Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/misty-mountain-vapors-llc-593283-09242019
Timestamp: 2020-01-28 12:08:09
Document Index: 659635871

Matched Legal Cases: ['§ 321', '§ 387', '§ 1143', '§ 1143', '§ 1143', '§ 1143', '§ 1100', '§ 1100', '§ 1100']

Misty Mountain Vapors, LLC - 593283 - 09/24/2019 | FDA
Misty Mountain Vapors, LLC - 593283 - 09/24/2019
Misty Mountain Vapors, LLC MARCS-CMS 593283 — September 24, 2019
RW1901179
Brenda Berry Long	and Brian Dooley
Misty Mountain Vapors, LLC
BLB Distributors, LLC
114 Zinnia Lane
Garner, NC 27529-5034
Brian@mistymountainvapors.com
Dear Brenda Berry Long and Brian Dooley:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, https://www.mistymountainvapors.com, and determined that the e-liquid products listed there are advertised and offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including e-liquids, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
Our review of the website https://www.mistymountainvapors.com revealed that the labeling and/or advertising for several e-liquid products that you sell, offer for sale or distribute in the United States does not include the required nicotine warning statement in the manner required by 21 C.F.R. § 1143.3(b), for example: A Dope Life Berry Fun, Angry Penguin, Cookie Monster, Dekang Juicy Peach, Good Life Vapor 925, RΩD Shortcakez, Rebel Dynasty Vapors Chopper, and Space Wars Sauce Wookey Cookie. Under 21 C.F.R. § 1143.3(b), advertising for cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars), such as waterpipe tobacco products, must bear the following warning statement:
For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for a tobacco product manufacturer, packager, importer, distributor, or retailer of the tobacco product to advertise or cause to be advertised within the United States any tobacco product unless each advertisement bears the required warning statement (21 C.F.R. § 1143.3(b)(1)). Under 21 C.F.R. § 1143.1, a “covered tobacco product” is defined as any tobacco product deemed to be subject to the FD&C Act under 21 C.F.R. § 1100.2, excluding components or parts not made or derived from tobacco. Before 21 C.F.R. § 1100.2 became effective, only cigarettes, smokeless tobacco, roll-your-own tobacco, and cigarette tobacco were subject to chapter IX of the FD&C Act. 21 C.F.R. § 1100.2 deems all other tobacco products, except accessories of such tobacco products, subject to chapter IX and its implementing regulations. The products cited in this violation are “covered tobacco products.”
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.
Please note your reference number, RW1901179, in your response and direct your response to the following address:
Misty Mountain Vapors, LLC/BLB Distributors, LLC
Attn: Brian Dooley
1114 Tunstall Way
86 Technology Dr.
5710-C Capital Blvd