Natural Products Insider

JAN-FEB 2018

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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4 INSIDER January/February 2018 In the News GNC Holdings Inc., the specialty retailer of supplements, is among critics questioning the wisdom of FDA's proposal to develop an authoritative list of dietary ingredients marketed before Oct. 15, 1994. Dietary ingredients marketed before the above date are exempt from a safety- related notifi cation to FDA, per the Dietary Supplement Health and Education Act of 1994 (DSHEA). Some critics of FDA's proposal said the agency's use of its resources would be better spent on other initiatives, such as a fi nal guidance document explaining when a new dietary ingredient notifi cation (NDIN) is required. DSHEA didn't require FDA to develop a list of "old dietary ingredients" (ODIs) exempt from an NDIN, and industry veterans have noted challenges developing such a list nearly a quarter of a century after passage of the law. "Preparing a pre-DSHEA dietary ingredient list may have made some sense in 1995, but 23 years after DSHEA, it is an exercise in futility," GNC asserted in Dec. 1, 2017, comments fi led with FDA by A. Wes Siegner Jr. of the law fi rm Hyman, Phelps & McNamara P.C. "The reason is simple. The critical issue now is not whether an ingredient is an ODI or a new dietary ingredient (NDI), but whether an NDI requires notifi cation." FDA should focus on the safety of ingredients, wrote Siegner, who added "the best way to accomplish that goal would be to provide clear guidance to industry as to what ingredients fall within the listed types of dietary ingredients under the dietary supplement defi nition, and when an NDI notifi cation is required." Comments submitted to FDA through the Dec. 4, 2017 deadline refl ect a diversity of views on the pros and cons of FDA's proposal, the evidence that should be considered in developing a list of ODIs, and whether the agency's initiative should be more comprehensive than envisioned by regulators. For example, Jarrow Formulas Inc., a supplement company in Los Angeles, proposed a "fast-track" notifi cation process for "middle-aged" ingredients on the market for at least fi ve years. "For post-DSHEA dietary ingredients with a history of safe use in any country, the full procedure of the notifi cation—with 10 safety and toxicology tests being recommended in the revised guidance— should not be required," Susan D. Brienza and P. Scott Polisky, attorneys representing Jarrow Formulas, wrote in Dec. 4, 2017 comments submitted to FDA. "Instead, a much more streamlined procedure, but one still providing the statutory (per Sec. 8 of DHSEA) safety standard for the new supplement, should be permitted by the FDA." The Council for Responsible Nutrition (CRN) recommended FDA expand its list beyond ODIs to already-fi led NDINs without FDA objections, and substances present in the food supply that may be eligible for use in supplements without a required notifi cation to FDA. "Such an expanded list would be more meaningful to industry and FDA because it provides fi rms with additional transparency and confi dence when assessing a dietary ingredient's regulatory status and serves as a tool for FDA in determining enforcement priorities," the Washington-based trade association wrote in Dec. 4, 2017 comments fi led with FDA. However, developing a list of ODIs is challenging enough for FDA. It's been nearly a quarter of a century since DSHEA was passed into law, and industry sources have said it could be diffi cult, if not impossible, to obtain the kinds of records FDA is looking for, such as mail order catalogs, sales records and paperwork on how a supplement was manufactured in the 1990s. Commenting on the types of documentation FDA recommends to show an ingredient was marketed before Oct. 15, 1994, the American Herbal Products Association (AHPA) noted such records "most likely no longer exist or … only marginally exist." In Dec. 4, 2017 comments signed by AHPA's president, Michael McGuffi n, and its general counsel, Anthony Young, AHPA asked FDA to consider lists of ODIs previously submitted to the agency by trade associations. FDA has stated it doesn't consider such lists to be authoritative, but AHPA argued such lists shouldn't be dismissed entirely. Wrote McGuffi n and Young: "Again, AHPA encourages FDA to accept the 'good' represented by these lists rather than rejecting them for their absence of the 'perfect,' and so therefore strongly recommends that FDA state its intention to consider exercising its enforcement discretion by recognizing each of the ingredients in these lists as a pre-DSHEA ingredient unless there is some specifi c reason to determine otherwise on an ingredient-by-ingredient basis." The Consumer Healthcare Products Association (CHPA) urged FDA to expand its list of the types of evidence that could show an ingredient was marketed before DSHEA to certifi cates of analysis (CoAs) and affi davits attesting to the existence of the latter documents. In comments fi led with FDA, the Natural Products Association (NPA) highlighted its new book, "Pre-DSHEA List of Old Dietary Ingredients." The book, written and compiled by NPA executives, alphabetically organizes a list of pre-DSHEA ingredients. "We are pleased to continue our collaboration with the FDA to develop a list of its pre-DSHEA dietary ingredients," said Daniel Fabricant, Ph.D., president and CEO of NPA, in a press release, commenting on NPA's fi ling. It remains to be seen what weight, if any, FDA will give to such materials if it moves forward with its proposal. GNC Among Critics of FDA Proposal to Develop List of Old Dietary Ingredients by Josh Long

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