FDA 向 Terramed 发出警告信 735070，指其网站四款产品为未经批准新药

Delivery Method:

VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED

Product:

Drugs
Over-the-Counter Drugs

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

October 1, 2026

9310 Towne Center Dr Unit 72
San Diego, California, 92121

WARNING LETTER
Reference Number: 735070

To Krystsina Uradzimskaya:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://terramed.info, 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 any address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

As discussed below, the “Genital Herpes Intimate Wash,” “HerpCare Ointment,” “HerpCare Spray,” and “HerpCare Genital Wart Remover Ointment” products on your website are unapproved new drugs. 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 website https://terramed.info/ in July 2026. Based on our review, “Genital Herpes Intimate Wash,” “HerpCare Ointment,” “HerpCare Spray,” and “HerpCare Genital Wart Remover Ointment” are unapproved new drugs 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, “Genital Herpes Intimate Wash,” “HerpCare Ointment,” “HerpCare Spray,” and “HerpCare Genital Wart Remover Ointment” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are 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 these products as drugs include, but may not be limited to, the following:

Genital Herpes Intimate Wash

On the webpage https://terramed.info/products/genital-herpes-intimate-wash:

• “This genital herpes intimate wash is designed to support soothing relief for itching, tingling, burning, and irritation associated with genital herpes symptoms. The gentle cleansing formula helps maintain intimate hygiene while supporting skin comfort for sensitive intimate areas. The wash is suitable for daily intimate care for both men and women experiencing discomfort associated with herpes outbreaks.”
• “GENITAL HERPES INTIMATE WASH
  o Formulated for Herpes Relief”
• Supports Genital Herpes Comfort.”

HerpCare Ointment

On the webpage https://terramed.info/products/genital-herpes-treatment-fast-acting-ointment:

• “This genital herpes relief ointment is designed to support soothing comfort for genital sores, itching, tingling, burning, and irritation associated with herpes outbreaks. The soothing formula helps calm sensitive skin while supporting comfort and relief for intimate areas. Each tube provides targeted topical support for genital herpes symptoms.”
• “GENITAL HERPES SYMPTOMS
  o Soothes and calms genital sores”

HerpCare Spray

On the webpage https://terramed.info/products/genital-herpes-spray:

• “This genital herpes relief spray is designed to support soothing comfort for genital sores, itching, burning, tingling, and irritation associated with herpes outbreaks. The convenient spray format allows targeted application to sensitive areas while helping calm irritated skin.”
• “Fast-acting Genital Herpes Symptom Relief
  o Soothes and calms genital sores.”

HerpCare Genital Wart Remover Ointment

On the webpage https://terramed.info/products/genital-wart-remover-oitnment:

• “This genital wart remover ointment with salicylic acid is designed to support targeted treatment for genital warts, irritation, redness, itching, and discomfort. The formula helps soften and break down wart tissue while supporting gentle skin recovery. The ointment helps provide targeted wart treatment while supporting skin comfort for sensitive areas.”
• “HerpCare Genital Wart Remover Ointment
  o Targets Genital Warts”
• “Genital Wart Treatment Support
  o Designed to support treatment for genital wart symptoms.”
• “Supports Genital Wart Removal”

The above-referenced webpages for each product also provide the following:

• “Terramed Intimate Care
  o HerpCare – Proprietary Genital Herpes Care Line
  HerpCare is a proprietary and exclusively developed product line, fully owned and commercially distributed by Terramed Just Think Comfort, specifically created to support individuals managing genital herpes (HSV-2).”

“Genital Herpes Intimate Wash,” “HerpCare Ointment,” “HerpCare Spray,” and “HerpCare Genital Wart Remover Ointment” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their 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 applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products.¹ Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products 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 “735070” 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 We recognize that the “HerpCare Ointment” and “HerpCare Spray” labeling describes the products as being “homeopathic.”

First, we note that under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.

In addition, FDA issued a guidance in December 2022 that describes how the Agency intends to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States that potentially pose a higher risk to public health. (See Homeopathic Drug Products: Guidance for FDA Staff and Industry, available at https://www.fda.gov/media/163755/download). For purposes of this guidance, FDA defines a “homeopathic drug product” as “a drug product that is labeled as ‘homeopathic,’ and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS).” Your “HerpCare Ointment” and “HerpCare Spray” include the active ingredient, lemongrass, which is not listed in the HPUS. Thus, your “HerpCare Ointment” and “HerpCare Spray” products fall outside the scope of products addressed in this guidance.

Notwithstanding, even if your above listed products were considered “homeopathic drug products" under this guidance, these products would fall under the guidance’s category of homeopathic drug products marketed without the required FDA approval that FDA views as potentially posing higher risks to public health, and thus intends to prioritize for enforcement and regulatory actions.