Dietary Supplement Safety Touted

April 12, 2001

John Cordaro, president and CEO of the Council for Responsible Nutrition, criticizes "false statements (that) seriously damage consumer confidence in a wide range of useful and beneficial products" by linking those products to "seriouos public health issues" such as bovine spongiform encephalopathy (BSE) or mad cow disease.

"A lot of nonsense is being spread about dietary supplements and how they are regulated. These irresponsible and false statements mislead and confuse consumers and these tactics must stop immediately," said Cordaro.

For the past decade the USDA and the Food and Drug Administration (FDA) have enforced import restrictions to keep BSE out of the United States. These restrictions apply to ingredients used in dietary supplements as well as to ingredients used in drugs or in conventional foods. "Some media articles have falsely claimed that dietary supplements are not covered by government actions intended to protect against BSE," he said.

Bovine-derived ingredients used in dietary supplements include organ tissues such as liver and highly processed ingredients such as chondroitin or gelatin. Many of these ingredients are derived entirely from U.S. cattle and are considered free of BSE risk. Imports are permitted only according to government policies intended to avoid import of bovine ingredients from countries with BSE.

Cordaro said that at a February meeting with representatives of the dietary supplement industry, FDA official Dr. Robert Moore said, "FDA recognizes that the BSE problem relates to all foods, including conventional foods as well as dietary supplements." He said there is no more risk from dietary supplements than from conventional foods containing the same ingredients. All bovine ingredients are covered by the same regulations and import restrictions.

"In media coverage, it is often falsely claimed that dietary supplements are ‘unregulated' since passage of the Dietary Supplement Health and Education Act in 1994," said Cordaro. "In fact, the 1994 law reaffirmed that dietary supplements are regulated like foods. They have been regulated as a category of foods since the current Food, Drug and Cosmetic Act was enacted in 1938. They are not drugs and have never been regulated as drugs."

Dietary supplements are required to be safe. There is a procedure requiring notification of FDA 0before new ingredients are introduced into dietary supplements, and the agency has disapproved numerous ingredients on safety grounds. FDA has authority to remove products from the market that are unsafe. In recent years, FDA has in fact taken action against a number of dietary supplements, he added.

Like foods, dietary supplements are prevented from using bovine-derived ingredients from BSE countries. All U.S. beef is considered safe for use in this country in any product, from conventional foods to dietary supplements to pharmaceuticals. Beef and bovine-derived ingredients can be imported only if a company has a USDA import permit.

Such permits require a certificate of veterinary health from the country of origin, and imports are permitted only from countries where BSE is not a problem. FDA has issued import alerts, which apply these same requirements to conventional foods, dietary supplements, and drugs. FDA has a separate guidance document issued in 1997 that applies specifically to gelatin, a bovine-derived ingredient used to make capsules and also used as an ingredient in many foods and drugs, according to Cordaro.

"Consumers are being bamboozled by some media and some health professionals who have an axe to grind against dietary supplements and who do not have a good understanding of legal and regulatory issues," said Annette Dickinson, Ph.D., CRN's vice president for scientific and regulatory affairs. "Irresponsible statements falsely charging that dietary supplements are unregulated are creating unnecessary concern among consumers and are grossly unfair to the industry. This is especially outrageous when it relates to a serious issue such as BSE. In fact, the industry is complying with U.S. import policies and is working with government agencies to ensure that consumers continue to be fully protected."