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Legal and Regulatory updates for the food and supplement industry

ALLERGENS

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FDA to Discuss Allergen Thresholds in Three-Day Public Meeting

Posted on August 19, 2025
  • FDA will hold a virtual public meeting on November 18-20, 2025, to discuss food allergen thresholds and their potential applications. The first day of the meeting will feature presentations and
… Continue Reading FDA to Discuss Allergen Thresholds in Three-Day Public Meeting

FDA Issues Two Final Guidance Documents on Allergens

Posted on January 7, 2025
  • On January 6, 2025, FDA released two final guidance documents concerning food allergens. The guidance documents represent the Agency’s current thinking related to producing and labeling food products with both
… Continue Reading FDA Issues Two Final Guidance Documents on Allergens

FSIS to Begin Testing for Allergens in Ready-To-Eat Foods

Posted on July 23, 2024
  • USDA’s Food Safety and Inspection Service (FSIS) will begin testing products for the presence of allergens in its new allergen verification sampling program. The sampling will occur at establishments
… Continue Reading FSIS to Begin Testing for Allergens in Ready-To-Eat Foods

FDA’s Updated HARPC Draft Guidance Addresses Concerns Regarding Industry Approach to Sesame

Posted on September 29, 2023
  • As we reported previously, on September 26, 2023, the U.S. Food and Drug Administration (FDA) announced an updated draft guidance designed to assist food facilities with the requirements for
… Continue Reading FDA’s Updated HARPC Draft Guidance Addresses Concerns Regarding Industry Approach to Sesame

FDA Publishes Two New Chapters of Human Foods HARPC Draft Guidance

Posted on September 27, 2023
  • On September 26, FDA announced the availability of two new chapters of the Draft Guidance for Industry: Hazard Analysis and Rick-Based Preventive Controls for Human Food. The two new
… Continue Reading FDA Publishes Two New Chapters of Human Foods HARPC Draft Guidance

FDA Releases Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact

Posted on May 18, 2023
  • On May 16, FDA released a draft Compliance Policy Guide, “Sec. 555.250: Major Food Allergen Labeling and Cross-contact,” to provide guidance for FDA staff on the Agnecy’s enforcement policy regarding
… Continue Reading FDA Releases Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact

FDA Issues Food Allergen Labeling Draft Guidance

Posted on November 30, 2022
  • On November 29, the FDA issued an updated draft guidance document about food allergen labeling requirements: Questions and Answers Regarding Food Allergens, Including Food Allergen Labeling Requirements of the Federal

…
Continue Reading FDA Issues Food Allergen Labeling Draft Guidance

FDA Issues Draft Guidance Regarding Evaluation of Allergens

Posted on April 19, 2022
  • Yesterday FDA announced the release of draft guidance that outlines the Agency’s approach to evaluating the public health risks of allergens that are not among the nine major food allergens

…
Continue Reading FDA Issues Draft Guidance Regarding Evaluation of Allergens

FDA Issues Two Warning Letters for Undeclared Allergens

Posted on May 5, 2021
  • On May 4, the FDA published two Warning Letters for undeclared allergens and the “introduction or delivery for introduction into interstate commerce of any food that is misbranded” which is

…
Continue Reading FDA Issues Two Warning Letters for Undeclared Allergens

Sesame Allergen Labeling Becomes Law

Posted on April 26, 2021
  •  Since the enactment of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the label of a food that contains an ingredient that is or contains protein from

…
Continue Reading Sesame Allergen Labeling Becomes Law

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