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WARNING LETTER

Hadassah Healing Oils Ltd MARCS-CMS 729191 —

Delivery Method:
VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED
Product:
Drugs
Recipient:
Hadassah Healing Oils Ltd

14 Elm Street, City Villas
Irenepark
North West
2571
South Africa

hadassahhealingoils@gmail.com
admin@hadassahhea
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

June 17, 2026

WARNING LETTER
Reference Number: 729191

To Lechi van Rooyen:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations 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.

FDA Review

Violations were identified and documented during a review of your website https://hadassahhealingoils.com/ in May 2026. Based on our review, “Prostate Blend” 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).

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, “Prostate Blend” 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://hadassahhealingoils.com/product/prostate-oil-30ml-blend/:

  • “Assists with prostate healing and prostate cancer healing.”
  • “[H]elp relieve the urge to constantly urinate.”
  • “Refer to the Benign Prostate Enlargement (BPE) Protocol.”

“Prostate Blend” 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).

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

Send your written response to FDAAdvisory@fda.hhs.gov 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. Identify your response with reference number “729191” in the subject line of the email.

If you have information that you believe demonstrates that your product is not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

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

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