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Montana Man Fined $85,000 by FDA for Making Natural Products that Harmed No One

Friday, March 10, 2017 14:27
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by Tim Brown, Freedom OutPost:

A Livingston, Montana man has been faced with fines of $85,000 by the Food and Drug Administration for developing and selling topical bloodroot and graviola products, even though no one was injured in the process of either the manufacture or sale of the products.

Toby McAdam, owner of Risingsun Health, whose website is BloodrootProducts.com, manufactured black salves, oils and capsules as a treatment for diseases, including skin cancer. In 2010, the US Justice Department brought a case against him and his company on behalf of the FDA.

McAdam did claim that some of his products did treat breast cancer, asthma and epilepsy, according to the FDA. Understand there is a significant difference in claiming to “treat” a disease, and claiming a product “cures.”

Understand, as I’ve pointed out before, that our Constitution does not allow the central government to be involved in approving drugs or food. Second, there was no crime committed here because there is no victim. The central government is acting as both victim and prosecutor, which is a serious conflict of interest, something that Ammon Bundy attempted to demonstrate during the Malheur Wildlife Refuge occupation in Oregon in 2016.

The Montana Pioneer reports on what took place:

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 labeling expert. Furthermore, the FDA found McAdam in violation of several new claims and statements made on his website bloodrootproducts.com.

McAdam claims that the black salve significantly reduced tumors on his mother who had lung cancer, reduced a tumor on his dog to a quarter of the original size and that his products were used by a doctor in treating actress Suzanne Somers when she had cancer.

Mr. McAdam claims that the FDA began targeting him in 2006because of the 2004 conviction of Greg Caton, who owned Alpha Omega Labs, which manufactured products, including black salves, that actually injured people, leaving them severely burned.

“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 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 labeling expert for $3,600, according to the FDA.

He said he would not pay the fine, and had hoped to expand his company to employ 2-300 people and boost the local economy. Sadly, that did not take place.

in March 2015, the Ninth Circuit affirmed the 2013 ruling that McAdam was guilty of civil contempt by selling his products online via Amazon and Facebook, issuing nearly $85,000 in damages and attorney’s fees.

Read More @ FreedomOutPost.com

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