Where was the dietary supplements industry at yesterday’s Redbook hearing?


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Proposed revisions to the Redbook would regulate dietary ingredients as food additives
Proposed revisions to the Redbook would regulate dietary ingredients as food additives

Related tags: Dietary supplement ingredients, Dietary supplement, Fda

Proposed FDA revisions to CFSAN’s Redbook to include dietary supplement ingredients, and therefore regulate them as food additives, has created “real and legitimate” concerns for the industry. But also concerning was the limited presence by dietary supplement stakeholders at the hearing, says Marc Ullman.

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

The dietary supplements industry was represented by the Natural Products Association and Marc Ullman from Ullman, Shapiro & Ullman, LLP on behalf of Natural Organics, Inc.

“NPA and NOI were the only representatives from the supplements industry,”​ Ullman told NutraIngredients-USA. “It’s very concerning. I hope there will be more [from the industry] during the comment period [which runs until February].”

“There was zero interaction from the panelists, which had me asking if the whole thing was just for show.”

“Given the history of how FDA has viewed the supplements industry, especially with wanting to treat dietary supplement ingredients as food ingredients, I was taken aback by the lack of other industry participation.”

[Clarification: A representative from the Council for Responsible Nutrition was present at the hearing but did not give a presentation. We apologize for the inaccuracy.]

To read more about Ullman’s comments, please click here​.

Harkin & Hatch add their voice…

Both Ullman and Aimee Nichols, director of government affairs for NPA, reminded the FDA panel that one of the basic principles of DSHEA is that dietary ingredients for use in dietary supplements should be exempt from the food additive provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), including single ingredient and multiple ingredient dietary supplement products.

In NPA’s comments, Nichols told the panel: “DSHEA contained this critical exclusion, and it was passed by Congress without argument. Possibly updating the Redbook to include dietary supplement ingredients, a guidance document intimately associated with the FFDCA and the evaluation of food additives, is in direct conflict with DSHEA, and violates the intent of Congress.”

NPA’s full comments can be read here​.

In addition to the presentation by Ullman on behalf of NOI and Nichols for NPA, a letter from Senators Hatch and Harkin was also submitted to the FDA panel. “This is a letter signed by our greatest champions asking what this is all about,”​ said Daniel Fabricant, PhD, CEO of NPA. “The Senators are basically saying, ‘hey, wait a second, stay in your lane. The statute says dietary supplements are not to be treated as food additives’. [FDA’s actions] are a real concern.”

Please click the link below to download the letter from Senators Hatch and Harkin: 

Where is the NDI re-draft?

There was a also frustration voiced from a perceived lack of movement regarding the issuing of a re-draft of guidance for new dietary ingredients (NDIs).

“The NDI guidance is the document mandated through FSMA that will provide guidance of toxicological principles for the safety assessment of dietary ingredients, which is the appropriate venue for such distinctions,” ​explained Nichols. “This division between dietary supplement ingredients and food additives is clear, statutory, and dictates that guidance released for these two different types of ingredients would also be separated. The Redbook, traditionally reserved for food and color additives, is not the correct guidance document to publish the Agency’s current thinking regarding dietary supplement ingredients.”

But where is the NDI re-draft? “FDA was instructed by senators to get the NDI draft guidance out by the end of 2014,” ​Dr Fabricant told us. “We’re burning daylight in 2014 and yet FDA is spending time going off in a different direction.”

A spokesperson for the FDA told us: "This [NDI] guidance is still under development and the agency is actively working on it. [However,] we do not have a publication date."

Related topics: Regulation

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