Regulatory Update: October 1 – October 31, 2023

This update includes FDA updates, FDA warning letters, USDA updates, and other articles of interest, including a proposed ban of brominated vegetable oil, new draft guidance on allergens and acidified foods, a raw milk bacteria outbreak, and more.

FDA Updates

Listing of Jagua Blue Color Additive Exempt from Certification – Final Rule
November 3: FDA is amending the color additive regulations to provide for the safe use of jagua (genipin-glycine) blue as a color additive in various food categories at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) submitted by Exponent, Inc. on behalf of Ecoflora SAS (Ecoflora). The final rule is effective December 4, 2023.  Objections and requests for a hearing on the final rule must be submitted by December 4, 2023.  More information can be found here.

FDA Proposes to Ban Brominated Vegetable Oil in Food
November 2: The FDA proposed to ban brominated vegetable oil (BVO) previously used in soft drinks. BVO was authorized for use in small amounts.  However, after further study, FDA concluded that BVO use in no longer safe due to potential adverse health effects linked to thyroid, heart and liver issues. The proposed rule would revoke the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. Written comments on the proposed rule must be submitted by January 17, 2024. More information can be found here.  The proposed rule and information on how to submit comments can be found here.

FDA Files Food Additive Petition from Kerry Ingredients and Flavours Ltd
October 13: The FDA filed a petition submitted by Kerry Ingredients and Flavours Ltd. (“Kerry”) proposing that food additive regulations be amended to provide for the safe use of vitamin D3 as a nutrient supplement in powdered drink mixes added to water or carbonated water, excluding drinks or drink mixes that are specially formulated or processed for infants.  Kerry submitted the petition on April 26, 2023. More information can be found here.

FDA Information Collection Activities Announced for Recall Regulations
October 13: FDA is inviting comments on FDA Recall Regulations pertaining to the following topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA’s functions; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents.  Written comments on the collection of information are due by December 12, 2023.  More information can be found here.

FDA Information Collection Activities Announced for Food Canning Establishment Regulations
October 12:  FDA is inviting comments on registration of food processing establishments, filing of process or other data, and maintenance of processing and production records for acidified foods and thermally processed low-acid foods in hermetically sealed containers.  The respondents to this information collection are commercial processors and packers of acidified foods and thermally processed low-acid foods in hermetically sealed containers. Written comments on the collection of information are due by November 13, 2023.  More information can be found here.

FDA Released New Draft Guidance on Food Allergens and Acidified Foods
October 3:  As previously reported, FDA announced the availability of two additional draft chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, designed to help food facilities comply with the preventive controls for human food rule mandated by the FDA Food Safety Modernization Act, which could result in safer food options for people with allergies to sesame and other food allergens.  The new draft chapters are Chapter 11—Food Allergen Program and Chapter 16—Acidified Foods. Chapter 11 outlines ways to ensure protection from major food allergen cross-contact and to ensure that the finished food is properly labeled with respect to the major food allergens.  Chapter 11 also provides examples of ways manufacturers can significantly minimize or prevent allergen cross-contact and undeclared allergens using current good manufacturing practices. Chapter 16 applies to manufacturers of acidified foods (such as beans, cucumbers or cabbage that have an overall pH of 4.6 or below) and it explains how these manufacturers can use procedures, practices and processes that they have established to meet requirements in the acidified foods regulations.  Comments on the draft guidance must be submitted by March 25, 2024. More information, as well as the draft guidance and information for submitting comments, can be found here.

FDA Updates Food Traceability FAQ
October 2:  The FDA has updated its Food Traceability FAQ to provide additional information about the FDA’s Product Tracing System and explain how the agency intends to conduct initial inspections beginning in 2027.  The Food Traceability Final Rule was published in November 2022, establishing traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods included on the Food Traceability List.  The FDA is developing additional resources and offering technical assistance to help stakeholders come into compliance. The FDA also established a compliance date of January 20, 2026 to allow those subject to the rule time to come into compliance.

FDA Warning Letters

Unapproved New Drugs: FDA issued a warning letter to Day Light Nutrition alleging that its Above the Weather, Diabetic Support Blend, Joint Well, and ViruZap products are misbranded and unapproved new drugs because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.

A database of warning letters can be found here.

USDA Updates

FSIS Examining “Raised Without Antibiotics” Marketing Claim
October 9:  The U.S. Food Safety Inspection Service (FSIS) and the Agricultural Research Service (ARS) are commencing a new exploratory sampling program to assess whether antibiotics residues are detected in cattle intended for the “raised without antibiotics” market.  This sampling program is part of the USDA’s multi-step effort aimed at strengthening the verification of animal-raising claims.  More information can be found here.

Other Articles of Interest

California’s Red Dye No. 3 Food Coloring Ban Puts Pressure on FDA to get off the Sidelines
October 17:  There is new pressure on the FDA to take action on the synthetic food coloring, red No. 3, after California became the first state to pass a law to ban it.  While public health advocates are pressuring FDA to remove red dye from the food supply nationwide, manufacturers are pushing back.  According to a letter from the National Confectioners Association (“NCA”) to FDA, the California ban would create a patchwork of state requirements that could increase food costs and create confusion among consumers.  Confectioners are faced with a lack of federal expertise and authority needed to dispel myths and confusion, and correct misinformation about the food ingredients and additives.  NCA says “it’s time for the FDA to get off the sidelines and clear up this misinformation because California is out of its depth regarding national food safety standards and regulatory processes. That expertise and authority rests with the FDA alone.”  According to an FDA spokesperson, the FDA is reviewing a petition from consumer advocacy groups to halt the use of red No. 3 in foods and will assess whether there is “sufficient data” to revoke its use.  More information can be found here and here.

Raw Milk Leads to Bacteria Outbreak in Wyoming and Utah
October 12:  In September, one adult and four children became ill after drinking raw, unpasteurized milk in Wyoming.  The patients were infected with campylobacter and E. Coli bacteria.  State investigators traced the Wyoming illnesses to consuming raw milk or raw milk products but did not identify the specific seller.  Meanwhile, public health official in Salt Lake County, Utah, are investigating an outbreak associated with raw, unpasteurized milk.  The Salt Lake County Health Department confirmed 14 people with infections from campylobacter and all but two of the patients reported drinking raw milk before becoming sick.  The source of the Utah raw milk has not been determined.

This Regulatory Update covers information from October 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

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