FDA extends Redbook update comment period


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FDA extends Redbook update comment period

Related tags: Dietary supplements, Dietary supplement

The US Food and Drug Administration has extended the comment period for updates to the Redbook until May 11, 2015 in response to requests.

The FDA hosted a public meeting on December 9, in College Park, MD​ to discuss updating the Industry Guidance “Toxicological Principles for the Safety Assessment of Food Ingredients” (the ‘Redbook’) to include dietary supplements.

That meeting was attended by stakeholders for the dietary supplements industry, including Marc Ullman from Ullman, Shapiro & Ullman, LLP on behalf of Natural Organics, Inc., the Natural Products Association and the Council for Responsible Nutrition.

Senators Hatch and Harkin also submitted a letter to the FDA panel in which they stated that updating the Redbook to include dietary supplements would undermine the integrity of the Dietary Supplements Health and Education Act of 1994.

“We strongly urge the FDA to ensure that the intent of Congress in passing DSHEA is preserved and strike any remarks about dietary supplements and dietary ingredients from the FDA public meeting,”​ wrote the Senators. “Dietary supplement ingredient safety is already regulated by standards clearly defined in statute separately from the stands used to evaluate the toxicology of food additives. Therefore, dietary ingredients are not an appropriate or relevant topic in your meeting about the Redbook and, moreover, could create confusion where Congress has been explicit.”

Stakeholders may submit comments electronically to the docket, visit http://www.regulations.gov and enter FDA-2014-N-1497 in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2014-N-1497 on each page of your written comments.

Related topics: Regulation

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