AG/FDA Blog

Dietary Fiber Permissible in Nutrition/Supplement Facts

Dietary fiber is a macronutrient that permissibly may be declared in the Nutrition Facts on a conventional food’s label, and in the Supplement Facts on a dietary supplement’s label.  21 C.F.R. §§ 101.9(c)(6)(i), 101.36(b)(2)(i). To clarify wha…

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…

Extension of Compliance Date for Revised Nutrition Labeling of Foods and Supplements

While generally expected for months (e.g., since the menu labeling compliance date extension) and recently the subject of a “tweet” from FDA Commissioner Gottlieb, the agency now officially has proposed to extend by about 1.5 years the compliance…

“Grandfathered” Dietary Ingredients – It’s About Time

The Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994 – almost a quarter century ago.  It amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) in a number of significant ways that set the stage for present marketin…

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…

FDA Amends Food Additive Regulations to Expand Permitted Uses of Vitamin D in Food

Contributor: Rachel Rosenberg As of July 16, 2016, FDA’s amendment to expand the safe uses of vitamin D2 and D3 as nutrient supplements in food for human consumption became effective. This amendment stems from a food additive petition (FAP 3A4801)…
Categories: FDA

“Dietary Supplement” is a Proper Statement of Identity

FDA has revised a guidance document to acknowledge that “Dietary Supplement” alone properly may be used as the statement of identity in labeling a dietary supplement.  Announcement of this revision was published in a Federal Register notice on M…

FDA Announces Public Meeting on Nutrition Labeling Proposed Rules

The Food and Drug Administration (FDA) has announced a public meeting on June 26, 2014 to discuss its two pending proposed rules to update the Nutrition Facts label (and the Supplement Facts label for dietary supplements).  Those proposed rules are:…

Dietary Supplements: New Online Method Now Available for Reporting Serious Adverse Events

Industry may now use a new form, accessible on the Department of Health and Human Services’ (HHS) Safety Reporting Portal, to satisfy requirements for reporting to HHS (including FDA and the National Institutes of Health) any serious adverse event…

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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