OptiHealth Products, Inc.
FDA issued a warning letter to OptiHealth Products, Inc. (President Russell Dickson) regarding their dietary supplement Super Antioxidant (OPCXtra), finding that disease-treatment claims on the company's website and Facebook page caused the product to be regulated as an unapproved new drug under the FD&C Act. The flagged claims included assertions that the product could help manage diabetes, reduce heart disease risk, combat Alzheimer's and Parkinson's disease, and treat macular degeneration. FDA determined the product is both an unapproved new drug under section 505(a) and a misbranded drug under section 502(f)(1) for lacking adequate directions for use. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.
Flagged claims (8)
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…
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.
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…
Antioxidants can help reduce oxidative damage in brain cells, potentially lowering the risk of age-related cognitive decline and diseases like Alzheimer's.
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.
[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.
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.
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).
Required actions (2)
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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