FDA 就网站销售未经批准新药向 Amazon.com 发出警告信 736006

Delivery Method:

VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED

Product:

Drugs
Over-the-Counter Drugs

Recipient:

Recipient Name

Andy Jassy

Recipient Title

CEO

Amazon.com, Inc.

P.O. Box 81226
Seattle, WA 98108-1226
United States

(b)(6)

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

October 1, 2026

WARNING LETTER
Reference Number: 736006

To Andy Jassy:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of drug products that were purchased on your website, www.amazon.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 any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

As discussed below, the “FemiClear,” “Hclear for him,” “HerpCare Ointment,” “HerpCare Spray,” “Herstat GST,” “Genital Herpes Ointment,” “RoyceDerm Herpes Relief Cream,” “Terragen HG Formula,” and “Genital Herpes Intimate Wash” products available for purchase 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 review of the product labeling of products purchased on your website www.amazon.com in July 2026. FDA purchased, “FemiClear,” “HClear for him,” “HerpCare Ointment,” “HerpCare Spray,” “Herstat GST,” “Genital Herpes Ointment,” “RoyceDerm Herpes Relief Cream,” “Terragen HG Formula,” and “Genital Herpes Intimate Wash” through your website and these products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.¹ Based on our review, “FemiClear,” “HClear for him,” “HerpCare Ointment,” “HerpCare Spray,” “Herstat GST,” “Genital Herpes Ointment,” “RoyceDerm Herpes Relief Cream,” “Terragen HG Formula,” and “Genital Herpes Intimate Wash” 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 the product labeling, “FemiClear,” “Hclear for him,” “HerpCare Ointment,” “HerpCare Spray,” “Herstat GST,”² “Genital Herpes Ointment,” “RoyceDerm Herpes Relief Cream,” “Terragen HG Formula,” and “Genital Herpes Intimate Wash” 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 of claims observed on the product labeling 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:

FemiClear

• “Genital Herpes Symptoms”
• “Fast-acting ointment for recurring outbreak symptoms”
• “>90% OF USERS REPORTED LESS SEVERE OUTBREAKS”
• “[I]ntended to relieve symptoms associated with diagnosed genital herpes, including itching, burning and/or pain.”
• “[B]est used at first sign of outbreak. Early use ensures the best results.”

HClear for him

• “GENITAL HERPES SYMPTOMS”
• “>90 of USERS REPORTED LESS SEVERE OUTBREAKS”
• “FAST-ACTING OUTBREAK SYMPTOM RELIEF ITCHING, TINGLING, PAIN & BURNING”
• “[I]ntended to relieve symptoms associated with diagnosed genital herpes, including itching, burning and/or pain.”
• “[B]est used at first sign of outbreak. Early use ensures the best results.”

HerpCare Ointment

• “FAST-ACTING GENITAL HERPES SYMPTOM RELIEF”
• “Soothes and calms genital sores”
• “Purpose:
  o Anti-Fungal
  o Anti-microbial”
• “Provides temporary relief from skin inflammation, irritation, and/or tingling caused by genital herpes.”

HerpCare Spray

• “Relief on the Go:
  o Fast-acting formula in a convenient spray format . . .
  o Herpes Symptoms”
• “To maintain optimal hygiene and support skin health, incorporate the HerpCare Genital Wash into your daily routine. Formulated specifically for sensitive skin, it helps maintain a balanced environment and supports the natural healing process . . . help manage symptoms effectively throughout the day and night.”
• “Gentle & effective care for intimate areas”
• “Soothes irritation, burning & itching quickly”

Genital Herpes Intimate Wash

• “Formulated for Herpes Relief”
• “Antiviral Action . . . reduce viral activity . . . powerful antimicrobial properties”
• “Pain Relief . . . numbs pain and soothes itching by targeting nerve endings, providing fast and lasting relief during flare-ups”
• “Anti-Inflammatory . . . reduce redness, swelling, leaving your skin feeling refreshed.”
• “Healing Support . . . hydrates and promotes skin repair, aiding in faster recovery”

Herstat GST

• “Genital Sore Treatment”
• “Soothes and calms genital sores”
• “[R]elieves pain and itching associated with genital sores.”

Genital Herpes Ointment

• “FAST ACTING GENITAL HERPES RELIEF”
• “Soothes Genital Sores.”
• “Purpose:
  o Anti-Fungal
  o Anti-Microbial”
• “[R]elief of inflammation, irritation, and tingling caused by genital herpes.”

RoyceDerm Herpes Relief Cream

• “Helps relieve the symptoms of rashes or blisters, itchy, redness and pain.”
• “FIGHTS OUTBREAKS”
• “SOOTHES & COOLS”
• “REDUCES RECURRENCE”
• “[S]pecifically formulated to help relieve the symptoms of Herpes, rashes or blisters, redness & pain.”

Terragen HG Formula

• “Uses . . . relief of swelling and pain associated with genital sores.”

“FemiClear,” “Hclear for him,” “HerpCare Ointment,” “HerpCare Spray,” “Herstat GST,” “Genital Herpes Ointment,” “RoyceDerm Herpes Relief Cream,” “Terragen HG Formula,” and “Genital Herpes Intimate Wash” 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. 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).

We recognize that the “Terragen HG Formula” product available for purchase on your website is labeled as a homeopathic drug with active ingredients measured in homeopathic strengths. 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.³

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 “736006” 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 Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products discussed below was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a program that lets you outsource order fulfillment to Amazon and offer customers free, two-day shipping through Prime. By enrolling in FBA, you can send your products into Amazon’s global network of fulfillment centers, and we’ll pick, pack, and ship orders, as well as handle customer service and returns. FBA is part of a fully automated set of services we call Supply Chain by Amazon.” (See https://sell.amazon.com/fulfillment-by-amazon).

2 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/drugsatfda_docs/omuf/monographs/OTC%20Monograph_M017-External%20Analgesic%20Drug%20Products%20for%20OTC%20Human%20Use%2005.02.2023.pdf).

3 We recognize that the “FemiClear,” “HClear for him,” “HerpCare Ointment,” “HerpCare Spray,” and “Genital Herpes Ointment” products available for purchase on your website are also labeled as being “homeopathic.” FDA issued a guidance in December 2022 that describes how the Agency intends to prioritize enforcement and regulatory actions for certain categories of homeopathic drug products 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).” These products do not meet the definition of a “homeopathic drug product” because they include lemongrass, which is not listed in the HPUS as an active ingredient. Therefore, these products fall outside the scope of products addressed in this guidance.

Notwithstanding, even if the 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.