Regulatory Update: May 1 – May 31, 2023

This update includes FDA updates, USDA updates, and FDA warning letters, including a draft compliance guide for major food allergen labeling, the availability of FSIS Ready-to-Eat Fermented, Salt-cured, and Dried Products Guideline, and more.

FDA Updates

Draft Compliance Guide Available for Major Food Allergen Labeling and Cross-contact
May 16: The FDA released a draft Compliance Policy Guide (CPG) entitled “Sec. 555.250 Major Food Allergen Labeling and Cross-contact” for public comment. The CPG, when finalized, will replace existing guidance for FDA staff on FDA’s enforcement policy regarding major food allergen labeling and cross-contact. The current CPG was written before the enactment of the Food Allergen Labeling and Consumer Protection Act (2004), FDA Food Safety Modernization Act (2011), and the Food Allergy Safety, Treatment, Education and Research Act (2021). The current CPG also does not reflect requirements in FDA’s regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.”

The draft CPG describes (1) the labeling requirements for major food allergens and the proper use of the ingredient list and the “Contains” statement for major food allergen declarations; (2) requirements for firms to implement controls to prevent or significantly minimize allergen cross-contact; (3) describes additional allergen labeling violations; and (4) directs FDA staff to examine potential product adulteration due to allergen cross-contact as well as potential labeling violations. Comments on the draft CPG are due July 17, 2023. A copy of the draft CPG can be found here along with a link for submitting comments.

FDA Releases Small Entity Compliance Guide on Requirements for Additional Traceability Records for Certain Foods
May 18: The FDA published a Small Entity Compliance Guide (SECG) entitled “Requirements for Additional Traceability Records for Certain Foods: What you need to know about the FDA Regulation” to help small entities comply with the final rule. The Food Safety Modernization Act Food Traceability Rule was issued in November 2022 and the compliance date for recordkeeping requirements is January 20, 2026. The SECG can be found here.  More information about the Food Traceability Rule can be found here.

FDA Receives Color Additive Petition Regarding Use of Titanium Dioxide in Food
May 3: Earlier this year, FDA received a color additive petition from Environmental Defense Fund, et al., asking the agency to revoke the color additive listing for the use of titanium dioxide in food. On May 3, FDA published notice of the filing in the Federal Register. The petitioners assert that the intended use of this color additive no longer meets the safety standard under 21 CFR 70.3(i). A copy of the petition can be found here. Comments on the petition are due by September 1, 2023 and may be submitted using the link here.

FDA Warning Letters

In May 2023, the FDA posted nine warning letters, including the following notable letters:

FSVP: FDA issued three warning letters related to alleged violations of the Foreign Supplier Verification Program (FSVP). 

Produce Safety: A warning letter was issued to a Nebraska-based alfalfa sprouts producer for alleged violations of the Produce Safety Regulation (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption).

Unapproved New Drug: A warning letter was issued to an Oregon entity selling tea and herbal products alleging the use of marketing claims that render the products an unapproved new drug.

A database of warning letters can be found here.

USDA Updates

Availability of FSIS Ready-to-Eat Fermented, Salt-cured, and Dried Products Guideline
May 5: USDA’s Food Safety and Inspection Service (FSIS) announced the availability of a guidance document for manufacturing ready-to-eat (RTE), shelf-stable, fermented, salt-cured, and dried meat and poultry products that do not use cooking as the primary lethality step. The guideline addresses commonly asked questions concerning the food safety hazards associated with these products and the key steps in each process to ensure safety. This guideline replaces and expands upon information previously found in other guidance documents addressing the safe production of RTE fermented meat and poultry products. FSIS also published Instructions for Training associated with the guideline. The Ready-to-Eat Fermented, Salt-cured, and Dried Products Guideline can be downloaded here and Instructions for Training can be downloaded here.

This Regulatory Update covers information for May 2023. 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

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