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Government takes action against Montana drug manufacturer
Company is charged with selling unapproved drugs

The U.S. Food and Drug Administration today announced that Toby McAdam and Greta Armstrong, doing business as Risingsun Health and The Center for Complimentary and Alternative Health of Livingston, Montana, have signed a consent decree that prohibits them from manufacturing and selling unapproved new drugs and adulterated or misbranded dietary supplements in violation of the law.

Prior to entry of the consent decree, Risingsun manufactured and distributed a variety of unapproved new drugs under names such as Black Salve, Cancema, and Can-Support. These products included topical salves purported to treat skin cancer, as well as oils and capsules claimed to be therapies for other serious diseases such as breast cancer, asthma, anemia, and epilepsy. These products were ineffective in treating the diseases they claim to treat. Risingsun characterized many of these unapproved new drugs as dietary supplements.

“The FDA will not tolerate unsubstantiated health or disease claims that may mislead customers,” said Deborah M. Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that consumers do not become victims of false cures."

Under the consent decree, Risingsun agreed to stop making and selling unapproved new drugs and products with unauthorized health claims. Risingsun also agreed to hire an independent expert to review the claims made for future products and to certify that all violative claims have been omitted. The FDA can order Risingsun to stop manufacturing and distributing any product that fails to comply with the consent decree or the Federal Food, Drug, and Cosmetic Act (FFDCA). The consent decree also provides for damages to be assessed against Risingsun in the event of such violations.

The consent decree was filed in the U.S. District Court for the District of Montana today, October 13, 2010, and is subject to court approval.

Consumers should be aware that the products already manufactured and distributed by Risingsun have not been shown to be safe or effective. Individuals should not delay or avoid seeking legitimate medical treatment. Consumers are advised to consult a healthcare professional with any health concerns they have.

According to FDA experts, drinking the amount recommended on product labels can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration. Some labels claim vomiting and diarrhea are not uncommon after the product is ingested—and even maintain such reactions are evidence MMS is working.