The FDA has some fairly new powers to regulate the herbal supplement industry. Recently, those powers have been tested by the agency’s effort to remove Hydroxycut from the market. Under the regulatory scheme, manufacturers of dietary supplements must adhere to specific manufacturing standards and they must notify the FDA when consumers of their products suffer adverse health effects.
Prior to taking action against Hydroxycut makers, the FDA found 72 weight-loss formulations on the market contained undeclared prescription medications, including some drugs that were not approved for use in the U.S. Some of the prescription drugs found in the dietary supplements included diuretics, anti-seizure medications, stimulants and a laxative known to cause cancer and DNA damage. The FDA threatened to pull all 72 of those products from the market. That move was well within the FDA’s powers, since medications were involved, even though those medications were hidden within dietary supplements. However, the action taken against Hydroxycut tested the limits of the FDA’s authority to regulate weight-loss products that don’t contain medications or claim to treat disease. Dietary supplements don’t require FDA approval before going on the market. The FDA can only take action regarding a supplement if enough evidence has been gathered to show that the supplement poses serious health risks.