NATREN WARNED FOR MISLEADING LABELING AND WEBSITE INFORMATION

Natren received an FDA warning letter for misleading information on its website and the labeling for its products Gy-Na-Tren Vaginal Health Solution and Life Start.

Claims on the products' labeling qualify them as new drugs, according to the warning letter, which was sent Nov. 21 and posted to the FDA website this week. Because Gy-Na-Tren and Life Start lack approved new drug applications, they cannot be legally marketed in the U.S., the letter said.

Gy-Na-Tren's outer labeling says it is "scientifically proven to promote a positive balance in the vaginal and intestinal ecology when taken as directed," the warning letter said. According to the FDA, this means the product is intended to affect the structure or function of the human body, qualifying it as a drug.

Additionally, the letter noted that Gy-Na-Tren's intended vaginal route of administration prohibits it from being considered a dietary supplement, which can only be taken orally.

Life Start is a product for infants that Natren labels as a dietary supplement, according to the letter. Statements on the Natren website qualify Life Start as a drug, the FDA said. The warning letter cited statements saying Life Start "helps to establish an optimal flora found to be a key component in helping to deter predisposition to allergies and asthma." At press time, these statements were no longer on the Natren website.

The company did not respond to a request for comment.

The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6140d.pdf (http://www.fda.gov/foi/warning_letters/g6140d.pdf).