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 notification 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 final guidance document explaining when a new dietary ingredient notification (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-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 comments filed with FDA by A. Wes Siegner Jr. of the law firm, 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 notification."
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 definition, and when an NDI notification is required."
Comments submitted to FDA through the Dec. 4 deadline reflect 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 dietary supplement company in Los Angeles, proposed a “fast-track" notification process for “middle-aged" ingredients on the market for at least five years.
“For post-DSHEA dietary ingredients with a history of safe use in any country, the full procedure of the notification—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 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 old dietary ingredients to already filed NDINs without FDA objections and substances present in the food supply that may be eligible for use in supplements without a required notification to FDA.
“Such an expanded list would be more meaningful to industry and FDA because it provides firms with additional transparency and confidence 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 comments filed with FDA.
However, developing a list of ODIs is challenging enough for FDA. It’s been nearly a quarter-century since DSHEA was passed into law, and industry sources have said it could be difficult, 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 comments signed by AHPA’s president, Michael McGuffin, and its general counsel, Anthony Young, AHPA asked FDA to consider lists of ODIs previously submitted to the agency by trade associations. FDA has said it doesn’t consider such lists to be authoritative, but AHPA argued such lists shouldn’t be dismissed entirely.
Wrote McGuffin 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 specific reason to determine otherwise on an ingredient-by-ingredient basis."
In comments filed 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 filing.
It remains to be seen what weight, if any, FDA will give to such materials if it moves forward with its proposal.
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 certificates of analysis (CoAs) and affidavits attesting to the existence of the latter documents.
It’s not a foregone conclusion FDA will move forward with its proposal.
Speaking Oct. 10 at the Rocky Mountain Dietary Supplement Forum in Boulder, Colorado, an FDA official, Cara Welch, Ph.D., raised a hypothetical situation that could halt the ODI listing. If FDA reviews comments on the ODI list after the Dec. 4 comment period closes, “and we see that the overwhelming majority says, ‘It is not worth our resources and it’s not worth your resources to move forward,’ it may be scrapped," said Welch, senior advisor to FDA’s Office of Dietary Supplement Programs. “That may be the extent of the process."
Pieter Cohen, M.D., an associate professor of medicine at Harvard Medical School, is among those who questioned whether FDA’s proposal is worth the effort. Cohen’s research over the years has identified potentially unsafe stimulants in dietary supplements on the U.S. market.
After hearing from stakeholders during an Oct. 3 meeting in College Park, Maryland, the Massachusetts-based physician said he was “not convinced that the time and effort the FDA would need to devote to creating a useful list would provide meaningful public health benefits at present.
“In the future, in the context of a stronger law, perhaps having a more flexible approach to creating a list of ‘pre-DSHEA’ ingredients would be possible," Cohen wrote in comments filed with FDA, “but, at the present time, I would encourage the agency to focus attention on finalizing the guidance for new dietary ingredients, developing a FDA-based registry of products, revamping the system to detect hazardous products, and enhancing enforcement of the law."