P&G Is Warned By The FDA Over Vitamin C in NyQuil
The Federal Drug Administration (FDA) has given warning to Procter & Gamble (P&G) on Wednesday for adding vitamin C to its Vicks cold formulas, which is a combination that is not allowed by the FDA.
We have heard vitamin C is good for a common cold, and Nyquil can help a common cold, however, the FDA will not permit a natural product like vitamin C to be combined with a non-natural product such as Nyquil.
According to the Food and Drug Administration, experts found "no study which demonstrated that vitamin C is unequivocally effective for the prevention or treatment of the common cold." In general, the FDA discourages companies from packaging drugs with dietary supplements because it gives the impression that the FDA has evaluated both when in fact the agency regulates only drugs.
The labels on products such as DayQuil Plus Vitamin C say the products contain “more than 150 percent of the recommended daily value of vitamin C.” The FDA said listing vitamin C as both a dietary ingredient and an inactive ingredient in the labeling could be misleading consumers.
"Because the vitamin C in these products is an active drug ingredient, it is therefore both false and misleading to state that it is an inactive ingredient in these drug products," the FDA wrote to P&G President and Chief Executive Bob McDonald.
P&G said the way vitamin C is promoted on the NyQuil and DayQuil labels is designed to distinguish the benefits provided by the products’ active ingredients compared to the dietary supplement use of vitamin C. The company issued a statement saying it is “marketing within the FDA regulations and will work with the FDA to resolve the concern together.”
In recent years the FDA has begun cracking down on manufacturers who overstate the benefits of their products. The FDA has warned drug manufacturers about labeling claims of benefits from dietary supplements and in October 2008, the agency said some over-the-counter Bayer aspirin products were being illegally marketed because they contained dietary supplements that had not been proven effective.
What is interesting to take note of is this comes weeks after U.S. antitrust regulators approved P&G's plan to sell its pharmaceuticals business to Ireland's Warner Chilcott Plc (WCRX.O) for $3.1 billion. Vicks products, which are sold over the counter and do not need prescriptions, are not included in that sale.
The FDA has issued its warning and has asked Procter & Gamble to respond within 15 days to say how the company plans to address the concerns about labeling claims.
Reference: Associated Press and FDA.gov
Written by Tyler Woods Ph.D.
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