Certification of vitamins seen as way to fill regulatory void

Research findings are reinforcing dietary supplements' medical credentials, but their regulation lags behind.

By Susan J. Landers, amednews staff. Nov. 5, 2001.

Washington -- As the sale of vitamins and other dietary supplements continues to increase, the safety and efficacy of these products remain a concern of physicians, their patients, researchers, regulators and supplement manufacturers alike.

Since 1994, sales of dietary supplements increased by nearly 80%, from $8.8 billion to an estimated $15.7 billion for 2000, according to an article published in the March 26 Archives of Internal Medicine.

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Sales of specific herbal remedies such as echinacea, ginseng, ginkgo biloba and St. John's wort exceeded $200 million per product per year, said the article.

Meanwhile, as the Food and Drug Administration continues its several-year struggle to bring out regulations regarding the production of supplements, claims of some alleged attributes are being put to the test in well-designed federally funded clinical studies.

And those studies are finding evidence that some products do indeed constitute effective medical treatments.

For example, a study published in the October Archives of Ophthalmology concluded that high levels of antioxidant vitamins and zinc reduce the risk of vision loss from age-related macular degeneration.

The Age-Related Eye Disease Study, supported in part by the National Eye Institute and the National Institutes of Health, found that people at high risk for developing advanced stages of age-related macular degeneration lowered their risk by about 25% when treated with high-doses of vitamins C and E, beta-carotene and zinc.

Researchers calculated that if the approximately 6 million people at risk for a specific form of the disease were treated for five years with the vitamin regime, a quarter of a million of them would not have suffered any vision loss. The findings are especially exciting because, until now, there has been no effective treatment for the eye disease.

However, before patients rush to the stores for supplies of the nutrients, the researchers caution them to check first with their ophthalmologist to make sure they can be helped by the treatment and then to check with their primary care physician to make sure they aren't consuming excessively high levels of the vitamins. Smokers should also be cautioned that taking beta-carotene could lead to an increased risk of lung cancer. Smokers are urged to take a zinc-copper preparation instead.

On one hand, disease-lowering information is likely to further fuel consumer interest in particular supplements. But some experts maintain a level of concern about existing safeguards for purity and other controls of products now on the market -- products currently regulated by the FDA under a framework some say has gaps.

While the federal agency wrestles with a framework affording additional oversight, several certification programs are being undertaken in an effort to provide consumer confidence.

U.S. Pharmacopeia is piloting one such voluntary program to evaluate and confirm a dietary supplement's content, manufacturing processes and compliance with purity standards. It expects to launch the program next spring.

The new Dietary Supplemental Certification Program will verify the ingredients listed on a supplement's label and inspect the manufacturing facilities to ensure appropriate quality systems are in use.

The program will join other, similar programs run by NSF International and ConsumerLab.com.

Additional scrutiny

The new drive for certification has caught the eye of Paul M. Coates, PhD, the director of the National Institutes of Health Office of Dietary Supplements that was created in 1994 by Congress amid concerns for the safety of the nutrients.

The office has already funded numerous studies examining such issues as the effect of St. John's wort on the metabolism of several widely used medications and the relationship of B-vitamins and cognitive function. Findings will be forthcoming.

Dr. Coates noted that there is a range in quality within the categories of supplements. "The plain fact is that some products in this category meet very high standards of quality, and there is a lot of information to support their efficacy and safety -- with appropriate warnings -- while, for other products, no such information exists," he said.

While there is still a long way to go, Dr. Coates said, progress has been made by private organizations, such as U.S. Pharmacopeia, to raise standards and the quality of products in the marketplace.

"Those standards and certification activities, I think, will pay off for consumers and for those of us who really would like to do good research using reliable ingredients for appropriate clinical studies," he said.

Certification programs also have gained favor with trade groups for the supplements.

"Insomuch as it will restore consumer confidence that the bottle contents are what they say they are on the label, I think it's a good thing," said Joseph Betz, PhD, vice president of Scientific and Technical Affairs for the American Herbal Products Assn.

Dr. Betz faulted the Food and Drug Administration for failing to promulgate regulations and making it necessary for private organizations to "step up to the plate to fill the void."

John Cardellina, PhD, vice president for botanical science at the Council for Responsible Nutrition, also applauded the certification programs for combating negative reports that surface periodically and say "somewhere between 20% and 40% of dietary supplement products fail to meet analyses for label claim."

As for its part, the FDA published a regulatory proposal in 1997. However, the proposal was caught between administrations.

Drafted under the Clinton administration and sent to the Office of Management and Budget, the proposal was returned to the agency for further review under the Bush administration.

On track once again, the rules may be released soon, which is a good thing, said Dr. Cardellina.

"If the FDA gets those rules out soon, we can focus these relatively new audit programs on the right rules," he said.