FDA WARNING_LETTER - Apollo Holding LLC - May 18, 2020

The FDA and FTC issued a Warning Letter to Apollo Hempire and NoronaPak following reviews of their websites (apollohempire.com, noronapak.com) and social media in May 2020. The agencies found that the companies were offering "NoronaPak" products, including CBD and other supplements, with unapproved and unsubstantiated claims to mitigate, prevent, treat, diagnose, or cure Coronavirus Disease 2019 (COVID-19). Specifically, the products are deemed unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 (21 U.S.C. § 352). Their introduction into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)). Furthermore, the advertising claims violate the FTC Act (15 U.S.C. 41 et seq.) because they lack competent and reliable scientific evidence, including well-controlled human clinical studies, to substantiate their efficacy against COVID-19. The companies are required to immediately cease the sale of these unapproved and unauthorized products. Within 48 hours, they must provide separate emails to both the FDA and FTC detailing specific corrective actions taken, steps to prevent recurrence, and supporting documentation. Failure to comply could lead to legal action, including seizure and injunction, placement on FDA's public warning list, and potential detention of imported products. FTC violations may also result in consumer refunds.