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NyQuil, DayQuil Vitamin C Claims Prompt FDA Warning

16 October 2009 1,925 views No Comment

Another big name in the pharmaceutical industry has caught the U.S. Food and Drug Administration’s (FDA) attention for making allegedly bogus claims about one of its products. In this case, Procter & Gamble Company has been touting the vitamin C benefits of is Vicks DayQuil and NyQuil products, said Reuters.

It seems that based on the FDA’s list of ingredients approved for over-the-counter (OTC) cough and cold medications, there is no allowance for combining vitamin C with the active ingredients that can be found in the two medications, according to Reuters, citing the agency’s warning letter.

Also, according to the FDA, because vitamin C is listed among the inactive ingredients, the products are misbranded, said Reuters. “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,” quoted Reuters from the FDA letter addressed to Proctor & Gamble’s President and Chief Executive, Bob McDonald.

The complete letter was posted on the FDA’s Website, but was later removed. Agency spokesman Christopher Kelly told Reuters, “The warning letter was posted in error. We have no further comment at this time.” No other information has been provided regarding the letter’s online posting, but the agency did not deny the letter’s existence, said Reuters.

Reuters pointed out that Proctor & Gamble markets DayQuil Plus Vitamin C as containing in excess of 150 percent of the recommended value of vitamin C. The agency noted that indicating a vitamin as an inactive ingredient, while also including it as a dietary ingredient under “Supplement Facts” was misleading and could confuse consumers, said Reuters.

Proctor & Gamble is just the latest firm to attract for claims about an ingredient in one of its products We recently wrote about some trouble pharmaceutical giant, Bayer, got itself into over allegedly false claims about its Men’s One A Day multivitamins. The Center for Science in the Public Interest (CSPI) was planning to sue Bayer for claims that the selenium in the popular men’s vitamins could help reduce prostate cancer risks, said CSPINet.

In June, the CSPI contacted Bayer, demanding it change how it markets Men’s One A Day following a prior study—SELECT, considered the largest prostate cancer prevention trial—that revealed selenium supplements to not prevent prostate cancer, said CSPINet previously, which noted that the discovery was made eight months prior.

Immediately following CSPI’s demand to Bayer, the FDA issued its own letter that contained “qualified health claim language for use on labels,” said CSPINet, that noted, among other things, that it was “highly unlikely that selenium supplements reduce the risk of prostate cancer,” quoted CSPINet. The letter put the drug maker in a position in which it had to change a good amount—but not all—of its marketing; however, it refused to recall existing stock that contained the bogus information, did not remove false claims from some Men’s One A Day marketing, and would not confirm in writing that it would refrain from making those bogus claims going forward, said CSPINet.

source from:www.newsinferno.com

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