“Clinically proven” statements are high risk
Use caution with “clinically proven” or “clinically studied” statements
#WarningLetterWednesday
Implying "Clinically Proven" or even "Clinically Studied" is high risk. This is a trend to watch out for. We are seeing references to "clinically proven" types of claims showing up not just in warning letters but also in class action lawsuits and NAD complaints.
The highest burden of proof is "clinically proven". This is rare in dietary supplements and should be used only if proper substantiation exists.
The next highest burden of proof is "clinically studied". This requires the formula to be studied with scientifically significant methods. Bench or pilot tests may not qualify as "clinically studied". This can be difficult when using branded ingredients that may have been researched but perhaps do not meet a "clinically studied" standard. Most branded ingredients have sound research but some may not. It is important to conduct a proper review before using ingredient science on face value.
A "clinically studied ingredient" is different than a "clinically studied product". There are many factors including serving size, formulation, and delivery form that play a role in this. We talk about what defines clinically proven here.
If accurate, I prefer using descriptions such as "thoughtfully formulated with well-researched ingredients".
What are your thoughts?
Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.