The Food and Drug Administration (FDA) has
recently commenced a new assault against the dietary supplement industry
– one that could threaten the availability of supplements currently on
the market and that will discourage manufacturers from innovating new
and more beneficial products in the future. In July the agency issued a
draft Guidance document which sets forth its current thinking
concerning provisions of the law that dictate what ingredients can be
included in dietary supplement products, and what information companies
must submit to the FDA if they desire to market a supplement that
contains a new dietary ingredient (i.e., one that was not sold prior to
October 15, 1994).
The FDA’s draft Guidance ignores the intent of Congress by seeking to
impose insurmountable obstacles to the introduction of new dietary
ingredients and includes interpretations that will threaten the
continued sale of supplements if even the most minute of changes are
made. If the Guideline is finalized and enforced by the FDA it will go a
long way towards establishing the agency’s long-standing goal of
requiring pre-market approval for dietary supplements.
The following are a few highlights of the Guidance document:
