The Truth Must Be Told About Dietary Supplement Regulation

WASHINGTON, D.C., April 11, 2001— "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 John Cordaro, President and CEO of the Council for Responsible Nutrition. "False statements seriously damage consumer confidence in a wide range of useful and beneficial products and are especially critical when the statements are linked to concerns about serious public health issues such as BSE."

For the past decade the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have been diligently enforcing import restrictions to keep BSE (bovine spongiform encephalopathy, known also as mad cow disease) out of the U.S. 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. 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 thus considered free of BSE risk. Imports are permitted only in accordance with current government policies intended to avoid import of bovine ingredients from countries with BSE.

At a February meeting with representatives of the dietary supplement industry, FDA official Dr. Robert Moore stated: "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 of 1994 (DSHEA). 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.

Like foods, dietary supplements are required to be safe. There is a procedure requiring notification of FDA before 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.

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.

Like foods, dietary supplements are required to provide full information to consumers through product labeling. This includes information such as nutrition labeling and ingredient labeling. The extensive labeling regulations are codified in Title 21 of the Code of Federal Regulations. The law requires that all labeling for dietary supplements be truthful and not misleading, and FDA has authority to take action against any false statements made in labeling. DSHEA imposed some additional requirements on dietary supplements, requiring companies to notify FDA when claims are made about beneficial effects on the structure or function of the body ("structure/function claims"). Marketers of conventional foods are not required to notify FDA when structure/function claims are made.

Like foods, dietary supplements are required to be manufactured in accordance with Good Manufacturing Practices (GMPs), and plants are inspected by FDA to determine whether such practices are being followed. Regulations describing food GMPs are set out in Title 21, Code of Federal Regulations, Part 110. DSHEA authorized FDA to establish a set of GMPs specifically applying to dietary supplements. The industry supports such GMPs and has supported FDA development of a new regulation, which is moving through the regulatory process.

In short, dietary supplements are regulated like foods. Like foods, dietary supplements must be safe and truthfully labeled. They must be made under good manufacturing practices. And they are subject to the same protections as other foods when it comes to guarding against BSE.

"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.

The Council for Responsible Nutrition (CRN) is a science-based, trade association founded in 1973 and represents more than 100 companies in the dietary supplement industry, including ingredient suppliers and manufacturers. CRN members adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.