Ohio-based P&G spokesperson Crystal Harrell said P&G believed it was, “marketing within FDA guidelines and regulations” about the products in question - Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C.
She said her company wanted to better understand the regulations in relation to products that contained both pharmaceutical and dietary supplement ingredients, and was working with the FDA towards this end.
The company has 15 days to alert the FDA of its intended actions and Harrell said no product withdrawal had been demanded or actioned by the company, despite the fact the FDA stated the products, “are illegally marketed combinations of drug ingredients and a dietary ingredient.”
The FDA said it acted 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.”
It also noted that: “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.”
“Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs, which are regulations that set requirements for the drugs' labeling, formulations and indications. The two Vicks products 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.”
The FDA cited former cases involvingBayer HealthCare in 2008 and Omni Nutraceuticals in 2001 that saw combination products incur the wrath of the regulator.
Harrell noted the latest warning letter had not arrived in addition to a previously issued warning letter about the same products that the FDA subsequently withdrew over an administrative mix-up.
The products have been available in the US since July, 2008.
The ruling can be found here.