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  5. Diamond-Herpanacine of PA, Inc. - 713854 - 01/22/2026
  1. Warning Letters

WARNING LETTER

Diamond-Herpanacine of PA, Inc. MARCS-CMS 713854 —

Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Leslie A. Diamond
Recipient Title
President
Diamond-Herpanacine of PA, Inc.

1518 Grove Avenue
Jenkintown, PA 19046-2302
United States

Issuing Office:
Human Foods Program

United States

January 22, 2026

WARNING LETTER

CMS # 713854

Dear Ms. Diamond:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://diamondformulas.com in September 2025 and has determined that you take orders there for the products Diamond Eye Health and Herpanacine Skin Support. We also reviewed your social media website at www.facebook.com/DiamondHerpanacine, where you direct consumers to your website, https://diamondformulas.com, to purchase your products. The claims on your website and social media webpage establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the claims that provide evidence that your products are intended for use as drugs include:

On your website for Diamond Eye Health https://diamondformulas.com/diamond-eye-health/:

  • “In conclusion of the long-awaited studies, the National Eye Institute, a department of the NIH, announced that several of our powerful ingredients – are effective … in the fight against ocular degenerative disease.”

On your website https://diamondformulas.com/maintaining-skin-health/ under the Blog tab:

  • "[A] potent formula of eleven herbs, vitamins and powerful antioxidants called Herpanacine Support System…from the Inside Out, to effectively combat ALL forms of these bacterial and viral skin conditions."
  • “Studies show the unique Herpanacine Skin Support formula, works in the following ways: [...] Selenium - to attack bacterial and viral particles. L-Lysine - to help eliminate any presence of the herpes virus....”

On your Facebook page for Diamond Herpanacine www.facebook.com/DiamondHerpanacine:

  • "This little cutie has taken Herpanacine Skin & Immune Support since she was three for severe eczema. Safe, effective and completely under control…"
  • "LYSINE1 Attacks the herpes virus…"
  • "SELENIUM Directly attacks viral particles”
  • "DANDELION Soothes inflammation […] Antibacterial, antifungal […] properties"
  • "Fights most skin conditions. (acne, herpes, cold sores, shingles, rosacea, eczema, psoriasis, dermatitis, rashes, hives & more!)”

Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Diamond Eye Health for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

On your Diamond Eye Health webpage https://diamondformulas.com/diamond-eye-health/ under the Satisfied Customers slideshow:

  • “In 2007, I had cataracts surgery. Although the operation removed my cataracts, for years afterward, I suffered from almost constant eye pain and soreness. After reading and watching television too long I would sometimes even have blurred vision. Then I started taking Diamond Eye Health and everything changed. Within three weeks of starting this supplement, I noticed that my eyes did not get tired or sore or painful even after hours of reading, internet surfing, or watching television. I never get blurry vision anymore, and I feel that my vision has actually improved since I started taking this product.”
  • “I’ve been aware that I have the beginnings of macular degeneration for more than a year. As soon as I learned this problem, I began taking a supplement with ingredients proven in AREDS studies. Diamond Eye Health has all I require and more.”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products Diamond Eye Health and Herpanacine Skin Support are intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis, treatment, or prevention without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Diamond Eye Health and Herpanacine Skin Support fails to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written reply should be directed to Natalie J. Reese, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS # 713854 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.

Sincerely,
/S/

Thomas Kuntz
Acting Deputy Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

______________________

1 – Lysine, Selenium, and Dandelion are ingredients in Herpanacine Skin Support.

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