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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FDA Issues Food Allergen Labeling Draft Guidance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  • On November 29, the FDA issued an updated draft guidance document about food allergen labeling requirements: Questions and Answers Regarding Food Allergens, Including Food Allergen Labeling Requirements of the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Continue Reading FDA Issues Food Allergen Labeling Draft Guidance

FDA Updates Prior Notice of Imported Food Draft Guidance

Posted on September 14, 2022
  • On September 13, the FDA announced the availability of the 4th edition of a draft guidance for industry entitled “Prior Notice of Imported Food Questions and Answers; Draft Guidance

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Continue Reading FDA Updates Prior Notice of Imported Food Draft Guidance

New Draft Guidance on Remote Regulatory Assessments

Posted on July 27, 2022
  • On July 22, the FDA published a draft guidance on conducting Remote Regulatory Assessments. Remote Regulatory Assessments (RRAs) were originally developed during the COVID-19 health emergency and are a set

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Continue Reading New Draft Guidance on Remote Regulatory Assessments

Lawmakers Press White House on FDA’s Draft Guidance for Plant-Based Dairy Alternatives

Posted on June 7, 2022
  • The White House Office of Management and Budget (OMB) received FDA’s proposed guidance on “Labeling of Plant-based Milk Alternatives and Voluntary Nutrient Statements” on March 31, 2022. The draft guidance,

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Continue Reading Lawmakers Press White House on FDA’s Draft Guidance for Plant-Based Dairy Alternatives

FDA Issues Draft Guidance Regarding Evaluation of Allergens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  • Yesterday FDA announced the release of draft guidance that outlines the Agency’s approach to evaluating the public health risks of allergens that are not among the nine major food allergens

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Continue Reading FDA Issues Draft Guidance Regarding Evaluation of Allergens

FDA Publishes List of Priority Guidance Documents

Posted on February 2, 2022
  • On January 31, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released a list of draft and final guidance topics

…
Continue Reading FDA Publishes List of Priority Guidance Documents

FDA Issues New Draft Guidance on Imported Food

Posted on July 12, 2021

FDA Releases Draft Guidance on Oversight of Food Products Covered by Systems Recognition Arrangements

  • On July 12, 2021, the U.S. Food and Drug Administration (FDA) published notice of a new

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Continue Reading FDA Issues New Draft Guidance on Imported Food

FDA Releases List of Draft & Final Guidance Topics

Posted on June 30, 2021
  • On June 29, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released a list of draft and final guidance topics

…
Continue Reading FDA Releases List of Draft & Final Guidance Topics

FDA Publishes Draft Guidance for the Voluntary Disclosure of Sesame

Posted on November 11, 2020
  • The FDA issued a draft guidance for the Voluntary Disclosure of Sesame as an Allergen to provide food manufacturers with the Agency’s current view on sesame as an allergen and

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Continue Reading FDA Publishes Draft Guidance for the Voluntary Disclosure of Sesame

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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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