天博体育

Walk into a pharmacy, grocery store, or vitamin shop and you鈥檙e likely to see dozens, if not hundreds, of vitamins, herbal remedies, and other so-called dietary supplements. You might think that someone, somewhere, tests these pills and potions to make sure they contain what they say, improve health as advertised, and are safe. But that isn鈥檛 happening.

Under the terms of the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplements with established ingredients (meaning those that had been sold in the United States before 1994) can be marketed without any evidence that they are effective or safe. For new supplement ingredients, the DSHEA requires manufacturers to give the FDA evidence that a new ingredient should be safe. 鈥淩egrettably, this aspect of DSHEA has thus far not been enforced,鈥� writes Dr. Pieter A. Cohen in a .

Compare this hands-off approach with the strict rules and regulations for drugs. No drug can be sold until the FDA has proof clear proof that it is safe and effective. And every FDA-approved drug must be made to strict specifications.

From the safety, effectiveness, and truth in advertising standpoint, DSHEA hasn鈥檛 been a good watchdog for public health. Take 鈥渘atural supplements鈥� for erectile dysfunction. Since 2004, the FDA has more than two dozen of these products, with names like Stiff Nights and True Man, because they contained sildenafil (the active ingredient in Viagra), or a chemical cousin of it. Sildenafil in a dietary supplement is a problem because 1) sildenafil isn鈥檛 a naturally occurring compound, 2) it is an FDA-regulated drug, and 3) when taken with heart drugs called nitrates, it can lower blood pressure to unsafe levels鈥攂ut the supplements don鈥檛 carry a warning about this, as sildenafil does.

Last July, the FDA to help it test new ingredients. This is a good first step, but the FDA鈥檚 plan doesn鈥檛 go far enough, argues Dr. Cohen, an assistant professor of medicine at Harvard Medical School whose research has explored the use of dietary supplements. Under the FDA鈥檚 plan, companies can give the FDA historical data to support the safety of an ingredient. Data from clinical trials would be better, and easier to evaluate. The plan also doesn鈥檛 require companies to give the FDA unfavorable data (as is required for new drug applications).

Americans on dietary supplements. Many people take supplements because they believe they are safer than drugs (since they are 鈥渘atural鈥�), or work better. The safer part has been challenged numerous times. Remember , a widely used weight-loss supplement that was banned after it was linked to deaths and adverse side effects? And solid clinical trials routinely knock down the effectiveness of dietary supplements for stopping the common cold (vitamin C), shrinking an enlarged prostate (saw palmetto), and preventing heart disease (beta carotene and vitamin E). In fact, high daily doses of vitamin E have been linked with an increased risk of prostate cancer, respiratory infection, and heart failure.

The dietary supplement industry is fighting the new FDA guidelines, saying they will be bad for business. I think they鈥檒l be good for the health of anyone who chooses to take dietary supplements. What do you think?