- Delivery Method:
- VIA UPS and Electronic Mail
Recipient NameJustin M. Roseman
- Comasphere LLC
4435 Aicholtz Road, Suite 850
Cincinnati, OH 45245-2038
- Issuing Office:
- Center for Tobacco Products
March 19, 2020
Dear Mr. Roseman:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed your submissions to the FDA and our inspection records, and has determined that Comasphere LLC manufactures and distributes e-liquid products for commercial distribution in the United States, and that the e-liquid products 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)) and 21 C.F.R. § 1100.1.
New Tobacco Products Without Required Marketing Authorization Are Adulterated and/or Misbranded
FDA has determined that you manufacture, sell, and/or distribute to customers in the United States the following e-liquid products without a marketing authorization order: Sharky’s Salt Nic Fruit Chum, Sharky’s Salt Nic Deep Blue Razz, Sharky’s Salt Nic Killer Manberry, Sharky’s Salt Nic Great Rainbow, Smokeless Salt Nic Original Blend, Smokeless Salt Nic Vanilla Beech, Smokeless Salt Nic Menthol Frost, and Smokeless Salt Nic Toucan Crunch.
The FD&C Act generally requires premarket review for any “new tobacco product,” which means any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). A marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) FDA issues an order finding the product to be exempt from the requirements of substantial equivalence and you make the required submission under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)). All deemed products that meet the definition of a “new tobacco product,” including e-liquids, are subject to the premarket requirements in sections 910 and 905 of the FD&C Act.
FDA has determined that the following e-liquid products were not commercially marketed in the United States as of February 15, 2007: Sharky’s Salt Nic Fruit Chum, Sharky’s Salt Nic Deep Blue Razz, Sharky’s Salt Nic Killer Manberry, Sharky’s Salt Nic Great Rainbow, Smokeless Salt Nic Original Blend, Smokeless Salt Nic Vanilla Beech, Smokeless Salt Nic Menthol Frost, and Smokeless Salt Nic Toucan Crunch. Therefore, these products are required to undergo premarket review and obtain FDA marketing authorization orders.
However, these products do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act. Therefore, they are adulterated under section 902(6)(A) of the FD&C Act. In addition, FDA has not issued an order finding these products to be substantially equivalent, nor has FDA issued an order exempting them from the requirements of substantial equivalence Therefore, they are also misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)). The introduction into interstate commerce of any tobacco product that is adulterated or misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). Additionally, to the extent that a report was required under section 905(j) of the FD&C Act, the failure to provide such report is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)).
Conclusion and Requested Actions
It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the type described above may result in FDA’s initiating action, including, but not limited to, civil money penalties, seizure, and/or injunction. However, this Warning Letter does not constitute “written notice” for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that any adulterated and/or misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct any violations that are referenced above, as well as violations that are the same as or similar to the ones stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.
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 manufacture, 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, ER2000037, in your response and direct your response to the following address:
DEM-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 Lillian Ortega at (240) 402-9041 or Lillian.Ortega@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products