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Legal and Regulatory updates for the food and supplement industry

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FDA Publishes List of 2023 Priority Guidance Topics

Posted on February 27, 2023
  • FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) routinely publish a list of possible new topics for guidance documents or revisions
… Continue Reading FDA Publishes List of 2023 Priority Guidance Topics

FDA Releases Draft Guidance on Labeling of Plant-Based Milk Alternatives

Posted on February 24, 2023
  • On February 22, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance to ensure appropriate labeling of plant-based products that are marketed and sold as milk alternatives
… Continue Reading FDA Releases Draft Guidance on Labeling of Plant-Based Milk Alternatives

FDA Issues Guidance on Protein Quality Studies for Infant Formula

Posted on February 16, 2023
  • On February 9, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance to manufacturers of infant formula and laboratories conducting testing on infant formula to assist in
… Continue Reading FDA Issues Guidance on Protein Quality Studies for Infant Formula

FDA Finalizes FSVP Guidance for Importers of Human and Animal Food

Posted on January 11, 2023
  • On January 10, the FDA issued a final guidance for the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. As our readers know, under
… Continue Reading FDA Finalizes FSVP Guidance for Importers of Human and Animal Food

FDA Publishes Industry Guidance on Shell Egg Rule

Posted on August 11, 2022
  • On August 10, 2022, FDA announced that it had issued a final guidance document for shell egg producers who provide laying hens with access to outside areas. The guidance intends

…
Continue Reading FDA Publishes Industry Guidance on Shell Egg Rule

FDA Finalizes NAC Enforcement Discretion Guidance

Posted on August 2, 2022
  • FDA issued final guidance regarding its decision to exercise enforcement discretion with respect to the sale and distribution of dietary supplements containing N-acetyl-L-cysteine (NAC). The final guidance is substantively identical

…
Continue Reading FDA Finalizes NAC Enforcement Discretion Guidance

FDA Finalizes Guidance for Animal Food Facilities

Posted on July 7, 2022
  • On July 6, 2022, FDA announced it had finalized its Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. The guidance aims to

…
Continue Reading FDA Finalizes Guidance for Animal Food Facilities

FDA Webinar on Genome-Edited Animals for Food Use

Posted on June 30, 2022
  • On June 27, 2022, FDA’s Center for Veterinary Medicine (CVM) announced that it had published a pre-recorded animal biotechnology case study webinar. The webinar addresses the agency’s risk-based review

…
Continue Reading FDA Webinar on Genome-Edited Animals for Food Use

FDA Publishes Guidance on Oversight of Food Covered by SRAs

Posted on June 22, 2022
  • On June 21, the FDA published a final guidance for FDA staff entitled “FDA Oversight of Food Covered by Systems Recognition Agreements” (SRAs). The guidance covers FDA’s regulatory

…
Continue Reading FDA Publishes Guidance on Oversight of Food Covered by SRAs

FDA Webinar on Action Levels for Lead in Juice

Posted on May 26, 2022
  • FDA will hold a webinar on Tuesday, June 14, 2022, at 1:00 pm (ET) to provide an overview of the recent draft guidance that the Agency issued on action levels

…
Continue Reading FDA Webinar on Action Levels for Lead in Juice

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Keller and Heckman, founded in 1962, has a broad practice in the areas of regulatory law, public policy, and litigation, serving both domestic and international clients. Our firm is a pioneer in the use of interdisciplinary approaches to problem-solving. Since 1971, we have had an in-house scientific staff that works closely with the firm’s attorneys on matters of technical complexity. Many of our attorneys also have government experience and expertise in multiple areas of the law.

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