On December 12, 2016, the nonprofit American Botanical Council (ABC) filed comments in response to the US Food and Drug Administration’s (FDA’s) revised draft guidance for industry, titled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”1
ABC stated in its comments to the FDA that the draft guidance exceeds the original intent of Congress behind the Dietary Supplement Health and Education Act of 1994 (DSHEA)2 — the hallmark piece of bipartisan legislation that created a regulatory framework specific to dietary supplements — and requests the FDA to revise the 2016 draft guidance to more closely align with the intent and explicit text of DSHEA.
At issue is the FDA’s development of a guidance document that is intended to provide more exact instructions to the 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.”
The amount of time it took the FDA to issue the revised draft gudiance is an indication of the complexity of the matter. In 1997, three years after DSHEA was passed, the FDA issued a Final Rule7 (regulations) on the NDI provision within DSHEA that provided the procedure for NDI notifications. Then, in 2004 — 10 years after DSHEA was passed — the FDA held a meeting and solicited comments from the public and industry “concerning the content and format requirements for NDI notifications.” The FDA wanted the input to clarify the type, quantity, and quality of information that should be included in NDI notifications to the FDA.8 In 2011, the FDA issued a draft NDI guidance — 17 years after DSHEA — which received a large volume of comments from the public. The FDA never finalized the 2011 guidance document. Then, in August of 2016, the 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 the 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 the 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 in which 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 Mark Blumenthal, ABC founder and executive director.
Blumenthal added: “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. However, some provisions proposed by the FDA go well beyond what Congress intended when it conceived of NDIs and what the law actually requires, and ABC is concerned that the FDA’s proposed guidance will not result in any meaningful consumer benefit.”
Even though guidance documents are not binding for the FDA or the industry, ABC believes that an FDA guidance document sets a precedent and important guardrails to industry and regulators. Therefore, ABC recommended that the FDA revise the 2016 draft guidance to align with the intent of Congress and the explicit text of Section 8 of DSHEA. ABC also encouraged the 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, since 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).
- 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).