AG/FDA Blog

Isolated or Synthetic Non-Digestible Carbohydrates that Qualify as Dietary Fiber

FDA has published a guidance that specifies eight (8) additional substances that qualify as dietary fiber for purposes of nutrition labeling: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition… Read More
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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
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FDA Announces Medical Device Quality System Regulation Change

FDA recently announced a potential massive overhaul to its Medical Device regulations.  Specifically, the agency intends to “harmonize and modernize” its medical device Quality System Regulation (21 C.F.R. Part 820) with an international consens… Read More
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FDA Finalizes Nutrition Facts Compliance Date Extension by 1.5 Years

On May 4, 2018, the FDA issued its final rule extending the compliance date for the updated nutrition information on the labels of most conventional foods and dietary supplements. The final rule is consistent with FDA’s October 2, 2017 proposed rul… Read More
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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
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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
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Food Labeling Modernization Act of 2018 Likely Reveals Consumer Groups’ Priorities for FDA Nutrition Innovation Strategy – May Spur More Class Action Lawsuits

The Food Labeling Modernization Act of 2018 (H.R. 5425) was introduced on April 4, 2018, by Rep. Frank Pallone, Jr. (D-NJ), the ranking member of the House Energy and Commerce Committee.  A joint press statement announcing the bill was released by R… Read More
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John Block: Clean Meat

By former USDA Secretary John R. Block All the time, we hear the loud voices of consumer groups that insist the public must be informed about the food we eat. “Label it organic.”  “If it has GMOs, the consumer must know.” … Read More
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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
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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
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