WASHINGTON, D.C. — The U.S. Food and Drug Administration unleashed a one-two punch this week — first targeting companies peddling dangerous counterfeit Botox online, then accelerating approval for life-saving treatments under its fast-track “national priority” program.
On Wednesday, the agency issued 18 warning letters to websites illegally selling unapproved and misbranded botulinum toxin products, commonly known as Botox. Officials warned that some of the fake injectables have been linked to botulism-like symptoms, a potentially fatal condition caused by nerve paralysis.
“Unapproved and misbranded Botox products carry serious health risks,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Today we’re taking action to protect American consumers and prevent online entities from selling these dangerous products.”
The FDA cautioned that approved Botox and similar treatments are prescription-only drugs that must be obtained from authorized medical professionals. The agency urged consumers to avoid online sellers such as acecosm.com, dermaxshop.com, glamderma.com, and maypharm.net, among others named in the warnings. Products purchased from unauthorized sources, officials said, may be counterfeit, contaminated, or unsafe.
Symptoms of botulism — including muscle weakness, slurred speech, and difficulty breathing — require immediate medical attention.
The crackdown comes as the FDA also announced six new awardees in its National Priority Voucher pilot program, designed to speed up reviews of breakthrough drugs that address major health and security challenges.
“National priority vouchers are granted to a select group of products where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We are pioneering new ways of bringing these cures and meaningful treatments to the market faster.”
Among the drugs selected are Zongertinib for HER2 lung cancer, Bedaquiline for drug-resistant tuberculosis in children, Dostarlimab for rectal cancer, and Casgevy for sickle cell disease. Two obesity drugs — Orforglipron and Wegovy — were also named, reflecting a surge in federal interest in combating chronic metabolic disease.
Voucher recipients will receive accelerated FDA review, potentially cutting approval times from years to months through a new “tumor board–style” evaluation involving multidisciplinary experts.
The dual announcements highlight an agency under Commissioner Makary that is cracking down on consumer safety threats while overhauling the regulatory pipeline to speed critical medical innovation — a balancing act that could reshape both patient access and pharmaceutical accountability.
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