In a news release by the U.S. Food and Drug Administration (FDA) dated October 13, 2010, Toby McAdam and Greta Armstrong, who run Rising Sun Health and The Center for Complimentary and Alternative Health of Livingston (Montana) have signed a prohibitory consent decree. This document prohibits them manufacturing and selling drugs that they have developed, and products that they have either adulterated or misbranded in violation of the law.
Briefly, a consent decree is a legal term used to refer to a voluntary agreement between the parties involved in a suit. At issue were claims that a variety of drugs not approved by the FDA, such as Black Salve, Cancema and Can-Support, were branded or marketed as treatments for skin cancer. Other products manufactured and marketed by this group were capsules and oils that made claims as being therapies for serious diseases such as asthma, anemia, epilepsy, and breast cancer.
At the time of the FDA’s news release, the website for Rising Sun Health bore the statement that read (roughly): the FDA has rules concerning claims made regarding the medicinal benefits of herbal products. While we (at Rising Sun Health) believe that the products we offer are effective, these products have not been approved by the FDA.
The statement released by the FDA is a little stronger and it states that the products (listed above) are ???ineffective.???
As stated by the decree signed by McAdam and Armstrong, Rising Sun Health will no longer make and sell ???unapproved??? drugs and other dietary supplements that are marketed as therapies for diseases and disorders. In addition, Rising Sun Health will hire an independent expert that will be tasked with reviewing the claims made by the team at Rising Sun Health relative to all new products they manufacture and sell.
Finally, the FDA retains the right to order Rising Sun Health to discontinue making and selling any products that are not in compliance with the Federal Food, Drug and Cosmetic Act (FFDCA).