WARNING LETTER
DC Laboratories Inc., d/b/a Dynamic Creations
MARCS-CMS 565520 —
April 10, 2019
Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Leonard V. Lombardo
Recipient Title
Chief Executive Officer
DC Laboratories Inc., d/b/a Dynamic Creations
80 13th Avenue
Ronkonkoma
,
NY
11779
United States
llombardo@dynamiccreations.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
APRIL 10, 2019
WARNING LETTER
Dear Mr. Lombardo:
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 DC Laboratories Inc., d/b/a Dynamic Creations, 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 Salted The Fourth Firecracker Popsicle, Chill Salted Cool Lime, Chill Salted Cool Mango, Chill Salted Cool Melon, Chill Salted Tropicool, Corn Bread Pudding Salts, Cherri Bombz, Squeez Berryade Salt, Coheiba 29 Menthol, Coheiba 29 Light Menthol, Twisted Sour Peach, INA Bottle Sour Grapes, Twisted Sour Strawberry, Lemon Law Raspberry, Hit That Donut Chocolate, Hit That Donut Strawberry, Milk By The Pound, and Squeez Strawberry Lemonade e-liquids are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) for not having 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.
In addition, FDA has determined that your Salted The Fourth Firecracker Popsicle and Hit That Cookie Smores e-liquids are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) because their labeling is false or misleading. FDA has also determined that these e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) and section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) because their labeling does not display the required nicotine warning statement for these e-liquid products, in the manner required by 21 C.F.R. § 1143.3.
New Tobacco Products Without Required Marketing Authorization Are Adulterated and 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: Salted The Fourth Firecracker Popsicle, Chill Salted Cool Lime, Chill Salted Cool Mango, Chill Salted Cool Melon, Chill Salted Tropicool, Corn Bread Pudding Salts, Cherri Bombz, Squeez Berryade Salt, Coheiba 29 Menthol, Coheiba 29 Light Menthol, Twisted Sour Peach, INA Bottle Sour Grapes, Twisted Sour Strawberry, Lemon Law Raspberry, Hit That Donut Chocolate, Hit That Donut Strawberry, Milk By The Pound, and Squeez Strawberry Lemonade.
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.  As a matter of enforcement discretion, FDA has extended compliance dates for the submission of premarket applications (i.e., premarket tobacco applications, substantial equivalence reports, substantial equivalence exemption requests) for certain deemed products that were on the market as of August 8, 2016.
FDA has determined that the following e-liquid products were not commercially marketed in the United States as of February 15, 2007: Salted The Fourth Firecracker Popsicle, Chill Salted Cool Lime, Chill Salted Cool Mango, Chill Salted Cool Melon, Chill Salted Tropicool, Corn Bread Pudding Salts, Cherri Bombz, Squeez Berryade Salt, Coheiba 29 Menthol, Coheiba 29 Light Menthol, Twisted Sour Peach, INA Bottle Sour Grapes, Twisted Sour Strawberry, Lemon Law Raspberry, Hit That Donut Chocolate, Hit That Donut Strawberry, Milk By The Pound, and Squeez Strawberry Lemonade.  Additionally, FDA has determined that these new tobacco products were not on the market as of August 8, 2016. Because these products are new tobacco products that were not on the market as of August 8, 2016, they are not subject to FDA’s extended compliance dates relating to premarket review requirements.
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)).
Tobacco Products With False or Misleading Labeling Are Misbranded
FDA’s investigation of regulatory submissions, inspection records, and your labeling revealed that you sell or distribute Salted The Fourth Firecracker Popsicle and Hit that Cookie Smores e-liquids with labeling that causes them to imitate food products, particularly ones that are marketed toward, and/or appealing to, children (see Exhibits A-D).
A.
The Fourth Firecracker Popsicle Salted
The labeling of Salted The Fourth Firecracker Popsicle e-liquid imitates the labeling of Popsicle Firecracker, a product that is marketed toward and/or appealing to children.
(see Exhibits A-B). For example, the labeling for this e-liquid includes statements and representations, such as “Firecracker,” and “Popsicle,” prominently placed on the front of the product. In addition, the labeling of Salted The Fourth Firecracker Popsicle e-liquid includes imagery that depicts a Popsicle Firecracker, and representations of the product name and color scheme that are substantially similar to Popsicle Firecracker ice pops. Further, Salted The Fourth Firecracker Popsicle e-liquid has a strong, sweet scent that is detectible without opening the bottle. These aspects, for example, of the Salted The Fourth Firecracker Popsicle e-liquid cause the product to imitate Popsicle Firecracker, which is a product marketed toward, and/or appealing to, children. As a result, the labeling of the
Salted The Fourth Firecracker Popsicle e-liquid is misleading.
B.
Hit That Cookie Smores
The labeling of Hit That Cookie Smores
e-liquid depicts s’mores products, which are products that are commonly marketed toward, and/or appealing to, children (see e.g., Pop Tart S’mores, Golden Graham S’mores Treats, and Chips Ahoy! S’mores products (see Exhibits C-D)). For example, the labeling for this e-liquid includes statements and representations, such as “Cookie,” and “Smores,” prominently placed on the front of the product. In addition, the labeling of Hit That Cookie Smores e-liquid includes prominent images of s’mores that are highly similar to s’mores products, such as Pop Tart S’mores, Golden Graham S’mores Treats, and Chips Ahoy! S’mores products. Further, Hit That Cookie Smores e-liquid has a strong, sweet scent that is detectible without opening the bottle. These aspects, for example, of the Hit That Cookie Smores e-liquid cause the product to imitate s’mores products, which are products that are marketed toward, and/or appealing to, children. As a result, the labeling of the
Hit That Cookie Smores e-liquid is misleading.
Children are at particular risk for ingesting e-liquid products with labeling and/or advertising that cause the product to imitate a food or beverage, particularly a food or beverage that is typically marketed toward, and/or appealing to, children.  Moreover, children are at particular risk because exposure to the nicotine in the e-liquid product, even in relatively small amounts, could result in acute toxicity.  Child poisonings due to the ingestion of liquid nicotine have recently increased substantially.  Severe harms can occur in small children from ingestion of liquid nicotine, including death from cardiac arrest, as well as seizure, coma, and respiratory arrest.
The nicotine content in the e-liquid products identified above appears to vary from 3mg/mL to 6mg/mL for Hit That Cookie Smores e-liquid, and from 35mg/mL to 50mg/mL for Salted The Fourth Firecracker Popsicle e-liquid. For products with a nicotine content of 3mg/mL, an accidental ingestion of slightly less than a teaspoon would reach the lower end of the fatal dose range for an average two-year-old.  Additionally, an accidental ingestion of approximately 3% of a teaspoon would reach the lower end of the non-fatal acute toxicity range for an average two-year-old. For products with a nicotine content of 6mg/ml, an accidental ingestion of slightly less than half a teaspoon would reach the lower end of the fatal dose range for an average two-year-old.  Additionally, an accidental ingestion of approximately 2% of a teaspoon would reach the lower end of the non-fatal acute toxicity range for an average two-year-old. For products with a nicotine content of 35mg/mL, an accidental ingestion of approximately 8% of a teaspoon would reach the lower end of the fatal dose range for an average two-year-old.  Additionally, an accidental ingestion of approximately 0.3% of a teaspoon would reach the lower end of the non-fatal acute toxicity range for an average two-year-old. Finally, for products with a nicotine content of 50mg/mL, an accidental ingestion of less than 6% of a teaspoon would reach the lower end of the fatal dose range for an average two-year-old.  Additionally, an accidental ingestion of approximately 0.2% of a teaspoon would reach the lower end of the non-fatal acute toxicity range for an average two-year-old.
The FD&C Act provides, in part, that a tobacco product shall be deemed to be misbranded if its labeling is false or misleading in any particular (section 903(a)(1)).  The labeling for Salted The Fourth Firecracker Popsicle and Hit That Cookie Smores e-liquids is misleading because it causes the products to imitate food products, particularly ones that are marketed toward, and/or appealing to, children.  Therefore, the products are misbranded under section 903(a)(1) of the FD&C Act.
E-Liquid Products with Labeling that Does Not 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 Salted The Fourth Firecracker Popsicle and Hit That Cookie Smores e-liquids revealed that the labeling for these e-liquid products that you manufacture, distribute, 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.
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.
Specifically, the labeling for Salted The Fourth Firecracker Popsicle e-liquid does not display the required nicotine warning statement. Instead, it states: “WARNING: This product
may
contain nicotine. Nicotine is an addictive chemical.” (emphasis added). Further, the labeling 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. In addition, the labeling for Hit That Cookie Smores e-liquid 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.
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)). 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 products cited in this violation are “covered tobacco products.” 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 these e-liquid products does not display the required nicotine warning statement for these products, in the manner required by 21 C.F.R. § 1143.3, in violation of 21 C.F.R. § 1143.3(a), your e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
In addition, a tobacco product is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) if its labeling is false or misleading in any particular. Under section 201(n) of the FD&C Act (21 U.S.C. § 321(n)), in determining whether labeling and/or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product. Because the labeling for these e-liquid products does not display the required nicotine warning statement for these products in the manner required by 21 C.F.R. § 1143.3, your e-liquid products are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)).
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 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 and 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, RW1901069, 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
Attachments:
Exhibits A – D
EXHIBITS
Content current as of:
04/10/2019
Regulated Product(s)
Tobacco