Law Blog 4 Fighting Abuse

How do you know that the dietary supplements that you consume are safe? All dietary supplements are not created equal. This is why the Dietary Supplement and Health Education Act of 1994 (DSHEA) was signed into law. This act, established in October 1994 by President Clinton makes it mandatory that the manufacturer of a dietary supplement ensures that the supplement is safe before marketing it. DSHEA amended the Federal Food Drug and Cosmetic act to define the term dietary supplement, and to establish a separate regulatory agenda for dietary supplements.

Under this law a dietary supplement is defined as any product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. These supplements can take several forms such as pills, capsules, liquids, powders, or bars. Regardless of the form they take, DSHEA places dietary supplements under in a special category under the general umbrella of foods, as opposed to drugs, and requires that every supplement be labeled as a dietary supplement. These supplements cannot be labeled as conventional food or sole item of a meal. Manufacturers must also make sure that product labels are truthful and not misleading. The label cannot claim that the supplement treats cures or prevents any specific disease.

In addition, under DSHEA, the manufacturer is expected to take full responsibility for ensuring that a dietary supplement is in compliance with DSHEA before marketing it. They are not required to get approval from the FDA before marketing a dietary supplement. However, if the manufacturer is intending to produce a dietary supplement with a “new dietary ingredient” they are required to notify the FDA. Under this law, a “new dietary ingredient” is one that was not marketed in the United States as a dietary supplement before October 15, 1994. The manufacturer must express to the FDA why the new dietary ingredient is safe for use in a dietary supplement.

This article is for informational use only and not intended as legal advice.

For a better understanding of dietary supplement regulations, visit the website of Searcy Law, serving the Tallahassee area.