FDA WARNING_LETTER - www.onlycigs.net

The FDA's Center for Tobacco Products reviewed www.onlycigs.net and found that the company is offering cigarette products for sale or distribution in the U.S. that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, several cigarette products are deemed adulterated under section 902(8) of the FD&C Act because they are "modified risk tobacco products" (e.g., "Lights," "Ultra Lights," or similar descriptors like "Blue," "Gold," "Silver") sold without a required FDA order. Examples include Bond Special Selection, Marlboro Gold, and Parliament Aqua Blue.

Additionally, other cigarette products are adulterated under section 902(5) or misbranded under section 903(a)(1) or 903(a)(7)(A) of the FD&C Act because they purport to contain a natural or artificial characterizing flavor (e.g., Aroma Rich Apple, Kiss Mohito, Richmond Cherry). This violates section 907(a)(1)(A) which prohibits characterizing flavors in cigarettes (other than tobacco or menthol). If these products do not contain the stated flavors, they are misbranded due to false or misleading labeling/advertising.

The FDA requires immediate correction of these violations and similar ones, along with a plan for maintaining compliance. Failure to comply within 15 working days may result in further action, including civil money