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  5. Kilo E-Liquids Inc. d/b/a Kilo Distribution - 1111111 - 04/02/2019
  1. Warning Letters

WARNING LETTER

Kilo E-Liquids Inc. d/b/a Kilo Distribution MARCS-CMS 1111111 —


Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW1901058
Product:
Tobacco

Recipient:
Recipient Name
Jonathan Lee and James Kim
Kilo E-Liquids Inc. d/b/a Kilo Distribution

16831 Knott Ave
La Mirada, CA 90638
United States

jon@kiloeliquids.com
Issuing Office:
Center for Tobacco Products

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


Dear Jonathan Lee and James Kim:
 
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed labeling and/or advertising for your tobacco products, as well as your submissions to the FDA, and determined that Kilo E-Liquids Inc. d/b/a Kilo Distribution manufactures, distributes, and offers for sale or distribution e-liquid products 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 OMG E-Liquids WTF and OMG E-Liquids SMH e-liquids 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.
 
Tobacco Products With False or Misleading Labeling and/or Advertising Are Misbranded
 
FDA’s investigation of your labeling and/or advertising and your submissions to FDA revealed that you manufacture, sell, and/or distribute OMG E-Liquids WTF and OMG E-Liquids SMH e-liquid products with labeling and/or advertising that cause the products to appear to be ingestible, when they are not (see Exhibits A and B, respectively). Adults and children are at risk from ingestion of liquid nicotine when nicotine-containing e-liquid products misleadingly appear to be ingestible because exposure to the nicotine in the e-liquid product, even in relatively small amounts, could result in severe harms such as death from cardiac arrest, as well as seizure, coma, and respiratory arrest. 
 
OMG E-Liquids WTF
 
The labeling and/or advertising for OMG E-Liquids WTF e-liquid include statements, representations, and graphical elements that cause the product to appear ingestible by imitating the cough syrup, Qualitest Promethazine with Codeine Syrup (see Exhibit C). For example, the bottle’s labeling features: the terms “WTF,” “THE ORIGINAL,” and “STRAWBERRY SOURBELT,” set against a yellow background above a thick brown line and thin white line that circle the bottom of the entire label, similar to the design and placement of “PROMETHAZINE WITH CODEINE SYRUP” on the drug product; the phrase “OMG E-Liquid ®” in thick white font within the brown line that circles the bottom of the entire label, similar to the design and placement of “Qualitest ®” on the Qualitest product; what appears to be dosage information and a list of ingredients, the color, font, and formatting of which imitates the drug fact label on the Qualitest product; and “WTF 0603-1585-24,” which, in its content, design, and placement, appears to mirror the National Drug Code (NDC) given to human drugs in the United States, particularly the NDC for Qualitest Promethazine with Codeine Syrup, which is “NDC 0603-1585-58.” Qualitest Promethazine with Codeine Syrup is intended to be taken orally at a recommended dosage of 5mL – 10mL. Thus, by imitating the Qualitest product, the e-liquid product suggests it is meant to be ingested like cough syrup.  
 
OMG E-Liquids SMH
 
The labeling and/or advertising for OMG E-Liquids SMH e-liquid include statements, representations, and graphical elements that cause the product to appear ingestible by imitating the cough syrup, Qualitest Promethazine with Codeine Syrup (see Exhibit C).  For example, the bottle’s labeling features: the terms “SMH,” “STRAWBERRY,” and “KIWI,” set against a yellow background above a thick brown line and thin white line that circle the bottom of the entire label, similar to the design and placement of “PROMETHAZINE WITH CODEINE SYRUP” on the drug product; the phrase “OMG E-Liquid ®” in thick white font within the brown line that circles the bottom of the entire label, similar to the design and placement of “Qualitest ®” on the Qualitest product; what appears to be dosage information and a list of ingredients, the color, font, and formatting of which imitates the drug fact label on the Qualitest product; and “SMH 0603-1585-24,” which, in its content, design, and placement, appears to mirror the National Drug Code (NDC) for Qualitest Promethazine with Codeine Syrup, which is “NDC 0603-1585-58.” Qualitest Promethazine with Codeine Syrup is intended to be taken orally at a recommended dosage of 5mL – 10mL. Thus, by imitating the Qualitest product, the e-liquid product suggests it is meant to be ingested like cough syrup. 
 
The overall presentations of the e-liquid products, including of their respective names and the accompanying statements, representations, and graphical elements on their labeling and/or advertising, make it appear that the products are ingestible products, such as cough syrup products, and could reasonably result in a child or adult ingesting the products. Because the labeling and/or advertising cause the products to appear to be ingestible products, when they are not, the labeling and/or adversiting are misleading.
 
E Liquid Syrup   
 
Adults and children are at risk of poisoning by nicotine-containing e-liquid products that appear to be ingestible, when they are not. An adult might unknowingly consume these products that appear to be ingestible, when they are not, which could result in ingesting toxic amounts of liquid nicotine. Likewise, nicotine exposures of these sorts are extremely problematic and could be fatal for children. For both adults and children, 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 the labeling and/or advertising of OMG E-Liquids WTF and OMG E-Liquids SMH e-liquid products describe their nicotine content as being as high as 6mg/mL, with a total volume of 120mL, 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. The average adult dosage of codeine cough syrup is 5mL – 10mL. At the high cough syrup dosage, 10mL, e-liquid with a nicotine content of 6mg/mL thought to be cough syrup would expose an adult to 60mg of nicotine which could cause moderate or fatal nicotine toxicity, depending upon inter-individual differences in adult toxicity responses.
 
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 OMG E-Liquids WTF and OMG E-Liquids SMH e-liquid products cause the products to appear to be ingestible products, when they are not, and are therefore misleading. Therefore, the products are misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act.
 
Conclusion and Requested Actions
 
The violation discussed in this letter does not necessarily constitute an exhaustive list. You should immediately correct the violation that is referenced above, as well as violations that are the same as or similar to the one 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 any 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, 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, RW1901058, 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
 
 
 
 
VIA UPS and Electronic Mail
 
cc:
 
Kilo E-liquid Inc.
8475 Artesia Blvd
Ste 103
Buena Park, CA 90621-8423
Telephone: 562-322-5133
 
Jonathan Lee
Kilo E-liquid Inc.
1241 Newcastle Ln
Fullerton, CA 92833-1411
OMG E-Liquid Inc.
Charles Ji
702 S. Stoneman Avenue #C
Alhambra, CA 91801
 
Project X Vapes, LLC d/b/a Bazooka Vape
James Kim
16831 Knott Ave
La Mirada, CA 90638
info@bazookavape.com