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For Immediate
Release:
March 25, 1999

For more information:
202/332-9110

  Statement of Bruce Silverglade on the Food and Drug
Administration’s (FDA) implementation of the

Dietary Supplement Health and Education Act of 1994 (DSHEA)

WASHINGTON - Recent scientific developments have shown that dietary supplements can play an important role in maintaining good health and can sometimes provide a valuable adjunct to conventional medical treatment. As Americans increasingly use supplements to promote their health, it is all the more important that Congress ensure that such products are safe and that label claims are truthful and non-misleading.

Unfortunately, DSHEA has made it difficult to achieve those objectives. In enacting this law, Congress changed the prevailing approach to product safety under the Federal Food Drug and Cosmetic Act. The manufacturers of food additives, drugs and medical devices must prove that their products are safe before they can be sold. Under DSHEA, dietary supplements are presumed safe until FDA can prove that they may pose a significant or unreasonable risk. While assigning the FDA this new enforcement burden, Congress failed to provide the agency with any additional resources. Thus, as a practical matter, the FDA has not been able to effectively utilize its authority to remove dangerous products from the marketplace and instead has been forced to rely on inadequate remedies such as issuing public warnings and requesting voluntary recalls.

The wisdom of this approach must be seriously questioned. Since DSHEA became law, the FDA has had to issue numerous consumer alerts, industry alerts, public warnings, and requests for voluntary recalls about supplement ingredients that pose health threats. Such ingredients include:

  • Chaparral - liver disease, possibly irreversible
  • Comfrey - obstruction of blood flow to liver, possibly leading to death
  • Dieter’s teas- nausea, diarrhea, vomiting, stomach cramps, chronic constipation, fainting, possibly death
  • Ephedra - high blood pressure, irregular heartbeat, nerve damage, injury, insomnia, tremors, headaches, seizures, heart attack, stroke and death
  • Germander- liver disease, possibly leading to death
  • Lobelia - breathing problems, rapid heartbeat, low blood pressure, coma and death
  • Magnolia-Stephania preparation - kidney disease, possibly leading to permanent kidney failure
  • Willow bark- Reye syndrome, allergic reaction
  • Wormwood- neurological symptoms, characterized by numbness of legs and arms, delirium, and paralysis.
  • Germanium - kidney damage, possibly death
  • Herbal “Fen-Phen”- high blood pressure, heart rate irregularities, insomnia, nervousness, tremors, headaches, seizures, heart attacks, stroke and death.
Yet, because of the enforcement burdens imposed by DSHEA, and the lack of resources provided by Congress, the FDA is forced to “regulate by news release,” warning the public of the dangers of particular dietary supplements but not actually removing them from the marketplace.

In addition, DSHEA permits supplement producers to make claims regarding their products’ health benefits without first demonstrating that such products are truly effective. This is particularly disturbing considering that the presumed benefits of supplements are often based on anecdotal evidence, folklore, or studies that were not conducted in accordance with modern scientific techniques.

Congress should begin addressing these problems by mandating a research program, paid for by the industry and overseen by the Department of Health and Human Services, that would systematically review the safety and efficacy of dietary supplement ingredients. Vitamin and minerals known to be Generally Recognized as Safe (GRAS), and whose role in maintaining health is not the subject of controversy within the scientific community, could be exempted from such review.

In developing such a program, Congress could look to other statutory programs it has created whereby members of an industry jointly contribute to study the health effects of their industry’s products. For example, under EPA’s pesticide reregistration program, pesticide manufacturers pay fees, based on market share, that fund the agency's review of pesticides. Under Congressionally enacted “checkoff programs,” administered by the U.S. Department of Agriculture, cattle ranchers, hog farmers, egg and dairy producers pay into funds that conduct research on beef, pork, egg and dairy consumption.

None of those programs has operated perfectly. The EPA’s pesticide reregistration program has moved at a glacial pace. The USDA “checkoff programs” devote some resources to questionable research activities. Nevertheless, we urge Congress to examine those programs, identify the best elements in them, and craft a new program that requires the supplement industry to sponsor reviews of existing research and, if necessary, conduct additional research to demonstrate the safety and efficacy of supplement ingredients.

Dietary-supplement consumers deserve no less. As Americans come to depend on supplements to address serious health concerns, it is all the more important that government ensure that products are safe and that claims on labels are backed by solid scientific evidence.