FDA WARNING_LETTER - Jordan’s Crossing Herbal Connections - July 14, 2021

On July 20, 2021, the FDA issued a Warning Letter to Jordan's Crossing after reviewing their website on July 14, 2021. The FDA found that the firm was offering "Germaphobe’s Delight Spray" for sale, making claims that it is intended to mitigate, prevent, treat, diagnose, or cure COVID-19. Based on these claims, the product is an unapproved new drug, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and a misbranded drug under section 502 (21 U.S.C. § 352). The introduction of this product into interstate commerce is also prohibited under sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FDA requested immediate action to cease the sale of all unapproved and unauthorized COVID-19 related products. The firm must respond within 48 hours via email to COVID-19-Task-Force-CDER@fda.hhs.gov, detailing corrective steps, recurrence prevention, and providing documentation. Failure to comply may result in legal action, including seizure and injunction, and the firm will be added to FDA’s public list of fraudulent COVID-19 product sellers.