A Tennessee company made false claims that its “light therapy” has benefits for fungal meningitis, the FDA said.
The Avalon Effect, of Franklin, Tenn., has been illegally marketing the Quantum Series Personal Wellness Pack — which its website says emits “non-invasive, stress reducing light” — with claims to cure disease, the agency said.
In particular, the FDA said, the Quantum Series device was claimed to be able to “cure or treat” the symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus (MRSA), concussions, Lyme disease, and other diseases.
In a warning letter sent Monday, the agency told Mike Haarlander, chief executive officer of the company, that claims on the website about the device violate the Federal Food, Drug, and Cosmetic Act.
The CDC has reported more than 400 infections, including many cases of fungal meningitis, caused by a contaminated steroid, as well as some 30 deaths.
“Consumers should be aware that, especially during disease outbreaks or other public health crises, they may see opportunistic advertisements for products touted as cures or treatments,” according to Steve Silverman, director of compliance at the agency’s Center for Devices and Radiological Health.
“Bogus medical claims can actually harm consumers by causing them to delay seeking treatments that have been proven to be safe and effective,” Silverman said in a statement.
The company’s website now says: “This system is not intended to diagnose, treat, cure, mitigate, or prevent disease.”
But earlier claims were illegal, the agency said, because the company has neither an approved application to market the device nor an exemption to investigate it for purposes of safety and effectiveness.
The device also is misbranded, the agency said, because the company did not submit a premarket notification — a so-called 501(k) — telling the FDA it intended to sell the device.
The fungal meningitis outbreak has been linked to a steroid – preservative-free methylprednisolone acetate – made by the New England Compounding Center (NECC) in Framingham, Mass.
The company, licensed as a compounding pharmacy, has been described as operating in a “regulatory black hole” that left it without adequate oversight by federal health officials.
As the outbreak grew, an FDA investigation found that the company did not even follow its own sterility procedures properly.
FDA Commissioner Margaret Hamburg is scheduled to testify Nov. 14 about the role the agency played before a subcommittee of the House Energy and Commerce Committee.
The Subcommittee on Oversight and Investigations has also asked James Coffey, director of the Massachusetts Board of Registration in Pharmacy, to testify and subpoenaed NECC owner Barry Cadden after his lawyer said he would not appear voluntarily.
In a statement, four members of the committee said: “NECC has a history of problems, some of which were documented in an FDA warning letter in 2006.”
“We want to know what went wrong at this facility, the views and actions of its regulators, and what steps can be taken to ensure such an outbreak never happens again,” the committee members said.
Source: Med Page Today at http://www.medpagetoday.com/Neurology/GeneralNeurology/35784?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&xid=NL_DHE_2012-11-07&eun=g514381d0r&userid=514381&[email protected]&mu_id