Dangerous Supplements Pose Challenges to FDA

In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which effectively allowed manufacturers of everything from weight loss pills to cholesterol-lowering supplements to put their products in front of consumers without regulatory oversight. The Federal Food and Drug Administration is tasked with approving prescription and over-the-counter medications — a process that can take up to ten years of research and development — but it is able to address health supplements only after a product is on the market and claims of injury have been lodged by consumers and/or health care professionals.

The FDA has a limited selection of responses with which to address potentially dangerous dietary supplements, one of which is a public warning. In May 2009, the FDA issued warnings stating that the weight-loss product Hydroxycut may cause serious liver damage. After the warning was issued, the manufacturer instituted an immediate voluntary recall of the product.

Similarly, FDA agents raided American Cellular Labs' (ACL) Maurice Sandoval's home and affiliated retail shops in July of 2009, responding to reports of products containing substances covered by the Steroid Control Act of 2004. A warning was issued instructing the public to stop using several body-building products manufactured by ACL and an active criminal investigation is continuing.

In both cases, the substances were already on the market, putting the health of consumers at risk, before the FDA could act.

Regulations regarding advertising and labeling health supplements fall under the Qualified Health Claims section of FDA guidelines. Under these guidelines, before marketing their product, manufacturers must file a petition with the FDA detailing the supplement's health claim prior to going to market. No studies or testing, however, are required to back up any of the statements. Although the FDA must approve these statements, it is up to the consumer to read the complete label, including any disclaimers, before making the decision to take a supplement. And the consumer must keep in mind that any punitive action is available only after a product is on the retailer's shelf and has received enough complaints to be suspected of being unsafe, as in the case of Baltimore Orioles pitcher, Steve Bechler, whose 2003 death ultimately lead to the ban on ephedra.

In what some analysts classify as an effort to dilute FDA regulations regarding disclaimers and standardized manufacturing processes, the agency has been named in a series of lawsuits citing First and Fifth Amendment rights. The plaintiffs contend that the FDA is guilty of censorship, overzealous application of the qualified health claims system, and the imprecise wording of the Good Manufacturing Practices regulations.

The FDA has not yet responded to these allegations, although several industry experts have weighed in on the side of the government agency. However, in light of the national focus on health and wellness and health care reform, these legal actions have the potential to significantly change the way the health supplements industry presents its products to U.S. consumers.