Who Should Be Responsible for Hydroxycut's Safety?

When the Food and Drug Administration (FDA) issued a letterto healthcare professionals calling Hydroxycut dietaids a "serious public health risk," the manufacturer, IovateHealth Sciences, decided to withdraw all 14 varieties of the nutritionalsupplement named by the FDA.  The FDA'saction was in response to 23 reports of liver damage associated with the use ofthe weight loss product, that led to 16 hospitalizations, two livertransplants, 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 iswhat is known as a "dietary supplement," and it is subject to verylittle regulation, less regulation, in fact, than most food products.  Essentially, Iovate Health Sciences and otherfirms producing dietary supplements are on a kind of honor system.  They are removed from the burden of provingthe safety and effectiveness of their product in exchange for fullresponsibility for resulting injuries and the FDA's threat that it will publiclyexpose any injuries caused by their product.

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

Hydroxycut and theDSHEA

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

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

The DSHEA requires that dietary supplements carry anutrition information panel similar to foods, but, other than a list ofingredients, it does not specify exactly what the panel must contain.  It requires that if a dietary supplementincludes what is described as a "new ingredient," the companymanufacturing 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 dietarysupplements like Hydroxycut state ingredients like "Hydroxagen Plus,"whose composition is hinted at, but not made exactly clear. 

What the FDA Can andCannot Do about Hydroxycut

The FDA has no power to stop a dietary supplement fromentering the market.  Dietary supplementsare not required to be evaluated for effectiveness or even safety before theygo on sale.  Claims made on the labelabout what a dietary supplement accomplishes do not fall under the FDA'sauthority.  Instead, these claims areevaluated by the Federal Trade Commission (FTC), which can sue companies overfalse claims if it gathers sufficient information to prove the claims false.

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

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

Who Is Responsiblefor the Safety of Hydroxycut?

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