Ongoing Federal Trade Commission demands for more scientific information to back marketing claims may affect some devicemakers, experts said Tuesday at the Food & Drug Law institute in Washington, D.C.

The U.S. FDA has primary regulatory authority over drug and device marketing. However, some products – such as most mobile apps and certain types of exercise equipment – may not be considered devices by the FDA. When that’s the case, the FTC comes in to ensure marketing is fair and accurate. The Commission has recently taken action against several mobile app manufacturers, including the makers of an app said to detect melanoma (IDDM, April 20).

Richard Cleland, assistant director of the FTC’s advertising practices division, says specific health claims made in marketing require specific substantiation, including randomized clinical trials. Peer-reviewed literature may be acceptable if it allows the FTC to assess the reliability of the original study.

The FTC frowns on scientific evidence gathered in foreign clinical studies if the original trial results cannot be subpoenaed, Cleland says.

“We’ve seen fabricated data submitted,” he explains. “There’s no way for us to detect fraud unless we can get to the underlying data.”

The evidence standards aren’t entirely new, Ivan Wasserman, a partner with Manatt, Phelps & Phillips law firm, told IDDM. But the FTC is being more specific in explaining what it wants. “It used to be that consent orders were written more generally,” he says. “Now they tend to include more specific language with regard to what kind of substantiation companies need to make specific claims.”

The FTC has taken some prominent actions regarding unsupported health claims recently, including administrative claims against pomegranate juice manufacturers Pom Wonderful that led to an ongoing court case. The company included claims on its website that the juice could cure heart disease, prostate cancer and erectile dysfunction.

In January, the U.S. Court of Appeals for the D.C. Circuit upheld the FTC’s order on the grounds that Pom Wonderful had mischaracterized the scientific evidence.

In a similar case, Bayer and the FTC are involved in a dispute as to whether FTC requests for information on a probiotic supplement constitute an unfair attempt to hold the product to the same standards as a drug. The Department of Justice is seeking a civil contempt order against Bayer for violating court orders to change its marketing.

While neither of those cases involves a device, they help to indicate current FTC concerns, Wasserman says. And when finalized, the law they create will apply to all products whose manufacturing is subject to FDA scrutiny.

To prepare, devicemakers should make sure they’re doing their own scrutiny of any external research they use to build marketing claims, he says.

“Manufacturers should make sure they have access to underlying data and procedures,” he says. “They should consider doing a deep dive themselves, rather than relying on published studies.” — Elizabeth Orr