Air Date: Week of March 14, 2003

The Food and Drug Administration is proposing new rules that would regulate how dietary supplements are manufactured and labeled. Host Steve Curwood talks with FDA commissioner Dr. Mark McClellan about what the rules call for and why they're necessary.

Transcript

CURWOOD: Right now, there's no way to tell if that pill you're about to swallow marked 200 milligrams of pure echinacea actually contains 200 milligrams of the popular herbal remedy for colds. But the U.S. Food and Drug Administration is proposing new rules on the production and labeling of echinacea, and all other so-called dietary supplements. The law considers these substances to be neither foods nor drugs. And they include botanicals like echinacea and minerals like calcium, as well as vitamins. I'm joined now by Dr. Mark McClellan, commissioner of the FDA. Dr. McClellan, just what do these dietary supplement rules call for?

McCLELLAN: The proposed regulations would establish standards to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities in the manufacturing process, and to ensure that they are labeled to accurately reflect the active ingredients and the other ingredients in the product. So, in particular, on the manufacturing regulations, this would include regulations about the design and construction of manufacturing plants, quality control procedures, testing of the final products and of the materials used in making the dietary supplements, new processes and requirements for handling complaints from consumers, and requirements to keep records to demonstrate that a company is in compliance with the new regulations.

On the labeling side, we're going to require that the identity, the purity, the quality, the strength, and the composition of dietary supplements are accurately reflected. And this is intended to help make sure that consumers are getting accurate information about the type and amount of ingredients in dietary supplements that they are purchasing.

CURWOOD: Why are these proposed rules necessary?

McCLELLAN: Some dietary supplement manufacturers have not included the amounts of dietary supplements that would be expected based on their labels. For example, some work by an independent private laboratory tested a number of probiotic products, products that contain bacteria. These, in many cases, about a third of those tested contain substantially less than were advertised on the label, or that would be expected to be found in such a product.

In addition, we've had a number of reports of adverse events associated with dietary supplements. And we think a number of these are probably caused by contaminants in the dietary supplements resulting from the manufacturing process. And again, there are examples of cases where products have had to be recalled because of containing too much, or too little, of the ingredients they were supposed to contain. Or, contaminants like glass or bacteria that should not be there.

CURWOOD: On this dosage question, how serious have the problems been?

McCLELLAN: The dosage question is not really what these regulations address. Dietary supplements, unlike drugs, do not have to demonstrate their safety and effectiveness before they come to market. They're in this zone between the way that we regulate foods, and the way that we regulate drugs. And so, there is not any specific guidance on appropriate dosage coming out of these regulations. We do think that the regulations will be helpful to consumers, though, in terms of letting them know exactly the amounts of dietary supplements’ active ingredients that are included in the products that they're using. And we also think it will help further research.

The head of the National Center for Complementary and Alternative Medicine, Dr. Steven Straus, noted that the standards that we are putting out will make it easier to do research to determine whether different levels of dietary supplements might have different safety or health effects. And by providing good standards, we think it will be possible to develop better evidence about how well dietary supplements work, in general.

CURWOOD: To go back for a moment to the proposed regulations, how would these rules be enforced? Are we looking at spot checks, factory inspections? Or, is just the own test results of the manufacturer going to be used for enforcement here?

McCLELLAN: We're certainly not going to depend only on voluntary compliance and self-reporting. In many of the activities, where FDA conducts regulatory oversight, we rely on a combination of making clear what our regulatory standards are, conducting education and outreach activities, and conducting inspections and taking enforcement actions where appropriate. There are a lot of very reputable dietary supplement manufacturers out there which are already largely, if not fully, in compliance with the kind of regulations that we have proposed. Our expectation is that by being clear about what these rules are, giving the companies a little bit of time to comply, most of them will be able to come into compliance. But, of course, we're going to make sure that that's the case, and we will take further enforcement actions, including seizing products, stopping distribution, and so forth, in cases where the manufacturers are not in compliance.

CURWOOD: Before we go, I have to ask you, what supplements do you take yourself?

McCLELLAN: I don't take any dietary supplements myself. I don't think that for someone like me, who's a rapidly approaching middle aged male, there are any particular dietary supplements that, on a daily basis, would be useful for me. I try to eat a good nutritious diet and that gives me access to the vitamins and minerals that I need.

I don't want to imply that all dietary supplements are useless. There are a number that have been shown to lead to significant health benefits. But, I don't take any of them myself.

CURWOOD: You're a physician, right?

McCLELLAN: Yes.

CURWOOD: So, you might recommend to a patient of yours, if you were in practice, to take these supplements.

McCLELLAN: That's right. There are a number of dietary supplements that millions of Americans use that have important health benefits, that have been demonstrated in scientific studies. A good example of that is calcium, in reducing the risk of fracture from thin bones. There are other examples as well that may be beneficial in particular kinds of patients with particular kinds of health problems.

CURWOOD: Dr. Mark McClellan is commissioner of the Food and Drug Administration. Thanks for filling us in.

McCLELLAN: Thank you.

CURWOOD: And you're listening to NPR's Living on Earth.

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