Retailers May be Responsible for Supplement Safety

WASHINGTON, DC -- Proposed legislation recently introduced by Sen. John McCain could hold retailers and health club operators responsible for the safety of the sports supplements they sell.

The new bill, called the Dietary Supplement Safety Act of 2010, was designed to give the U.S. Food and Drug Administration (FDA) additional powers over supplement retailers and suppliers, and update the existing Dietary Supplement Health and Education Act (DSHEA) of 1994.

In its current form, the bill requires changes in adverse events reporting, facility registration and policing responsibility on the part of retailers. The bill also removes the grandfather clause from DSHEA for ingredients introduced before Oct. 15, 1994, replacing it with a new list of “accepted dietary ingredients” to be determined by the Secretary of Health and Human Services office, according to Functional Ingredients magazine.

The bill states that retailers would be required to “obtain adequate written evidence from the preceding responsible entity on the chain of commerce that the product is registered as required by section 415 and that the requirements of subsection A have been met. Such facility or retailer shall maintain such evidence of compliance for review and inspection by the secretary upon request.”

Although the preliminary version of the bill doesn’t specify what sort of liability club operators and retailers would be held to, it would require extra paperwork for them if passed, says Jason Phillips, associate editor of the Nutrition Business Journal.

“Any business that sells supplements will need to obtain some sort of certificate of compliance from the supplement manufacturer, which the manufacturer and retailer will be required to update annually,” says Phillips, who stresses that this is his own interpretation of the bill’s language. “The certificate will prove that the company is properly registered and its products are certified as containing compliant ingredients with the Health and Human Services secretary.”

Suppliers in the $25.2 billion U.S. supplement industry fear the new requirements could cause significant losses in sales. The Nutrition Business Journal estimates that U.S. consumers spent $2.7 billion on sports supplements in 2008, and that the sports supplement category could see a sales retraction of 30 percent or more if the bill resulted in one or more popular ingredients being removed from the market.

Industry trade groups feel existing laws need to be more stringently upheld.

“What we cannot support is wholesale changes to a regulatory structure that is working, and could work better if the measures we have supported were adopted,” John Gay, executive director and CEO of the Natural Products Association, said in a statement. “A series of new laws for criminals to ignore is not the answer. For example, the idea that the 150 million Americans who use dietary supplements are gambling with their health by shopping at mainstream stores just doesn’t stand up to scrutiny. Hyperbole does not lead to sound policy.”

The United States Anti-Doping Agency (USADA) voiced support for the bill. It is similar to that organization’s Supplement Safety Now campaign, which proposes to limit sales of steroids in dietary supplements. USADA’s campaign garnered the support of the National Football League, Major League Baseball, the National Basketball Association, the National Hockey League and the U.S. Olympic Committee.

In addition, the American College of Sports Medicine (ACSM) expressed its support for USADA’s efforts, as well as the McCain bill.

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