Manufacturers of general wellness products wondering how the U.S. FDA might regulate their goods should check how the agency deals with similar devices, an attorney says.
The FDA issued guidance in January clarifying that products that help manage weight loss, fitness, stress, sleep and other aspects of good health may enter the market unregulated. But Frederick Stearns, with the law firm Keller and Heckman, says the line between regulated and unregulated products may be blurry.
Stearns advises companies to see if similar products are actively regulated. If they are, “it is unlikely anything similar will be exempt” from regulation, he says.
The guidance defines general wellness products as products that maintain or encourage a general state of health without referencing a disease or condition or making claims about health benefits.
Generally, if products are of low enough risk, they are exempt from active oversight, Stearns says.
The FDA’s broadening of its exemptions from jurisdiction to include products that claim to reduce the risk or impact of certain conditions as exempt from regulatory jurisdiction “is a surprise, but welcome to industry,” he adds.
According to the guidance, weight management, physical fitness, and stress and sleep management are common subjects for wellness products, provided they don’t reference a disease or condition. Examples include exercise equipment, video games and products such as pulse and food consumption monitors.
Products are not considered low risk if they are invasive or involve technology that risks user safety if controls are not applied, such as lasers that emit radiation.
Stearns notes that FDA’s expansion of its regulatory exemptions, while a welcome development, contains “potential for abuse, since FDA will devote less attention to this category. Enforcement in this area may fall to the FTC to a large extent — such as claims made in advertising.”
Stearns spoke during a recent FDAnews webinar on general wellness apps. — Charlotte Astor