ABC Requests FDA to Continue to Revise
the New Dietary Ingredient Draft Guidance
Nonprofit
science organization says FDA’s NDI draft guidance exceeds scope of current law
and intent of Congress
(AUSTIN, Texas, December 13, 2016) 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draft guidance for industry titled “Dietary Supplements: New Dietary Ingredient
Notifications and Related Issues” (2016 draft guidance).1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forth in its comments to the FDA that the draft guidance exceeds the original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FDA to revise the 2016 draft guidance to more closely align with the intent and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 a 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 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.
“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
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 revise 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.
References
- 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).