Ozone therapy marketing rules: what clinics can and cannot claim

Ozone shows up on the menus of wellness centers, integrative and functional medicine practices, chiropractic offices, med spas and IV lounges. It is sold as ozone saunas and steam cabinets, ozonated blood treatments, ozone injections into joints, rectal or ear insufflation, and ozonated oils. Patients find these services through search ads, social posts and the clinic’s own website, so the marketing is often the first thing a regulator sees.

Federal rules on ozone are unusually direct. FDA has a regulation that says, in its own words, that ozone is a toxic gas with no known useful medical application. That sentence shapes what an ozone clinic can safely say. This guide covers the FDA rule, how device law applies to ozone generators, what the FTC requires for health claims, what enforcement during COVID-19 looked like, and how to write pages that describe a service without promising medical results. For the wider category, see our guide to integrative medicine marketing claims. For drip and injection services, see IV therapy clinic marketing. Clinics that also offer chelation should read our guide to chelation therapy marketing rules.

The short version

• FDA’s rule is blunt. 21 CFR 801.415(a) says ozone is “a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy.”
• Ozone generators used for medical conditions face device law. Under 21 CFR 801.415(c)(4), a device that generates ozone is considered adulterated and/or misbranded under sections 501 and 502 of the Federal Food, Drug, and Cosmetic Act (21 USC 351 and 352) if it is used or intended for use “in any medical condition for which there is no proof of safety and effectiveness.”
• We found no FDA clearance for treating patients with ozone. In openFDA’s 510(k) data, the 11 records with “ozone” in the device name are sterilizers, sterilization indicators and wraps, dialysis water disinfection systems and test strips. A premarket approval search for “ozone” in the trade name returned no records.
• Health claims need competent and reliable scientific evidence. The FTC Act bars deceptive acts and false advertisements for devices and services (15 USC 45, 52), and the FTC’s guidance applies that standard to health claims.
• Enforcement has happened. In April 2020, a federal court entered a permanent injunction, agreed to by the defendants, barring a Dallas ozone therapy center from representing that ozone could treat or cure COVID-19, and FTC staff sent a warning letter over ozone COVID-19 claims the same day.

What FDA’s ozone rule says

21 CFR 801.415 is titled “Maximum acceptable level of ozone.” It sits in FDA’s device labeling regulations, and it is short. Paragraph (a) says ozone is a toxic gas with no known useful medical application in specific, adjunctive or preventive therapy, and that to work as a germicide it must be present “in a concentration far greater than that which can be safely tolerated by man and animals.”

Paragraph (b) describes the effects FDA relied on. It says the predominant effect of ozone is primary irritation of the mucous membranes, that inhaling it can irritate the lungs enough to cause pulmonary edema, that the onset of pulmonary edema is usually delayed for some hours after exposure, and that the smell of ozone is not a reliable index of its concentration because olfactory fatigue develops readily.

Paragraph (c) says a device that generates ozone, by design or as a byproduct, will be considered adulterated and/or misbranded if it is used or intended for use in any of five ways:

• Generating ozone above 0.05 part per million by volume of air circulating through the device, or causing ozone to accumulate above 0.05 part per million in enclosed spaces people occupy for extended periods, such as houses, apartments, hospitals and offices.
• Generating ozone and releasing it into the air in hospitals or other establishments occupied by the ill or infirm.
• Releasing ozone into the air without labeling that states the maximum acceptable concentration and the smallest area in which the device can be used without exceeding 0.05 part per million.
• Use “in any medical condition for which there is no proof of safety and effectiveness.”
• Generating ozone below 0.05 part per million while being labeled for use as a germicide or deodorizer.

For a clinic’s marketing, item four is the one that matters most. The rule ties the legal status of the equipment to the conditions it is used or intended for, and intended use can be shown by what is said about it. FDA’s general definition of a device covers instruments and machines intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or intended to affect the structure or any function of the body (21 USC 321(h)).

Why the claims on your website matter

Sections 501 and 502 of the Act, referenced in the ozone rule, are the adulteration and misbranding provisions for drugs and devices (21 USC 351 and 352). Under 21 USC 352(a)(1), a device is misbranded if its labeling is false or misleading in any particular. Under 21 USC 352(j), it is misbranded if it is dangerous to health when used in the manner or with the frequency or duration prescribed, recommended or suggested in its labeling.

Those duties fall on whoever makes, labels and sells the generator. A clinic that buys a generator is usually not the manufacturer. But a clinic that publishes a page saying its ozone machine treats Lyme disease, cancer, autoimmune conditions or infections is stating an intended medical use for that equipment in public. Under 801.415(c)(4), that is the use the rule addresses. Separately, the FTC Act applies directly to the clinic’s own ads, as the next sections explain. A safer approach is to keep disease and treatment claims off ozone pages entirely.

What we found in FDA’s device data

We searched openFDA, FDA’s public data service, on November 1, 2026 (510(k) and premarket approval data last updated October 19, 2026). The 11 510(k) records with “ozone” in the device name cover:

• Ozone sterilizers, which FDA’s data files under a gas sterilizer product code, plus a chemical indicator and a wrap used in sterilization.
• Ozone disinfection systems for dialysis water holding tanks and dialysate delivery systems.
• Test strips for residual ozone in dialysate.

None of these records is for putting ozone into or onto a patient, and the premarket approval search returned no records with “ozone” in the trade name. A database search is not a legal conclusion, and a device can appear under a name that does not include the word ozone. Before you write “FDA-approved” or “FDA-cleared” about any equipment, ask the vendor for the 510(k) number or approval number and look it up yourself. If the number is for a sterilizer, it does not support a patient treatment claim.

What the FTC requires

Section 5 of the FTC Act declares unfair or deceptive acts or practices in commerce unlawful (15 USC 45(a)). Section 12 makes it unlawful to disseminate a false advertisement to induce the purchase of devices, services or drugs (15 USC 52). Under 15 USC 55(a)(1), whether an ad is misleading includes what it fails to reveal about the consequences of using the product under the conditions the ad describes.

The FTC Health Products Compliance Guidance says health-related claims must be supported by competent and reliable scientific evidence, and that the agency looks at the net impression of an ad, including implied claims, not only the literal words. For ozone services, claims that need that kind of evidence include:

• “Kills viruses, bacteria and fungi in the body” or “eliminates infections.”
• “Treats” or “reverses” a named disease, such as cancer, Lyme disease, autoimmune disease or chronic fatigue.
• “Oxygenates your blood,” “boosts immunity” or “detoxifies,” when used to suggest a health benefit.
• “Safe for everyone,” “no side effects” or “natural, so it cannot hurt you.”
• Numbers such as “95 percent effective” or “results in 3 sessions.”

Given what FDA’s rule says about ozone, the gap between those claims and the evidence a regulator expects is wide. Our guide to prescription treatment advertising explains how FDA and FTC rules divide up treatment ads.

What enforcement has looked like

FDA’s page on fraudulent COVID-19 products (content current as of April 22, 2026) lists a court action titled “Court Prohibits Dallas Wellness Center from Touting ‘Ozone Therapy’ as COVID-19 Treatment.” The Department of Justice press release of April 24, 2020 says a federal court entered a permanent injunction against the center and one of its principals. It says the defendants agreed to be bound by an injunction barring them from representing that ozone could be used to treat or cure COVID-19.

The release describes what the complaint alleged: that the center told a caller posing as a customer its treatment was safe even for children and was 95 percent effective even for someone who had tested positive, that it claimed on Instagram ozone was the “only prevention” for COVID-19, and that it claimed ozone could combat other diseases, including cancer, SARS and Ebola. The release notes that the claims in the complaint were allegations that the government would have had to prove at trial. The case was investigated by the FBI and FDA’s Office of Criminal Investigations.

The same day, FTC staff in its Southwest Region sent a warning letter to a seller of an ozone machine. The letter quoted website claims that ozone therapy kills COVID-19 and could be done at home with the seller’s machine, and it said it is unlawful under the FTC Act to advertise that a product can prevent, treat or cure human disease without competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies. It told the recipient to stop the claims, to review all other claims for its products, and to reply within 48 hours. A joint FDA and FTC letter to an integrative medicine practice that also quoted claims about an ozone blood treatment is covered in our guide to advertising during outbreaks and flu season.

Two lessons carry beyond COVID-19. Regulators read Instagram posts and listen to what staff say on the phone, not just the website. And a claim made during a news event, such as an outbreak, draws attention quickly.

Ozone saunas, steam cabinets and room air

Ozone saunas and steam cabinets are often marketed alongside infrared saunas and cold plunges. The same rule applies: describe the session, not a medical outcome. Two parts of 801.415 also bear on how a clinic runs these rooms. Paragraph (c)(1) sets 0.05 part per million as the limit for ozone accumulation in enclosed spaces occupied for extended periods, and paragraph (c)(2) addresses releasing ozone into the air in establishments occupied by the ill or infirm. Ask your vendor how the equipment is labeled on both points. For heat-based services, see our guide to infrared sauna marketing claims, and for cold and light services, cryotherapy and red light claims.

Testimonials, reviews and before-and-after stories

Ozone clinics lean on patient stories: “my Lyme symptoms are gone,” “my joint pain disappeared after three injections.” Under 16 CFR 255.2(a), an advertiser must have substantiation for what consumer endorsements convey, just as if it had made the claim itself. Under 16 CFR 255.2(b), an endorsement about a central attribute is likely to be read as representative of what people generally get unless the ad clearly and conspicuously discloses the generally expected results. A testimonial cannot carry a disease claim that the clinic could not make directly. Our guide to patient testimonials and before-and-after photos covers consent and privacy for these stories.

Packages, memberships and prices

Ozone services are usually cash-pay and often sold in packages. State the price per session, what a package includes, how long it is valid, and the refund and cancellation terms. A “was $300, now $199” offer needs a former price you actually offered in good faith for a reasonably substantial period of time (16 CFR 233.1(a)). Do not tie a package to a promised medical outcome, such as “10 sessions to clear your infection.” See our guides to advertising cash prices and money-back guarantees.

What you can say

A page can describe what happens during a session without making medical claims. Examples of lower-risk wording:

• What the visit involves: how long it takes, what the patient will feel, what to wear, who performs it, and whether a clinician reviews the patient’s health history first.
• Who should not book without talking to a clinician first, and a plain statement that the service is not a treatment for any disease.
• Price, package terms and cancellation policy.
• A statement that FDA’s regulation describes ozone as a toxic gas with no known useful medical application, if you want to be candid with patients about the regulatory picture.

What to leave out: disease names next to the service, “kills” or “eliminates” claims about germs in the body, “FDA-approved” or “FDA-cleared” unless you have checked a record that covers that patient use, safety absolutes, effectiveness percentages, and links to outside articles that make the claims for you.

An example (made up)

This illustration is invented to show how the rules fit together. A wellness clinic’s landing page says: “Ozone therapy kills viruses, bacteria and Lyme in your blood. FDA-approved equipment. 100 percent natural and safe. Clear chronic infections in 10 sessions, $1,500, was $2,500.” A search ad sends traffic to it, and the clinic posts patient videos saying their symptoms went away.

Fixes: “kills viruses, bacteria and Lyme” and “clear chronic infections” are disease treatment claims that need competent and reliable scientific evidence, and they state the kind of medical use 801.415(c)(4) addresses, so they come off. “FDA-approved equipment” comes off unless the clinic has a record that covers patient treatment; a sterilizer clearance does not. “100 percent natural and safe” comes off. The patient videos come down or are edited so they do not carry disease claims. The page then describes the session, the clinician screening, the price per session and the package terms. The $2,500 former price stays only if patients actually paid it for a reasonable period.

Checklist

• No disease, infection, cancer, immune or detox claims for ozone services (21 CFR 801.415(a), (c)(4); 15 USC 45, 52; FTC guidance).
• No “FDA-approved” or “FDA-cleared” wording unless you have looked up a record that covers that patient use (openFDA, Drugs@FDA, device databases).
• No safety absolutes or effectiveness percentages.
• Testimonials and reviews do not say what the clinic could not say (16 CFR 255.2).
• Material risks and who should not book are stated where the service is sold (15 USC 55(a)(1)).
• Social posts, ads and phone scripts match the website.
• Ozone rooms and saunas: vendor labeling checked against the 0.05 part per million limits (21 CFR 801.415(c)(1)-(3)).
• Prices, package terms and former prices are real and clear (16 CFR 233.1).
• No claims tied to outbreaks or news events.
• Who may perform each service checked against your state’s rules.

How we help

We build service pages for integrative, wellness and cash-pay practices with claims checked against the sources above: website design, healthcare SEO for service searches, and lead generation campaigns that describe services without disease claims. We do not decide whether a service is safe or effective, we do not give legal opinions, and we are not a law firm. If you offer naturopathic or functional services too, see our guides to naturopathic doctor marketing and functional medicine practice marketing.

Sources

• 21 CFR 801.415: Maximum acceptable level of ozone
• 21 USC 321: Definitions (device)
• 21 USC 351: Adulterated drugs and devices
• 21 USC 352: Misbranded drugs and devices
• openFDA device 510(k) data (last updated October 19, 2026)
• openFDA device premarket approval data (last updated October 19, 2026)
• FDA: Fraudulent Coronavirus Disease 2019 (COVID-19) Products (content current as of April 22, 2026)
• Department of Justice: Court Prohibits Dallas Health Center from Touting Ozone Therapy as a COVID-19 Treatment (April 24, 2020, archived copy)
• FTC Southwest Region warning letter on ozone COVID-19 claims (April 24, 2020, archived copy)
• 15 USC 45: Unfair methods of competition unlawful
• 15 USC 52: Dissemination of false advertisements
• 15 USC 55: Additional definitions
• FTC: Health Products Compliance Guidance (December 2022)
• 16 CFR 255.2: Consumer endorsements
• 16 CFR 233.1: Former price comparisons

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