FDA must clarify drug-supplement borderline, says AHPA

It has called on the Food and Drug Administration (FDA) to make clear its policy in the area, despite the fact FDA has issued written warnings to companies marketing combination products in the past.

The product in question is Bayer Healthcare's "analgesic phytosterol supplement" called Bayer Aspirin With Heart Advantage.

The product contains 81mg of aspirin and 400mg of phytosterols, and makes both OTC drug and dietary supplement labeling and claims.

AHPA, and FDA - previously at least - takes issue with this kind of marketing because it implies both active ingredients have been submitted to pharma-level testing when in fact only the OTC drug ingredients will have.

This is potentially deceptive for consumers.

FDA actions In a May 29 letter to FDA, AHPA referenced former FDA associate commissioner for policy, Margaret Dotzel, advising companies in 2000 about problems marketing combination products.

"Consumers may be confused about the degree of scrutiny FDA gives such combination products," Dotzel wrote.

"Consumers may believe that both components have been subjected to the more stringent drug regulatory requirements when, in fact, only the drug component may have been reviewed by the agency for safety and effectiveness. "

She also noted how the introduction of a new ingredient to a drug product could have efficacy and safety ramifications.

In 2001 FDA wrote warning letters to B.F. Ascher & Company (over a sleep aid containing 500 mg of acetaminophen and 1.5 mg of melatonin) and Omni Nutraceuticals (a joint relief product containing glucosamine, chondroitin and acetaminophen) for marketing products that did not have new drug approval.

The rulings echoed Dotzel's earlier missive in which she sated: "FDA strongly recommends that firms refrain from marketing products that combine both drug and dietary supplement ingredients (except for products marketed under an approved new drug application)."

AHPA called on FDA to act on the Bayer launch or make public a change of policy in the area.

"If FDA has not changed its policy, we assume the agency should evaluate Bayer's product in the same manner it evaluated the OTC drug-dietary supplement combinations cited in these previous warning letters," said AHPA President Michael McGuffin.

"If, on the other hand, there is a new policy, it appears as if the marketplace may now be open to other OTC drug-dietary supplement products."

In its May 29 letter to FDA, AHPA added: "AHPA is concerned that reports of adverse events that may come to be associated with OTC drug-dietary supplement combination products could fail to differentiate between the separate product classes, or that duplicate reporting for individual adverse events may occur."