AG/FDA Blog

Synthetic Flavors’ Safety Questioned – Strategy Needed to Address Consequence

Food manufacturers using the following seven (7) synthetic flavoring substances and adjuvants should take note that the safety of these ingredients is being challenged: Benzophenone (a/k/a diphenylketone), Ethyl acrylate, Eugenyl methyl ether (a/k/a… Read More
Read More

Menu Labeling – Supplemental Guidance

On the same day that FDA’s menu labeling regulation became effective for compliance by industry, the agency published notice of the availability of its finalized Menu Labeling: Supplemental Guidance for Industry (May, 2018). This guidance is “sup… Read More
Read More

Caffeine in Dietary Supplements

The Office of Dietary Supplement Programs within CFSAN at FDA has prepared and published guidance for industry, warning that powdered and liquid dietary supplements containing pure or highly concentrated caffeine may be deemed to be adulterated under… Read More
Read More

FDA Maintains Focus on Nutrition to Foster Human Health

In a speech, entitled “Reducing the Burden of Chronic Disease,” delivered on March 29th by FDA Commissioner Scott Gottlieb before the National Food Policy Conference in Washington, D.C., FDA kicked-off its Nutrition Innovation Strategy. … Read More
Read More

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… Read More
Read More

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… Read More
Read More

FDA Updates Some Recall Practices

FDA has released a draft guidance, “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff” (1/17/2018).  It essentially discloses FDA’s intent to accelerate the release of recall informa… Read More
Read More

Focus on Food Recalls

In planning for your company’s 2018 regulatory priorities, you might want to review and optimize its recall procedures.  Recall policies and procedures likely will be a focus of FDA in the coming year. The Office of Inspector General (OIG) within… Read More
Read More

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
Read More

Open Date Labeling Revisions for Food Appear To Be on the Horizon

Over 30 years ago, the National Conference on Weights and Measures (NCWM) collaborated with the Association of Food and Drug Officials to establish an initial open dating regulation.  This regulation — now the Uniform Open Dating Regulation (U… Read More
Read More

Follow Blog Via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.