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No Escape for Disease Claims

Updated: Dec 28, 2020

Reading warning letters and finding trends and notable items is a hobby of mine. This

Quten Research Institute's warning letter is interesting as the company implies benefits in the context of a disclaimer.

From Warning Letter:

Researchers theorize that some people that suffer from high blood pressure also exhibit CoQ10 deficiency. Multiple studies have reported that CoQ10 had a blood pressure lowering (hypotensive) effect and that this might be caused in part by correcting this deficiency. However, CoQ10 is not a substitute for your doctor prescribed treatment or acceptable treatment for high blood pressure on its own. The use of CoQ10 to help you manage your high blood pressure should only be done as part of a doctor-supervised and recommended regime (always consult your doctor!).

Although warranted this letter is lighter in claims than most we see these days, but in the world of risk, companies receiving commercial value by insinuating a supplement is used for hypertension will attract attention. Always remove any disease words from marketing material. This includes "informational" blogs which are where many of the warning letter claims are being cited from. Also, no other platforms are mentioned here which is uncommon (socials, YouTube, hashtags). I did a quick social media search of this company and they appear to be compliant.

Interestingly and justifiably we have seen more pain and inflammation statements pop up on recent letters, a sign of FDA enforcement trends getting stricter in this area.

💡 This is a warning to clever marketers looking for ways to sell products directly implied for disease claims.

Inspired by a LinkedIn post by Rick Collins who perfectly said The overall point is that trying to be cute and dance around the wording of drug claims isn’t protective"

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