BRADENTON — The Food and Drug Administration is investigating companies nationwide that are advertising and selling unauthorized H1N1 products.
The FDA has sent warning letters to 70 companies that are advertising unauthorized swine flu products on their Web sites, FDA spokesman Chris Kelly said. The more than 135 products include air systems, hand sanitizers, immunizations, gloves, inhalers, masks and vitamin supplements.
The warning letters state the companies have 48 hours to come into compliance by adjusting their claims.
“We’ve gotten 80 percent compliance; 20 percent still have some products that are up there,” Kelly said. “What we’re saying to consumers is ‘Buyer beware.’ That goes for any kind of product that says it’s a sure cure-all, it’s able to cure germs and kill bacteria.
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“If it sounds too good to be true, then it probably is.”
Companies that fail to comply could face enforcement action from the FDA, such as seizure or injunction for violations of the Federal Food, Drug and Cosmetic Act. Businesses also could be referred to the FDA’s Office of Criminal Investigations for potential prosecution.
In Manatee County, at least three companies are selling air purification systems that claim to help fight the swine flu.
The companies are distributing Guardian Air, manufactured by RGF Environmental Group Inc. in West Palm Beach. RGF advertises that testing by Kansas State University of the air purification system shows “inactivation of the H1N1 swine flu.” Unique Air Services of Bradenton, a distributor of Guardian Air, advertises that “test results show 99 plus% effective against swine flu.” A/C Warehouse in Bradenton, another distributor, has advertised that the system “has been proven to kill the H1N1 virus” on the company’s Web site and in the Herald.
Gator Air Conditioning, a third distributor, advertises the system “kills 99 plus% of swine flu virus.”
Kelly said the claims could make the product a target for review by the FDA’s swine flu consumer fraud team.
Consumers should be cautious about advertising that states a product helps prevent swine flu, Kelly said.
“It’s a false claim and it’s something the FDA wants to look into,” he said.
The FDA wants consumers to be aware of a disclaimer on an Oct. 16 news release by the manufacturer announcing the results of the Kansas State University study. The disclaimer states that RGF’s products “have not yet been approved, cleared or otherwise authorized by (the) FDA and are not intended to diagnose, mitigate, prevent, treat or cure the H1N1 flu virus.”
Mike Lynch, a spokesman for RGF Environmental Group, said the company is not concerned about possibly being contacted by the FDA regarding its Guardian Air product.
“It’s not designed to diagnose, mitigate or cure H1N1 and we have not been advertising it as such,” Lynch said. “We’ve always been very up front about that.”
But Kelly said the companies are making statements that are too strong and not giving a disclaimer prominent positioning.
“If the company clearly states that it’s not intended to cure or treat the swine flu, that’s fairly important and they need to say that up front,” Kelly said.
Kevin Henault, owner of A/C Warehouse, said he’s never promised consumers that the Guardian Air system is guaranteed to prevent the swine flu. A/C Warehouse’s Web site includes a link to RGF Environmental Group’s news release on the product, which includes the product disclaimer that it is not FDA-approved.
“I haven’t stepped out of my boundaries by telling them this is going to kill everything and they’re never going to get swine flu or the flu,” Henault said.
Mike Montgomery, president of Unique Air Services, said the Bradenton-based company is simply restating the manufacturer’s claims and study results on its Web site when advertising Guardian Air to consumers.
“As far as I’m concerned, I’m believing what they’re telling us,” Montgomery said.
According to RGF’s Web site, Guardian Air uses advanced oxidation technology that the manufacturer developed more than 20 years ago.
“This product has been around for a while,” Montgomery said. “It’s not some new gimmick that just came out.”