Friday, October 15, 2010

The Fed took action against unapproved "drug" manufacturer

The federal government has barred a Montana company from the manufacture and sale of unapproved new drugs and dietary supplements, the FDA announced this week.  The order came in the form of a consent decree, filed in U.S. District Court for the District of Montana Wednesday and subject to court approval.

According to the FDA, the company manufactured and distributed a variety of unapproved new drugs that "were ineffective in treating the diseases they claim to treat."

The products - sold under such names as Black Salve, Cancema and Can-Support -- included topical salves purported to treat skin cancer, and oils and capsules to combat "serious diseases such as breast cancer, asthma, anemia and epilepsy," according to the FDA.

The FDA characterized many of these products as dietary supplements.
"The FDA will not tolerate unsubstantiated health or disease claims that may mislead customers," Autor said. "The FDA is committed to ensuring that consumers do not become victims of false cures."

In signing the consent decree, the company agreed to stop making and selling unapproved new drugs and products with unauthorized health claims and to hire an independent expert to review claims made for any future products, according to the statement.

Had the company hired an independent expert to review claims made for their products before they put them on the market, I suspect they would not have ended up in such deep trouble.