New Senate Supplements Bill Expected
April 20, 2010
Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), both supporters of
natural health and supplements, plan to introduce new legislation, the
Dietary Supplement Full Implementation and Enforcement Act of 2010,
within the coming weeks. The bill will fully fund FDA implementation of
the Dietary Supplement Health and Education Act (DSHEA), the legislation
that governs the regulation of dietary supplements.
At the present time, opponents of dietary supplements and natural health
make false claims that supplements are not regulated and therefore
unsafe.
We completely disagree. In the first place, federal regulation does not
ensure safety. Second, supplement producers are currently regulated by
DSHEA, mandated to report adverse events, and required to comply with
Good Manufacturing Practice regulations. The Dietary Supplement Full
Implementation and Enforcement Act of 2010 is intended to fund all DSHEA
regulatory provisions and therefore rebut the argument by supplement
opponents that the supplement industry is not really regulated due to a
lack of funding.
Will this work as intended? No one can say for sure. It is possible that
the FDA will misuse the funds to persecute supplements. On the other
hand, this funding means that, for the first time, some FDA employees
will see their jobs as being funded by supplements and likely to
disappear if supplements disappear. Perhaps that will work to the
advantage of natural health. Only time will tell. In the meantime, the
bill will effectively rebut those who keep claiming, falsely, that
supplements are unregulated.
Important note: the bill is likely to include some provisions drafted by
Senator John McCain (R-AZ). McCain might even end up as a bill sponsor.
But this does not worry us. One of the two McCain provisions requires
the Food and Drug Administration (FDA) to notify the Drug Enforcement
Administration (DEA) if a new supplement ( so-called New Dietary
Ingredient or NDI) may contain anabolic steroids. This is not an
objectionable provision.
The second McCain provision that may be included in the bill will
attempt to clarify the New Dietary Ingredient Process. This is the
process whereby supplement manufacturers may petition the FDA to sell
substances not sold prior to 1994, the year DSHEA passed. This is a very
sensitive area for natural health supporters because of the recent
tendency of drug companies to try to convert supplements not sold prior
to 1994 into exclusive prescription drugs. We are confident that any
provision agreed to by Senators Harkin and Hatch will protect natural
health and supplements. But we will have to wait for the particular
language. We will report back to you as soon as we have more
particulars.
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