What happened
Original notice title
Crystal Clear Supplements MARCS-CMS 620285, February 04, 2022
From the archived source record
The claims on your website, social media websites and product packaging establish that your products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, FDA has warned consumers about products containing tianeptine, which is used as a prescription drug in some European, Asian, and Latin American countries but is not an FDA-approved drug in the United States. Noopept is fast acting and provides a cognitive boost. . . has mild anxiolytic effects. . . . neuroprotective, has antioxidant abilities, and aids in blocking neurotoxicity. . . treat Alzheimer’s disease, meaning it has positive effects on memory and learning abilities.” “L-Theanine Capsules” From the product webpage at [see original source] • “Tags: anxiety, . . . memory, mental performance, natural depression remedy” • “Medical studies indicate that L-theanine is neuroprotective and can improve symptoms of depression, anxiety, insomnia, and cognitive impairment. . . . The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. You should take prompt action to address the violations cited in this letter. Failure to promptly address these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction. Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps that you have taken to address these violations.
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
- a1cf9b729a1f
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 →