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Additional Thoughts on FDA's Reaction to NDI Comments

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by Sandy Almendarez -

Daniel Fabricant, Ph.D., Director, Division of Dietary Supplement Programs, FDA, asked industry what kind of legacy it wants to have—one with unsafe products on the market with the potential to harm consumers, or one that is compliant with the law—during last week's post new dietary ingredient (NDI) comment period webinar hosted by the United Natural Products Alliance (UNPA). Fabricant answered industry's assertion that dietary supplements have shown to be safe because of the lack of adverse event reports (AERs) by noting 400 spiked products have been recalled since 2008. Yet, he said only 50 new dietary ingredient notifications (NDINs) are submitted each year on average. "Looking at the numbers, is that the legacy people want to put out there?" he asked.

Well, no, Dr. Fabricant, that's not how industry wants to be remembered. But I think his straw man argument doesn't really address the issue of safety. I haven't read all of the comments submitted, but I my guess is not one of the 7,000 entries Fabricant said were submitted argued FDA should be more lax on the notification process because we want spiked products getting on to the market.

From the dozen or so comments I've read, industry is interested in keeping consumers safe in line with the meaning of the Dietary Supplement Health and Education Act of 1994 (DSHEA). And no, spiked products are not good, but Fabricant didn't directly address supplement safety.

As Mark Blumenthal, founder and executive director, the American Botanical Council (ABC), said at a UNPA conference in July, dietary supplements were not associated with one death in 2007 or 2008 per the American Association of Poison Control Centers. He said the one death reported in 2009 was from a cancer patient taking a number of prescription drugs as well as homeopathic product used for colon cleansing.“In general, dietary supplements appear to be one of the safest consumer goods," Blumenthal said.

Beyond that leading question, Fabricant noted not all submitted comments challenged the Draft Guidance. Fabricant said some comments told FDA it didn't go far enough regarding safety standards and synthetics. According to one of his PowerPoint slides, one commenter suggested four safety modifications: 1) historical use should rarely, if ever, be sufficient to replace experimental data; 2) entirely novel ingredients should undergo, at a minimum, 90-day human testing; 3) manufacturers should be required to submit to FDA all available data regarding new ingredients, both favorable and unfavorable; and 4) before assuming consumers follow instructions on supplement labels, this assumption should be confirmed empirically.

From what Fabricant said during the webinar (check out the full press coverage here), it seems FDA isn't going to budge on a lot of the points industry took issue with in comments filed. Fabricant referred to, and read directly from, DSHEA more than once. He said the plain reading of the statue shows NDINs are for supplements, not ingredients.

Fabricant also offered case examples of NDINs the agency objected to. "Understanding the basis for objection is important, and I believe we captured a lot of that in the guidance," he said. The objections can be divided into three categories, he said: unresolved safety concerns, incomplete information and other reasons (such as substances that aren't dietary ingredients).

These case examples are helpful, and I'd suggest companies dig into FDA's article " The Safety and Regulation of Natural Products Used as Foods and Food Ingredients," which offers safety assessments used by the agency. Fabricant referred to this paper during the webinar, which I also found helpful.

As I noted in my last blog, from here, industry is stuck waiting to see what FDA's next move it, unless a company wants to try to challenge the Draft Guidance in court. But issues of standing could be problem. Now, we twiddle our thumbs and hope FDA can be persuaded by comments submitted by industry. Time will tell.

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