FDA ISSUES WARNING LETTER TO PURAVIDA HEALTH

The FDA has issued a warning letter to PuraVida Health on grounds that the company is illegally promoting its herbal product Fluvicet as an influenza drug.

In a letter last month, the FDA cites the firm's website that claims Fluvicet can be used to treat and prevent influenza, which would cause the FDA to classify the product as a drug. A company cannot legally market a product as a drug unless the FDA recognizes it to be safe and effective.

In addition, the agency said PuraVida's claims are not supported by scientific evidence, and that Fluvicet's name is misleading because it includes the word "flu."

The agency cited several examples of such unsubstantiated claims posted on the company's website, including: "Can you protect your family from the ravages of pandemic flu? Fluvicet is an all natural herbal formula designed to support your body's response to this type of virus," and "You should ONLY consider using this product at the first signs of sickness during a pandemic."

The FDA ordered PuraVida to correct these violations within 15 days, or to indicate why the violations cannot be corrected within that time and when PuraVida would correct them. PuraVida declined to comment.

The warning letter is at http://www.fda.gov/foi/warning_letters/g5693d.pdf (http://www.fda.gov/foi/warning_letters/g5693d.pdf).