In light of the recently finalized Deeming Rule, the FDA has been conducting periodic compliance check inspections to determine tobacco retail establishment’s compliance with the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and found several violations of the federal tobacco laws and regulations while conducting inspections. As a result, the FDA has issued a total 443 Warning Letters to tobacco retailers for selling to minors.
The FDA’s authority under the Act now extends to all tobacco products, including e-cigarettes, cigars, hookah, pipe tobacco, and e-liquids. This new regulations has extended its reach to manufacturers and retailers. As a result of the Deeming Rule, retailers are now required to comply with specific notice requirements, are subject to new prohibitions (i.e. it is now unlawful to give free samples), check photo ID of everyone under the age of 27 that attempts to purchase any tobacco product, and may need to comply with the registration and listing requirements if they fall within the definition of “manufacturer.”
FDA Warning Letters require a response within 15 working days, leaving companies with little time to develop a corrective and preventive action plan in resolution of the noted deficiences. Failure to promptly and adequately address all violations and ensure compliance with FDA regulations may lead to the imposition of fines referred to as Civil Money Penalties and No-Tobacco-Sale orders. Civil Money Penalties are used to initiate an administrative legal action against a retailer that can result in fine ranging anywhere from hundreds of dollars to thousands of dollars. No-Tobacco-Sale (NTSO) orders to tobacco retailers prohibits retailers from selling regulated tobacco products at the specified location during the period allocated to the NTSO. These sanctions can significantly affect the profitability of tobacco retailers.
The tobacco industry should be mindful of the new FDA regulations and the FDA’s extended reach to ensure that their business is in compliance with said regulations.
To speak with an attorney on how to respond to a Warning Letter and/or bring your tobacco business into compliance with FDA regulations, contact Ann Marie Gaitan, Esq. at 786.440.8115 or via e-mail at email@example.com.