Ingredient Claims Are Marketing claims
Blogs are still top of mind for FDA
I love it when warning letters reveal how interconnected marketing can be. In this example, FDA cites a social media post that discusses and links to a blog on the company’s website. That link functions as the “commercial bridge,” connecting the promotional content to commerce because the products are sold on the same website.
From warning letter (social post). “[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.”
Promoting the benefits of ingredient constituents is a marketing claim. In this example, the FDA cites claims that antioxidants (part of the ingredient) are beneficial for preventing or treating diseases. The key takeaway here is that all marketing, even ‘ingredient-adjacent’ statements, should be reviewed for compliance, especially when high-risk diseases like Alzheimer’s are mentioned.
From warning letter. “Antioxidants can help reduce oxidative damage in brain cells, potentially lowering the risk of age-related cognitive decline and diseases like Alzheimer’s.”
The timing is interesting. FDA reviewed the company’s website in December, but the warning letter wasn’t posted until 4 months later. This shows that there may have been an opportunity for the company to remove the disease claims. Although the timeline in this letter doesn’t state it, FDA often reviews a website over several months. In my opinion, if the disease claims are removed, a warning letter can sometimes be avoided. The moral here is it’s never too late to be compliant!
Also, Apex Compliance has received a unique API validation from Meta. Apex can now scan captions and images of essentially any business Facebook/Instagram account. It identifies issues, helps users understand the risks, and suggests possible lower-risk alternatives. It’s great!
Read the FDA warning letter here.
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