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HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more

FDA Issues Final Guidance Setting Action Levels for Lead in Food Intended for Babies and Young Children

The U.S. Food and Drug Administration (FDA) issued a final guidance for industry titled Action Levels for Lead in Processed Food Intended for Babies and Young Children (Final Guidance). The final action levels apply only to...more

FDA Finalizes Two Food Allergen-Related Guidance Documents

On January 6, 2025, FDA published two final guidance documents related to food allergens: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and...more

FDA Issues Draft Guidance on Evaluating Public Health Impacts from Non-Major Food Allergens

The U.S. Food and Drug Administration (FDA) recently published draft guidance that explains the approach the agency intends to take when evaluating the public health importance of food allergens that are not one of the nine...more

U.S. Congress passes the FASTER Act to require sesame allergen labeling

On 14 April 2021, the U.S. Congress passed the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 (S. 578), which now heads to the White House for signature. ...more

FDA issues draft guidance on voluntary disclosure of sesame when added as flavoring or spice

On 10 November 2020, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance recommending that companies voluntarily declare sesame in the ingredient list when it is used as a “flavor” or...more

COVID-19 Update: FDA and USDA Issue Guidance for Industry and Inspectors

As the novel coronavirus (COVID-19) crisis has continued to escalate, both the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) have taken additional action to provide industry, the...more

COVID-19 Preparedness Considerations for the Food Industry

As you likely know, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are closely monitoring the spread of the novel coronavirus (COVID-19), a respiratory disease that has...more

California Chamber of Commerce Challenges the Proposition 65 Acrylamide Warning for Foods

A lawsuit filed yesterday by the California Chamber of Commerce challenges the legality of Proposition 65 warnings on foods that contain acrylamide. The Complaint, which named the Attorney General of the State of California...more

The Use of an Alternate Name for Potassium Chloride in Food Labeling: Guidance for Industry

Last week the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name...more

National Academies Release Dietary Reference Intakes for Sodium and Potassium

The National Academies of Sciences, Engineering and Medicine (NASEM) recently released updated Dietary Reference Intakes (DRIs) for sodium and potassium. For the adequate intake of sodium, the report reaffirms the existing...more

FDA Announces Plans for Modernizing and Reforming Dietary Supplement Oversight and Issues Batch of Warning Letters Over Unlawful...

The Food and Drug Administration (FDA) recently announced a plan for “policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25...more

FDA Deauthorizes Seven Synthetic Flavorings and Adjuvants as Food Additives

On October 9, 2018, the U.S. Food and Drug Administration (FDA) issued a final rule revoking authorization for seven synthetic flavorings and adjuvants as food additives. Notably, FDA’s rigorous scientific analysis determined...more

FDA Holds Public Meeting on Nutrition Innovation Strategy

On July 26, 2018, the FDA held a public meeting to discuss issues related to the agency’s comprehensive multi-year Nutrition Innovation Strategy. This public meeting and comment period follows FDA Commissioner Dr. Scott...more

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