Virtual supplier of smoking products smokers-mall.com could face the music, as the FDA has clamped down on it for flouting rules. The agency has issued a warning to correct violations regarding illegal sale of tobacco products and an unapproved drug/device combo, and urged it to work towards regaining of compliance.
The FDA's Center for Tobacco Products or CTP and the Center for Drug Evaluation and Research or CDER have jointly issued a warning letter to smokers-mall.com, as several of their products for sale to consumers in the U.S. were in violation of the Federal Food, Drug, and Cosmetic Act or FD&C Act.
This is the first time CTP has jointly issued a warning letter with another FDA Center. The agency claimed the website illegally sells and markets both violative tobacco products and an unapproved drug/device combination product.
The warning letter says that even as the retailer's Merilyn Blue Slims and Merilyn Pink Slims contain tobacco, they are currently marketed as drug-device combination products. The FDA believes the Merilyn Blue Slims and Merilyn Pink Slims offered for sale on the website are unapproved new drugs.
FDA has determined that the website, http://www.smokers-mall.com, offers for sale or distributes cigarette tobacco and/or roll-your-own tobacco products.
The regulator also determined that several cigarette products are adulterated because they are modified risk tobacco products sold or distributed without an FDA order in effect that permits such sale or distribution.
Additionally, the watch dog believes that several cigarette and cigarette tobacco and/or roll-your-own tobacco products are adulterated as they purport to contain a natural or artificial characterizing flavor.
The FDA has asked the retailer to immediately correct the violations and take any necessary actions to bring its tobacco and drug products into compliance with the FD&C Act.
by RTT Staff Writer
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