FDA WARNING_LETTER - thecompanymfg.com - April 08, 2025

On April 4, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to "To Whom It May Concern" at 1733 Monrovia Avenue, Suite F, Costa Mesa, CA 92627, following a review of the website https://thecompanymfg.com. The FDA determined that e-liquid products, specifically "Flakey French by Crumbz" and "Pear Parfait by Crumbz," are manufactured and offered for sale or distribution in the U.S.

These e-liquid products are classified as "tobacco products" under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include products containing nicotine from any source. The FDA found that these products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required marketing authorization and proper notice. The letter states that all new tobacco products on the market without premarket authorization