WARNING LETTER

Electric Lotus, LLC MARCS-CMS 568710 — November 29, 2018

Delivery Method:: VIA UPS and Electronic Mail

Recipient:: Recipient Name

Christopher M. Davis; Recipient Title

Chief Executive Officer; Electric Lotus, LLC; Electric Lotus, LLC; 1740 Howard Place
Redlands, CA 92373
United States; chris@electriclotus.com; info@electriclotus.com

Issuing Office:: Center for Tobacco Products; 10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

Dear Mr. Davis:

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed your submissions to the FDA, our inspection records, and your website, https://www.elwholesale.com, and determined that Electric Lotus, LLC manufactures and distributes e-liquid products for commercial distribution in the United States, and that the e-liquid products listed on your website 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 Cereal Treats Crunch e-liquid, Cereal Treats Loopz e-liquid, Cereal Treats Charms e-liquid, Cereal Treats Krispies e-liquid, Jammin Berries Blueberry Jam e-liquid, Jammin Berries Peanut Jamz Raspberry e-liquid, Dripflavors Strawberry Lemonade Salt e-liquid, Dripflavors Sour Apple Kiwi Gummy Salt e-liquid, and Heavy Custard Unicorn Cake e-liquid 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. FDA has also determined that your Cereal Treats Crunch e-liquid, Cereal Treats Loopz e-liquid, Cereal Treats Charms e-liquid, and Cereal Treats Krispies e-liquid are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because you failed to include these products in a list required by section 905(i) of the FD&C Act (21 U.S.C. § 387e(i)).

Additionally, FDA has determined that the nine products listed above are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because their labeling and/or advertising are false or misleading. Further, FDA has determined that your Cereal Treats Crunch e-liquid is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product to a person younger than 18 years of age.

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: Cereal Treats Crunch, Cereal Treats Loopz, Cereal Treats Charms, Cereal Treats Krispies, Jammin Berries Blueberry Jam, Jammin Berries Peanut Jamz Raspberry, Dripflavors Strawberry Lemonade Salt, Dripflavors Sour Apple Kiwi Gummy Salt, and Heavy Custard Unicorn Cake.

The FD&C Act 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) to August 8, 2021 for deemed combustible new tobacco products, such as cigars, pipe tobacco and hookah tobacco; and to August 8, 2022 for deemed noncombustible new tobacco products, such as most electronic nicotine delivery systems. These extended compliance dates apply only to those deemed new tobacco 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: Cereal Treats Crunch, Cereal Treats Loopz, Cereal Treats Charms, Cereal Treats Krispies, Jammin Berries Blueberry Jam, Jammin Berries Peanut Jamz Raspberry, Dripflavors Strawberry Lemonade Salt, Dripflavors Sour Apple Kiwi Gummy Salt, and Heavy Custard Unicorn Cake. 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 August 8, 2022 compliance dates relating to premarket review requirements of deemed noncombustible new tobacco products.

Because 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, they are adulterated under section 902(6)(A) of the FD&C Act. In addition, 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)), these products are misbranded under section 903(a)(6) of the FD&C Act. 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 Not Listed are Misbranded

FDA has also determined that the Cereal Treats Crunch, Cereal Treats Loopz, Cereal Treats Charms, and Cereal Treats Krispies tobacco products manufactured by Electric Lotus, LLC are misbranded under section 903(a)(6) of the FD&C Act because you failed to include these products in a list required by section 905(i) of the FD&C Act (21 U.S.C. § 387e(i)). Section 905(i)(3)(A) of the FD&C Act (21 U.S.C. § 387e(i)(3)(A)) requires that each person who registers with FDA under section 905 biannually report to FDA a list of each tobacco product introduced by the registrant for commercial distribution which has not been included in any list previously filed by that person with the FDA under section 905(i). Failure to comply with section 905(i) of the FD&C Act renders a product misbranded under section 903(a)(6) of the FD&C Act. The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act. Additionally, the failure to provide any information required by section 905(i) of the FD&C Act is a prohibited act under section 301(p) of the FD&C Act.

Tobacco Products with False or Misleading Labeling and/or Advertising are Misbranded

FDA’s investigation of inspection records and your website, http://www.elwholesale.com, revealed that you sell or distribute the following e-liquid products with labeling and/or advertising that cause them to imitate food products, particularly ones that are marketed toward, and/or appealing to, children: Cereal Treats Crunch, Cereal Treats Loopz, Cereal Treats Charms, Cereal Treats Krispies, Jammin Berries Blueberry Jam, Jammin Berries Peanut Jamz Raspberry, Dripflavors Strawberry Lemonade Salt, Dripflavors Sour Apple Kiwi Gummy Salt, and Heavy Custard Unicorn Cake e-liquids (see Exhibits A – R).

I. Cereal Treats Crunch

The labeling and/or advertising of Cereal Treats Crunch e-liquid imitate the labeling and/or advertising for Cinnamon Toast Crunch cereal and Cinnamon Toast Crunch Treats, products that are commonly marketed toward, and/or appealing to, children (see Exhibits A and B). For example, the labeling and/or advertising for this e-liquid include statements and representations, such as “Cereal,” “Treats,” and “Crunch,” prominently placed on the front of the product, as well as a label on the back that is substantially similar to a food Nutrition Facts label. In addition, the labeling and/or advertising of Cereal Treats Crunch e-liquid include illustrations that appear to depict Cinnamon Toast Crunch cereal, images of cinnamon swirls, and representations of the product name and color scheme that are substantially similar to Cinnamon Toast Crunch products. The labeling and/or advertising also include a cartoon chef carrying a tray that appears to contain food. The use of this cartoon further enhances the appeal of Cereal Treats Crunch e-liquid to children and increases the likelihood that children will ingest the product as a food. Further, Cereal Treats Crunch e-liquid has a strong, sweet scent. This labeling and/or advertising cause the product to imitate Cinnamon Toast Crunch products, which are marketed toward, and/or appealing to, children, and are therefore misleading.

II. Cereal Treats Loopz

The labeling and/or advertising of Cereal Treats Loopz e-liquid imitate the labeling and/or advertising for Froot Loops cereal, a product that is commonly marketed toward, and/or appealing to, children (see Exhibits C and D). For example, the labeling and/or advertising for this e-liquid include statements and representations, such as “Cereal,” “Treats,” and “Loopz,” prominently placed on the front of the product, as well as a label on the back that is substantially similar to a food Nutrition Facts label. In addition, the labeling and/or advertising of Cereal Treats Loopz e-liquid include illustrations of vines and leaves and representations of the product name and color scheme that are substantially similar to Froot Loops cereal products. The labeling and/or advertising also include a cartoon toucan that is substantially similar to the Toucan Sam cartoon featured on the labeling of Froot Loops cereal products. The use of this cartoon further enhances the appeal of Cereal Treats Loopz e-liquid to children and increases the likelihood that children will ingest the product as a food. Further, Cereal Treats Loopz e-liquid has a strong, sweet scent. This labeling and/or advertising cause the product to imitate Froot Loops cereal, a product that is marketed toward, and/or appealing to, children, and are therefore misleading.

III. Cereal Treats Charms

The labeling and/or advertising of Cereal Treats Charms e-liquid imitate the labeling and/or advertising for Lucky Charms cereal and Lucky Charms Treats, products that are commonly marketed toward, and/or appealing to, children (see Exhibits E and F). For example, the labeling and/or advertising for this e-liquid include statements and representations, such as “Cereal,” “Treats,” and “Charms,” prominently placed on the front of the product, as well as a label on the back that is substantially similar to a food Nutrition Facts label. In addition, the labeling and/or advertising of Cereal Treats Charms e-liquid include an illustration of a rainbow with clouds at each end and small illustrations of stars, illustrations that appear to depict the “marbits” marshmallows in Lucky Charms cereal, and representations of the product name and color scheme that are substantially similar to Lucky Charms cereal products. The labeling and/or advertising also include a cartoon leprechaun that is substantially similar to the Lucky the Leprechaun cartoon featured on the labeling of Lucky Charms cereal products. The use of this cartoon further enhances the appeal of Cereal Treats Charms e-liquid to children and increases the likelihood that children will ingest the product as a food. Further, Cereal Treats Charms e-liquid has a strong, sweet scent. This labeling and/or advertising cause the product to imitate Lucky Charms products, which are products that are marketed toward, and/or appealing to, children, and are therefore misleading.

IV. Cereal Treats Krispies

The labeling and/or advertising of Cereal Treats Krispies e-liquid imitate the labeling and/or advertising for Rice Krispies Treats cereal, a product that is commonly marketed toward, and/or appealing to, children (see Exhibits G and H). For example, the labeling and/or advertising for this e-liquid include statements and representations, such as “Cereal,” “Treats,” and “Krispies,” prominently placed on the front of the product, as well as a label on the back that is substantially similar to a food Nutrition Facts label. In addition, the labeling and/or advertising of Cereal Treats Krispies e-liquid include illustrations of marshmallows and representations of the product name and color scheme that are substantially similar to Rice Krispies Treats cereal. Further, Cereal Treats Krispies e-liquid has a strong, sweet scent. This labeling and/or advertising cause the product to imitate Rice Krispies Treats cereal, a product that is marketed toward, and/or appealing to, children, and are therefore misleading.

V. Jammin Berries Blueberry Jam

The labeling and/or advertising of Jammin Berries Blueberry Jam e-liquid imitate the labeling and/or advertising for jam, jelly, and preserves products that are commonly marketed toward, and/or appealing to, children, such as Smucker’s Blueberry Preserves (see Exhibits I and J). For example, the labeling and/or advertising for this e-liquid include statements and representations, such as “Blueberry Jam” and “Jammin Berries,” prominently placed on the front of the product. In addition, the labeling and/or advertising of Jammin Berries Blueberry Jam e-liquid include illustrations depicting blueberries, illustrations of a jar of jam, a package of butter, and toast, with the words “Jam,” “Butter,” and “Toast,” and representations of the product name and color scheme that are substantially similar to Smucker’s Blueberry Preserves. The labeling and/or advertising also include an illustration of a blue gingham pattern extending over the edges of the package that resembles the gingham pattern of the lid of Smucker’s Blueberry Preserves, as well as an illustration that appears to depict blueberry jam leaking out from beneath a jam jar lid. Further, Jammin Berries Blueberry Jam e-liquid has a strong, sweet scent. This labeling and/or advertising cause the product to imitate jam, jelly, and preserves products, particularly ones that are marketed toward, and/or appealing to, children, and are therefore misleading.

VI. Jammin Berries Peanut Jamz Raspberry

The labeling and/or advertising of Jammin Berries Peanut Jamz Raspberry e-liquid imitate the labeling and/or advertising for peanut butter, jelly, and jam products that are commonly marketed toward, and/or appealing to, children, such as Smucker’s Goober Strawberry PB&J Stripes (see Exhibits K and L). For example, the labeling and/or advertising for this e-liquid include statements and representations, such as “Peanut Jamz,” “Jammin Berries,” and “Raspberry,” prominently placed on the front of the product. In addition, the labeling and/or advertising of Jammin Berries Peanut Jamz Raspberry e-liquid include an illustration that appears to depict peanut butter and representations of the product name and color scheme that are substantially similar to Smucker’s Goober Strawberry PB&J Stripes. The labeling and/or advertising also include cartoons of a smiling piece of fruit and smiling peanuts that are substantially similar to the cartoons of a smiling piece of fruit and smiling peanut featured on the labeling of Smucker’s Goober PB&J Stripes products. The use of this cartoon further enhances the appeal of Jammin Berries Peanut Jamz Raspberry e-liquid to children and increases the likelihood that children will ingest the product as a food. Further, Jammin Berries Peanut Jamz Raspberry e-liquid has a strong, sweet scent. This labeling and/or advertising cause the product to imitate peanut butter, jelly, and jam products, particularly ones that are marketed toward, and/or appealing to, children, and are therefore misleading.

VII. Dripflavors Strawberry Lemonade Salt

The labeling and/or advertising of Dripflavors Strawberry Lemonade Salt e-liquid imitate the labeling and/or advertising for candy products that are commonly marketed toward, and/or appealing to, children, such as Life Savers candy products (see Exhibits M and N). For example, the labeling and/or advertising for this e-liquid include statements and representations, such as “Strawberry,” “Lemonade,” and “Salt,” prominently placed on the front of the product. In addition, the labeling and/or advertising of Dripflavors Strawberry Lemonade Salt e-liquid include an illustration of stripes radiating outward that is substantially similar to the labeling for Life Savers candy products, illustrations of whole strawberries and cut lemons, and representations of the product name and color scheme that are substantially similar to Life Savers candy products. Further, Dripflavors Strawberry Lemonade Salt e-liquid has a strong, sweet scent. This labeling and/or advertising cause the product to imitate candy products, particularly ones that are marketed toward, and/or appealing to, children, and are therefore misleading.

VIII. Dripflavors Sour Apple Kiwi Gummy Salt

The labeling and/or advertising of Dripflavors Sour Apple Kiwi Gummy Salt e-liquid imitate the labeling and/or advertising for candy products that are commonly marketed toward, and/or appealing to, children, such as Life Savers candy products (see Exhibits O and P). For example, the labeling and/or advertising for this e-liquid include statements and representations, such as “Sour,” “Apple,” “Kiwi,” “Gummy,” and “Salt,” prominently placed on the front of the product. In addition, the labeling and/or advertising of Dripflavors Sour Apple Kiwi Gummy Salt e-liquid include an illustration of stripes radiating outward that is substantially similar to the labeling for Life Savers candy products, illustrations of whole and cut pieces of fruit, and representations of the product name and color scheme that are substantially similar to Life Savers candy products. Further, Dripflavors Sour Apple Kiwi Gummy Salt e-liquid has a strong, sweet scent. This labeling and/or advertising cause the product to imitate candy products, particularly ones that are marketed toward, and/or appealing to, children, and are therefore misleading.

IX. Heavy Custard Unicorn Cake

The labeling and/or advertising of Heavy Custard Unicorn Cake e-liquid imitate the labeling and/or advertising for confetti cake products that are commonly marketed toward, and/or appealing to, children, such as Pelican Bay Unicorn Magical Cupcake Kit, Duff Unicorn Cakes Premium Cupcake Mix, and Little Debbie Unicorn Cakes (see Exhibits Q and R). For example, the labeling and/or advertising for this e-liquid include statements and representations, such as “Unicorn,” “Cake,” and “Custard,” prominently placed on the product. In addition, the labeling and/or advertising of Heavy Custard Unicorn Cake e-liquid include images of cake with rainbow confetti and whipped cream. The labeling and/or advertising also include cartoon imagery of unicorns that are similar to cartoon imagery of unicorns featured on confetti cake products that utilize unicorns, such as Pelican Bay Unicorn Magical Cupcake Kit, Duff Unicorn Cakes Premium Cupcake Mix, and Little Debbie Unicorn Cakes. The use of this cartoon imagery further enhances the appeal of Heavy Custard Unicorn Cake e-liquid to children and increases the likelihood that children will ingest the product as a food. Further, Heavy Custard Unicorn Cake e-liquid has a strong, sweet scent. This labeling and/or advertising cause the product to imitate food products that are marketed toward, and/or appealing to, children, and is therefore 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 some, and from 30mg/ml to 50mg/ml for others. 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 30mg/mL, an accidental ingestion of approximately 9% 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 0.4% 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 (1) if its labeling is false or misleading in any particular (section 903(a)(1)), or (2) if the tobacco product is distributed or offered for sale in any State and its advertising is false or misleading in any particular (section 903(a)(7)(A)). The labeling and/or advertising for Cereal Treats Crunch, Cereal Treats Loopz, Cereal Treats Charms, Cereal Treats Krispies, Jammin Berries Blueberry Jam, Jammin Berries Peanut Jamz Raspberry, Dripflavors Strawberry Lemonade Salt, Dripflavors Sour Apple Kiwi Gummy Salt, and Heavy Custard Unicorn Cake e-liquids are misleading because they cause 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) and/or 903(a)(7)(A) of the FD&C Act.

Tobacco Products Sold to Minors are Misbranded

FDA’s investigation of the website, https://www.elwholesale.com, revealed that you sold an e-liquid product to a minor. Specifically, during our investigation of https://www.elwholesale.com, a person younger than 18 years of age purchased Cereal Treats Crunch e-liquid from your website. No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and dissolvable tobacco products, as well as electronic nicotine delivery system products that contain any tobacco derivative, to a person younger than 18 years of age under 21 C.F.R. § 1140.14(b). Under 21 C.F.R. § 1140.3, a “covered tobacco product” is defined as any tobacco product deemed to be subject to chapter IX of the FD&C Act by 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, 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 1140. Because this product is sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(b), this product is misbranded under section 903(a)(7)(B) of the FD&C Act.

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 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 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 labeling, 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, ER1800013, 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-R

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