Anti-Supplement Measure Slips into "Reform" Bill, HR 4173

(The FTC's) 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.

I gotta doubt that the person who wrote this knows what he is talking about. The FTC doesnt have a staff that knows anything about conducting clinical trials. Nor have I ever heard of such trials being required as part of a consent decree.

I just have a feeling something has been lost in the translation here. Waxman is a royal jack@ss but I really doubt he is stupid enough to rattle this hornets nest six months before the midterms.

I really discovered supplements including herbs, vitamins, certain amino acids and other compounds in a serious way about 10 years ago. They have revolutionized my health. Have never taken a prescription drug except an occasional antibiotic for a sinus infection, and I haven’t had one in the past 10 years.

The proper supplements along with a decent diet and exercise have cut at least 10 years off my age.

This can’t bel allowed to pass. Big Pharma surely has a hand in this just as they did the recent health care takeover.

the author noted the same. They’re attempting to do an end run around the FDA by delegation this authority to the FTC who has absolutley no expertise in this area.

The following was contained in the link:

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.

I don’t think this has much chance of surviving as it will surely create a firestorm. Too many people (like me) love their supplements.

The FTC once had this regulatory “rule-making” authority. It lost it in the 1980’s because Congress thought the Agency was abusing it.

I cant figure out what this person is talking about. Congress passes laws (statutes). If FTC is the agency in charge of administering the statute, it makes the rules that do so.

I really do think this person is confused.

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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!