44 Deleu S, Machiels K, Raes J, Verbeke K, Vermeire S
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Such inhibition could enhance the oral bioavailability and/or reduce the clearance of the drugs, prolonging tissue and systemic concentrations and increasing the risk of adverse effects
They were not waiting long enough
On February 6, however, FDAs approach appeared to shift with an announcement that it would be taking steps both to restrict GLP-1 active pharmaceutical ingredients (APIs) that continue to be used in non-FDA-approved compounded products to combat misleading direct-to-consumer advertising and marketing. Unequivocally, FDA warned: Entities engaged in the manufacture, distribution, or marketing of unapproved compounded GLP-1 products should be aware that failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction. FDA specifically named Hims & Hers a popular and outspoken telehealth provider that advertises compounded GLP-1 products in the announcement