Pharmaceutical

FDA sends warning letters to dietary supplement makers

supplement Jack3d 280x210 FDA sends warning letters to dietary supplement makersA dozen companies received warning letters from the Food and Drug Administration (FDA) for selling dietary supplements promoted to treat diseases, posing a risk to public health.

“The products are dangerous because they are targeted to patients with serious conditions, where treatment options proven to be safe and effective are available,” said Deborah Autor, the FDA’s director of drug compliance. People swayed by these promotions could waste time taking them and delay seeking medical treatment, which could be detrimental to their health.

Warning letters were sent to companies with names such as Medavir, Herpaflor and C-Cure, none of which the FDA says have been proven effective at treating any disease. For example, Medavir Medical Advances, claims on its website that its product Medavir to treat the herpes virus “has been proven effective in several official university research studies – including an official FDA trial.”

Arenvy Laboratories promotes ImmuneGlory solution to strengthen the immune system “so that herpes or cold sores have nowhere to hide.” The FDA says these claims are without basis.

The FDA warning letter told the dietary supplement companies that they had 15 days to take their products off the market or face legal action, including seizing the products and taking company officials to court.

Dietary supplements that make health claims are required to also carry the disclaimer: “This statements has not been evaluated by the FDA.” Otherwise, the products are considered pharmaceutical products. Federal law requires all drugs to treat diseases to undergo clinical trials and scientific review for safety and efficacy before they can be marketed.

Source: NY Daily News