Some of the natural product industries’ leading associations, including the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), American Botanical Council (ABC) and Natural Products Association (NPA), recently submitted comments to U.S. Food and Drug Administration (FDA) in response to the agency’s revised New Dietary Ingredient (NDI) Draft Guidance.
FDA issued on August 12, 2016 a revised draft guidance for industry titled, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” This revised draft guidance replaced draft guidance of the same name initially issued by FDA in July 2011. In the 2016 revised draft guidance, FDA identifies two goals: improving the rate of compliance with the NDI notification requirement; and improving the quality of notifications.
In its comments, AHPA “recognizes some improvements in the revised draft guidance compared to the 2011 draft guidance,” said AHPA President Michael McGuffin. “However, AHPA continues to have some of the same concerns about the content of the 2016 revised draft guidance and has additional concerns related to revisions in the 2016 revised draft guidance.”
AHPA noted in its comments that the 2016 draft NDI guidance would unnecessarily burden the dietary supplement industry and dietary supplement consumers and is wholly inconsistent with the economic and small business analyses prepared in connection with the NDI notification regulations in 21 CFR § 190.6.
According to Duffy MacKay, ND, senior vice president, scientific and regulatory affairs, CRN, “We have been waiting more than five years for this document and, after close review, consider it a step in the right direction. We’re appreciative that the revised draft guidance appropriately addresses several issues raised by industry in response to the 2011 draft guidance and provided a better explanation of the agency’s thinking, but there are still items we take issue with.”
MacKay said CRN takes issue with the agency’s approach to evaluating evidence of pre-DSHEA (Dietary Supplement Health and Education Act of 1994) marketing in order to create that an authoritative list, as well as its interpretation of other exceptions to NDI notification requirements. CRN remains concerned that a narrow interpretation of these exclusions will result in unnecessary NDI notifications for products with a long history of safe use. Also at issue is FDA’s interpretation of sections of the Federal Food, Drug and Cosmetic Act (FDCA) and DSHEA relating to the definition of “dietary ingredient.” Said MacKay, “In particular, the agency’s interpretation on this does not honor the spirit of DSHEA.”
One of ABC’s several primary concerns with the 2016 draft guidance is FDA’s focus on—and request for significant information on—the dietary supplement product itself. ABC set forth that the language in the NDI provision in DSHEA speaks to the dietary ingredient versus the finished dietary supplement product. ABC also references historic FDA actions that support the position that a NDI notification concerns the ingredient.
ABC also expressed its concerns that FDA’s language in the 2016 draft guidance suggests that almost any change in the manufacturing process or solvent used to make an extract might require an NDI notification due to possible chemical alteration of the ingredient. ABC provided examples where such chemical alteration may justifiably warrant a NDI notification and where it can be relatively insignificant and should not require a notification.
“ABC wishes to see rational regulations and guidance from the government that protects consumers from inauthentic and/or unsafe products and also allows members of industry to be able to produce supplements that meet or exceed required federal regulations for quality and safety,” said ABC Founder and Executive Director Mark Blumenthal. “However, some provisions proposed by FDA go well beyond what Congress intended when it conceived of NDIs and what the law actually requires, and ABC is concerned that FDA’s proposed guidance will not result in any meaningful consumer benefit.”
NPA also expressed concerns that the guidance could lead to unintended consequences and undermine the FDA’s ability to promote public health.
“The way it stands now, the guidance could actually result in more bad actors skirting the law entirely, which is the opposite of what a sensible regulatory regime should be,” said Dan Fabricant, PhD, CEO and executive director of NPA. “This economic burden to industry in following the food additive-level toxicology tests proposed in this draft guidance could harm small businesses and create a chilling effect on innovation, and lead to fewer submissions from legitimate firms, while encouraging fly-by-night companies to operate through NDI ‘piggybacking’ until they are caught. It becomes FDA whack-a-mole all over again. NPA’s 98-page comment brief underscores the need for significant changes to the current guidance in the best interest of public health.”