What happened
Original notice title
OptiHealth Products, Inc. MARCS-CMS 704899, April 29, 2026
From the archived source record
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. 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” [see original source] o “ Supporting Cognitive Function : Cognitive decline is a hallmark feature of aging and neurodegenerative diseases such as Alzheimer's and Parkinson's. 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). 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. 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.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 538a4037d93a
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →