WARNING LETTER

SaNOtize MARCS-CMS 727784 — April 17, 2026

Delivery Method:: Via Email
Product:: Drugs

Recipient:: Recipient Name

Mikael Svensson; Recipient Title

CEO; SaNOtize; 1-8755 Ash Street
Vancouver BC V6P 6T3
Canada; info@sanotize.com

Issuing Office:: Center for Drug Evaluation and Research (CDER); United States

WARNING LETTER

April 17, 2026

RE: 727784

Mikael Svensson:

This letter is to advise you that on February 17, 2026 the United States Food and Drug Administration (FDA) reviewed your product labeling, including your websites at the internet addresses https://www.nowonder.com/ and https://sanotize.com/ where your “NOWONDER™ Nasal Cleanser” is available for purchase in the United States without a prescription.

“NOWONDER™ Nasal Cleanser” is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). These violations are described in more detail below.

Unapproved New Drug Violations

Your “NOWONDER™ Nasal Cleanser” is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.

Examples from the “NOWONDER™ Nasal Cleanser” product labeling, including your websites listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:

“When people around you are sick, boost your body’s natural defenses with our Nasal Wellness Spray, powered by the wonder of Nitric Oxide. Nitric Oxide is naturally produced by your immune system and helps support your ability to fight germs that can cause the common cold, flu and other illnesses.” [from your product website]

“Powered by the Wonder of Nitric Oxide…Nitric Oxide safely and effectively improves your ability to fight common disease-causing germs and pathogens.” [from your product website]

“The Wonder of Nitric Oxide…Clinically proven to safely and effectively kill viruses and bacteria…Nitric oxide is a powerful, naturally occurring molecule that plays a critical role in supporting your immune defense and promoting overall health. Its antiviral and antimicrobial properties help protect against common infections and illnesses.” [from your product website]

“Effective…Clinical studies demonstrate that nitric oxide inhibits the replication of harmful viruses, including influenza and SARS-CoV-2, showcasing its powerful antiviral capabilities.” [from your product website]

“Effective cleansing whenever exposed to harmful elements such as bacteria, viruses…” [from your product label]

Your “NOWONDER™ Nasal Cleanser” drug product is not generally recognized as safe and effective (GRASE)¹ for use under the conditions prescribed, recommended, or suggested in its labeling and is therefore a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this drug product. Accordingly, “NOWONDER™ Nasal Cleanser” is a new drug in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). The introduction or delivery for introduction of such a product into interstate commerce violates section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “727784” in the subject line of your email.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

cc:
Mikael Svensson, CEO
NoWonder, Inc.
8180 South 700 East
Suite 350
Sandy, UT 84070
info@nowonder.com

___________________

1 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “NOWONDER™ Nasal Cleanser” drug product is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling.