Regulatory Update: August 1 – September 30, 2022

This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including available funding to create USDA Regional Food Business Centers, human and animal food facility registration renewal, Salmonella being added as an adulterant to breaded and stuffed chicken products, and more.

FDA Updates

MUST READ: Registration Renewal for Human and Animal Food Facilities Runs from October 1 to December 31
FDA is reminding facilities to renew human and animal food facility registrations. FDA will consider the registration of a food facility to be expired if a facility’s registration is not renewed by December 31, 2022. There is no fee associated with registration or renewal. Owners, operators, or agents in charge of food facilities must submit their renewal information electronically through their FDA Industry Systems account, unless they have received a waiver that allows for paper submission. More information can be found here.

White House and FDA Look to Define the Term “Healthy” with Proposed Rule
FDA has proposed an update to the definition for the use of the claim “healthy” and will seek comments from the public until December 28, 2022. “Healthy” has been used for centuries to describe food, but regulation around the term has been a challenge. On the heels of the White House Conference on Hunger, Nutrition, and Health, FDA has released a proposed rule that, if finalized, will prescribe regulatory requirements for using the term “healthy” in food labeling. A regulatory definition would be helpful to food manufacturers looking to ensure labels are truthful and non-misleading and limit risk of consumer actions associated with “healthy” claims. The proposed rule can be found here, in the Federal Register. To ensure consideration, comments on the proposed rule must be submitted by December 28.

FDA Releases Prevention Strategies to Enhance Food Safety in Mushrooms and Onions
In September, the FDA released food safety strategies to help prevent food safety issues in mushrooms and onions. The prevention strategies build on the foundational work established by the Food Safety Modernization Act (FSMA) and FDA’s Strategy for the Safety of Imported Food. The first two strategies include actions for addressing Salmonellosis and Listeriosis associated with imported enoki and wood ear mushrooms, as well as Salmonellosis associated with bulb onions. More information can be found here.

Comment Period Reopening for Information on the Use of Ortho-Phthalates for Food
The FDA is seeking comments through December 27, 2022, regarding the use of Ortho-phthalates in food contact products. Ortho-phthalates may be used as plasticizers for polymers, most commonly poly (vinyl chloride), to make the polymers less brittle or to soften them. These polymers are then used in a wide range of products, such as toys, vinyl flooring and wall covering, detergents, lubricants, food packaging, pharmaceuticals, and personal care products.

FDA Releases Overview of Activities Underway to Enhance the Safety of Imported Produce
In September, the FDA has released an overview of its comprehensive approach to enhancing the safety of food imported into the United States. The Agency seeks to provide an overview of the work underway to advance the safety of produce imported into the United States. The Overview can be found here.

Petition to Amend Color Additive Regulations to Include Calcium Carbonate
A petition was submitted proposing to amend the color additive regulations in 21 CFR § 73.70 “Calcium Carbonate,” by expanding the permitted uses of calcium carbonate to include use in dietary supplement tablets and capsules, including coatings and printing inks, in amounts consistent with good manufacturing practice. The petition can be found here.

FDA Releases Q & A on Shell Egg Rule
The Agency’s new guidance explains the FDA’s current interpretation of the requirements in the egg rule with regard to production systems that provide laying hens with access to areas outside of a poultry house. The questions and answers cover definitions, Salmonella enteritidis (SE) prevention measures, and environmental sampling for SE. The guidance can be found here.

FDA Announces the Renewal of the Allergenic Products Advisory Committee
The FDA Commissioner has determined that it is in the public interest to renew the Allergenic Products Advisory Committee for an additional 2 years beyond the charter expiration date. The nine-member committee reviews and evaluates the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic disease, and makes appropriate recommendations to the Commissioner of Food and Drugs of its findings. The new charter will be in effect until the July 9, 2024 expiration date.

FDA Hires External Experts to Evaluate Parts of Agency
FDA Commissioner Robert Califf announced he has recruited new external agency experts to conduct a comprehensive evaluation for the Agency’s human foods program, including the Office of Food Response and Policy (OFPR), Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parts of the Office of Regulatory Affairs (ORA). This comes after criticism of the Agency and calls for changes from both side of the political aisle.

FDA Releases Final Guidance Regarding “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House): Questions and Answers Regarding the Final Rule.”
This guidance provides recommendations on how egg producers who allow hens access to areas outside the poultry house can meet requirements to prevent Salmonella Enteritidis (SE) from contaminating shell eggs on the farm. The guidance designates porches as areas outside of the poultry house and would allow egg producers the ability to provide laying hens with access to areas outside the poultry house, which includes porches, outdoor runs and pastures, and still comply with the egg rule. To be compliant, egg producers must take steps to ensure there is no introduction or transfer of SE into or among poultry houses. The Guidance can be found here.

FDA adds Fumonisin Esterase to Permitted Feed and Drinking Water Additives for Swine
After receiving a petition for Biomin GmbH, FDA is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of fumonisin esterase to degrade fumonisin mycotoxins present in swine feed. A link to the final rule can be found here.

FDA Releases FY 2020 Pesticide Residue Monitoring Program Report
The FDA released the annual Pesticide Residue Monitoring Program Report for Fiscal Year 2020, summarizing findings from the program’s monitoring of human and animal foods in FY 2020. The report can be found here.

FDA Releases Final Guidance on Enforcement Discretion of Certain NAC Products
FDA announced the availability of a final guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). The guidance indicates the Agency’s intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products that are labeled as dietary supplements to permit the use of NAC in or as a dietary supplement. This enforcement discretion policy applies to products that would be lawfully marketed as dietary supplements if NAC were not excluded from the definition of “dietary supplement,” and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance can be found here.

FDA Moves into the Future with the Third Phase of Artificial Intelligence Imported Seafood Pilot Program
The FDA is using AI to strengthen import screening in its Imported Seafood Pilot program which is entering its third phase. The third phase will help to determine the feasibility of deploying in-house AI and Machine Learning models using the intelligence that FDA extracts from the data we collect reviewing millions of import entries per year. The Success in the Seafood Pilot Program is a good indicator of future screening methods for other products being imported. An update can be found here.

FDA Issues 2022 Voluntary National Retail Food Regulatory Program Standards
In August, the FDA release an update of The Retail Program Standards. The Retail Program Standards provide recommendations for designing and managing retail food regulatory programs and help regulatory jurisdictions (or other responsible organizations) facilitate more effective inspections, implement foodborne illness prevention strategies, and identify program areas in need of improvement. The Standards can be found here.

FDA Warning Letters
  • Deggeh Foods, Inc.: The company sold several misbranded dietary supplements that contained unapproved new drugs with various unsupported claims. When inspected, the facility had serious CGMP violations leading to product adulteration violations.
  • Oregon’s Wild Harvest, Inc.: The company’s CGMP program was found to have a variety of issues resulting in a warning letter citing adulteration.
  • Nutritional Laboratories International, Inc. dba Elite One Source Nutritional Services, Inc.: The company was issued a warning letter for adulteration after several mistakes were found on the product labels.
  • The Elderberry Fairy & Co., LLC: The FDA issued a warning letter based on numerous health claims made on the company’s website and social media that listed the products as intended for use in the cure, mitigation, treatment, or prevention of diseases.
  • Sun Sen Co. Inc.: The FDA issued a warning letter citing adulteration after an inspection found the bean and sprout facility were preparing, packing, or holding the product in insanitary conditions.
  • International Seafood HACCP Focus: Myllan-ORA ehf, an Icelandic company, Mahi Frozen Foods, a Pakistani Company, Vlazar Costa Caribe S.A., a Nicaraguan company, and CR Grupo Comercial Alvacora S.A., also a Nicaraguan company, were issued warning letters for violations of the seafood HACCP regulation.
  • The Royal Ice Cream Company Inc.: The ice cream manufacturer was issued a warning letter for adulteration in that the products were prepared, packed, or held in insanitary conditions. The inspection revealed two positive swabs for Listeria monocytogenes, a bacterium for which the facility had previously had positive swabs.

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

USDA Updates

USDA Announces $400 million in Funding Available to Create USDA Regional Food Business Centers
The USDA announced plans to use $400 million to fund USDA Regional Food Business Centers. The newly formed Regional Food Business Centers will provide coordination, technical assistance, and capacity building to help farmers, ranchers, and other food businesses access new markets and navigate federal, state and local resources, thereby closing the gaps and barriers to success. More information can be found here.

USDA Adds Salmonella as an Adulterant to Breaded and Stuffed Chicken Products
On August 1, 2022, USDA’s Food Safety and Inspection Service (“FSIS”) announced it will be declaring Salmonella an adulterant in breaded and stuffed raw chicken products. The notice is expected to publish in the Federal Register in the fall. FSIS will be proposing to set the limit at 1 cfu of Salmonella per gram for these products, a level that the Agency believes will significantly reduce the risk of illness from consuming breaded and stuffed raw chicken products. FSIS will be seeking public comments that address what the standard should be as well as to inform a final implementation plan, including a verification testing program. When the proposal is finalized, FSIS will announce its final implementation plans and the date it will begin routine testing for Salmonella in these products. More information can be found here.

Judge Backs Most of GMO Labeling Rule but Stops Short for QR Codes
A California federal judge on Wednesday shot down the majority of claims challenging a Trump-era organic food labeling rule but sided with food advocacy groups in ruling that electronic quick response codes aren’t adequate methods of informing shoppers that food was bioengineered.

Other Items of Interest

New Traceability Rule Becomes Official on Nov. 7
A variety of foods will have added traceability requirements as the FDA seeks to tighten safety of high-risk foods. The onerous requirements will likely shift the last holdouts of pen and paper recordkeeping to a barcode system, a cost that the Agency feels the benefits outweigh. For information on the requirements and a list of impacted foods, an overview of the proposed rule can be found here.

Growing Support for Including Environmental Issues in the Farm Bill
A letter signed by more than 150 organizations, and addressed to President Joe Biden, calls for the next farm bill to address economic inequality, racial divides, hunger, climate change, nutrition and food safety while supporting farmers, workers, and communities. This could signal a shift in farm policy toward ESG initiatives in the 2023 farm bill. A copy of the letter can be found here.

Former Blue Bell President Avoids Conviction for Listeria Deaths
A hung jury led to the acquittal of the former CEO of Blue Bell, who faced charges for alleged fraud and conspiracy committed during a Listeria outbreak in Blue Bell Ice Cream Products that killed three people. Nineteen expert researchers concluded that the lack of regulatory oversight was responsible for the low-level contamination without detection for years. Ice cream was not seen as a source of listeriosis before this outbreak, which has triggered increased scrutiny of ice cream manufacturers.

FDA Announces Targeted Sampling, Additional Efforts to Enhance the Safety of Leafy Greens
Under the Leafy Greens STEC Action Plan (LGAP), the FDA is announcing targeted sampling of leafy greens grown during the fall 2022 harvest season in the Salinas Valley region of California, releasing results from a 2021 sampling assignment, and providing an update on other work under the action plan. More details on the FDA’s action plan can be found here.

Canada Modernizes Food Labelling Framework and Moves Saturated Fats, Sugars, and Sodium Front and Center
The Canadian Government has updated the requirements for labelling prepackaged food products (Modernized Food Labelling Framework). Health Canada has also introduced a new requirement for front-of-package nutrition symbol labelling for select prepackaged products containing nutrients of public health concern (saturated fat, sugars, and sodium), and updated the requirements for certain nutrient content claims. Advocacy group the Center for Science in the Public Interest and other health groups have asked the FDA to require front-of-package nutrition labels to inform consumers about nutritional content of packaged foods.

California Plastics Law Impacts Packaging, Single-Use Service Ware Manufacturers Across the Country
California’s Plastic Pollution Prevention and Packaging Producer Responsibility Act (SB 54) will impose new sustainability regulatory requirements on all businesses manufacturing single-use packaging or plastic single-use service ware. Companies that produce these products must join a Producer Responsibility Organization by Jan 1, 2024, or they will be prohibited from selling, offering for sale, importing, or distributing such covered materials in California. These organizations are asked to reduce the amount of plastic packaging by 25% by 2032. A copy of the Act can be found here.

This Regulatory Update covers information from August 1 – September 30, 2022. Please contact Paul BensonTaylor 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

Leave a Reply

%d bloggers like this: