Tuesday, September 29, 2009

Stricter Regulation on the Way for Dietary Supplements?

According to a report on NPR this morning both the FDA and Congress are looking into the need for more government oversight and stricter regulation of the dietary supplement industry. The immediate precipitant of this renewed interest on the part of the government are the steroid abuse problems plaguing US sports, as many of the athletes caught up in it are claiming that they "didn't know" what they were taking and thought they were simply "supplements". The dubious merits of that defense aside, a new look at the need to provide a stricter and more consistent oversight of the industry is probably overdue.

I've been told many times that the dietary supplement industry in the USA is "unregulated". This is not true. The 1994 Dietary Supplement Health and Education Act (DSHEA), signed into law by President Clinton, created a new regulatory framework for dietary supplements and implemented new Federal labeling requirements. It also established a new office within the National Institutes of Health charged with coordinating and assessing research on supplementation, and acting as a clearinghouse for consumer information. Even prior to DSHEA, dietary supplements were not "unregulated". Up until 1994, supplements were considered to be either "foods" or "drugs", depending upon their intended purpose, and fell under the purview of the Food and Drug Administration. A food had to be proven to have "taste, aroma or nutritive value" before it could be marketed or sold, and it had to be proven to be safe. If classified as a drug, a supplement also had to prove that it was effective.

In many ways DSHEA actually weakened oversight. According to Marion Nestle, a professor in the department of nutrition, food studies and public health at New York University, "Congress passed DSHEA 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." Under the existing 1994 law, manufacturers cannot claim that their products "prevent or cure" any condition or disease. They can, however, claim to "support" various functions and structures of the body ("Builds strong bones!"), and they are not required to prove that their products can actually do any such thing.

"Wellness", of which dietary supplements are a part,  is projected to grow to be a trillion dollar industry over the next decade. Only the personal computer industry has passed that milestone. With an opportunity that large, and that much money being spent, we can expect a deluge of nutritional supplement products to enter the market. No doubt many of them will be of dubious health value. As we as a nation examine our entire health-care system, perhaps the time is right to take another look at the rules by which dietary supplement manufacturers play. At a minimum, companies should be required to substantiate any claims they make regarding the effectiveness of their products. We as consumers should not have to wait until after people die before an ineffective or even harmful product is removed from the market (ephedra, for example).

There are many reputable companies making and distributing nutritional supplements. For the most part they should be very supportive of new and more rational regulation of their industry. They have much to lose if the public loses all trust in their products because of the irresponsible actions of a few opportunists. Even with better standards, Americans still need to be adequately informed about what they're taking and purchasing, says Dr. David Heber, a supplement researcher who is director of the Center for Human Nutrition at the University of California in Los Angeles. He believes the FDA should form stricter rules for labeling and marketing, so consumers know exactly what they're getting. He says that supplement companies that do invest the time and money toward research should be rewarded.

Wishing doesn't make it real. What we don't know can hurt us.

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