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 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 However, the agency is also issuing a companion proposed rule in case the direct final rule is withdrawn because significant adverse comments are received, and the agency needs to move forward with a proposed rule to put these changes in place.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.
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.