FDA Says No to the Senators Who Drafted DSHEA
February 7, 2012
According to our sources, the rogue agency is digging in its heels
on the NDI draft guidance that threatens so many supplements, refusing
to listen to Congress or follow the intent of the law.
Senators Orrin Hatch and Tom Harkin met with Dr. Daniel Fabricant of the
FDA on January 26 to request that the FDA withdraw its NDI draft
guidance altogether—a meeting that ANH-USA, together with some trade
groups, helped set up. They were following up on
their recent letter to FDA Commissioner Margaret Hamburg asking the
FDA to stop the process altogether, withdraw the guidance, and start
again after meeting with interested parties to address the list of
significant concerns expressed by consumers and industry.
You may recall that the landmark Dietary Supplement Health and Education
Act of 1994 (DSHEA) required that guidelines be established for
supplement manufacturers to notify FDA when a new dietary ingredient was
introduced into the marketplace. The FDA’s Draft Guidance for New
Dietary Ingredients was supposed to fulfill that requirement.
Unfortunately, the FDA’s proposed regulations are in fact completely
contrary to the intent of Congress when DSHEA was passed, and Sens.
Harkin and Hatch wanted to make that clear to FDA. They should know—they
were the two principal authors of the legislation!
According to our sources, FDA has turned down the senators’ request. FDA
in effect said that it is refusing to reconsider its interpretation of
what the NDI section of DSHEA means, regardless of what Sens. Hatch and
Harkin say they meant when they wrote the law.
Does this mean FDA intends to use the NDI process as a de facto
pre-market approval system—something which regulatory observers believe
was specifically excluded by DSHEA? In a word, yes. We have been told
that FDA claims the NDI process is the only “preventive control” for
dietary supplements in federal law. Whatever “preventive control” means,
it is completely untrue that supplements are uncontrolled under federal
law or that the FDA lacks the power presently to regulate them.
In refusing to follow the intent of the law as clearly stated by the
law’s authors, the FDA is acting as a rogue agency. If you haven’t done
so already, please ask your legislators to
make a
one-minute floor speech opposing the FDA’s guidance document. FDA’s
plan would sweep many supplements off the shelf and make the ones that
survive much more expensive.
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