Functional Remedies, LLC D/B/A Synchronicity Hemp Oil

Warning LetterOpen

Andrew Campbell Functional Remedies, LLC D/B/A Synchronicity Hemp Oil 331 S. 104th Street, Suite 210 Louisville , CO 80027 United States hello@synchronicityhempoil.comIssued Mar 28, 2022Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations0

Issue DateMar 28, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Functional Remedies, LLC D/B/A Synchronicity Hemp Oil
Location: Andrew Campbell Functional Remedies, LLC D/B/A Synchronicity Hemp Oil 331 S. 104th Street, Suite 210 Louisville , CO 80027 United States hello@synchronicityhempoil.com
FEI Number: N/A
Country: United States
Issue Date: March 28, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Functional Remedies, LLC was cited for selling unapproved hemp oil and CBD products that claimed to mitigate, prevent, treat, diagnose, or cure COVID-19, violating Section 505(a) of the Federal Food, Drug, and Cosmetic Act by marketing them as unapproved new drugs. The products were further found to be misbranded under Section 502 of the FD&C Act. The FDA and FTC took enforcement action during the declared public health emergency for COVID-19, targeting the company's website claims in February and March 2022.

Functional Remedies, LLC D/B/A Synchronicity Hemp Oil FDA Warning Letter, March 28, 2022