- Stacy Straczynski

Proctor & Gamble has found itself under scrutiny by the Federal Drug Administration today. The FDA notified the company that two of its Vicks-branded over-the-counter medications—Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C—had been marketed illegally.

In the warning letter, the FDA called to attention the fact that P&G’s marketing repeatedly touted the products as both a cold medication as well as a dietary supplement—which is against FDA regulations.

Its marketing says the product works by “[c]ombining the powerful multi-symptom relief of DayQuil with more than 150% of the recommended value of vitamin C."

The FDA also said that P&G would be responsible for amending the violations within 15 days, as well as ensuring further violations do not occur. Amendment would require that the products in question be evaluated and approved for marketing for both its claims as a cold medication and a dietary supplment.

“This is not new news. It’s also not about the safety or quality of the Vicks NyQuil or DayQuil brands,” said P&G rep Kate DiCarlo. “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 FDA has sent warning letters to four different companies for similar reasons in the past several years. Two were sent to Bayer (Oct. 2008) regarding its Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin + Calcium tablet products, and one to B.F. Ascher & Company (Oct. 2001) regarding its Melagesic PM Caplets and Omni Nutraceuticals (Oct. 2001) regarding Inholtra Joint Pain Caplets and Inholtra Joint Pain Plus Caplets.
 
“Our policy and our public warnings on this topic are fairly well-known and very well established,” said Christopher Kelly, a press officer with the FDA.