FDA targets dietary supplements maker for selling unapproved, misbranded drugs
SILVER SPRING, Md. The Food and Drug Administration on Wednesday announced that Toby McAdam and Greta Armstrong, doing business at Rising Sun Health and The Center for Complementary and Alternative Health of Livingston, Mont., 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, Rising Sun manufactured and distributed a variety of unapproved new drugs under such names as Black Salve, Cansema 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. Rising Sun misbranded many of these unapproved new drugs as dietary supplements.
"The FDA will not tolerate unsubstantiated health or disease claims that may mislead customers," stated Deborah 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, Rising Sun agreed to stop making and selling unapproved new drugs and products with unauthorized health claims. Rising Sun 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 Rising Sun to stop manufacturing and distributing any product that fails to comply with the consent decree or the Federal Food, Drug, and Cosmetic Act. The consent decree also provides for damages to be assessed against Rising Sun in the event of such violations.
The consent decree was filed in the U.S. District Court for the District of Montana and is subject to court approval.