PolleyMed, LLC(CMS 726018)

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

May 14, 2026

WARNING LETTER

To Dr. John W Polley:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your product labeling and website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

FDA has observed that you market SaniiSwab™ on your firm’s website, where SaniiSwab™ is available for purchase in the United States without a prescription.

FDA Review

Violations were identified and documented during a review of your product labeling, including your website, www.saniiswab.com, in April 2026. We also reviewed your social media websites at Facebook, https://www.facebook.com/people/SaniiSwab/61583517491065/, and Instagram, https://www.instagram.com/Sanii.Swab, which direct consumers to your website to purchase your product. Based on our review, your SaniiSwab™ product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). In addition, this product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). As explained further below, introducing or delivering this product for introduction into interstate commerce is prohibited under sections 301(d) and 301(a) of the FD&C Act, 21 U.S.C. 331(d) and 331(a).

This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor-quality drugs.

Violations of the Federal Food, Drug, and Cosmetic Act

Unapproved New Drugs Violations

The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.

Based on a review of your product labeling, including your website and social media sites, your SaniiSwab™ product is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:

“Uses Two-step method to clean and sanitize the skin of the lower inner nostrils ● cleans ● sanitizes” [from the product label]

“Clean & Sanitize 2-step nasal protection” [from the product label]

“Your nose is an entry point for infection-which is why daily nasal cleaning is as important as washing your hands. My 2-step method-used in over 2,000 nasal surgeries with ZERO infection-is now available for anytime, anywhere use… SaniiSwab™” [from the product label]

“Learn how SaniiSwab helps prevent airborne pathogens from incubating and infecting . . . “Why should I clean my nose if other people around me are wearing masks? Our nasal passages are constantly bombarded with contaminants and allergens. In addition, we know that 30% of the population carry staph, as well as other bacteria and viruses. Daily nasal decolonization (just like daily hand-washing) helps reduce these contaminants during their incubation period to keep us healthy and minimize the spread of disease and infection.” [from the FAQs on your website at www.saniiswab.com/faqs]

“Why is it important to do a 2-step nasal cleaning and disinfection process? … The period of time from contaminants first entering the nose to starting the infectious process is known as the incubation period. The goal in nasal decolonization is to eliminate these contaminants during their incubation period, prior to them becoming infectious, as well as, causing allergic reactions. Because our noses are continuously being bombarded by contaminants, the best way to protect ourselves is to clean our noses daily before incubation begins. How long are incubation periods for various contaminants? Incubation periods (virus/bacteria) Staph A: 20-50% of population colonized, MRSA: 10-20% of population colonized, Pneumococcus: 103 days, Covid 19: 3-6 days RSV: 3-7 days, Influenza A: 1-4 days, Influenza B: 1-2 days, Rhinovirus: 2-4 days” [from the FAQs on your website at www.saniiswab.com/faqs]

“SaniiSwab transcends simple nasal sprays and sanitizing devices, offering a new standard for safeguarding public health and helping to reduce hospital acquired infections (HASIs).” [from the Medical Facilities USAGE on your website at https://www.saniiswab.com/medical-facilities]

“Flu season is still peaking…Preventing illness and stopping the spread of germs is key. Do both with SaniiSwab! SaniiSwab cleans and sanitizes where 90% of the air we breathe (and germs) enter first. In just 30 seconds: … Wash away germs …” [from Facebook post https://www.facebook.com/photo.php?fbid=122127036507117249&set=pb.61583517491065.-2207520000&type=3]

“Flu season is still in full swing. SaniiSwab, your daily nasal hygiene routine, helps stop the spread of germs. 2-step clean/sanitize process in just 30-seconds … Surgically-proven method …” [from Instagram post https://www.instagram.com/p/DVgUaatFIvL/]

Your SaniiSwab™ is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here,1 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 approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Misbranded Drug Violations

Your SaniiSwab™ product is also misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because your product’s website falsely states that the FDA has approved your product. On this website (https://www.saniiswab.com/order-medical), you display the phrase “…FDA OTC approved…,” which creates the impression that the drug product is approved or legally marketable (see 21 CFR 207.77(b)). As previously noted, your SaniiSwab™ is not the subject of an FDA approved application. Therefore, labeling suggesting that your SaniiSwab™ product is FDA-approved is false or misleading.

The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Conclusion

As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future compliance so that these violations and any others do not occur.

Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “726018” in the subject line of the email.

If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

Please note FDA posts warning letters on www.fda.gov.

Sincerely,
/S/

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

cc: 

Kim Young-joo (CEO)
IDO Pharm Co., Ltd.
41 Beonnyeong-ro 15beon-gil
Danwon-gu District
Ansan-si, Gyeonggi-do, Republic of Korea (15616)
(b)(6)

__________________________

1 The Over-the-Counter Monograph M003: First Aid Antiseptic Drug Products for Over-the-Counter Human Use (M003) is limited to topical application to the skin to help prevent infection in minor cuts, scrapes, and burns. Your product is intended for nasal administration, which is not a permitted route of administration under M003. Even if considered under the broader rulemaking history for topical antiseptics, such as the Tentative Final Monograph (TFM) for Topical Antimicrobial Drug Products (59 FR 31402, June 17, 1994), the product is not permitted, as the 1994 TFM and its subsequent amendments do not include provisions for antiseptic products intended for administration inside the nostrils. Moreover, claims to prevent infection from "airborne pathogens" and specific diseases like COVID-19 and Influenza go far beyond any permissible claim under any monograph. SaniiSwab does not conform to M003, the 1994 TFM, or any other final administrative order.