On July 8, 2020, federal prosecutors in the Southern District of Florida charged a father and his adult sons with criminal violations relating to distribution of misbranded drugs. According to the criminal complaint, the government is alleging that the men operated a church, the “Genesis II Church of Health and Healing,” through which they sold and marketed “Miracle Mineral Solution,” a bleaching agent that the men allegedly sold as a “miracle cure-all that could treat, prevent, and cure a variety of serious diseases and disorders, including cancer, Alzheimer’s, autism, malaria, Parkinson’s, multiple sclerosis, and HIV/AIDS.” Most recently, the men promoted Miracle Mineral Solution as a cure for COVID-19.
The government is alleging that the men were using their church, which they describe in their marketing materials as a “non-religious church,” to conceal their unlawful activity under the guise of constitutionally-protected religious exercise. In doing so, the government relies on statements made by the founder in which he discussed the different regulations that apply to churches and businesses. It bears reminding that the Supreme Court has deferred to whether an individual’s religious beliefs are legitimate as long as they are “sincerely held.”
While the freedom-of-religious angle makes this case interesting, the bigger battle will likely be over the elements for proving violations involving misbranded drugs. Clearly, the Miracle Mineral Solution was intended as a “drug” by the defendants, since it was marketed for use in the treatment of COVID-19 and other illnesses. It also appears undisputed that the FDA has not approved the Solution for any legitimate uses.
Harder to prove will be whether the men acted willfully–that they knew their conduct was unlawful and acted anyway. In other words, the government must prove that the defendants knew their product had to be FDA-approved in order to distribute and market it. FDA regulations are complicated, and the government will have to prove that the men knew the Solution had a toxic or harmful effect that had no medical benefits and violated the FDA’s labeling requirements. The nature of the evidence will drive the outcome of this case, especially any evidence that sheds light on how much the defendants knew.
The government also charged the men and church with contempt of court, citing a district court decision earlier this year enjoining the church from distributing and marketing drugs, including the Solution. The government’s complaint asserts that the men knew their activities were prohibited by this order and willfully violated the order anyway.
Click here to read more about the case at Talking Points Memo.