When the Food and Drug Administration (FDA) issued a letter to healthcare professionals calling Hydroxycut diet aids a "serious public health risk," the manufacturer, Iovate Health Sciences, decided to withdraw all 14 varieties of the nutritional supplement named by the FDA.  The FDA's action was in response to 23 reports of liver damage associated with the use of the weight loss product, that led to 16 hospitalizations, two liver transplants, and one death.

What in Hydroxycut causes liver damage?  No one knows.  The product has undergone no clinical trials, never received any FDA approval , and is not a prescription drug.  It is what is known as a "dietary supplement," and it is subject to very little regulation, less regulation, in fact, than most food products.  Essentially, Iovate Health Sciences and other firms producing dietary supplements are on a kind of honor system.  They are removed from the burden of proving the safety and effectiveness of their product in exchange for full responsibility for resulting injuries and the FDA's threat that it will publicly expose any injuries caused by their product.

But is this the best possible solution for this particular class of medical products?

Hydroxycut and the DSHEA

For regulatory purposes, Hydroxycut and other dietary supplements are not considered either a food or a drug.  The class of dietary supplements was created in 1994 with the signing of what is known as the Dietary Supplement Health and Education Act (DSHEA).  This act was something of a compromise between the industry and agency officials.

The supplement industry lobbied for the DSHEA because they wanted less regulation and inspection than they were currently undergoing because they were classed as "foods."  The FDA more or less endorsed the act because its manpower was already stretched thin, it was getting pressure to speed the approval process after the passage of the Prescription Drug User Fee Act (PDUFA), which required that it act on all new drug applications within 10 months, and the explosion of dietary supplement market might make the agency unable to effectively enforce current regulation anyway.

The DSHEA requires that dietary supplements carry a nutrition information panel similar to foods, but, other than a list of ingredients, it does not specify exactly what the panel must contain.  It requires that if a dietary supplement includes what is described as a "new ingredient," the company manufacturing the supplement must review safety data about the ingredient, although what constitutes a new ingredient is open to interpretation.  In addition, the labels of many dietary supplements like Hydroxycut state ingredients like "Hydroxagen Plus," whose composition is hinted at, but not made exactly clear.

What the FDA Can and Cannot Do about Hydroxycut

The FDA has no power to stop a dietary supplement from entering the market.  Dietary supplements are not required to be evaluated for effectiveness or even safety before they go on sale.  Claims made on the label about what a dietary supplement accomplishes do not fall under the FDA's authority.  Instead, these claims are evaluated by the Federal Trade Commission (FTC), which can sue companies over false claims if it gathers sufficient information to prove the claims false.

Since an amendment to the DSHEA was passed in 2007, the FDA has expanded its data collection of adverse events related to dietary supplements like Hydroxycut, but these reports only surface after a drug has hit the market.  The FDA seeks to monitor ingredients contained in the supplements.  In March 2009, the FDA identified dietary supplements marketed by 72 companies that contained undeclared ingredients, some of which had been banned or not approved because of potentially deadly side effects.

The FDA cannot generally mandate a recall of suspicious products like Hydroxycut, but it can use its ability to publicize potential dangers to inspire companies to voluntarily recall dangerous products.

Who Is Responsible for the Safety of Hydroxycut?

The deal struck between the FDA and the dietary supplement industry, giving rise to the DSHEA gave manufacturers of dietary supplements unprecedented latitude in manufacturing and marketing their products.  In exchange, the dietary supplement industry took responsibility for ensuring the safety of their product.  If Hydroxycut turns out to have dangerous ingredients, victims who suffered adverse consequences as a result should be able to recover damages from Iovate Health Sciences, Inc.