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  5. OptiHealth Products, Inc. - 704899 - 04/29/2026
  1. Warning Letters

WARNING LETTER

OptiHealth Products, Inc. MARCS-CMS 704899 —

Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Russell Dickson
Recipient Title
President
OptiHealth Products, Inc.

275 River Rd
Saint James, NY 11780
United States

support@optihealthstore.com
Issuing Office:
Human Foods Program

United States

April 29, 2026

WARNING LETTER

CMS # 704899

Dear Mr. Dickson:

The U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://optihealthproducts.com in December 2025 and has determined that you take orders there for your product Super Antioxidant (OPCXtra). We also reviewed your social media website at https://www.facebook.com/OptiHealthProducts where you direct consumers to your website,
https://optihealthproducts.com/ to purchase your products. The claims on your website, https://optihealthproducts.com/ establish that this product is a drug 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 it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product 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 product is intended for use as a drug include:

“6 Remarkable Benefits of Bilberry Extract1” https://optihealthproducts.com/blogs/news/6-remarkable-benefits-of-bilberry-extract

  • Under the section, “Heart Health Support”
    o “The antioxidants in bilberries are believed to help reduce the risk of heart disease by improving blood vessel function, reducing blood pressure, and lowering cholesterol levels…”
  • Under the section, “Diabetes Management”
    o “Bilberry extract has shown promise in helping regulate blood sugar levels, making it a potential ally for individuals with diabetes or those at risk of developing the condition…”
  • Under the section, “Anti- Inflammatory Properties”
    o “Chronic inflammation is linked to a wide range of health issues, from arthritis to cancer. Bilberry's anti-inflammatory properties, may help alleviate inflammation and reduce the risk of chronic diseases associated with prolonged inflammation.”

“Antioxidants and Aging: The Key to a Youthful Glow and Enhance Health” https://optihealthproducts.com/blogs/news/antioxidants-and-aging-the-key-to-a-youthful-glow-and-enhanced-health

  • Under the section, “Cognitive Function”
    o “Antioxidants can help reduce oxidative damage in brain cells, potentially lowering the risk of age-related cognitive decline and diseases like Alzheimer's.”
  • Under the section, “Cardiovascular Health”
    o “Antioxidants like flavonoids and vitamin E can improve heart health by reducing oxidation of cholesterol, lowering blood pressure, and improving arterial flexibility. This can decrease the risk of cardiovascular diseases, which are a major health concern for aging populations.”

This post links to the following blog on the firm’s website “Seeing Clearly: Combating Oxidative Stress and Macular Degeneration – OptiHealth Products”
o “[A]s we age, the risk of vision-related conditions such as macular degeneration becomes increasingly prevalent. Central to this degenerative process is oxidative stress, which wreaks havoc on the delicate structures of the eye. In this blog, we explore the intricate relationship between oxidative stress and macular degeneration, shedding light on how OPC antioxidants offer a beacon of hope in preserving vision and ocular health.”

  • Under the section “Understanding Oxidative Stress and Macular Degeneration”
    o “In the context of ocular health, oxidative stress plays a significant role in the development and progression of macular degeneration. The macula, a small but crucial part of the retina responsible for central vision, is particularly vulnerable to oxidative damage. Over time, this oxidative assault leads to the deterioration of macular tissues, resulting in blurred vision, distortion, and eventual vision loss—a condition known as age-related macular degeneration (AMD).”

“The Neuroprotective Benefits of OPC Antioxidants” https://optihealthproducts.com/blogs/news/the-neuroprotective-benefits-of-opc-antioxidants
o “Supporting Cognitive Function: Cognitive decline is a hallmark feature of aging and neurodegenerative diseases such as Alzheimer's and Parkinson's. OPC antioxidants offer a ray of hope by promoting cognitive function and memory retention, potentially slowing the progression of age-related cognitive decline.”

Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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 Super Antioxidant (OPCXtra) product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, your Super Antioxidant (OPCXtra) product fails to bear adequate directions for its intended use, and therefore the product is 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 this misbranded drug 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 addressed to Dr. Aaron Dotson, Compliance Officer, 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-DietarySupplement@fda.hhs.gov. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.

Sincerely,
/S/

Maria Knirk, JD, MBA
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

____________________

1 Bilbery is an ingredient in the firm’s product “OPXtra” https://optihealthproducts.com/products/opcxtra-isotonic-opc-super-antioxidant-supplement

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