FDA raps Bayer in ‘combo' product crackdown
The two ‘combination’ products – Bayer Heart Advantage (aspirin plus plant sterols) and Bayer Women's (aspirin plus calcium carbonate) – sent a “mixed message”, the FDA wrote in warning letters to Bayer.
Commenting on the Bayer Women’s product, but applicable to both, the FDA said: “Notwithstanding your attempt to market this product as a combination drug-dietary supplement, the presence of aspirin in this product, with its intended uses as an analgesic and to mitigate, treat, and prevent cardiovascular diseases, renders the entire product a drug.”
The FDA said Bayer Women’s went into unregulated disease reduction territory by stating the product "helps strengthen bones to fight osteoporosis".
The disputed claims are centered on the reduction of heart disease and osteoporosis, whereas the approved FDA claims are softer, referring to the benefit of a nutrient to a bodily function rather than a direct disease reducing relationship.
The FDA also took umbrage at the fact the Bayer products did not provide adequate ‘directions for use’.
The regulator added that because Bayer was employing new drug formulations, it required fresh drug approvals, which Bayer had not sought, and were therefore in violation of drug law.
Blazing guns
Daniel Fabricant, PhD, vice president, scientific and regulatory affairs at the Washington DC-based Natural Products Association (NPA), said the FDA is taking an uncompromising position that makes it clear no company, no matter how large, could “get around the claims approval process”.
“They have come out with two guns blazing,” Fabricant told NutraIngredients-USA.com. “They have drawn a very clear line in the sand with this position and it is hard to imagine how Bayer can do anything but comply with the FDA’s wishes. It is good for the supplements industry because it stops companies from making unsubstantiated claims about borderline products.”
Regulatory challenges
But another Washington DC-based dietary supplements trade association, the Council for Responsible Nutrition (CRN), supported combination products.
“CRN continues to believe that combination dietary supplement-OTC drug products have a useful and important role to play in integrated healthcare and wellness,” said CRN president, Steve Mister.
Rather than cracking down on companies attempting to negotiate the varying sets of laws in place for different ingredients, Mister suggested the FDA should help companies “maneuver the regulatory challenges of developing products that combine these ingredients and meet the labeling and formulation requirements of both drugs and dietary supplements, as required by the law.”
Mister referred to a 1994 FDA statement to the effect that combination products should not be barred from making claims if safety could be demonstrated, and noted this position had not been “publicly reversed”.
“It would be unfortunate if overly formalistic interpretations of labeling regulations carried the day and kept these beneficial products from consumers,” he added.
Troubling
Bayer has 15 days to take “corrective action”, and a spokesman told NutraIngredients-USA.com it was formulating its response. In the meantime there were no plans to remove the products from retail shelves, he said, noting the Women's product had been on-market since 2002.
The Heart product was launched in the summer.
"The marketing of these unapproved drugs is troubling," said Janet Woodcock, MD, the director of the FDA’s Center for Drug Evaluation and Research.
"Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations."
