Herbal Formula Manufacturer Vows to Fight the Feds
BY LISA BARIL
03/05/14
A Livingston, Mont., man has found himself on the wrong side of a powerful federal agency. Toby McAdam, owner of Risingsun Health, was fined $85,000 on Dec. 4, 2013, for failing to comply with a 2010 order, issued by the U.S. District Court of Montana, to stop “developing and selling topical bloodroot and graviola products, new drugs, new animal drugs and dietary supplements,” according to a Dec. 19, 2013, FDA news release.
In 2010, the United States Department of Justice initiated the case against Risingsun Health and McAdam on behalf of the FDA, stating that McAdam was selling unapproved drugs with unsubstantiated medical claims. These products included escharotic salves, also known as black salves, alleged to treat skin cancer by drawing out or dissolving cancerous cells, as well as oils and capsules advertised as treatments for other serious diseases such as breast cancer, asthma, anemia, and epilepsy, according to the FDA.
The case was resolved when McAdam signed a consent decree on Nov. 4, 2010, that barred him from manufacturing and selling unapproved new drugs and products with unsubstantiated medical claims. The consent decree also required McAdam to hire an independent expert to review the claims made for future products and to certify that all claims violating FDA regulations have been omitted. McAdam further agreed to provide for monetary damages if he continued to violate the court order.
Although manufacturers of dietary supplements and topical therapies are not required to obtain FDA approval, products with unsubstantiated medical claims are considered new drugs and therefore require considerable proof of safety and effectiveness prior to sale and distribution. The FDA contends that the “new drugs” sold by Risingsun Health are unsafe and ineffective in treating the diseases they claim to treat.
“The FDA is committed to ensuring that consumers do not become victims of false cures,” said Deborah M. Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, in an Oct. 13, 2010, press release.
“I’ve done everything the FDA wanted me to do in the consent decree,” said McAdam in an interview with the Montana Pioneer, “including obtaining an outside expert to review the labels.” He said he sent the new labels to the FDA for review, but that he never heard from them.
McAdam said he was forced to sign the consent decree and disagrees with portions of it, particularly a section that indicates the FDA would issue approval for his products if he provided accurate labels that did not make unsubstantiated medical claims. “They are supposed to put it in writing,” said McAdam.
But, according to the FDA, McAdam has never been in compliance with the court order, nor does the FDA issue approval for dietary supplements. The FDA states that McAdam failed to cease operations per the orders of the consent decree despite several warnings and that they never received any certification by an outside labelling expert. Furthermore, the FDA found McAdam in violation of several new claims and statements made on his website bloodrootproducts.com.
“These products help people,” said McAdam. Although he told the Montana Pioneer that his products do not cure cancer, he admits to formerly claiming his products were cancer treatments.
McAdam said that within seven to ten days of using the black salve on his mother who had lung cancer her tumors were significantly reduced. He also claimed that his dog had a “soccer ball-sized tumor” that was reduced to one quarter of its original size after use of the black salve, and that the actress Suzanne Somers’ doctor treated her with Risingsun Health products when she had cancer.
According to McAdam, the FDA began a war against black salves and other bloodroot-related products following the 2004 conviction of Greg Caton, owner of Alpha Omega Labs, by the U.S. Department of Justice. The case resulted in jail time, and bears some similarity to McAdam’s. Caton was convicted of defrauding customers and violating FDA regulations for the sale and distribution of unapproved new drugs, some of which caused bodily harm to its customers, according to an Aug. 24, 2004, U.S. Department of Justice news release.
“And now,” says McAdam, “the FDA wants to ban all black salve sales, “but,” he says, “my products are a different formula and only cause tingling of the skin” rather than the severe burns Caton’s products caused.
McAdam’s troubles with the FDA began in 2006 when he and his business associate, Greta Armstrong, received several warning letters stating they were in violation of FDA regulations. An April 6, 2006, letter published on the FDA’s website states that “because there is no evidence that [Risingsun’s products] are generally recognized as safe and effective for the intended uses conveyed in their labeling” they should be taken off the market. However, despite repeated warnings Rising-sun Health continued to manufacture and distribute unapproved new drugs and misbranded dietary supplements according to the FDA, leading to the 2010 consent decree.
McAdam claims FDA’s criteria for the labelling of dietary supplements is not clear and wants clarification on what constitutes a medical or drug claim. “The FDA will tell you what you are doing wrong, but won’t tell you if what you are doing is acceptable,” said McAdam.
McAdam requested to be compensated $8,000 per month since Nov. 5, 2010, for lost revenues and to be reimbursed for his expenses in hiring an outside labelling expert for $3,600, according to the FDA.
McAdam said he filed two motions and a separate civil lawsuit seeking to vacate or modify the consent decree and said he will take his case all the way to the Supreme Court if necessary. “They assumed I would back down, but I’m not. I’m going to fight this.”
FDA said, though, that, “The only motion pending [related to the case] is an appeal to the finding that McAdam was in contempt of court. All other arguments and cases are closed and have been addressed by the U.S. District Court of Montana.”
The U.S. District Court of Montana stated that Mr. McAdam’s appeal “will not be taken in good faith due to the frivolous nature of the issues raised.”
McAdam told the Montana Pioneer that if he wins his civil suit against the FDA that he would be the first supplement manufacturer to gain FDA approval. “Imagine if you’re the only supplement company with FDA approval?” McAdam said. “They’ve never done that before. That would be huge.”
McAdam says he is working with the state of Montana to become a licensed manufacturer and distributor of bloodroot products and topical salves and hopes this will circumvent the need for FDA involve-ment. He said his formulas are under state review and now the FDA is trying to get the formulas from the state, but so far the state has not complied with the request.
Prior to the FDA fine McAdam planned, he said, to expand Risingsun Health to 200 to 300 employees, thereby boosting the local economy. McAdam told the Pioneer he does not plan to pay the fine and that he would file bankruptcy and give the company to a non-profit organization first.
McAdam stopped selling Rising-sun Health products on his websites and has been ordered to cease posting about the case or his products on the company’s Facebook page until the case is resolved.