FDA WARNING_LETTER - www.tob-one.com/Fundacion Private Whois

The FDA's Center for Tobacco Products issued a Warning Letter to tob-one.com after reviewing their website and determining that cigarette products were offered for sale in the U.S. The FDA found multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Firstly, several products were deemed adulterated under section 902(8) of the FD&C Act because they were promoted as "modified risk tobacco products" without an FDA order. Specifically, products described as "LIGHTS CIGARETTES" (e.g., Bond Special Selection, Marlboro Gold) and "ULTRA LIGHTS CIGARETTES" (e.g., Bond Fine Selection, Marlboro Silver) use descriptors like "light" or "ultra light," which classify them as modified risk tobacco products under section 911(b)(2)(A)(ii). Introducing these without an FDA order under section 911(g) is a violation.

Secondly, the website offered flavored cigarettes (e.g., Aroma Rich Apple, Kiss Super Slims Fresh Apple 100s). Section 907(a)(1)(A) of the FD&C Act prohibits cigarettes from containing artificial or natural flavors (other than tobacco or menthol) as a characterizing flavor. These flavored cigarettes are adulterated under section 902(5). If they do not contain a characterizing flavor, they are misbranded under