FDA Targets Unauthorized E-Cigarettes Promoted at Industry Trade Show

In September, the U.S. Food and Drug Administration (FDA) took action to enforce compliance with the Federal Food, Drug, and Cosmetic (FD&C) Act, issuing six warning letters to manufacturers and retailers for the sale or distribution of unauthorized e-cigarette products promoted at an industry trade show. FDA's Center for Tobacco Products (CTP) discovered the violations while attending an industry trade show. Investigations revealed that six entities were selling or distributing unauthorized e-cigarettes.

John Verbeten, Director of the CTP’s Office of Compliance and Enforcement, emphasized that trade shows are monitored for compliance, and violations are addressed. Recipients of the warning letters must respond within 15 working days, detailing corrective actions to address and prevent further violations. Failure to comply can result in severe consequences, including injunctions, seizures, or civil money penalties.

Businesses must prioritize compliance to avoid penalties. Our firm can assist with responding to warning letters, preparing for FDA inspections, and developing compliance strategies to mitigate risks and protect your business from costly enforcement actions. In need of assistance? Have questions? Give our office a call today at (917) 546-6997, we would be happy to speak with you.

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