Congressman Waxman Slips Obscure Anti-Supplement
Measure into Wall St. 'Reform' Bill Passed by the House;
Please Take Action to Prevent Same Thing Happening in the Senate!
April 27, 2010
FTCThe American public is becoming fed up with “sneak” provisions tacked
onto largely unrelated bills that are likely to pass. A glaring recent
example was tacking onto the Healthcare bill a complete change to
student loans. Often the “sneak” provision is so buried that hardly
anyone is aware of it.
The Wall Street Reform and Consumer Protection Act of 2009 (H.R. 4173),
recently passed in the House of Representatives, includes language going
far beyond finance inserted by Congressman Henry Waxman (D-CA). This
language could be used for an end run around the Dietary Supplement
Health and Education Act (DSHEA), the legislation that governs dietary
supplement regulation by the FDA.
The Senate is expected to vote on its finance “reform” bill as early as
this weekend. We need your help to ensure that it is not amended to
include a similar provision going far beyond finance that could be used
against supplements. Please take action now. TAKE ACTION
Congressman Waxman is well known as an opponent of the dietary
supplement industry. This is somewhat ironic: his district includes
Hollywood and presumably many of his closest supporters are health store
shoppers and supplement users. Most of these people simply don’t know
what Waxman is doing in this area.
This powerful Congressman, chair of the House Energy and Commerce
Committee (which includes health as a subcommittee), would appear to
want supplements regulated like drugs, a step that would effectively
eliminate them. He is determined and has stated: “One enduring truth
about Washington is that no issue is ever settled for good.”
ANH-USA has been on alert to see how Waxman would use his committee
chairmanship to strike at DSHEA. He is very clever and we knew a covert
attack was a possibility.
A direct attack on supplements would take the form of an amendment to
DSHEA, since that legislation governs FDA regulation of supplements. In
this case, Waxman has left DSHEA alone, and has instead inserted
language in the Wall St. “reform” bill that gives the Federal Trade
Commission (FTC) important new powers that could be used to circumvent
key supplement protections in DSHEA. TAKE ACTION
To see how this would work, let’s see how the FTC operates today. Its
chief mission is to combat commercial fraud. It has full authority to
pursue companies making fraudulent claims. But the FTC can’t go beyond
that, can’t set other regulatory requirements, without advance approval
of Congress. The FTC once had this regulatory “rule-making” authority.
It lost it in the 1980’s because Congress thought the Agency was abusing
it.
At the present time, if the FTC moves against a dietary supplement
company for false or misleading advertising, the FTC typically requires
the company, as part of a consent decree agreed to by both parties, to
back up its claims by undertaking at least two random controlled human
trials. This is done on a case-by-case basis and is legal because the
targeted company has agreed to it.
If the FTC had general rulemaking authority, which Waxman’s language
reinstates, the Agency would be expected to create a new legal
requirement for all supplement companies. Such companies would have to
perform at least two of these human studies before making any claims for
their products.
Why should we care whether supplement companies are required to perform
two random controlled human trials for each product? Because such trials
take a long time and would be beyond the financial means of most
supplement companies. Even if the companies could find the money, the
FTC could require more and more costly versions of these studies, or
more of these studies. At each stage, fewer supplements would be
available, and those available would cost more and more, until they
became as costly as drugs.TAKE ACTION
Supplements are not drugs. In most cases, drugs are non-natural and
therefore patentable substances. Why patentable? Because no company will
spend a billion dollars on studies and FDA approval trials without the
monopoly provided by the patent. To insist that supplements be treated
like drugs is really to sound the death knell for the supplement
industry, something that drug companies would be delighted to see,
because they know that supplements are their chief potential
competition, are often more effective than drugs, are often less toxic,
and are always much less expensive.
Supplements are already regulated by the FDA under DSHEA. If the Waxman
provision is included in the final Wall St “reform” bill, the FTC will
gain the power to override the limited protections for supplements that
already exist under DSHEA. The FDA would still have to respect DSHEA,
but the FTC would not be so constrained.
Five unelected FTC commissioners would issue binding regulations in a
wide range of areas, including the regulation of dietary supplements.
And companies that did not comply with the new FTC rules could
effectively be put out of business.
According to renowned constitutional attorney Jonathan Emord, “The
provision removing the ban on FTC rulemaking without Congressional
preapproval contained in H.R. 4173 invites the very same irresponsible
over-regulation of the commercial marketplace that led Congress to enact
the ban in the 1980s. FTC has no shortage of power to regulate deceptive
advertising; this bill gives it far more discretionary power than it
needs, inviting greater abuse and mischief from an agency that suffers
virtually no check on its discretion.”
The bottom line is that FTC would be given power to regulate areas they
don’t understand, and their first order of business would likely be to
regulate supplements, an area far outside their area of expertise.
The Senate Wall St “reform” bill, the Restoring American Financial
Stability Act of 2010 (S. 3217), doesn’t contain the Waxman provision
yet. But we know that Senator Rockefeller (D-WV) may offer an amendment
including Waxman’s language. Please help us stop this. Please take
action now to help us maintain access to low cost, high quality
supplements. Tell your senators not to support any amendments that give
FTC unchecked power to over-regulate areas they don’t understand,
including dietary supplements.
Article originally published at:
http://www.anh-usa.org/congressman-waxman-slips-obscure-anti-supplement-measure-into-wall-st-%E2%80%9Creform%E2%80%9D-bill-passed-by-the-house-please-take-action-to-prevent-same-thing-happening-in-the-senate/
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