Industry Critiques Proposals on Premarket Notice Procedures and Notice of Statements of Nutritional Support
Dec 24, 1997
The dietary supplement industry has given mixed reviews to the
Food and Drug Administration's two proposals regarding premarket
notification of use of a new dietary ingredient and notification
regarding statements of nutritional support, both of which were
issued last September. 61 Fed. Reg. 50771
(nutritional support statement notification procedure), and 50774
(premarket notification for a new dietary ingredient).
Statements of nutritional support
By way of background, the Dietary Supplement Health and
Education Act of 1994 (DSHEA) permits manufacturers of dietary
supplements to include on the label or labeling statements (1)
claiming a benefit related to a classical nutrient deficiency
disease, (2) describing the "well-being" achieved by
consuming the dietary ingredient, or (3) describing the
supplements effects on the "structure or function" of
the body. To make such claims, the manufacturer must have
substantiation that the claims are truthful and not misleading
and the product label must include the statement: "This
statement has not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat,
cure or prevent any disease." In addition, FDA must be
notified no later than 30 days after a product that bears a
statement of nutritional support is first marketed. One of FDA's
September 27, 1996, proposed rules would establish the procedure
by which manufacturers and others who are marketing a dietary
supplement that bears a statement of nutritional support are to
notify FDA of that fact.
The Nutrition Health Alliance (NHA), in December 6 comments,
criticized the proposal for ignoring many substantive issues
concerning statements of nutritional support. According to a
description of the comments in the December 19, 1996 Food
Labeling & Nutrition News (FLNN), NHA contended that the
proposal should have addressed the type of claims which can be
made, the form and amount of substantiation FDA demands, and the
circumstances under which the FDA disclaimer language is
required. NHA argued that certain structure/function claims have
been evaluated by FDA and therefore it would be inaccurate to use
the FDA disclaimer with such claims. The group also stated that
it is contradictory to state, as the proposal does, that a claim
can be made with respect to the role of a supplement in a
classical nutritional deficiency disease, but at the same time
require a label statement that the product is not intended to
prevent, treat or cure disease. Finally, NHA argued that there is
no statutory support for the proposed requirement that a
"responsible individual" sign the notification or
certify that the firm has substantiation for the claim.
Premarket notification for new dietary ingredients
FDA's other proposal would establish a procedure for providing
the premarket notification of use of a new dietary ingredient
required under DSHEA. DSHEA requires that at least 75 days before
introducing into interstate commerce a supplement with a new
dietary ingredient FDA must be given notice of the basis for the
manufacturer or distributor concluding that a dietary supplement
containing the new dietary ingredient will reasonably be expected
to be safe.
In comments submitted on December 19, Mead Johnson reportedly
contended that the notification should not need to be signed by
an authorized official of the manufacturer or distributor of the
supplement containing the ingredient; rather it should be
sufficient if it is signed by "the person who is directly
responsible for assimilating and submitting the pre-market
notification." According to the January 9, 1997 FLNN,
the company also urged FDA to modify the proposal to allow
marketing of a product less than 75 days after filing a
notification in the event that FDA completes its review and
decides that there is no basis for concern about marketing of the
dietary supplement in less than 75 days. In addition, Mead
Johnson expressed concern about the provision that submission of
additional information would restart the clock on the 75 day
waiting period. The company suggested that FDA restart the 75 day
period only if the additional information amounts to a
substantive amendment to this submission.
The Council for Responsible Nutrition (CRN) also submitted
comments on the pre-market notification proposal, according to
the January 9 FLNN. CRN reportedly urged FDA to state in
the proposed regulation that notification is not required if the
new dietary ingredient has been present in the food supply as an
article used for food in a form in which it has not been
chemically altered. This provision, which is in DSHEA, is
acknowledged in the preamble to the proposed rule, but not in the
proposed regulation itself. Due to the absence of significant
legislative history of DSHEA and FDA's unwillingness to interpret
the law, the exact meaning and scope of this provision have been
uncertain since DSHEA became law. CRN also objected to the
proposed requirement that notifications include copies of
published information supporting the notification, noting that
scientific data are readily available electronically.
The comment period on both proposals ended on December 26,
1996, although FDA will consider late comments. It is not clear
when FDA intends to issue final rules concerning pre-market
notifications and notification of statements of nutritional
support.