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Herbal Science Group Proposes Expert Committee to Clarify Old Dietary
Ingredients
The nonprofit
organization American Botanical Council (ABC) has filed public comments with the US Food and Drug Administration
(FDA) in response to publication of its Draft Guidance on New Dietary
Ingredients (NDIs) in July 2011.
FDA issued the long-awaited draft guidance document for companies in the
dietary supplement industry in order to provide guidelines on when and how to
file NDI pre-market notifications, a process in which the marketer of the NDI
must provide safety data for FDA review and acceptance before the NDI can be
legally marketed. Such 75-day pre-market notifications are required for dietary
ingredients intended to be sold in the United States after the date of the
passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) on
October 15, 1994.
In its comments, ABC
called for FDA to adopt and officially recognize the existing consolidated list
of so-called Old Dietary Ingredients (ODIs)—i.e., dietary ingredients sold in
the US market prior to the passage of DSHEA.* FDA has previously declined to
recognize such lists as having any official bearing in the determination of an
ingredient’s pre-DSHEA status. ODIs are not normally subject to an NDI
notification in order to establish a basis for their safety; their general
safety is presumed.
ABC noted that its
proposal for FDA recognition of an official list of ODIs is intended to ensure that
the list is dynamic, not static, and also subject to revision with added
ingredients, as appropriate. ABC also emphasized that the existence of such a
list should not be misinterpreted as a legal burden on industry members to
prove that ingredients in dietary supplements are ODIs, as there is currently
no such legal requirement for industry to do so. ABC also called for the
creation of an expert advisory panel of industry and other appropriate experts
who can clarify the entries in the “List of Old Dietary Ingredients.”* The
panel would evaluate any entries that may be ambiguous (e.g., plants included
by their common and Latin names) and ascribe the correct plant part(s) known to
have been sold in the market prior to passage of DSHEA.
“One of the biggest
problems in the NDI notification process has been the ambiguity of what
ingredients are in fact ODIs, so-called ‘grandfathered’ ingredients that are
not required to go through the NDI notification procedure,” said ABC Founder
and Executive Director Mark Blumenthal. “What ABC is proposing is a process in
which more clarity can be brought to this entire area. Eventually this
would reduce or eliminate confusion and provide benefit to both industry and
the FDA.”
Additionally, ABC’s
comments address the matter of whether FDA’s proposed draft NDI guidelines
create a virtual pre-market approval system; raise questions about FDA’s
proposed requirement for notifications on all new dietary supplements—not just
new ingredients; and examine the issue of solvents used in the production of
botanical extracts, among other issues.
The complete text of the
ABC comments can be found here.
* The “List of Old Dietary
Ingredients” was published in 1999 by the then-named Utah Natural Products Alliance
(now the United Natural Products Alliance; UNPA). It is a consolidation of
lists of ODIs prepared by three other trade associations: the American Herbal
Products Association (AHPA), the Council for Responsible Nutrition (CRN), and
the then-named National Nutritional Foods Association (now the Natural Products
Association; NPA).
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