U.S. health business sidesteps FDA censure
Misleading claims shifted to separate website
A Montana-based natural health supplier is still pursuing business after the U.S. Food and Drug Administration demanded it stop making claims for its unapproved drugs and devices.
Rising Sun Health operates an internet business selling substances such as topical salves purported to treat skin cancer, as well as oils and capsules claimed as therapies for other serious diseases such as breast cancer, asthma, anemia and epilepsy.
According to the FDA, the products are ineffective in treating the diseases they claim to treat.
"The FDA will not tolerate unsubstantiated health or disease claims that may mislead consumers," said Deborah Autor, compliance director with the FDA's Center for Drug Evaluation and Research.
'The FDA is committed to ensuring that consumers do not become victims of false cures'—Deborah Autor, Food and Drug Administration
"The FDA is committed to ensuring that consumers do not become victims of false cures."
Under a consent decree filed in Montana District Court, Wednesday, Rising Sun Health is prohibited from making and selling unapproved new drugs and products with unauthorized health claims.
On its website Thursday, Rising Sun was still offering its products, but with the following caveat:
"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."
"Because of this, we make no medicinal or beneficial claims for any of our products."
Visitors are then directed to a website for the Center for Complimentary and Alternative Health, in Livingston, Montana, which contains the following message:
"FDA regulations strictly prohibit products to be listed on the same web site as information regarding ailments or health conditions. Additionally, testimonials and information about herbs can not be on the same site that promotes or sells alternative health products."
'We can tell you about the site, but can not provide a link to the site.'—Message on alternative health info site, directing consumers to a sister site
"Therefore, we recommend bulk herbs and herbal products at the website 'www.bloodrootproducts.com' As you will notice there is no link to this site, just cut and paste 'www.bloodrootproducts.com' in the address bar of your browser. We can tell you about the site, but can not provide a link to the site."
Bloodrootproducts.com is a commercial alternative health business located at the same address as the Center For Complementary and Alternative Health. As well, Bloodrootproducts and Rising Sun Health share the same phone number.
When contacted by CBC News, the FDA said it was unaware that health claims had simply been shifted to a non-commercial website.
Under the consent decree filed Wednesday, the FDA can order Rising Sun to stop manufacturing and distributing any product that fails to comply with the order.