On this page are answers to frequently-asked questions about dietary supplements which have been provided by the Natural Products Association. If you have a question that you don't see answered here, please contact us by clicking here.
Q: Are dietary supplements regulated by the FDA?
A: Dietary supplements are regulated, although not in the way prescriptionor over-the-counter drugs are. Because dietary supplements are foods, and not drugs, the Food and Drug Administration (FDA) has the power toensure that products on the market are both safe and accurately labeled. Before a product can be sold, a manufacturer must first notify the FDA of all intended label claims and ensure that they can be substantiated.
Q: How did the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994 effect theFDA's enforcement powers over the dietary supplement industry?
A: The passage of the DSHEA actually increased the FDA's enforcement powersover dietary supplements by establishing new labeling and potency standards. Violations of these standards are crimes. Under the DSHEA, the FDA has the power to:
- Refer for criminal action any company that sells a dietary supplement that is toxic or unsanitary [Section 402 (a)].
- Seize dietary supplements that pose an "unreasonable or significant risk of illness or injury" [Section 402 (f)].
- Stop a new dietary ingredient from being marketed if the FDA does not receive enough safety data in advance [Section 413].
- Stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard [Section 402 (f)].
"Obtain an injunction against the sale of a dietary supplement that has false or unsubstantiated claims" [Section 403 (a), (r6)].
- Require dietary supplements to meet strict manufacturing guidelines (Good Manufacturing Practices), including potency, cleanliness, and stability [Section 402 (g)].
In addition, there are industry self-regulatory efforts that supplement these governmental powers (see NNFA Leads the Industry's Self-Regulation), and the Federal Trade Commission has power over advertising and safety laws.
Q: Are dietary supplements safe?
A: According to a study published in the April 14, 1998 issue of The Journal of the America Medical Association (JAMA), adverse drug reactions, resulting from prescription and over-the-counter drugs, cause more than 100,000 deaths a year. Furthermore, the study estimates that 2.2 million people annually experience a serious adverse drugreaction.
In contrast, the FDA has on file approximately 2,500 "adverse event reports" (AERs), including 79 deaths, that may be related to dietary supplements. However, the FDA admits that these AERs may be flawed since there is "no certainty that an adverse event can be attributed to a particular product or ingredient." In addition, these AERs for supplements represent all reports to the FDA of adverse incidents allegedly connected to dietary supplements.
In addition, the February/March 1998 issue of Nature's Impact reports that dietary supplements are far safer to consume than foods, causing 1/60,000 as many deaths as foods each year. Consumers can check the safety of dietary supplements over the last two decades by comparing the incidence of deaths from all causes that are reported in either the Journal of Emergency Medicine or by the American Association of PoisonControl Centers in Washington, D.C.
Q: What scientific studies show the efficacy of dietary supplements?
A: Each year, numerous studies are published in major medical journals that support the use of dietary supplements for the treatment of specific conditions, prevention of diseases or for general nutritional enhancement. Such studies can be found in The Journal of the American Medical Association, New England Journal of Medicine, American Journalof Cardiology, American Journal of Clinical Nutrition, and The Journal of the National Cancer Institute.
In addition, several leading research institutes and national associations such as John Hopkins University and the American Heart Association, have conducted and released studies on the benefits of dietary supplements.
Provided courtesy of the Natural Products Association