Last Thursday, 10/29/2009, FDA sent P&G a warning letter regarding Vicks DayQuil Plus Vitamin C and Vicks NyQuil Plus Vitamin C. The FDA takes the position that these two products are unapproved drugs because they combine a (OTC) drug and a dietary supplement. The relevant passage from the FDA warning letter is:
Notwithstanding your attempt to market each of these products as a combination drug-dietary supplement, the presence of acetaminophen and dextromethorphan HBr, along with phenylephrine HCl (“VICKS DayQuil Plus Vitamin C”) or doxylamine succinate (“VICKS NyQuil Plus Vitamin C”), with the intended uses of these ingredients as, respectively, pain reliever/fever reducer, cough suppressant, nasal decongestant, and antihistamine, render the entire product a drug in both cases. The vitamin C in these products could be marketed separately as a dietary supplement. However, where, as here, drug and dietary ingredients are combined into a single dosage form, the combination becomes a “drug” under section 201 (g) of the Act (21 U.S.C. 321(g)).
This follows a public relations snafu in mid October where FDA posted a warning letter then retracted it, saying there was no warning letter. Indeed, there was.
What can P&G do? One possibility is to go the 505(b)(2) route and get the combination approved. Camargo has been engaged in drug-dietary supplement 505(b)(2) NDA product development projects and has had pre-IND meetings to discuss the requirements.