FDA warns companies about fake Ebola drugs
(CNN) — When it comes to purchasing products on the Internet that claim to treat or cure Ebola, the U.S. Food and Drug Administration has one word for consumers: Beware!
This week the FDA sent warning letters to three companies the government agency says are selling products over the Internet that claim to treat, prevent or even cure the deadly disease. The letters were issued after an alert warning consumers about fraudulent Ebola products being hawked online went out last month.
“We have a program at FDA that monitors the Internet to look for health fraud products, products not approved by FDA that claim to cure or treat disease,” said Howard Sklamberg, the FDA’s deputy commissioner for global regulatory operations and policy. “We noticed that when there is a public health issue that really comes to the fore(front) — for example H1N1 a few years ago, and now Ebola — there tends to be an increase in health fraud products, which are products that claim to prevent, treat or cure disease and the product has not been approved by FDA.”
The agency says they’ve had consumer complaints about the number of products making these claims, and that the websites of Natural Solutions Foundation of Newton, New Jersey; Young Living in Lehi, Utah and doTERRA International, LLC, based in Pleasant Grove, Utah, all offer products that are in direct violation of the Federal Food, Drug and Cosmetic Act because they’re being promoted as drugs that can fight the infection.
In early August, FDA says a doTERRA consultant posted these tweets about Ebola prevention: “Treating the symptoms of Ebola Virus with DoTERRA Essential Oils,” and “Many Essential Oils are highly Anti-viral. I list here a few of them those (sic) oils that could help prevent your contracting the Ebola virus.”
According to the agency, Young Living essential oils products were being sold on various websites with claims including, “Viruses (including Ebola) are no match for Young Living Essential Oils,” and “Ebola Virus can not live in the presence of cinnamon bark (this is in Thieves) nor Oregano.”
“Thieves” is one of the oils Young Living sells. The company’s website says “It is highly effective in supporting the immune system and good health.” The listed ingredients are clove, lemon, cinnamon eucalyptus and rosemary.
Travis Ogden, chief operating officer of Young Living issued this statement to CNN:
“Young Living is cooperating fully with the FDA regarding its inquiry. Young Living Members are provided specific instructions on how to promote our products to their customers. In the coming days we will be contacting all our membership to ensure that they understand how to best use our products and remain compliant with regulatory directives. We have already contacted each of the Members cited in the FDA letter to help get them into compliance.”
Natural Solutions Foundation, which claims its product Nano Silver kills every pathogen it’s been tested against without exception, had plenty to say in defense of the posted claims, including that “NANO SILVER, AT 10 PPM (parts per million) effectively kills the Ebola virus.”
Ralph Fucetola, a retired lawyer and trustee at Natural Solutions Foundation, says the company was advocating the nutritional benefits of Nano Silver years before the Ebola outbreak.
“We feel obligated to speak the truth, especially during a world health emergency that is happening in West Africa. So we welcomed WHO’s declaration that even ‘unproven interventions’ can be used in this crisis and that is what we have tried to do,” Fucetola said.
“Insofar as the word ‘cure’ is used, it was not intended to be the equivalent of an FDA-approved treatment but rather in the common usage of the word as something which would help a person get over the disease.”
Fucetola cites a 2009 study on Nano Silver sponsored by the Department of Defense’s Defense Threat Reduction Agency as support for the product. He says a presentation created from that study (PDF) showed “the nutrient at 10 ppm (parts per million) regulated Ebola virus replication which may prevent the disease from killing it’s victims.”
Those familiar with the government research say the Defense Threat Reduction Agency (DTRA) funds a tremendous number of early stage science and technology projects that are tasked with countering nuclear, chemical or biological threats. Nano Silver was studied, but scientists determined there were other things that were a better investment. If the early research had proven promising, they say the research would have picked up by other agencies.
“The DTRA funded a research project between fiscal year 2007 and fiscal year 2009 into a product called Nano Silver,” a spokesperson, who did not want to be identified, said. “The researchers produced slides at the end of that early science research. The data in that presentation was not peer reviewed.”
The FDA is firm: “At this point there are no drugs or vaccines that have been shown to be safe and effective to treat or prevent Ebola disease,” Dr. Luciana Borio, the FDA’s Assistant Commissioner for Counterterrorism Policy and Acting Deputy Chief Scientist, says. “FDA is doing all it can do to help expedite development programs.”
Borio says there are currently two vaccines in development. One is already in “Phase I” clinical trials; the other is expected to begin trials soon. She also says there are a handful of drugs in early stages of development for Ebola, but that it’s very difficult to say how soon it will be before we have treatments available for patients. It depends in part on the results of these trials.
In the meantime, the agency says, Internet “cures” are not the answer.
“We are continuing to monitor the internet and monitor how these three companies respond,” Sklamberg said. “They have 15 working days to take corrective action. If they don’t take the corrective action, we can take enforcement action against them…seizure, injunction, criminal prosecution.”
Natural Solutions says they will meet that deadline.
“We will offer to make further disclosures and disclaimers, including more carefully nuanced terminology,” Fucetola said. “We are not in the business of violating the law but we are in the business of speaking the truth as we know it.”
CNN made several efforts to contact representatives of doTERRA over two days and left messages, but there was no response.