Texas OTC Medtech Firm Refuses FDA Inspection, Continues Selling Unapproved Products
RoyalVibe Health makes and sells unapproved devices in kits and individually “intended for the diagnosis and treatment of several diseases including but not limited to cancer, Alzheimer’s, ischemic stroke, arthritis, and type 1 diabetes,” FDA warning states.
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Industry trade groups say FDA decision against starting rulemaking for lawful use of hemp ingredients is not only overdue but failed to clear the air for businesses making or using the ingredients.
It could take next farm bill, on lawmakers’ 2023 to-do list, to extinguish inferno of disagreement between FDA and regulated industries over lawful use of hemp-based ingredients in supplements as well as food and non-drug topicals. Before 2018 bill de-scheduled hemp, 2014 bill expanded access to hemp for research.
Decision, explained by Principal Deputy Commissioner Woodcock, turns page on FDA’s 2019 announcement, after hemp was de-scheduled in 2018 farm bill, it would consider rulemaking for lawful use of hemp in supplements.