Photo by theogeo/FlickrCC
If the FDA is now going after health claims (see yesterday's post), will it also start going after dietary supplements? These, as I explained in my most recent column in the San Francisco Chronicle, excerpted below, get to make all kinds of unsubstantiated claims without the FDA being able to do much about them.
Congress passed the Dietary Supplement Health and Education Act of 1994 on the basis of two quite questionable assumptions: that supplements are basically harmless, and that supplement-makers are basically honest. The law does not require supplement manufacturers to demonstrate the safety or effectiveness of their products to the FDA before selling them. Instead, the FDA must prove a supplement harmful by providing documentation from clinical trials or multiple case reports in court--a tedious process.More and more evidence is coming in suggesting that supplements can be harmful as well as ineffective. The latest example: antioxidant supplements are said to interfere with the beneficial effects of physical activity. Will such studies encourage the FDA to insist that manufacturers demonstrate safety and efficacy before they put supplements on the market? That would be a refreshing change, no?
Consider that it took the FDA 10 years to get ephedra (ma huang) off the market, despite at least 30 deaths and hundreds of reports of illness among young people who were taking it as an "upper" or to lose weight. The FDA could only institute a ban after ephedra appeared to be implicated in the 2003 death of Steve Bechler, a young pitcher for the Baltimore Orioles. That ban must be working; I cannot find ephedra in any of my local health food stores.
DSHEA did one other thing. Although it did not allow manufacturers to claim that a supplement could prevent or treat disease, it did allow "structure/function" claims that the product could support some structure or function of the body. Thus, labels cannot claim that a supplement prevents colds or AIDS, but they can say that it "supports a healthy immune system."
If this distinction is too subtle for anyone but a company lawyer or a FDA regulator to understand, that is the point. The purpose of DSHEA was to allow supplement-makers to market the health benefits of their products, with or without scientific proof.
SHOP THE ATLANTIC FOOD MARKETPLACE
Subscribe to Atlantic Food
No, it wouldn't. The overwhelming scientific evidence is that the FDA kills more people than it saves. It may be a "tedious process" of using scientific evidence to get bad supplements off the market, but the alternative is another "tedious process" that kills people as well.
Considering the weight of studies against you, I consider your claim to have the same merit as one that a federal censor should review all books for accuracy before they're published, to save the "tedious process" of libel claims.
What would happen if the FDA required vitamin manufacturers to adhere to the same proof criterion as drug manufacturers? Obviously the expense of supplements would become comparable to the expense of patented drugs since the enormous costs of that process would have to be recovered. However, since vitamins and other food supplements cannot be patented the net effect would be to simply outlaw supplements. This would destroy all benefits that now derive from them.
The only beneficial role of government would be to finance research that would clarify the scientific case for or against these supplements. There seems to be significant benefit from many of them but in many cases that benefit is documented in very small scale studies which could be improved. Since supplements cannot be patented the government or charitable nonprofit agencies are the only entities which can document the benefit of supplements.
We are currently living in an overly medicated society because drug companies can patent drugs and can advertise extensively to promote them. In many cases good nutrition including supplements would produce better outcomes than now occur with the drugs.
We know that people with depression have on average lower levels of Vitamin D in their blood. There are some qualified scientists who think that vitamin D supplementation could be as effective an antidepressant as the drugs which are now used. This would certainly be the case where people feel awful due to a deficit of Vitamin D. The recommended level of this vitamin has been increased from 400 to 1000 IU (International Units) per day due to recent research. There are many people who get depression in the winter months when sunlight is scarce and less Vitamin D is created by sunlight reaching the skin. This is just one area where increased research could document significant societal benefit.
Oh posh and bother, John Thacker. Even your hero, Adam Smith, would disagree that government regulation of business is a bad idea. Just because an agency is imperfect does not mean that it should not exist.
"People of the same trade seldom meet together, even for merriment and diversion, but the conversation ends in a conspiracy against the public, or in some contrivance to raise prices. It is impossible indeed to prevent such meetings, by any law which either could be executed, or would be consistent with liberty and justice. But though the law cannot hinder people of the same trade from sometimes assembling together, it ought to do nothing to facilitate such assemblies; much less to render them necessary. "
I.x.c.27 (Part II)
Some supplements are very helpful, e.g., niacin (as inositol) and fish oil, which I used (along with weight loss and exercise) to get my blood lipids very much under control, from about 220 total with a somewhat unfavorable LDL/HDL ratio and triglycerides to a nice 150 total with a very favorable profile without the use of a statin. My former MD and the registered dietician he sent me to recommended that and it worked great.
Yes, an optimal diet is the 100% right way to go but it's not always practical. For instance, I absolutely loathe the taste of oily fish and simply won't eat it; it's not good for you if you won't eat it. Enteric capsules of sardine oil, on the other hand, I never taste and so I can get the equivalent of several oily fish meals a week without disgust. The real problem is that people don't recognize that these are, strictly speaking, drugs and they often take mega doses without talking to a nutritionist to find out the details. For instance, both niacin and fish oil have levels you don't want to cross, niacin because it stresses the liver (like a statin does, in fact) and fish oil because it excessively thins your blood and inhibits coagulation.
I can see some major hurdles to the FDA banning sales of supplements without evidence of efficacy, but I think it would be extremely reasonable for the FDA to prohibit health claims that weren't backed up. There are lots of bottles of vitamin C out there sold already without any claim on them at all. And claims like "supports the immune system" are meaningless as well as unverifiable, but they mislead consumers. Supplement makers could still sell their products without making unsubstantiated claims.