Bio-Botanica, Inc./Nature’s Answer, Inc.
FDA issued a warning letter to Bio-Botanica, Inc./Nature's Answer, Inc. regarding their Coral Calcium dietary supplement, which declares cesium chloride as a dietary ingredient. FDA determined that cesium chloride is a new dietary ingredient for which no required pre-market notification was submitted, rendering the product adulterated under sections 402(f) and 413(a) of the FD&C Act. Additionally, FDA found no evidence of safety for cesium chloride as a dietary ingredient and cited animal and human reports of serious cardiac adverse events. The agency warned that failure to address these violations may result in seizure or injunction.
Flagged claims (1)
cesium chloride as a dietary ingredient in Coral Calcium
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker