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Senator Durbin’s Credibility Problem

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supplements-banThe Washington Times recently printed an opinion piece discussing the threat nutritional supplements are facing from the FDA and Sen. Durbin’s bill. The senator’s response makes one wonder if he has read his own bill. A follow-up to our Action Alert.

Durbin says he introduced the bill in response to “a product on the market now that is escaping regulation as an adulterated food by marketing itself as a ‘dietary supplement.’” This refers to the melatonin-laced brownies sold as Lazy Cakes we’ve been telling you about (melatonin is a natural hormone that puts us to sleep). But the FDA has in fact moved against Lazy Cakes and quite appropriately shut them down. The agency could have done this from the start. It always had the authority to do so, as Durbin surely knows. Why did it wait so long? Perhaps to support Durbin’s bill, or to avoid revealing how misleading the senator’s arguments are?

Note also that of the bill’s eight pages, only two sentences address food companies like the one that made Lazy Cakes. Almost all of the bill is aimed at nutritional supplements.

The senator’s credibility problem doesn’t stop there. He says that his bill is designed to stop “mislabeling products and making health claims that have no scientific basis” and “marketing supplements with impure or incorrectly identified ingredients.” If that’s the case, he would be pleased to know that all those things are already against the law! That’s right: everything he mentioned is already prohibited under current law. Of course, the senator knows that perfectly well.

Since the purpose of this bill is clearly not the one stated, what is the purpose? It would seem to be an attempt to move us one step closer to a full FDA approval system for supplements. That, of course, would just make supplements insanely expensive, like drugs, if you could get them at all. If supplements are not yanked from the market, or turned into drugs, the high prices would kill demand and drive supplement companies out of business. The drug industry would be waiting, ready to pick up the pieces and make their current monopoly position even tighter. That’s why our Action Alert is so important—if you haven’t already done so, please take action now!

Under Durbin’s bill, the FDA would not be the sole evaluator of supplements. It would be assisted by the government’s Institute of Medicine. Perhaps this is supposed to satisfy critics of the FDA. But it doesn’t make the proposal any better. This is the same Institute of Medicine whose recent reevaluation of vitamin D doses has been ridiculed by scientists actually expert about vitamin D. Even conventional medical societies such as the American Association of Clinical Endocrinologists criticized the Institute’s work.

Here’s an example of the IOM’s logic. It recommended 600 IU of D for a pregnant woman. It then said that the moment the baby is born, it should have 400 IU while the mother continues to need 600 IU. On the face of it, this makes no sense at all. The IOM committee was also apparently about to restate the safe upper intake level of D well above the previous 2,000 IU per day. Then just before publication and for no apparent reason—certainly no reason based on science—it reversed course and pulled a meager 4,000 IU out of thin air as the new upper limit. Scientists such as John Cannell, MD, who have really studied D, suggest that 4,000 IU would be a more reasonable recommended daily allowance, not an upper limit.

Don’t forget that the FDA in 1972 tried to ban any supplement dose higher than 400 IU unless taken under a doctor’s prescription. What both the FDA and the Institute of Medicine have in common is that both agencies know very little about supplements but are nevertheless deeply biased against them. In the FDA’s case, this may be because of all the fees that the agency gets from drug companies. Or because many of the agency’s outside panelists are paid by drug companies. In the IOM’s case, many of its experts of course also receive fees from drug companies. Yet these are the people whom Senator Durbin wants to give completely arbitrary power over supplements!

For example, under the senator’s bill, the FDA could require warnings on supplement labels of any length that would say anything the government wants, no matter how unreasonable. It would create lists of “bad” ingredients or “bad” dosages based on completely arbitrary or nonexistent standards. Whatever the FDA says would go. And once an ingredient or supplement is singled out for this treatment, there is no process to challenge the determination, not even if new or contradictory evidence comes to light. This is really bad legislation.

Assuming that Sen. Durbin is sincere—and we assume he is, despite his misleading arguments—he should create a new federal agency to be in charge of supplements. That would at least begin to make possible sensible federal oversight of the supplement industry.

Michelle Minton, who works at the prestigious Competitive Enterprise Institute, got it exactly right in her July 28 article, “The Coming War on Vitamins.” Sen. Durbin’s Dietary Supplement Labeling Act (S. 1310) is part of a one-two punch aimed at eventually pulling supplements into the current and completely dysfunctional drug approval regime.

The second part of this one-two punch is the equally insidious proposed FDA New Dietary Ingredient (NDI) guidance, which applies to supplements created after 1994. Was it a coincidence that the bill and the proposed new standards rolled out at the same moment? Was the idea that if one was shot down, the other might get through? We don’t know. We do know that the American people need to know what is actually in the bill and the guidance, both of which are cloaked in obscure bureaucratic legalese intended to mask their true purposes.

It is past time for a return to honesty and openness in American politics. Sen. Durbin could start by abandoning the falsehood that his bill has anything to do with tainted brownies that have already been removed from the market.

If you have not already done so, please write to your senators and representatives immediately and ask them to oppose Sen. Durbin’s Dietary Supplement Labeling Act. Please take action now!

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