AG/FDA Blog

RACC and Serving Size Guidance

CFSAN/FDA has made available a guidance document and a small entity compliance guide to assist industry in complying with its revised nutrition labeling requirements for conventional foods and dietary supplements: Guidance for Industry: Reference Am…

CFSAN Soon Will Issue Certificates of Free Sale for Exports Online

U.S. purveyors of foods, food additives, dietary supplements, and cosmetics for export are often asked by foreign customers or foreign governments to supply a “certificate” for products regulated by FDA.  Review of a certificate may be r…

Adverse Event Information Now Available Online for CFSAN-Regulated Products

FDA has begun posting online (and intends to update quarterly) information derived from adverse event reports the agency has received about conventional foods (including food/color additives), dietary supplements, and cosmetics.  This information is…

CFSAN Issues Updated Guidance on Food Facility Registration

FDA today published notification of the availability of an updated, draft guidance on food facility registration, Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry (Nov. 2016). Publication of this dra…

Aspartame Potentially Subject to Prop 65 Listing

The Carcinogen Identification Committee (CIC) – California’s qualified experts on carcinogenicity for purposes of Proposition 65 (Prop 65)) – pursuant to a meeting scheduled for November 15, 2016, will be providing the state’s Office of Envir…

CFSAN Changes Address

Today, the Food and Drug Administration (FDA) published in the Federal Register a final rule that amends relevant FDA regulations in Title 21 of the C.F.R. to change the address of the Center for Food Safety and Applied Nutrition (CFSAN).   81 Fed.…

CFSAN Office Restructuring

FDA has created within CFSAN the Office of Dietary Supplement Programs (ODSP), elevating the program from its previous status as a division under the Office of Nutrition, Labeling and Dietary Supplements (ONLDS).  Elevating the program’s position…

FDA Seeks Input on the Meaning of “Natural” for Foods -- First Impact of FDA Action Will Be on Class Action Cases

For over two decades, when assessing the propriety of a “natural”-type claim (e.g., “natural,” “all natural,” “100% natural,” “from nature,” “naturally grown,” or “naturally sourced”) made in food labeling, FDA has applied…

FDA Public Meeting Will Consider Fundamental Changes to, and Expansion of, the Redbook

By Mark L. Itzkoff   In the October 30 Federal Register, FDA that it will hold a public meeting to receive public input on updating its commonly known as “the Redbook.” The meeting will be held on December 9. Requests to make oral comments d…

Nutrition Labeling Reform Is on the Horizon

Two long-awaited, proposed rules to revise the regulatory requirements for nutrition labeling of conventional foods and of dietary supplements have been sent by FDA to the Office of Information and Regulatory Affairs within OMB for final review befor…

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