Should Regulation of Dietary Supplements Be Toughened?
By: Source: AARP.org Date Posted: 2003-09-03 13:50:00-04:00
Yes
1994 Law Leaves Consumers at Risk
By Linda F. Golodner
Consumers have assumed a more active role in their own health care than ever before; many are exploring nontraditional and complementary approaches to medicine and health, including taking dietary supplements. Supermarket and drugstore shelves are filled to capacity with a great variety of vitamins, minerals, herbals, amino acids and botanical products.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) is the main law that defines what products are dietary supplements and what types of claims manufacturers can make about health benefits. The law does not go far enough. Many consumers mistakenly believe that these products are reviewed for safety and efficacy by the federal government just as other health care products are. They are not. As long as a product was on the market before the DSHEA was passed, the Food and Drug Administration can only take action once it has enough evidence to prove that a product is unsafe or harmful.
Why should the government have a greater role? Because many products have dangerous side effects or are potentially harmful, even causing fatal interactions with over-the-counter or prescription medicines. Often consumers think that if a product is "natural," it is safe. But that is not true.
There is also an increasing number of dietary supplement manufacturers who make inappropriate health-related claims that mislead or provide false hope. These claims not only violate the law, but they are potentially harmful to consumers who sometimes use these supplements in place of appropriate and necessary medical treatment.
In addition to safety, consumers often are in the dark about what is in the bottle they are buying. There are no regulations about what is an appropriate dosage, standards of quality or potency. Even though two products appear to be equivalent, there is no government agency that assures the buyer that they are equal.
What can a consumer do? Most important, talk to your health care professional about all the dietary supplements you take or think you might like to try. And be sure your doctor knows all the prescription and over-the-counter medicines you take, even if another doctor has prescribed them.
Linda F. Golodner is president of the National Consumers League, a nonprofit advocacy organization.
No
Feds Now Assure Safety and Quality
By John Cordaro
The Dietary Supplement Health and Education Act (DSHEA) of 1994 reaffirmed the regulation of dietary supplements as foods. All facets of dietary supplement manufacturing, including labeling and advertising, are covered by extensive regulations enforced by the Food and Drug Administration (FDA), the Federal Trade Commission (FTC) and 50 states.
The 1994 act preserved the FDA's 95-year fundamental authority to take immediate enforcement action against any food, including a dietary supplement, considered unsafe. Before marketing a new dietary ingredient for supplements, manufacturers must provide the FDA with their basis for judging that the ingredient is safe. The FDA has the option to accept or reject this evidence. The law also mandated labeling dietary supplements, so the FDA now requires a facts box on each product, featuring the names and quantities of all nutrients and other dietary ingredients.
The 1994 measure did not change the law or regulations regarding health claims, which describe how a product can treat or prevent disease. For all foods, health claims generally are permitted on the label if the statement is preauthorized by the FDA and based on significant scientific agreement.
The new law allows dietary supplement labels to provide useful information in the form of a statement of nutritional support, which describes the role of dietary supplements in affecting the structure or function of the body and general well-being. The law requires that these nutritional statements be truthful and not misleading, and manufacturers must notify the FDA within 30 days of making the label statement. The FDA can warn manufacturers that the statement is unacceptable.
In sum, consumers should have confidence in using dietary supplements to enhance health and well-being and to protect against disease. The FDA, the FTC and the states oversee a comprehensive regulatory framework that ensures the safety and quality of these products. The 1994 law did not weaken this regulatory framework.
To support these extensive laws and regulations, the FDA should take stronger enforcement action. Consumers also must act responsibly by reading labels and following directions.
John Cordaro is president and chief executive officer of the Council for Responsible Nutrition.
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