The FDA has 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.
