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FDA warning comes too late

By Carol Gentry
9/2/2010 © Health News Florida

A Boca Raton company that had distributed the "BAX 3000” received a warning letter from the Food and Drug Administration last month ordering it to stop claiming that the biofeedback-plus-laser system worked for asthma, allergies, autism and other ailments.

But by the time that BioVeda received the Aug. 5 letter fromEmma Singleton, director of FDA's Florida district office, the company was no longer selling the machine, a spokesman told a reporter.

However, another Boca Raton company is now selling similar machines under a different brand, making similar claims online. And the same chiropractors are buying and using it, according to a list on the company's website.

All this is a concern to Jann Bellamy, a Tallahassee attorney who studied the BAX system and wrote about it at her website, the Campaign for Science-Based Healthcare. Her description of the earlier BAX system was: "Clinically proven to lighten wallets."

Earlier this week, when she heard that the FDA had sent a warning letterto BioVeda, she said, "I'm glad they finally got caught. This thing is such a rip-off."

On Friday, when Bellamy heard that another company is now marketing a similar device, she said, "There is no evidence that these biofeedback machines benefit asthma, allergies, ADHD and the like."
She's glad the FDA is trying to stop the claims for the machines, she said, but she wishes the agency would move a bit faster.

Tampa Bay chiropractor Micah Richeson, who was profiled last year in the St. Petersburg Timespraising the BAX 3000, says he sent that one back when he tried  the NRG Immune Enhancement System. After set-up on the biofeedback machine, he said, the laser treatments take three minutes or less and the protocol is just four to six treatments, instead of more than 20.

The hardware and software system also cost less than the BAX, Richeson said, so he's able to charge $50 instead of $85. 

"We've had multiple patients" who benefited, said Richeson, who practices at  Cypress Creek Chiropractic in Wesley Chapel. "We use it for allergies, skin conditions, headache and migraine."

Four other chiropractic clinics in Florida -- in Boca Raton, Dunedin, Lake Worth and Oldsmar -- are using the new NRG system, according to Two of them, which operate under the name AllergiCare Relief Centers, appear to be the same company that the Times reported had trademarked and marketed the BAX 3000.

All of the clinics use the information from the website, which says: "Just as your car needs a routine maintenance check, so does your body's immune system. The NRG Immune Enhancement System is just the tool to get you back on the road and feeling good again."

At the top of the page is a list of indicators that should trigger a visit to the clinic: allergies, sneezing, runny nose, headaches, digestive issues, IBS (irritable bowel syndrome), acid reflux, skin irritations, insomnia, weight fluctuation, respiratory issues, sensitivities, lack of energy . . . or any other symptoms." 
The site says that the biofeedback system has FDA clearance. FDA press officer Erica Jefferson said Friday that she couldn't find a record of the NRG company in the agency's database.
A request for an interview sent to "contact us" link at drew this response: "Thank you for your email. We are simply a distributor of the product, which is manufactured by another entity which has FDA clearance for the device. Due to the holiday weekend and the staff not being available, as I do not possess the contact details, I will have someone email you the contact information for the whom the device is registered on Tuesday."

Richeson said the device is manufactured by Star Tech Health Systems. That company's Web site indicates that it does manufacture a biofeedback device.

In any event, the question isn't whether a device has FDA clearance, the agency says; it's whether the claims that are being made for it exceed those for which the FDA granted clearance.  

--Carol Gentry, Editor, can be reached at 727-410-3266 or by e-mail.


Carol Gentry, founder and special correspondent of Health News Florida, has four decades of experience covering health finance and policy, with an emphasis on consumer education and protection.