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 These regulations were enacted on November 27, 2015, and a draft guidance of the same title was issued January 24, 2018.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 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 michaelbest.com.

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