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Message Subject Those Sneaky Bastards Did It Again! "Slipped In", Obscure, Anti-Supplement Measure Passed By The House!
Poster Handle Interesting
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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.

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.
 
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