New Drug/Misbranded: FDA Warning Letter to OptiHealth Products, Inc., April 29, 2026

FDA Warning Letter — Violations FDA cited at OptiHealth Products, Inc.

WARNING LETTER OptiHealth Products, Inc. MARCS-CMS 704899 — April 29, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Extract 1 ” 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 respon