AG/FDA Blog

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… Read More
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“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… Read More
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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… Read More
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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)… Read More
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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… Read More
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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:… Read More
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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… Read More
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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… Read More
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Increased FDA Testing of Pet Foods May Provide More Support for the FSMA Proposed Rule on “Preventive Controls for Animal Food”

When I was growing up on a farm in Pennsylvania, my twin sister and I always savored the sweet feed that we fed to our horses.  We would also occasionally “chew on the oats,” but Sis and I never found our way to eating the dog or cat food.  Thi… Read More
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DMAA Dietary Ingredient Withdrawn from Market

FDA’s publication last week, on April 11th, of a warning to consumers about dietary supplements containing dimethylamylamine (DMAA) (a/k/a 1,3-dimethylamylamine, methylhexanamine or geranium extract) followed up on Warning Letters issued on Apr… Read More
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