FDA vs. Applied Ozone Systems

Posted by markO3 on February 18, 2010 under Uncategorized | Read the First Comment

In late January, US Marshals seized 77 ozone generators (models AOS-1M and AOS-1MD) from Applied Ozone Systems of Auburn, California.  This action was taken on behalf of the FDA in response to a request-for-recall which was delivered to Applied Ozone in December, 2009.  Applied Ozone never responded to that FDA request, which led them to take further action (the seizure of inventory).

The stance of the FDA is that these particular models of ozone generator were being marketed as “medical devices”, and as such require FDA approval for safety and effectiveness.  These devices were not approved, and the FDA has gone on record stating their concern for possible infection related to use, as well as their concern that individuals may delay or stop prescribed medical treatments while doing ozone treatments.  Claims on the Applied Ozone website indicated applications for cancer, AIDS, hepatitis, herpes, and colon cleansing.

Chuck Ankeney, owner of Applied Ozone, has since said “You do a recall on something that’s broke.  You don’t do it on their claims.”  He is said to have received no past complaints about his products, except for a woman who used a product for too long and began coughing from excess ozone.  Mr. Ankeney has removed a number of health-related claims from his website and has added disclaimers to indicate that any health statements “have not been evaluated by the Food and Drug Administration”.

While ozone has not been approved by the FDA for medical purposes in the US, it is important to keep in mind that ozone has a proven track record for success in a number of other industries.  This includes FDA approval for direct ozone contact with food during processing – a move that allows ozone to be used as a “green” sanitizer for the food industry.  This can help to increase shelf life and prevent outbreaks of food-borne illnesses such as salmonella and E. coli, without the use of chemicals. Other industry-recognized uses of ozone include water treatment, wastewater treatment, and groundwater remediation.

For further information on ozone, refer to the following links:
FDA Approval for Ozone as an Anti-Microbial Agent on Food
Application of Ozone in Various Industries

For further resources on this story:
Article on news-medical.net
Article on News 10