Heaven’s Organic LLC – FDA Warning Letter, Mar 9, 2022

On March 28, 2022, the FDA and FTC issued a Warning Letter to Heavens Organics regarding the sale of unapproved and misbranded cannabidiol (CBD) products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. An FDA review of the company's website and social media on February 15 and March 9, 2022, found these products to be unapproved new drugs, violating section 505(a) of the FD&C Act, and misbranded drugs under section 502. Their introduction into interstate commerce is prohibited by sections 301(a) and (d). The FTC also cited violations of the FTC Act, 15 U.S.C. § 41 et seq., for making unsubstantiated claims about preventing or treating human disease, specifically COVID-19, without competent and reliable scientific evidence. The company is required to immediately cease the sale of these products and remove all unsubstantiated claims. Within 48 hours, Heavens Organics must email both the FDA and FTC, detailing corrective actions taken to address these violations and prevent recurrence. Failure to comply may result in legal action, including seizure, injunction, civil penalties up to $46,517 per violation, consumer refunds, and inclusion on FDA's public list of non-compliant firms.