Nonprofit science organization says FDA’s NDI draft guidance exceeds scope of current law and intent of Congress
On December 12, 2016, the nonprofit American Botanical Council (ABC) filed comments in response to the US Food and Drug Administration’s (FDA’s) Notice of Availability of a revised draft guidance for industry titled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” (2016 draft guidance).1
ABC sets forth in its comments to the FDA that the draft guidance exceeds the original intent of Congress behind the Dietary Supplement Health and Education Act of 1994 (DSHEA)2 — the hallmark piece of bipartisan legislation that created a regulatory framework specific to dietary supplements — and requests FDA to revise the 2016 draft guidance to more closely align with the intent and explicit text of DSHEA.
At issue is FDA’s development of a guidance document that is intended to provide more exact instruction to industry on how to bring a “new dietary ingredient” 3 (NDI) to market.
DSHEA outlines two types of dietary ingredients that are allowed in dietary supplement products: “Grandfathered” ingredients or dietary ingredients that were marketed pre-DSHEA (before October 15, 1994), and NDIs that were not marketed pre-DSHEA. Regardless of whether a dietary ingredient is grandfathered or an NDI, a manufacturer must comply with each labeling and safety provision of DSHEA, including the adulteration4 section and current Good Manufacturing Practices (cGMPs).5
However, if the ingredient is an NDI, a manufacturer or distributor of the NDI or dietary supplement product that contains the NDI must notify the FDA 75 days before going to market with the basis for concluding that the NDI, when used under recommended conditions, will reasonably be expected to be safe.6 The FDA and various members of the herb and dietary supplement industry have a difference in opinion on what data and information are needed to satisfy the standard of “reasonably be expected to be safe.”
To demonstrate the complexity of this matter is the amount of time it has taken to get to this point. Three years after DSHEA passed in 1997, FDA issued a Final Rule7 (regulations) on the NDI provision within DSHEA that provided the procedure for NDI notifications. Then in 2004 — ten years after DSHEA passed — FDA held a meeting and solicited comments from the public and industry “concerning the content and format requirements for NDI notifications.” FDA wanted the input to clarify the type, quantity, and quality of information that should be included in the NDI notification to FDA.8 Then in 2011 FDA issued a draft NDI guidance — 17 years after DSHEA — which received a large volume of comments from the public. FDA never finalized the 2011 guidance document. Then in August of 2016, FDA issued a revised draft NDI guidance document — 22 years after DSHEA — and that version is the subject of ABC’s comments.
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 an 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 an NDI notification and where it can be relatively insignificant and should not require a notification.
“As an independent nonprofit research and education organization, and as the founding and lead organization in an international consortium of medicinal plant research and analytical experts focusing on herb identity and quality control, ABC supports the proposition that all botanical ingredients used in dietary supplements should be authentic, properly tested for their identity, and safe for their intended use,” said ABC Founder and Executive Director Mark Blumenthal.
“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 the industry to be able to produce supplements that meet or exceed required federal regulations for quality and safety. 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,” he added.
ABC outlined several additional areas of concern for FDA’s consideration. ABC strongly believes in a rationally regulated supplement industry and is a proponent of fully implementing the provisions of DSHEA.
Even though guidance documents are not binding for FDA or the industry, ABC believes that an FDA guidance document sets a precedent and important guardrails to industry and regulators. Therefore, ABC recommends that FDA revises the 2016 draft guidance to align with the intent of Congress and the explicit text of Section 8 of DSHEA. ABC also encouraged FDA to continue to prioritize enforcement measures on adulterated raw materials sold as dietary ingredients, adulterated and mislabeled products, and violations of government-mandated (cGMPs as these areas have a greater likelihood of positive impact on product quality and public health.
- FDA Draft Guidance. Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry. August 2016 (replaces draft guidance issued July 2011). Available at:www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM515733.pdf. Accessed December 12, 2016.
- Dietary Supplement Health and Education Act of 1994 (DSHEA), Pub. L. 103–417, 108 Stat. 4325.
- Food, Drug, and Cosmetic Act (FDCA) §413 (21 USC §350b).
- FDCA §413 (21 USC §342(f)), Adulterated food.
- 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
- 21 USC §350b(a)(2), New dietary ingredients.
- 21 CFR 190.6, New Dietary Ingredient Notification, Requirement for premarket notification (62 Federal Register 49886, Sept. 23, 1997).
- Food and Drug Administration, Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting, 69 Federal Register 61680 (October 20, 2004).