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  1. Warning Letters

WARNING LETTER

Vape Orb/Slackers Brew Enterprise MARCS-CMS 597078 —

Delivery Method:
VIA Electronic Mail
Product:
Tobacco
Recipient:
Recipient Name
Kim Po Lim
Vape Orb/Slackers Brew Enterprise

Malaysia

contact@vapeorb.com
sales@vapeorb.com
opmikmil@gmail.com
Issuing Office:
Center for Tobacco Products

United States

DEC 6, 2019

WARNING LETTER


Dear Kim Po Lim:

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.vapeorb.com and determined that thee-liquid products listed there are advertised 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 lntensed Juice - Oreo Dunked! e-liquid product is 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 its labeling and/or advertising is false or misleading. Additionally, FDA has determined that your lntensed Juice - Oreo Dunked! 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. Furthermore, FDA has determined that several e-liquid products that are advertised and offered for sale or distribution on your website are misbranded under section 903(a)(7)(B) and section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because your website advertising e-liquid products fails to include the required nicotine warning statement.

Tobacco Product With False or Misleading Labeling and/or Advertising is Misbranded

FDA's investigation of the website https://www.vapeorb.com revealed that you sell or distribute lntensed Juice - Oreo Dunked! e-liquid with labeling and/or advertising that causes it to imitate food products, particularly ones that are marketed toward, and/or appealing to, children (see Exhibit A). Specifically, the labeling and/or advertising for lntensed Juice - Oreo Dunked! e-liquid describes, names, and depicts the product in a realistic manner that causes it to appear substantially similar to food products that are marketed toward, and/or applealing to, children, such as Nabisco OREO Chocolate Sandwich Cookies (see Exhibit B). For example, the graphics of the outer carton and bottle of lntensed Juice - Oreo Dunked! are both visually similar, in terms of design and positioning, to Nabisco OREO Chocolate Sandwich Cookies products. The outer carton is rectangular, dark blue in color, and presents an image of a large chocolate cookie splashing in a white liquid substance that appears to be milk, with the terms, "CAUTION TASTY!" and "Oreo Dunked in Milk." In addition, the outer carton features a rectangular box with the title "eJuice Facts" that is nearly identical in appearance to the "Nutrition Facts" label appearing on most food products. Likewise, the graphics of the bottle are substantially similar to the outer carton, and contain the words "CLASSIC OREO DIPPED IN MILK."

This labeling and/or advertising causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children and is therefore misleading.

Oreo

Children are at particular risk for ingesting e-liquid products with labeling and/or advertising that causes 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 a 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.

Given that lntensed Juice - Oreo Dunked! e-liquid nicotine content can be as high as 6 mg, with a total volume of 60mL, an accidental ingestion of approximately 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.

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 lntensed Juice - Oreo Dunked! e-liquid is misleading because it causes the product to imitate food products, particularly ones that are marketed toward, and/or appealing to, children. Therefore, the product is misbranded under section 903(a)(1) and/or section 903(a)(7)(A) of the FD&C Act.

Sales to Minors Violation

FDA's investigation of the website https://www.vapeorb.com revealed that you sold an e-liquid product to a minor. Specifically, during our investigation of https://www.vapeorb.com, a person younger than 18 years of age purchased lntensed Juice - Oreo Dunked! 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 ENDS 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 (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 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 (21 U.S.C. § 387c(a)(7)(B)).

E-Liquid Products with Advertising that Fails to Include the Required Nicotine Warning Statement are Misbranded

Additionally, our review of the website https://www.vapeorb.com revealed that the advertising for several eliquid products that you sell, offer for sale or distribute in the United States does not include the required nicotine warning statement in the manner required by 21 C.F.R. § 1143.3(b), for example: Final FantasyOrange, Play More - Cooling Watermelon, VD Juice - Doublegum Watermelon Mint, Holly MollyStrawberry Milkshake, 60 Symbols - Strawberry Lemonade, Yogurt Ice - Grape, Chinggey Darkness Series - Chocolate Butterscotch, and Jam Toast- Blackberry. Under 21 C.F.R. § 1143.3(b), 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 a tobacco product manufacturer, packager, importer, distributor, or retailer of the tobacco product to advertise or cause to be advertised within the United States any tobacco product unless each advertisement bears the required warning statement (21 C.F.R. § 1143.3(b)(1)). Further, the required warning statement must meet the requirements of 21 C.F.R. § 1143.3(b)(2). Under 21 C.F.R. § 1143.1, 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 your website regarding e-liquid products does not include the required nicotine warning statement for these products, in violation of 21 C.F.R. § 1143.3(b), 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)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) if, in the case of any tobacco product distributed or offered for sale in any State, its advertising 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 your website regarding e-liquid products does not include the required nicotine warning statement for these products, your e-liquid products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).

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 those 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), and in any other media in which you advertise 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, 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, RW1901173, 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 via email at CTPCompliance@fda.hhs.gov.

Sincerely,
/S/

Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products

VIA Electronic Mail

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Shopify, Inc.
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