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Senator McCain: Bill Threatens Dietary Supplements

On Monday, Senator McCain released a Senate Floor Statement defending his Dietary Supplement Safety Act of 2010. He lashed out at "opponents of the bill and their well-paid Washington lobbyists" who have "spread false statements and rumors about the legislation".

OK. So what are these alleged "false statements and rumors"?

McCain again:

"Opponents have stated that the legislation would seek to limit consumers' ability to purchase dietary supplements, vitamins, or prescription drugs. That is completely false . If you take a vitamin now, this bill will in no way restrict your ability to take that vitamin."

McCain clearly hasn't read his own bill. Perhaps he needs a plain English version. Under current law, the FDA cannot arbitrarily ban a supplement that was sold prior to October 15, 1994, the date that the Dietary Supplement Health and Education Act (DSHEA) was passed. McCain's bill wipes out that protection. What supplements would be legal to sell if this bill passes? Only those supplements "included on [a] list prepared, published, and maintained by the [FDA]". In other words, traditional (pre 1994) supplements would no longer be protected. The FDA would have arbitrary power to choose permitted supplements and (importantly) supplement doses.

Senator McCain is engaging in patent falsehoods here, not the critics. And let's not forget: the FDA has repeatedly shown its hostility to supplements and favoritism toward drugs (perhaps because drugs pay the FDA's bills). An FDA with arbitrary power over supplements could very well be expected to institute a European style regulatory regime, one that restricts the amount of beta carotene in a supplement to what is available from half a carrot. Sound ridiculous? It is happening right now in Europe, and the FDA is in close touch with the European regulators.

McCain touches on just this point. He says that "Opponents also claim the bill establishes a new regulatory structure for dietary supplements. That is completely false." But it's not false; it's true. The broad regulatory framework for supplements at the moment is provided by DSHEA. McCain's bill guts the protections provided by DSHEA and gives the FDA complete and arbitrary authority. If that isn't a new regulatory structure, what is?

Until now, supplement producers have also been allowed to market a "new dietary ingredient", that is, one not sold as a supplement prior to 1994, if it has been "in the food supply as an article used for food in a form not chemically altered." McCain's bill also wipes this out. If passed, supplement producers would have to prove the safety of the ingredient to the satisfaction of the FDA even if the item has been in food for millennia. This is a big change. But McCain still insists that it isn't a new regulatory structure. Need we add that the FDA almost never agrees that a supplement has been proven safe? The Agency wants full drug trials, but who can afford to pay for full drug trials on a non-patentable substance? Are we going to end up paying $100 for a supplement tablet?