FDA 就 Herstat GST 未经批准新药向 Bioactive Services USA 与 Herstat Inc. 发出警告信（编号 734784）

Delivery Method:

VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED

Product:

Drugs

Recipient:

Recipient Name

Kevin Aspinall Nessling

Recipient Title

CEO

Bioactive Services USA, LLC / Herstat Inc.

1309 Coffeen Ave, STE 1200
Sheridan, WY 82801
United States

[email protected]

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

October 1, 2026

Herstat (USA) Inc.
680 S Cache Street
Suite 100 – 10219
Jackson, WY 83001
United States

WARNING LETTER
Reference Number: 734784

To Kevin Aspinall Nessling:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your websites, https://drsosnowski.com/ and https://www.herstat.com/, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them 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.

As discussed below, the “Herstat GST” product on your website is an unapproved new drug. Unapproved drug products marketed for the treatment of sexually transmitted infections (STIs) and/or their symptoms and sold directly to consumers present a serious public health concern. Individuals who rely on these products may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death. Further, a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners. FDA has not approved any over-the-counter (OTC) drug product for the treatment, cure, mitigation, or prevention of any STI. Effective treatment requires diagnosis and supervision by a licensed healthcare professional.

FDA Review

Violations were identified and documented during a review of your websites, https://drsosnowski.com/ and https://www.herstat.com/ in July 2026. We have also reviewed your Facebook and Instagram accounts at https://www.facebook.com/DoctorSosnowski and https://www.instagram.com/drsosnowskis/ where you direct consumers to your website to purchase your products. Based on our review, “Herstat GST” 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). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.

Violations of the Federal Food, Drug, and Cosmetic Act

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.

Unapproved New Drug Violations

Based on a review of your website, “Herstat GST”¹ 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, including on your website, 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:

On the webpage https://drsosnowski.com/products/herstat-gst:

• On product label: “Genital Sore Treatment”
• “Herstat GST provides rapid and targeted relief of genital sores at tingle, blister or scab, getting to work from 1st use at any stage of an outbreak”
• “The formula is dual action, designed to provide effective relief of symptoms (itching, pain, irritation) and aid healing of skin during outbreaks by calming inflammation and balancing PH”

On the webpage https://www.herstat.com/products/herstat-genital-sore-treatment?variant=52463728689494:

• “Dr Sosnowski’s Herstat GST is formulated to provide effective relief from the symptoms of genital sores.”
• “The carefully balanced formula of GST helps to soothe and calm the symptoms of genital sores and provides temporary relief of pain, itching and inflammation.”
• “Effective for the treatment of genital sores”

On an October 12, 2022 post on your Facebook and Instagram page https://www.facebook.com/DoctorSosnowski and https://www.instagram.com/drsosnowskis/ respectively:

• On product label: “Genital Sore Treatment”
• “Herstat GST provides rapid, targeted relief from the symptoms of genital sores.”
• “[P]rovides targeted pain relief . . . soothing relief to calm the discomfort associated with genital sores.” . . . 
• “[A]nalgesic action . . . penetrate deep into the epidermis.”

“Herstat GST” 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, 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is 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).

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 and sustained compliance so that these violations and any others do not occur.

Send your written response to [email protected] 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. 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. Identify your response with reference number “734784” in the subject line of the email.

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
U.S. Food and Drug Administration

______________________

1 The permitted indications under OTC Monograph M017: External Analgesic Drug Products for OTC Human Use (M017) are for the treatment of pain, itching, and minor skin irritation generally and for the prevention of premature ejaculation. The “Herstat GST” product available for purchase on your website is intended to provide relief from genital sores and their associated symptoms, which goes beyond the permissible indications under M017. “Herstat GST” therefore does not conform to M017 or any other final OTC administrative order. Accordingly, there is no basis under section 505G of the FD&C Act under which “Herstat GST” could be legally marketed without an approved application. (see https://www.accessdata.fda.gov/drugsatfdadocs/omuf/monographs/OTC%20MonographM017-External%20Analgesic%20Drug%20Products%20for%20OTC%20Human%20Use%2005.02.2023.pdf).