Risingsun Health to stop selling skin treatments for cancer FDA says don't work
Toby McAdam and Greta Armstrong, doing business as Risingsun Health and The Center for Complimentary and Alternative Health of Livingston, Mont., signed a consent decree prohibiting them from manufacturing and selling unapproved new drugs and adulterated or misbranded dietary supplements in violation of the law.
"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, in a statement. "The FDA is committed to ensuring that consumers do not become victims of false cures."
Before the agency's enforcement arm stepped in, Risingsun manufactured and distributed a variety of unapproved new drugs under names such as Black Salve, Cancema and Can-Support. Risingsun's products included topical salves marketed as a skin cancer treatment. The company also marketed oils and capsules it claimed were therapies for other serious diseases including breast cancer, asthma, anemia, and epilepsy.
None of these unapproved drugs – many of which Risingsun marketed as dietary supplements – were effective, the FDA said.
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 claims made for future products and to certify that all "violative claims" have been omitted.
Risingsun's website now contains the following disclaimer on every page:
The FDA has very stringent rules about claiming medicinal benefits for herbal remedies. While we believe our products are effective, they have not been tested nor approved by the FDA.
The FDA can also 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.Because of this, we make no medicinal or beneficial claims for any of our products.
The consent decree, filed in the U.S. District Court for the District of Montana and subject to court approval, also provides for damages to be assessed against Risingsun in the event of such violations.
The FDA cautions consumers that products already manufactured and distributed by Risingsun have not been shown to be either safe or effective.