WASHINGTON — Federal drug regulators warned Procter & Gamble on Wednesday for adding vitamin C to its Vicks cold formulas, a combination not allowed by federal regulations.
The Food and Drug Administration said medications like Vicks Nyquil and Dayquil are not permitted to contain the vitamin.
According to the agency, a panel of experts found "no study that demonstrated that vitamin C is unequivocally effective for the prevention or treatment of the common cold."
P&G advertising for Vicks says the vitamin "can help blunt" the effects of a cold.
In general, the FDA discourages firms from packaging drugs with dietary supplements because it gives the impression both have been evaluated by the FDA, when in fact, the agency only regulates drugs.
Vicks formula contains three drug ingredients: acetaminophen, a pain reliever and fever reducer; dextromethorphan, a cough suppressant; and phenylephrine, a decongestant.
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The Cincinnati-based company said Wednesday it believes its marketing materials meet federal regulations.
"P&G has clearly differentiated benefits by the Nyquil or Dayquil active ingredients versus the dietary supplement vitamin C," said spokeswoman Crystal Harrell in a statement. P&G launched the new formulations of the medicines last September.
The FDA's letter, posted online Wednesday, gives the company 15 business days to respond with a plan for addressing the violations.
The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing and marketing. The letters are not legally binding, but the agency can take companies to court if they are ignored.
