FDA reminds the industry that OTC drug and dietary ingredient combo products are unapproved new drugs in its latest warning letter, this time going to Procter & Gamble. The letter, dated Oct. 29 and announced Oct. 30, addresses P&G's Vicks DayQuil Plus Vitamin C and NyQuil Plus Vitamin C products, both marketed for cold and flu symptoms.
A warning letter also concerning those products was posted recently on FDA's Web site, but as "The Tan Sheet" reported here, the agency quickly retracted it, saying it was wrongly posted.
But, here it is again.
In the Oct. 29 letter, FDA notes previous warning letters regarding combination products, including the October 2008 warning to Bayer Healthcare regarding Bayer Aspirin with Heart Advantage (aspirin/phytosterols) and Bayer's Women's Low Dose Aspirin + Calcium tablets.
FDA notes the Vicks product contains various drug ingredients, as well as vitamin C, which the labeling clearly states. However, marketing the combination product is unlawful, the agency says.
Further, FDA warns P&G the agency "previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold."
In an Oct. 30 statement, P&G said FDA'a action does not involve the safety or quality of the product.
"We believe we are marketing within FDA guidelines and regulations, and we'll continue to work closely with the FDA to resolve any concerns," the Cincinnati-based firm responds.
A spokeswoman told "The Tan Sheet" the firm does not have a recall planned. "Beyond that, it would be premature to comment on any next steps other than to say we are working closely with the FDA to resolve any concerns."
FDA explains in its announcement that certain OTC drugs can be marketed without FDA approval, but must comply with relevant monographs.
The two Vicks products, however, "do not comply with the applicable FDA monograph and must first be evaluated and approved under the FDA's new drug approval process to be legally marketed," according to the agency.
FDA says it sent the letter to "clarify that these single-dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective."
Bayer has since relabeled its women’s aspirin product without calcium-related bone health claims, and removed aspirin from its Heart Health Advantage product, as the "The Tan Sheet" reported here.
- Katie Stevenson (k.stevenson@elsevier.com)
