FDA Warns Websites Selling Unapproved Botulinum Toxin Products

The US Food and Drug Administration (FDA) has issued 18 warning letters to website operators illegally marketing unapproved and misbranded botulinum toxin products for cosmetic and medical use. The enforcement action follows reports of adverse events, including symptoms consistent with botulism, linked to these unauthorized products.

“Unapproved and misbranded Botox products carry serious health risks,” said FDA Commissioner Marty Makary, MD, MPH. “Today, we’re taking action to protect American consumers and prevent online entities from selling these dangerous products.”

The FDA emphasized that botulinum toxin injections should only be administered by licensed health care professionals using approved products sourced through authorized channels.

"Products purchased from unauthorized sources may be unapproved, misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe," the FDA said in a statement.

Websites named in the warning letters include:

• acecosm.com

• aesthetic-essentials.com

• celestapro.com

• cosmenic.net

• cosmo-korea.com

• derma-solution.com

• dermaxshop.com

• ellepharm.com

• estaderma.com

• filleroutlet.com

• glamderma.com

• glowface.store

• glownestbeauty.com

• koreafillerexperts.com

• koreanfillers.com

• maypharm.net

• meamoshop.com

• mjsmedicals.com

Health care professionals and consumers are encouraged to report adverse events associated with botulinum toxin products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.