FDA 向 Aidance Scientific 发出警告信，指 Terragen HG Formula 为未获批新药

WARNING LETTER

Aidance Scientific, Inc. MARCS-CMS 735346 — October 01, 2026

Delivery Method:

VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED

Product:

Drugs
Over-the-Counter Drugs

Recipient:

Recipient Name

Perry Antelman

Recipient Title

President

Aidance Scientific, Inc.

184 Burnside Ave
Woonsocket, RI 02895
United States

[email protected]

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

October 1, 2026

WARNING LETTER
Reference Number: 735346

To Perry Antelman:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://www.aidanceproducts.com/, and provides you and 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 “Terragen HG Formula” product on your website and available for purchase by clicking through to your Amazon storefront 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 website https://www.aidanceproducts.com/ and your Amazon storefront¹ in July 2026. Based on our review, “Terragen HG Formula” 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 this product 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 and Amazon storefront, “Terragen HG Formula” 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 and Amazon storefront, 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 www.aidanceproducts.com, consumers can “Shop by Condition” and select “Herpes,” which redirects to your Amazon storefront page for “Terragen HG Formula.”

On the webpage https://www.amazon.com/Terragen-HG-Formula-Max-Sufferers/dp/B06XT8CWCC/?th=1:

• “Genital sores treatment, outbreak support”
• “FAST RELIEF & SOOTHING OINTMENT: . . . treatment cream relieves genital sores and symptoms including tingling, itch, irritation, redness, pain and inflammation. Provides relief quickly with natural, soothing ingredients. For men and woman, for daily use. Discreet packaging.”
• “EFFECTIVE PROTECTION & HEALING: Terragen HG MAX . . . to protect the genital area from irritation and support natural healing.”
• “Product description . . .
  o Herpes Sores
  o Stinging Pain”
• On Drug Facts image:
  o “[R]elief of swelling and pain associated with genital sores.”

“Terragen HG Formula” 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 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).

We recognize that your “Terragen HG Formula” product 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.

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 “735346” 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 https://www.amazon.com/stores/terrasil/page/3A25CD33-872F-419D-A8CB-B86731BDC2DA?lpasin=B06XT8CWCC&ref=astbln&storeref=blastdpbrandlogosto&blgrdstatus=override