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INSIGHTS

July 10, 2023

FDA Releases Update for the FDA Foods Program

Update to FDA’s 2023 Priorities for Foods FDA Releases Update of Priority Guidance Topics for the FDA Foods Program

In efforts to provide continued transparency for stakeholders regarding foods program priorities, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Food Policy and Response (OFPR) released an updated list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during 2023. This list updates the guidance agenda released in February 2023.

 

FDA has added the following guidance topics to the agenda for the balance of its 2023 priorities:

  • Draft Guidance on Dietary Supplement Master Files
  • Draft Guidance on Low-Moisture Ready to Eat Foods (including infant formula)
  • Draft Guidance on Action Levels for Arsenic in Food Intended for Babies and Young Children
  • Draft Guidance on Action Levels for Cadmium in Food Intended for Babies and Young Children
  • Amendment to the Menu Labeling Supplemental Guidance
  • Guidance on Protein Efficiency Radio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein

 

Since FDA’s February 2023 agenda goals, FDA has issued the following guidance:

  • Draft guidance for Industry: Questions and Answers About Dietary Guidance Statements in Food Labeling Sec 555.250
  • Major Food Allergen Labeling and Cross-contact Draft Compliance Policy Guide – Guidance for FDA Staff
  • Guidance for Industry: Action Level for Inorganic Arsenic in Apple Juice
  • Draft Guidance for Industry: Insanitary Conditions in the Preparation, Packing and Holding of Tattoo Inks and the Risk of Microbial Contamination

 

FDA’s final and draft guidance documents represent the agency’s current thinking on specific topics which allow businesses to plan for potential changes that may impact their businesses and trade. Stay tuned for more information on FDA’s issuance of these guidance documents and more for the balance of the year.

For any questions on FDA’s Guidance Documents, or for any support on FDA regulatory compliance or enforcement, please contact us at info@garg-law.com.

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I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
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