Editor’s Note: CRE applauds FDA actions to control adulertated tobacco products. However we encourage FDA to go a step farther and respond to CRE requests to address the adverse health effects of counterfeit cigarettes.
Press Trust of India | Updated: August 11, 2013 14:15 IST
In a warning letter issued to the two websites, the Food and Drug Administration (FDA) said that their several products have been found to be “adulterated” under relevant regulations and did not carry the required permits for sale in the US.
The FDA said that the two websites, desismoke.com and wantsmokes.com, could be affiliated with one another and the cigarette products and/or smokeless tobacco products listed by them are being promoted for sale to customers in the US.
It said the websites were selling products like ‘bidi’, Indian cigarettes, flavoured cigarettes and flavoured ‘bidis’.
It further said that several products being sold on the two websites have been found to be adulterated or misbranded and they were being promoted as “modified risk tobacco products” without an FDA order permitting such promotion.
The regulator said ‘bidis’ also meet the definition of a cigarette under relevant section of the US Federal Food, Drug, and Cosmetic Act and therefore come under FDA jurisdiction.
‘Bidis’ are small, thin, hand-rolled cigarettes and comprise tobacco wrapped in a tendu or temburni leaf.
As per information available with the Centers for Disease Control and Prevention (CDC), bidis are imported to the US mostly from India and other South Asian countries and have higher concentrations of nicotine, tar and carbon dioxide than the conventional cigarettes sold in the US.
In its warning letter, dated July 26, the FDA also said that the websites contained some smokeless tobacco product advertisements that do not include any warnings that are required as per the law.
Seeking their written response within 15 days of receipt of the letter, FDA has asked them to immediately correct the violations and take necessary actions to bring their tobacco products into compliance with the US law.
“Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.
“Please note that adulterated and misbranded tobacco products offered for importation into the US are subject to detention and refusal of admission,” the FDA said.