warning letters can be found here.

USDA Updates

USDA Announces Funding Available to Expand Meat and Poultry Processing Options for Underserved Producers and Tribal Communities
April 19: USDA announced the availability of up to $125 million through two new grant programs that will create more options for producers by investing in independent, local meat and poultry processing projects that increase competition and enhance the resiliency of the food supply chain, including new capacity for indigenous meat processing to support tribal food systems. 

The new grant programs, the Indigenous Animals Harvesting and Meat Processing Grant Program and the Local Meat Capacity Grant Program, are part of the $1 billion American Rescue Plan investment by the Biden Administration to expand processing capacity for small and midsized meat and poultry processors. More information is available on the Agricultural Marketing Service’s Local MCap webpage and here. Grant applications will be accepted through July 19, 2023.

Other Developments

Groups Oppose California Bill to Ban Unsafe Food Additives
Earlier this year, legislators in California introduced Assembly Bill 418, a bill that would prohibit the manufacture, sale or distribution of any food product in California containing red dye No. 3, titanium dioxide, potassium bromate, brominated vegetable oil, or propyl paraben beginning January 1, 2027. The Consumer Brands Association, the American Beverage Association, the American Bakers Association and The North American Millers’ Association are among a number of groups opposing the bill. The groups opposing the bill said California already has a process by which unsafe chemicals are removed from the market or mandated to include warning labels. The bill, which passed the Assembly and is currently in committee in the State Senate, would be the first in the nation to ban chemicals intentionally added to foods as preservatives or to enhance colors and flavors.

This Regulatory Update covers information for June 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.

Regulatory Update: March 1 – March 31, 2023

This update includes FDA updates, USDA updates, and FDA warning letters, including the issuance of a notice announcing the status of COVID-19 guidance documents, proposed updated rules governing voluntary “Product of USA” claims, and more.

FDA Updates

FDA Issues Draft Guidance About Dietary Guidance Statements in Food Labeling
March 27: FDA issued a draft guidance for industry titled “Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry.” The draft guidance will provide information and FDA’s current thinking on the use of Dietary Guidance Statements on packaged food labels and more broadly in the labeling of foods, including any written, printed, or graphic material accompanying a food, such as labeling on websites. In general, Dietary Guidance Statements are statements relating a food or food group to a nutritious dietary pattern, with such statements based on key or principal recommendations from consensus reports. The draft guidance can be found here. The deadline to submit public comments has been extended to September 25, 2023.

FDA Issues Notice Announcing the Status of COVID-19 Guidance Documents
March 13: The FDA issued a notice in the Federal Register to explain how the end of the federal Public Health Emergency (PHE) associated with COVID-19 impacts the agency’s pandemic-era guidance documents. As of the expiration of the PHE on May 11, 2023, many of the guidance documents are no longer in effect or will expire shortly after the PHE ends, while FDA has indicated that other guidance will continue to be effective. A list of affected guidance documents and their current status can be found here.

FDA Warning Letters

RTE Product: Upon inspection, a Florida food manufacturer of ready-to-eat (RTE) sandwiches received a warning letter after FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. During this inspection, FDA collected environmental samples from various areas and found the presence of Listeria monocytogenes.

Soft Cheese: A Michigan soft and semi-soft cheese producer was inspected after a multistate outbreak of Listeria was linked to RTE soft cheese products supplied by the facility. FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulations leading to a warning letter.

Pretzels: During an inspection of a Michigan RTE seasoned hard pretzels producer, inspectors found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

A full list of warning letters can be found here.

USDA Updates

FSIS Proposes Updated Rules Governing Voluntary “Product of USA” Claims
March 6: UDA’s Food Safety and Inspection Service (FSIS) proposed to amend its regulations to define the conditions under which the labeling of meat, poultry, and egg products, as well as voluntarily inspected products, may bear voluntary label claims indicating that the product is of United States origin. View the Federal Register notice here.

Other Developments

Fourth Circuit Affirms Gruyere Certification Mark Rejection
The federal Court of Appeals for the Fourth Circuit affirmed a lower court’s grant of summary judgment in favor of the opposers of a certification mark (a type of trademark used to show consumers that certain standards have been met by a product) for “GRUYERE” to designate cheese that originates in the Gruyère region of Switzerland and France. The three-judge panel concluded that “cheese consumers in the US understand ‘GRUYERE’ to refer to a type of cheese, which renders the term generic,” and thus deemed the term unregistrable as a certification mark. This ruling is a win for cheese producers that make cheeses with names associated with physical places such as Gruyere, Havarti, Cheddar, and Swiss.

This Regulatory Update covers information for March 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.

Regulatory Update: February 1 – February 28, 2023

This update includes FDA updates, USDA updates, and FDA priority guidance topics for 2023, including the withdrawal of a proposed rule on general principles and food standards modernization, enforcement discretion for claims related to high flavanol cocoa powder, and more.

FDA Updates

FDA Withdraws Proposed Rule on General Principles and Food Standards Modernization
February 28: FDA and USDA’s Food Safety and Inspection Service (FSIS) have announced the withdrawal of the proposed rule titled “General Principles and Food Standards Modernization,” originally published in the May 20, 2005 Federal Register. In what was viewed as a part of renewed efforts by FDA to work towards modernizing standards of identity, FDA held public meetings on the topic in July 2018 and September 2019. FDA subsequently reopened the comment period in 2020 for FDA-specific aspects of the 2005 proposed rule. As a result of comments received in 2005 and 2020, FDA and FSIS are now withdrawing the proposed rule with plans to create a new proposed rule on principles for food standards modernization in the future. The withdrawal is effective March 1, 2023. More information can be found here and in this Constituent Update.  

FDA Releases Draft Guidance on the Labeling of Plant-Based Milk Alternatives
February 22: FDA released draft guidance that will provide industry with FDA’s view on the labeling of plant-based food products that are marketed and sold as alternatives to milk (plant-based milk alternatives) and recommendations for the use of voluntary nutrient statements on such products. More information on the changes can be found here. The comment period has been extended through July 31, 2023.

FDA Announces Enforcement Discretion for Claims Related to High Flavanol Cocoa Powder
February 3: The FDA issued a letter of enforcement discretion stating that it “does not intend to object to the use of certain qualified health claims regarding the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease for conventional foods, provided that the qualified claim is appropriately worded so as not to mislead consumers and that other factors for the use of the claim are met.”

FDA’s decision to exercise enforcement discretion comes in response to a qualified health claim petition submitted by Barry Callebaut AG, Switzerland. It applies specifically to cocoa flavanols in high flavanol cocoa powder and foods that contain high flavanol cocoa powder. The claim may not be used in connection with regular cocoa powder, foods containing regular cocoa powder, or other food products made from cacao beans, such as chocolate. More information can be found here.

FDA Launches Directory of Dietary Supplement Ingredients
March 6: The FDA introduced a new Dietary Supplement Ingredient Directory, a webpage where the public can look up ingredients used in products marketed as dietary supplements and quickly find what the FDA has said about that ingredient and whether the Agency has taken any action with regard to the ingredient. The directory can be found here.

FDA Priority Guidance Topics for 2023

FDA has released a list of draft and final guidance topics related to food and nutrition (including allergen labeling, food safety, food additives, Food Safety Modernization Act (FSMA) implementation, and nutrition) that are a priority for the agency to publish by December 2023. The targeted guidance documents currently include:

  • Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Guidance for Industry
  • Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact; Draft Guidance for FDA Staff
  • Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for FDA Staff and Stakeholders
  • New Dietary Ingredient (NDI) Notifications and Related Issues: NDI Notification Procedures and Timeframes; Guidance for Industry
  • Dietary Supplement Master Files: Draft Guidance for Industry
  • Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations): Draft Guidance for Industry
  • Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry
  • Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry
  • Inorganic Arsenic in Apple Juice: Action Level; Draft Guidance for Industry
  • Detention Without Physical Examination (DWPE) of Fish and Fishery Products Due to the Appearance of Adulteration by Bacterial Pathogens, Unlawful Animal Drugs, Scombrotoxin (Histamine), or Decomposition – Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer’s Goods from DWPE; Draft Guidance for Industry
  • Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff
  • Evaluation and Establishment of Safety of Low-Moisture Ready-to-Eat Foods Following Equipment Microbiological Contamination Event: Guidance for Industry
  • Action Levels for Arsenic in Food Intended for Babies and Young Children:  Draft Guidance for Industry
  • Action Levels for Cadmium in Food Intended for Babies and Young Children:  Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 9: Validation of Process Controls; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 17: Classifying Food as Ready-To-Eat or Not Ready- to-Eat; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 16: Acidified Foods; Draft Guidance for Industry
  • Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations: Guidance for Industry
  • Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry
  • Questions and Answers About Dietary Guidance Statements in Food Labeling; Draft Guidance for Industry
  • Use of Nutrient Content Claims for Added Sugars in the Labeling of Human Food Products: Draft Guidance for Industry
  • Amendment to Guidance for Industry: Menu Labeling Supplemental Guidance
  • Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein:  Guidance for Industry

Stakeholders should monitor the Federal Register for the opportunity to comment on guidance that affects their business operations. More information can be found here.

USDA Updates

USDA Reports on Salmonella Trends
February 10: The National Antimicrobial Resistance Monitoring System (NARMS) released a report highlighting Salmonella antimicrobial resistance (AMR) trends from 2014-2019. The report outlines the trends in antibiotic resistance in slaughter facilities and is linked here.

USDA Aligning Regulations for Cured and Cooked Meats
February 21: USDA has issued notice to revise the regulations for cured or cooked meat from regions where foot-and-mouth disease exists to reflect changes to the USDA FSIS regulations regarding thermally processed, commercially sterile meat. The Federal Register notice can be found here.

Other Developments

Child Labor Caught in Tug of War During Labor Shortage
In Michigan, a New York Times article exposing the employment of migrant children led to the Department of Labor and Department of Health & Human Services announcing action to “increase their efforts to thoroughly vet sponsors of migrant children, investigate child labor violations and hold the companies accountable.” More information on the New York Times article can be found here.

This Regulatory Update covers information for February 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.

Regulatory Update: January 1 – January 31, 2023

This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including the deadline for front of package labeling comments, a Legionnaire’s Disease outbreak, FSIS guidelines for label approval, and more.

FDA Updates

FDA Commissioner Califf Proposes Redesign of Human Food Program
FDA Commissioner Robert Califf announced a new vision for the FDA Human Foods Program that would unify the functions of the Center for Food Safety and Applied Nutrition (“CFSAN”), the Office of Food Policy and Response (“OFPR”), and certain functions of the Office of Regulatory Affairs. The Agency seeks to kick off the restructuring by appointing a new Deputy Commissioner of the Human Foods Program and establishing an Advisory Committee. The announcement can be found here.

Front of Package Labeling Comments Open Until March 27
The FDA is seeking comments regarding front of package (“FOP”) labeling and information in contemplation of a system to help consumers interpret the nutrient information on food products. The increased attention in recent years to FOP labeling, and the experiences of countries that have adopted FOP labeling, suggests that FOP labeling may aid consumer’s nutrition comprehension and lead to healthier choices. The request can be found here, and comments are due March 27, 2023.

FDA Allows Vitamin D in Breakfast Cereals and Grain-Based Bars
The FDA is amending its food additive regulations to provide for the safe supplementation of vitamin D3 in breakfast cereals and grain-based bars, and to update the Vitamin D3 specifications. The Agency is taking this action in response to a petition filed by Kellogg Company, and the Register Notice can be found here.

Final Guidance on Foreign Supplier Verification Programs Arrives
The FDA has issued a final guidance entitled “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry.” This guidance document covers how importers of food for humans and animals can comply with the regulation on foreign supplier verification programs (FSVPs). These regulations were enacted on November 27, 2015, and a draft guidance of the same title was issued January 24, 2018. The final guidance can be found here.

FDA Punts on CBD Rules
The FDA denied three citizen petitions that asked it to conduct rulemaking to allow the marketing of CBD products as dietary supplements. The FDA opted to work with Congress on a new way forward, as the existing regulations are not appropriate for CBD Products. The announcement can be found here.

FDA Seeks Comments on Food Additives and Color Additive Petitions
The FDA is seeking comments until April 4, 2023 on several topics related to food additive petitions and color additive petitions (“FAPs and CAPs”) used in food production. The Agency is requesting feedback on the information collection provisions and the labeling requirements. More information can be found here.

Final Guidance on Practices to Prevent Contamination of Medicated Feeds Now Available
A final guidance has been released by the FDA describing practices that medicated feed manufacturers should use to prevent unsafe contamination from drug carryover into a non-medicated animal feed and to prevent an animal feed containing a different approved new animal drug. Errors surrounding medicated feed are a huge liability to feed producers. This guidance provides details on preventative measures such as cleanout, flushing, and sequencing that the Agency will expect to see implemented in forthcoming inspections. Feed producers should view the guidance found here.

FDA Warning Letters

Hummus and Cheese: A ready-to-eat hummus and cheese manufacturing facility was issued a warning letter after investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (“CGMP & PC rule”).

Salmonella Outbreak Leads to Warning Letter for J.M. Smucker: An inspection was initiated as part of a multistate foodborne outbreak investigation of Salmonella illnesses linked to the manufacturer’s Jif peanut butter. Investigators found serious violations of the CGMP & PC rule. The Agency had concerns associated with water allowed to puddle in the facility. Environmental monitoring showed multiple positive environmental swabs. However, the outbreak was not contained.

Legionnaire’s Disease Outbreak: After three passengers were diagnosed with Legionnaire’s disease aboard American Cruise Line Cruises, the company was inspected and subsequently issued a warning letter. During the inspection, FDA investigators collected biofilm swabs and potable water samples from the vessels which identified Legionella in the potable water system.

Low-Acid Canned Food Recall Leads to Warning Letter: A commercial processor of low-acid foods packaged in hermetically sealed containers was issued a warning letter after the processor released product with microbiological contamination (Cronobacter sakazakii and Clostridium botulinum) and continued processing. Intensive action has since been taken as the processor has recalled products and taken steps to correct the contamination issue.

A database of warning letters issued by the FDA can be found here.

USDA Updates

USDA Strengthens Certified-Organic Regulations
USDA has strengthened the National Organic Program (“NOP”) with the intent to reduce the incidences of suppliers selling conventional products as certified organic. One change is that the new rules will require the use of NOP import certificates for all organic products entering the United States. Changes go into effect March 19, 2024. More information can be found here.

USDA FSIS Issues Strategic Plan for 2023-2026
USDA’s FSIS has released its strategic plan for 2023-2026 with three strategic goals: “Prevent Foodborne Illness and Protect Public Health,” “Transform Inspection Strategies, Policies, and Scientific Approaches to Improve Public Health,” and “Achieve Operational Excellence.” More information can be found here.

USDA FSIS Issues Guidelines for Label Approval
USDA’s Food Safety and Inspection Service (“FSIS”) has released guidance to help establishments determine whether their labels must be submitted to FSIS Labeling and Program Delivery Staff (LPDS) for approval. The guidance expands the generic labeling approval of meat, poultry, and eggs products. More information can be found here.

Consumer Reports Promotes Petition to Ban Red Dye No. 3
Consumer Reports has been on the offensive against Red Dye No. 3, which is already banned in cosmetics but allowed in foods. According to the organization, the dye has been linked to hyperactivity and other neurobehavioral effects in children. More information can be found here on Consumer Reports’ website.

Other Items of Interest

Plaintiff’s Suit Secures $4 Million for Victim of an Ice Cream Listeria Outbreak
A judge awarded $4 million in damages to the family of a 79-year-old woman that died as a result of a listeria outbreak in Big Olaf Creamery’s Ice Cream.

This Regulatory Update covers information from January 1 – January 31, 2023. Please contact Paul Benson, Taylor Fritsch, Liz Simonis, 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.

Regulatory Update: December 1 – December 31, 2022

This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including the adding of sesame to the major allergen list, listeria in ice cream, the legalization of raw milk, and more.

FDA Updates

Reminder: Sesame Added to Major Allergen List
The Food Allergy Safety, Treatment, Education, and Research Act of 2021 established sesame as the 9th major food allergen. As of January 1, 2023, any food containing sesame is subject to specific food regulatory requirements regarding major allergens. At the end of November, the FDA issued a question-and-answer guidance document to help provide information regarding the new labeling requirements for products containing sesame. The guidance can be found here.

FDA Releases 2022 Food Code
The annual update (and 30th edition) of the Food Code was released by the FDA in December. The 2022 Food Code specifically addresses food donations, creates new requirements for the allowance of pet dogs in outdoor dining spaces and revises the definition of intact meat. It also updates provisions related to sesame which is now a major food allergen. A summary of the changes, more information, and a copy of the 2022 Food Code can be found here. 

FDA Denies Requests From Industry on Yogurt Standards
The FDA received objections and requests for a hearing from the International Dairy Foods Association (IDFA) and Chobani, Inc. on a final rule published on June 11, 2021, which revoked the standards of identity for lowfat yogurt and nonfat yogurt and amended the standard of identity for yogurt in numerous respects. The FDA denied the request on Dec. 15th, 2021 which lifted the stay of the effectiveness on the final regulation. Though the objections and requests were not moved forward by the FDA, the changes were a major advocacy win for the industry as seeks to modernize. The final regulation comes into force on January 17, 2023 with a deadline for compliance on Jan. 1, 2024. The notice in the Federal Register can be found here.

FDA is Seeking Public Comments on Proposed Collection of Information Related to Animal Feed
The FDA is seeking public comment on the proposed collection of certain information by the Agency related to animal feed including dog, cat, cattle, horse, and livestock feed. The Center for Veterinary Medicine and the Partnership for Food Protection developed a web-based tracking network to allow Federal, State, and Territorial regulatory and public health agencies to share safety information about animal food. The notice in the Federal Register can be found here.

FDA Releases Guidance for Best Practices for Convening GRAS Panel
The FDA released a final guidance for industry entitled “Best Practices for Convening a GRAS Panel.” The guidance helps individuals involved in the process of determining if a substance may be used in food on the basis that it is Generally Recognized as Safe (“GRAS”). The guidance can be found here.

FDA Warning Letters

Listeria in Ice Cream: December’s lone warning letter was issued to a Ice Cream producer after a Listeria outbreak linked to one death and one fetal fatality was traced back to the facility. The ice cream products were found to be adulterated because they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. The inspection also cited serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation. No response was issued to the Form 483 and the December 9 warning letter was subsequently issued.

A database of warning letters issued by the FDA can be found here.

USDA Updates

FSIS Sets January 1, 2026, for Implementing Meat and Poultry Labeling Regulations
FSIS established January 1, 2026, as the uniform compliance date for new meat and poultry product labeling regulations that will be issued between January 1, 2023 and December 31, 2024. This gives packers time to implement changes as a result of new meat and poultry product labeling regulations to minimize the economic impact of label changes. As new labeling requirements are issued, meat and poultry packers should keep this timetable in mind.

USDA Publishes Pesticide Residue Results
The 2021 Pesticide Data Program was released and reflected producers’ commitment to halt pesticide residues in food. Each year, the USDA and EPA work together to sample thousands of food products for pesticide residues. Overall, over 99% of the 10,127 samples tested had residues below the tolerances established by the EPA, with 24.0% having no detectable residue.  Residues exceeding the tolerance were detected in only 54 samples and of those detections, 29 were domestic (53.7%), 24 were imported (44.4%), and 1 was of unknown origin (1.9%). The full Pesticide Data Program Summary can be found here.

Other Items of Interest

FDA Faces Heavy Scrutiny for Lack of Leadership Despite Increasing Budget
Earlier this year, Commissioner Robert Califf authorized an independent evaluation of the FDA by the Reagan-Udall Foundation to evaluate the agency’s human food program and provide recommendations for the agency. Major questions surrounding the FDA include whether the food divisions should be severed from the agency to form a new agency reporting directly to HHS. The report weights the options and cites the current culture including a lack of clear vision, disparate structure, and lack of leadership as major factors in the agency’s struggle. There is a silver lining for the agency: a recently signed omnibus spending bill covering FY 2023 appropriations funding gives the FDA an additional $226 million in budget authority funding, a more than 6.5% increase. Changes are expected as food security gets a larger focus from the FDA. The full Reagan-Udall Report can be found here. 

Group Urges for the Inclusion of Cranberries in the Definition of “Healthy”
A bipartisan group of twenty-eight (28) House Members and Senators joined together to urge the FDA to amend its proposed definition of “healthy” to include more cranberry products. The current proposed rule would exclude most cranberry and tart cherry products.

Missouri Seeks to Legalize the Sale of Raw Milk
This January, the Missouri Legislature will look at legislation that would legalize the sale of Grade A raw milk or cream in Missouri as long as it has a clearly marked warning label. This follows the apparent trend of relaxing food laws gaining popularity within state legislatures over the last ten years.

Hershey’s is Among Chocolatiers Facing Scrutiny for Lead and Heavy Metals
In December 2022, a suit was filed in a New York federal court related to lead and cadmium levels in chocolate bars. This isn’t the only bitter news for chocolatiers. The National Confectioners Association has had to defend the safety of dark chocolate after Consumer Reports brought attention to the amount of cadmium and lead in the products in a report issued December 15, 2023. This likely signals an increased focus on heavy metals in chocolate products moving forward.

This Regulatory Update covers information from December 1 – December 30, 2022. Please contact Paul Benson, Taylor Fritsch, Liz Simonis, 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.

Regulatory Update: November 1 – November 30, 2022

This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including the final rule issued for records of products on the Food Traceability List, warning letter for unapproved CBD products, the Biden administration’s investment in meat and poultry processing, and more.

FDA Updates

Draft Guidance on Question and Answers for Allergen Labeling Released  
The FDA released draft guidance that, when finalized, will explain FDA’s current thinking on several issues related to the labeling of food allergens, including requirements in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act).  Comments can be submitted until January 30, 2023. The Register Notice can be found here.

Final Rule Issued for Records of Products on the Food Traceability List 
The FDA is issuing a final rule establishing additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods that the agency designated for inclusion on the Food Traceability List (FTL). The final rule adopts provisions requiring these entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods. FDA is issuing this regulation in accordance with the Food Safety Modernization Act (FSMA). More information from FDA can be found here.

Comment Period for “Healthy” Definition Extended through February
The comment period for the proposed rule entitled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy’ ” was extended by FDA through February 16, 2023.

FDA Allows Spirulina as a Color Additive After Petition
In a response to a petition filed by GNT USA, Inc., the Food and Drug Administration is amending the color additive regulations to allow the safe use of spirulina (Arthrospira platensis) extract as a coloring agent in certain products. The notice can be found here. 

 FDA Issues Updated Manufactured Food Regulatory Program Standards
The U.S. Food and Drug Administration (FDA) has issued revised food safety standards for state regulatory programs, known as the Manufactured Food Regulatory Program Standards (MFRPS), that oversee food facilities that manufacture, process, pack, or hold foods. The update includes changes to defined terms, new job aides, as well as updates to the current standards. More information can be found here.

FDA Warning Letters

Grain Elevator: CHS River Plains was issued a warning letter after an inspection revealed evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.

Feed Mill Warned for VFD Violation: Land View, Inc. was issued a warning letter for various violations at its Rupert Feed Mill. Notably, the letter cited VFD requirement violations after feed was produced with an incorrect level of oxytetracycline.

CBD Companies Warned: Five companies that produce CBD gummies, fruit snacks, lollipops, pet treats, and more were issued warning letters for selling unapproved CBD products. The warning letters emphasized the products’ appeal to children. This could explain the focus on the CBD product despite the largely temperate response the agency has to CBD which is not allowed in foods sold interstate commerce.

Response to Hepatitis A in Strawberries: Bainbridge Beverage West was issued a warning letter for serious violations of the FDA’s juice Hazard Analysis and Critical Control Point (HACCP) regulation related to their response to a potential contamination of Hepatitis A in strawberries used in their products.

Cardiovascular Claim Crackdown: In November, FDA warned seven companies for selling dietary supplements with claims to treat cardiovascular disease. The warning letters were issued to: Essential Elements (Scale Media Inc.); Calroy Health Sciences LLC; BergaMet North America LLC; Healthy Trends Worldwide LLC (Golden After 50); Chambers’ Apothecary; and Anabolic Laboratories, LLC.

Winfrey’s Olde English Fudge: A Massachusetts fudge company was issued a warning for misbranding and adulteration after inspectors found labeling and preventive control violations.

Claims for Herbal Teas: Wise Woman Herbals was issued a warning letter for making multiple drug claims on their website.

Dollar Tree: Dollar Tree was issued a warning letter for serious pest issues. Highlights include numerous dead animals found through the warehouse, and samples of human food products were tested and found to be contaminated with rodent urine, excreta, and hair.

A database of warning letters issued by the FDA can be found here.

USDA Updates

USDA Organic Standards Board Updates National List
The Organic Standards Board submitted recommendations for updates to the National List of Allowed and Prohibited Substances. The National List identifies the synthetic substances that may be used and the non-synthetic (natural) substances that may not be used in organic crop and livestock production.  This rule allows low-acyl gellan gum and paper-based crop planting aids, adds a definition for “paper-based crop planting aids” to 7 CFR 205.2, and replaces the term “wood resin” at 7 CFR 205.605(a) with the term “wood rosin” to reflect the popular spelling. The Federal Register notice can be found here.

Biden-Harris Administration Invests in Meat and Poultry Processing
USDA Secretary Tom Vilsack announced the investment of $73 million in projects through the first round of the Meat and Poultry Processing Expansion Program (MPPEP). The goal is to increase meat processing capacity and competition to deliver lower meat costs to working families. The press release can be found here.

USDA Updates Listeria and E. Coli Procedures in Two Directives
The FSIS’s new directive provides Enforcement, Investigations and Analysis Officers (EIAOs) with instructions for collecting samples under the routine risk-based Listeria monocytogenes (RLm) sampling program. Information on the new sampling procedures can be found here. Similarly, FSIS expanded its routine testing of beef for six Shiga toxin-producing E. Coli strains. Information for those testing procedures can be found here.

Other Items of Interest

GAO Weighs In on FDA’s Role in Food Packaging
A report issued by the Government Accountability Office suggested the FDA could do more to ensure that food packaging products, like bags around salads or bread, are safe. There has been recent interest on whether compounds such as PFAs could leech into the food. The GAO has made two recommendations to FDA in support of their oversight of food packaging. The first recommends that the agency request specific legal authority from Congress to compel companies to provide the information needed to reassess the safety of substances. The second recommendation is for the FDA to track the dates of the last reviews for all food contact substances to allow FDA to easily identify substances that may need review.  The recommendation can be found here. 

Food Illness Outbreak Report for 2020 Released
On November 4, 2022, the Interagency Food Safety Analytics Collaboration’s (IFSAC) newest annual report, “Foodborne illness source attribution estimates for 2020 for Salmonella, Escherichia coli O157, and Listeria monocytogenes using multi-year outbreak surveillance data, United States,” was released. The update helps to shape agency priorities and determine if prevention measures are working. While the report attributes Salmonella to a variety of foods, it links E. coli O157 to vegetable row crops and Listeria monocytogenes to dairy products, fruits, and vegetable row crops. The full report can be found here.

Consumer Brands Association Urges FDA to Modernize
Sarah Gallo, vice president of product policy for the Consumer Brands Association (formerly known as the Grocery Manufacturers Association), urged the FDA to “create a modernized regulatory system, paired with key structural and governance changes, to better provide for consumer safety and keep pace with rapidly evolving consumer preferences and growing opportunities to introduce innovative products to the marketplace.” The article includes nine policy points by the CBA and can be found here.

This Regulatory Update covers information from November 1 – November 30, 2023. Please contact Paul Benson, Taylor Fritsch, Liz Simonis, 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.

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