FDA 就未经批准新药向 OrganiCare 发出警告信 734925

Delivery Method:

VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED

Product:

Drugs
Over-the-Counter Drugs

Recipient:

Recipient Name

Caroline Goodner

Recipient Title

Chief Executive Officer

OrganiCare, LLC / OrganiCare Nature’s Science, LLC

3900 Drossett Dr., Bldg 5, Suite G
Austin, TX 78744
United States

[email protected]

(b)(6)

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

October 1, 2026

WARNING LETTER
Reference Number: 734925

To Caroline Goodner:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://femiclear.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 “HClear for him” and “FemiClear Genital Herpes Symptoms” 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 a review of your website https://femiclear.com/ in July 2026. We have also reviewed your Facebook and Instagram accounts at https://www.facebook.com/FemiClear and https://www.instagram.com/femiclear, respectively, where you direct consumers to your https://femiclear.com/ website to purchase your products. Based on our review, “HClear for him” and “FemiClear Genital Herpes Symptoms” 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 allinclusive list of violations that may exist in connection with your products or operations.

Unapproved New Drug Violations

Based on a review of your website, “HClear for him” and “FemiClear Genital Herpes Symptoms” 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 and social media accounts, 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:

HClear for him
On the webpage https://femiclear.com/products/hclear-for-him-for-genital-herpes-symptoms-24-ea?selling_plan=3741548730:

• On the image of the product
  o “>90% OF USERS REPORTED LESS SEVERE OUTBREAKS”
  o “GENITAL HERPES SYMPTOMS”
  o “FAST-ACTING OUTBREAK SYMPTOM RELIEF ITCHING, TINGLING, PAIN & BURNING”
• “Try the FemiClear topical ointment for men that kills 99.9% of the herpes simplex I & II viruses”

On a September 10, 2024, post on your Facebook page https://www.facebook.com/FemiClear/posts/pfbid02GZLSvy4rJUch7SvLwKcZbP8r5aAipKeCruw7qjkDnjKVLigQPhSu8i7CroLJf6cjl:

• “Say goodbye to the discomfort of genital herpes symptoms with HClear for Him! This all-natural, organic ointment is designed specifically for men, targeting itching, tingling, and burning caused by herpes outbreaks. With a powerful formula that kills 99.9% of herpes simplex viruses (HSV1 & HSV2), you can trust HClear to bring fast relief. Over 90% of users reported milder symptoms, and over 50% experienced no blisters when used at the first sign.”
• “Explore The Benefits HClear for Him for Genital Herpes Symptoms”

FemiClear Genital Herpes Symptoms

On the webpage https://femiclear.com/products/femiclear-herpes-treatment-multi3symptom?selling_plan=3740434618:

• On the image of the product
  o “Fast-acting ointment for recurring outbreak symptoms”
  o “>90% OF USERS REPORTED LESS SEVERE OUTBREAKS”
• “Looking for genital herpes symptom relief? Try the FemiClear topical ointment that kills 99.9% of the herpes simplex I & II viruses (HSV1 & HSV2) and works fast to relieve Itching & Tingling + Pain & Burning symptoms caused by a herpes outbreak.”

On a January 29, 2026, post on your Facebook page https://www.facebook.com/photo.php?fbid=1343141094494950&set=pb.100063972160769.-2207520000&type=3:

• On the image of the product
  o “GENITAL HERPES SYMPTOMS
  Fast-acting ointment for recurring outbreak symptoms”

On an April 4, 2025, post on your Instagram page https://www.instagram.com/p/DICmMYfOANa/:

• “Herpes Relief for Less”
• “Genital Herpes Symptoms”
• “We know managing outbreak symptoms can be tough. The last thing you need is a price tag standing between you and relief. That’s why we dropped the price of FemiClear for Genital Herpes Symptoms.”

Additionally, your website contains evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the treatment of disease and/or to affect the structure or function of the body. Examples of such testimonials include, but are not limited to, the following from the Reviews section of the “FemiClear Genital Herpes Symptoms” product webpage https://femiclear.com/products/femiclear-herpes-treatment-multisymptom?selling_plan=3740434618:

• “Works like magic!
  I have had genital herpes for 35 years, and in the past 15 years, the outbreaks have been horrible and hard to get rid of. I won't take meds because they mess up my stomach. However, this ointment effectively eliminates the blisters within 24 hours. I have tried EVERYTHING, and this product truly works.”

“HClear for him” and “FemiClear Genital Herpes Symptoms” 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 “734925” 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 “HClear for him” and “FemiClear Genital Herpes Symptoms” 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 products include lemongrass, which is not listed in the HPUS; thus, these 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.