Mac Vapes LLC d/b/a Oishi Jusu MARCS-CMS 585031 —
- Delivery Method:
- VIA UPS and Electronic Mail
Recipient NameFrederick Mc Cullough
- Mac Vapes LLC d/b/a Oishi Jusu
361 Cleveland Place, Suite 105
Virginia Beach, VA 23462
- Issuing Office:
- Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
AUG 8, 2019
Mac Vapes LLC d/b/a Oishi Jusu
Attn: Frederick Mc Cullough
361 Cleveland Place, Suite105
Virginia Beach, VA 23462
Dear Frederick Mc Cullough,
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed the website http://www.oishijusu.com and determined that the e-liquid products listed there are manufactured 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-liquid products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that your The Ronins e-liquid product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because the labeling for this product that you manufacture, advertise, and offer for sale or distribution in the United States does not display the required nicotine warning statement in the manner required by 21 C.F.R. § 1143.3.
E-Liquid Tobacco Products with Labeling that Fails to Include the Required Nicotine Warning Statement in the Manner Required by 21 C.F.R. § 1143.3 are Misbranded
Our review of the labeling for your The Ronins e-liquid tobacco product revealed that the labeling for this product that you manufacture, advertise, and offer for sale or distribution in the United States does not display the required nicotine warning statement in the manner required by 21 C.F.R. § 1143.3. Specifically, the labeling for The Ronins e-liquid product does not display the required nicotine warning statement in a conspicuous and prominent place on the two principal display panels of the package and in a warning area that comprises at least 30 percent of each of the principal display panels.
Under 21 C.F.R. § 1143.3, labeling and advertising for cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars), such as e-liquid products, must bear the following warning statement:
WARNING: This product contains nicotine. Nicotine is an addictive chemical.
For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution in the United States such product unless such tobacco product package bears the following required warning statement on the package label: “WARNING: This product contains nicotine. Nicotine is an addictive chemical” (21 C.F.R. § 1143.3(a)(1)). Further, the required warning statement must meet the requirements of 21 C.F.R. § 1143.3(a)(2). Under 21 C.F.R. § 1140.3, 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 product cited in this violation is a “covered tobacco product.” Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1143. Because the labeling for this e-liquid product does not display the required nicotine warning statement for this product in the manner required by 21 C.F.R. § 1143.3, your e-liquid product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
Conclusion and Requested Actions
The violation discussed in this letter does not necessarily constitute an exhaustive list. You should immediately correct the violation that is referenced above, as well as violations that are the same as or similar to the one stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. 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 any adulterated or misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative labeling and/or advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C
Act. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
Please note your reference number, RW1901116, in your response and direct your response to the following address:
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or CTPCompliance@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail