Loading…
Dermacare LLC operating as BlueChew sold compounded sildenafil and tadalafil products online with claims that they were "the same active" ingredients as FDA-approved drugs like Viagra and Cialis, violating the Federal Food, Drug, and Cosmetic Act sections 502(a) and 502(bb) by making false or misleading statements about unapproved compounded drugs. The FDA's August 2025 website review found that BlueChew's marketing implied its compounded products were equivalent to FDA-approved medications, which is prohibited because compounded drugs cannot be FDA-approved and such claims constitute misbranding. The company was distributing these misbranded products into interstate commerce via the internet without lawful approval.