3 Considerations Before Offering Ozone Therapy at Your Med Spa

Our healthcare and business law firm works with many providers and medical practices to ensure compliance with state and federal laws, rules, and regulations for given procedures, treatments, and prescriptions.  Providers have differing opinions on the use and efficacy of certain treatments.  One such treatment is Ozone therapy.  This blog post outlines considerations prior to introducing Ozone therapy to your medical and wellness practices’ offerings.  If you need assistance understanding the full realm of considerations governing ozone therapy or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

1. Consider the Food and Drug Administration’s Regulations

21 C.F.R. 801.415 is a regulation of the Food and Drug Administration (“FDA”), which provides: “Ozone is a toxic gas with no known useful medical application in specific adjunctive, or preventative therapy.”  Further on the regulation provides: “A number of devices currently on the market generate ozone by design or as a byproduct.  Since exposure to ozone above a certain concentration can be injurious to health, any such device will be considered adulterated and/or misbranded within the meaning of sections 501 and 502 of the act if it is used or intended for use under the following conditions: (1) in such a manner that it generates ozone at a level in excess of 0.05 part per million by volume of air circulating through the device or causes an accumulation of ozone in excess of 0.05 part per million by volume of air . . . (4) in any medical condition for which there is no proof of safety or effectiveness.”

2. Consider the FDA’s Enforcement Actions for Adulterated Medical Devices

The designation as “adulterated” is significant.  21 U.S.C. Section 331 prohibits the introduction and delivery into interstate commerce and the receipt in interstate commerce of any medical device that is adulterated.  If a business purchases an ozone device from outside of the U.S., and the device is considered adulterated under the regulation identified above, then your business may also be found to be importing an adulterated device.  See Personal Importation, FDA.  Though the FDA more often takes issue with the companies importing and retailing adulterated devices, there are instances where the FDA has brought enforcement actions against practitioners for using unapproved devices on patients in violation of 21 U.S.C. Section 331.  One of few examples of this is a 2001 enforcement against a practitioner who used unapproved ultraviolet blood irradiation (UBI) devices on patients to treat HIV/AIDS and hepatitis.  FDA’s Notice, available here.

3. Consider the Department of Justice’s Prior Actions

A Department of Justice (“DOJ”) press release on April 24, 2020 shows that the DOJ brought a civil action in federal court against a Dallas, Texas “wellness center” because it advertised Ozone as a cure/prevention for COVID-19.  Erin Nealy Cox, the U.S. Attorney for the Northern District of Texas, stated: “This defendant preyed on public fear, peddling bogus treatments that had absolutely no effect against COVID-19.”  The fact that the advertising for this treatment was, in the DOJ’s mind, exploitative likely played a large role in the DOJ’s decision to take action.  U.S. Attorney Cox also stated: “As we’ve said in past COVID-19 civil cases: The Department of Justice will not permit anyone to exploit a pandemic for personal gain.”  Court Prohibits Dallas Wellness Center from Touting ‘Ozone Therapy’ as COVID-19 Treatment, available here.

The above provides a limited overview of three considerations before introducing ozone therapy to your practice.  There are may other considerations, such as your state licensing board’s stance and your insurer’s willingness to cover such services, as well as steps you can take to protect yourself and business.   If you need assistance understanding the full realm of considerations governing ozone therapy or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

 

 

 

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