WARNING LETTER
Mighty Vapors, LLC, d/b/a Ovo Manufacturing & Distribution
MARCS-CMS 582569 —
August 08, 2019
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Mr. Tyler D. Filyau
Recipient Title
Chief Executive Officer
Mighty Vapors, LLC, d/b/a Ovo Manufacturing & Distribution
3171 Independence Drive
Livermore
,
CA
94551-7595
United States
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
VIA UPS and Electronic Mail
Reference #: ER1900022
AUG 8, 2019
Mr. Tyler D. Filyau
Chief Executive Officer
Mighty Vapors, LLC, d/b/a Ovo Manufacturing & Distribution
3171 Independence Drive
Livermore, CA  94551-7595
tyler@ovodistro.com
WARNING LETTER
Dear Mr. Filyau:
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 determined that Mighty Vapors, LLC, d/b/a Ovo Manufacturing & Distribution, 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-liquids, 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 Hulk Tears NicSalts, Frozen Hulk Tears NicSalts, Majestic Mango NicSalts, Frozen Majestic Mango NicSalts, Mystery Pop NicSalts, and Frozen Mystery Pop NicSalts
e-liquids
are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) because they do not have a required FDA marketing authorization order in effect and/or misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because a required notice or other information respecting the products was not provided.
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: Hulk Tears NicSalts, Frozen Hulk Tears NicSalts, Majestic Mango NicSalts, Frozen Majestic Mango NicSalts, Mystery Pop NicSalts, and Frozen Mystery Pop NicSalts.
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 fi
n
ding the product to be exempt
f
r
o
m the requ
i
rements
o
f substantial equivalence and you ma
k
e the re
q
uired sub
m
ission und
e
r sec
t
ion 905(j
)
(
1
)(A
)(i
i
) 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: Hulk Tears NicSalts, Frozen Hulk Tears NicSalts, Majestic Mango NicSalts, Frozen Majestic Mango NicSalts, Mystery Pop NicSalts, and Frozen Mystery Pop NicSalts.
These products are required to have premarket review and 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, they are 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
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 the ones 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 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’s initiating further action without notice, including, but not limited to, civil money penalties, criminal prosecution, seizure, and/or injunction.  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.
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 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, ER1900022, 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
.
Sincerely,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products
Content current as of:
08/08/2019
Regulated Product(s)
Tobacco