(AUSTIN, Texas, December 13, 2016) On December 12,2016, the nonprofit American Botanical Council (ABC) filed comments in responseto the US Food and Drug Administration’s (FDA’s) Notice of Availability of a reviseddraft guidance for industry titled “Dietary Supplements: New Dietary IngredientNotifications and Related Issues” (2016 draft guidance).1
ABC setsforth in its comments to the FDA that the draft guidance exceeds the originalintent of Congress behind the Dietary Supplement Health and Education Act of1994 (DSHEA)2 — the hallmark piece of bipartisan legislation thatcreated a regulatory framework specific to dietary supplements — and requestsFDA to revise the 2016 draft guidance to more closely align with the intent andexplicit text of DSHEA.
At issue is FDA’sdevelopment of a guidance document that is intended to provide more exactinstruction to industry on how to bring a “new dietary ingredient” 3(NDI) to market.
DSHEAoutlines two types of dietary ingredients that are allowed in dietary supplementproducts: “Grandfathered” ingredients or dietary ingredients that were marketedpre-DSHEA (before October 15, 1994), and NDIs that were not marketed pre-DSHEA. Regardless of whether a dietary ingredientis grandfathered or an NDI, a manufacturer must comply with each labeling andsafety provision of DSHEA, including the adulteration4 section andcurrent Good Manufacturing Practices (cGMPs).5
However, if theingredient is a NDI, a manufacturer or distributor of the NDI or dietary supplementproduct 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.6The FDA and various members of the herb and dietary supplement industry have a differencein opinion on what data and information are needed to satisfy the standard of“reasonably be expected to be safe.”
Todemonstrate the complexity of this matter is the amount of time it has taken toget to this point. Three years after DSHEA passed in 1997, FDA issued a FinalRule7 (regulations) on the NDI provision within DSHEA that providedthe procedure for NDI notifications. Then in 2004 — ten years after DSHEApassed — FDA held a meeting and solicited comments from the public and industry“concerning the content and format requirements for NDI notifications.” FDAwanted the input to clarify the type, quantity, and quality of information thatshould be included in the NDI notification to FDA.8 Then in 2011 FDAissued a draft NDI guidance — 17 years after DSHEA — which received a largevolume of comments from the public. FDA never finalized the 2011 guidancedocument. Then in August of 2016, FDA issued a revised draft NDI guidancedocument — 22 years after DSHEA — and that version is the subject of ABC’scomments.
One of ABC’s severalprimary concerns with the 2016 draft guidance is FDA’s focus on — and requestfor significant information on — the dietary supplement product itself. ABC setforth that the language in the NDI provision in DSHEA speaks to the dietary ingredient versus the finished dietarysupplement product. ABC also references historic FDA actions that support theposition that a NDI notification concerns the ingredient.
ABC alsoexpressed its concerns that FDA’s language in the 2016 draft guidance suggeststhat almost any change in themanufacturing process or solvent used to make an extract might require an NDInotification due to possible chemical alteration of the ingredient. ABCprovided examples where such chemical alteration may justifiably warrant a NDInotification and where it can be relatively insignificant and should notrequire a notification.
“As anindependent nonprofit research and education organization, and as the foundingand lead organization in an international consortium of medicinal plantresearch and analytical experts focusing on herb identity and quality control,ABC supports the proposition that all botanical ingredients used in dietarysupplements should be authentic, properly tested for their identity, and safefor their intended use,” said ABC Founder and Executive Director MarkBlumenthal.
“ABC wishesto see rational regulations and guidance from the government that protectsconsumers from inauthentic and/or unsafe products and also allows members ofindustry to be able to produce supplements that meet or exceed required federalregulations for quality and safety. However, some provisions proposed by FDA gowell beyond what Congress intended when it conceived of NDIs and what the lawactually requires, and ABC is concerned that FDA’s proposed guidance will notresult in any meaningful consumer benefit,” he added.
ABC outlinedseveral additional areas of concern for FDA’s consideration. ABC stronglybelieves in a rationally regulated supplement industry and is a proponent offully implementing the provisions of DSHEA.
Eventhough guidance documents are not binding for FDA or the industry, ABC believesthat an FDA guidance document sets a precedent and important guardrails toindustry and regulators. Therefore, ABC recommends that FDA revise the 2016draft guidance to align with the intent of Congress and the explicit text ofSection 8 of DSHEA. ABC also encouraged FDA to continue to prioritizeenforcement 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 likelihoodof positive impact on product quality and public health.
- FDADraft Guidance. Dietary Supplements: New Dietary Ingredient Notifications andRelated Issues: Guidance for Industry. August 2016 (replaces draft guidanceissued July 2011). Available at: www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM515733.pdf.Accessed December 12, 2016.
- DietarySupplement 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.
- 21CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging,Labeling, or Holding Operations for Dietary Supplements.
- 21USC §350b(a)(2), New dietary ingredients.
- 21CFR 190.6, New Dietary Ingredient Notification, Requirement for premarketnotification (62 Federal Register 49886, Sept. 23, 1997).
- Foodand Drug Administration, Dietary Supplements; Premarket Notification for NewDietary Ingredient Notifications; Public Meeting, 69 Federal Register 61680 (October 20, 2004).