Dietary supplements such as vitamins and herbal medications are not subject to approval by the Food and Drug Administration (FDA) before they go to market. To date, the FDA has not required manufacturers to register with the FDA before selling or bringing a new supplement to market.
1994 Health and Education Act
In 1994, President Bill Clinton signed the Dietary Supplement Health and Education Act (DSHEA) into law. This law left the research, safety and claims of the supplement fall completely with the manufacturer. Previously to this bill, dietary supplements were scrutinized under the same standards as most foods. The new law brought supplements under a new regulatory umbrella for safety standards and labeling requirements.
False and Misleading
The 1994 law requires that companies bringing a dietary supplement to market have deemed them safe, and that the claims the product makes in treating conditions or helping maladies are substantiated by proven evidence. It also safeguards against manufacturers putting false or misleading information on product labels. The sole responsibility of ensuring safety guidelines have been met lies with the product producer.
Advertising and the Feds
In the case of advertising and false claims, manufacturers do have some more strict regulatory rules administered by the Federal Trade Commission (FTC). Advertising — including print ads and infomercials – is regulated by the FTC.
While the FDA and FTC work in tandem on issues of product advertising, the FTC is required to operate under a different set of laws. There are also strict guidelines about how manufacturers and distributors of dietary supplements are allowed to send promotional mailings and products via the U.S. Postal Office.
Failure of the Industry
It is this kind of loose regulation that has led to many dietary supplement failures over the last two decades. The most infamous being the herbal supplement for weight loss – ephedra. Ephedra was pulled from store shelves after federal regulators became concerned with the supplement’s role in dozens of deaths throughout the country. Ephedra and weight loss pills like Stacker 2 were linked with seizures, strokes, heart attacks and deaths and were listed as a dangerous and potentially deadly herbal supplement by Federal regulators.
It’s in the Labeling
While supplement manufacturers can make claims about promoting well-being and enhancing health, they cannot write on the packaging that the product can cure or prevent any specific disease. To make this claim, the FDA would consider it an unapproved drug – which is illegal in the United States. The DSHEA requires that labeling on packing must be fair and consistent. It must also show clear and concise dosing instructions.
The FDA states that manufacturers can make three types of claims on their supplement packing: health claims, nutrient counts and function claims. For example, a company can list what health benefit the supplement will give a consumer or which disease it can help alleviate.
About the Author: Kevin Clarke is a Pharmacist and maintains Drugsdb.com which is a health resource that provides health information for consumers on the most commonly used prescription and over-the-counter medications and supplements