FDA WARNING_LETTER - Crystal Clear Supplements - February 04, 2022

The FDA issued a Warning Letter to Crystal Clear Supplements on February 4, 2022, following a December 2021 review of their website (https://www.crystalclearsupplements.com/) and social media (Facebook, Instagram). The letter identifies that the company is selling unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act.

The products cited as unapproved new drugs include “Tianeptine Sodium Powder,” “Tianeptine Sulfate Powder,” “PEA Capsules,” “Phenibut Capsules,” “Synephrine Powder,” “Noopept Powder,” “L-Theanine Capsules,” and “Lutein Capsules.” The FDA determined these are drugs under section 201(g)(1) of the FD&C Act due to claims on their website, social media, and product packaging indicating intended use for diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect body structure or function.

Examples of drug claims include "Stress Reducing Mood Boosting" for Tianeptine, "treat ADHD" and "antidepressant effects" for PEA Capsules, "relieve anxiety, fear, tension, and to improve sleep" for Phenibut Capsules, "fat burning properties" for Synephrine Powder, "cognitive boost" and "treat Alzheimer’s disease" for Noopept Powder, "