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 BensonTaylor FritschLiz 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

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