VIA UPS and Electronic Mail

 

Hype City Vapors, LLC

Attn: Julian Violé 

29020 Old Carriage Court

Agoura Hills, CA 91301-1622

julian_viole@aol.com

sales@hypecityvapors.com

support@hypecityvapors.com

WARNING LETTER

Dear Julian Violé: 

This is to inform you that the Center for Tobacco Products of the U.S. Food and Drug 

Administration (FDA) and the U.S. Federal Trade Commission (FTC) recently reviewed the 

Facebook account of Jay Shrek (@jasonshrek), https://www.facebook.com/jasonshrek, 

containing social media posts with labeling and/or advertising for e-liquid products on behalf of 

Hype City Vapors, LLC, as well as the website, https://hypecityvapors.com, and determined that

the e-liquid products listed there are manufactured, 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)). In addition, the FTC has reviewed the above-referenced social media 

postings under section 5 of the FTC Act, 15 U.S.C. § 45(a).

FD&C Act Violation

FDA has determined that two e-liquid products manufactured, advertised, and offered for sale or 

distribution to customers in the United States by Hype City Vapors, LLC, with labeling and/or 

advertising on behalf of Hype City Vapors, LLC 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)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because

the labeling and/or advertising in social media posts on your behalf regarding these e-liquid

products fails to include the required nicotine warning statement for these e-liquid products.

E-Liquid Products with Labeling and/or Advertising that Fails to Include the Required 

Nicotine Warning Statement are Misbranded 

Our review of the website, https://hypecityvapors.com, revealed that Hype City Vapors, LLC

manufactures, advertises, and offers for sale or distribution to customers in the United States e-

_# 11 U.S. FOOD & DRUG -i~'- ADMINISTRATION ~ FTC 
Hype City Vapors, LLC 

2 

liquid products, including Hype City Vapors Mango Candy and Hype City Vapors Berry 

Lemonade. Our review of the Facebook account of Jay Shrek (@jasonshrek), 

https://www.facebook.com/jasonshrek, revealed that it contains posts on behalf of Hype City 

Vapors, LLC with labeling and/or advertising for these two e-liquid products advertised in the 

United States that does not include the required nicotine warning statement. 

 

Specifically, the social media account of Jay Shrek (@jasonshrek), 

https://www.facebook.com/jasonshrek, contains posts dated August 15, 2018, August 21, 2018, 

and September 4, 2018 with labeling and/or advertising for Hype City Vapors Mango Candy and 

Hype City Vapors Berry Lemonade e-liquid products that do not include the required nicotine 

warning statement (see examples below).

 

/ Jay Shr~k 

llugust 21 , 2018 · 0 

#handcheck can't watt to try this #MangoCancty juice From Hype 

aty Vapors #review coming soon! ·-· --- ·--

Juice: Hype City V.ipors Mango Candy 

Mod: Aspire Breeze 2 

#vapefam #officialvapefam #sponsored #vape llvapenation #vapelife 

#vapelyfe ff'letsgelsa.lty #5ponsoredby #hypecityvapors 11-sallnicotine 

#sallnicotineliquid #aspire~eeze2 llbreeze2 11aspire Holy SmoKes 

#holysmokesnj 

Jay Shiek 

September 4. 2018 -0 

rm loving mis #Mangocanay Juice rrom @nypearyvapors 1r s 

amazing• Tastes '>O m ch like #mango wiltl a sweet kick 10 i _ DefiMety an 

a ll-day JUicel -.· ~-- ~--

Juice: Hype City Vapors Mango Candy 

#vapefam #officialvapefam #sponsored #¥ape #vapenation #vapelife 

#vapelyfe l#lelsgetsally #sponsoredby #hypecttyvapors l#saltniootine 

l#sattnicolineliquid @11o lysmokes168 l#holysmokesnj #mangoes #fruit 

@officialvapefam /Ifill upmybreeze2 
Hype City Vapors, LLC 

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.

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)). It also is unlawful 

for such 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)). 

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 and/or advertising in the social media 

posts on behalf of the firm regarding these e-liquid products do not include the required nicotine 

warning statement for these products, in violation of 21 C.F.R. § 1143.3(a) and/or 21 C.F.R. 

• 

J:ayShrek 

Aogus:t 15, 2 0 1 8 (3 

Loving this #berrytemonade from Hype City Vapor-sl its a delieious 

all d ay ffsattnIc htjuicc 

Juice: H ype City Vapors Berry Lemonade 

Mod: Aspire Breeze 2 

#sponsored #vape #vapenation #vapelife #vapetyfe #let59ebaly 

#sponsoreooy #hypecl.yvapo1s #salnleol kle #saltnleollnellQuiCJ 

#aspl1et>reeze2 !t'Dreez.e2 #:aS(.)lre 

@llSIIISHREI @HTPlCITYVAPOIS 
Hype City Vapors, LLC 

4 

§ 1143.3(b), the 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. 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 the labeling and/or advertising in the 

social media posts on behalf of the firm regarding these e-liquid products does not include the 

required nicotine warning statement for these products, the e-liquid products 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)).

The violations discussed in this letter do not necessarily constitute an exhaustive list. You 

should immediately correct the violations 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, notobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that any 

adulterated or misbranded tobacco products offered for import into the United States are 

subject to detention and refusal of admission.

Unfair or Deceptive Marketing

The FTC has reviewed the social media postings concerning these Hype City e-liquid products. 

Section 5 of the FTC Act, 15 U.S.C. § 45, prohibits unfair or deceptive acts or practices in or 

affecting commerce. This prohibition includes the failure to disclose material health or safety 

risks. See Swisher Int’l, Inc., No. C-3964, 2000 WL 1207447 (MSNET Aug. 25, 2000) (consent 

order requiring health warnings for cigar packages and advertisements); Lorillard, 80 F.T.C. 455 

(1972) (consent orders requiring health warnings in cigarette advertisements). Hype City

Vapors Mango Candy and Hype City Vapors Berry Lemonade, the e-liquid products referenced 

in the above-referenced social media postings, contain nicotine. The U.S. Surgeon General has 

long recognized the addictive nature of tobacco products due to the presence of nicotine. See

U.S. Dept. of Health and Human Services, “The Health Consequences of Smoking: Nicotine 

Addiction,” A Report of the Surgeon General, 1988. Given the significant risk of addiction, 

failure to disclose the presence of and risks associated with nicotine raises concerns that the 

social media postings could be unfair or likely to mislead consumers. The FTC urges you to 

review your marketing, including endorsements by your social media influencers, and ensure 

that necessary and appropriate disclosures are made about the health risks of nicotine.

In addition, the FTC’s Guides Concerning Use of Endorsements and Testimonials in 

Advertising, 16 C.F.R. Part 255.5 (2018) (Endorsement Guides), state that if there is a “material 
Hype City Vapors, LLC 

5 

connection” between an endorser and the marketer of a product – in other words, a connection 

that might affect the weight or credibility that consumers give the endorsement – that connection 

should be clearly and conspicuously disclosed, unless the connection is already clear from the 

context of the communication containing the endorsement. Material connections could consist 

of a business, family, or personal relationship; monetary payment; or the provision of free 

products to the endorser. The Endorsement Guides apply to marketers and endorsers. FTC 

staff guidance makes clear that marketers should advise endorsers of their disclosure 

responsibilities and should monitor their endorsements to ensure that appropriate disclosures 

are made.

If your company has a material connection to someone endorsing your products, that 

relationship should be clearly and conspicuously disclosed in the endorsements, unless the 

relationship is otherwise apparent. To be both “clear” and “conspicuous,” the disclosure should 

use unambiguous language and stand out. Consumers should be able to notice the disclosure 

easily, and not have to look for it. For example, consumers viewing posts in their Instagram 

streams on mobile devices typically see only the first two lines of a longer post unless they click 

“more,” and many consumers may not click “more.” Therefore, an endorser should disclose any 

material connection above the “more” button. In addition, where there are multiple tags, 

hashtags, or links, readers may just skip over them, especially where they appear at the end of 

a long post.

If your company has a written social media policy that addresses the disclosure of material 

connections by endorsers, you may want to evaluate how it applies to the posts identified in this 

letter and to posts by other endorsers of your products. If your company does not have such a 

policy, you may want to consider implementing one that provides appropriate guidance to your 

endorsers. You may also want to review your company’s social media marketing to ensure that 

posts contain necessary disclosures and they are clear and conspicuous. 

Conclusion and Requested Actions

With regard to the FDA-related violations described in this letter, 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, RW1901098, 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. 
Hype City Vapors, LLC 

With regard to the FTC-related issues described in this letter, please notify Rosemary Rosso of 

the FTC via electronic mail at rrosso@ftc.gov within 15 days of receipt of this letter of the 

specific actions you have taken to address the FTC's concerns . . 

VIA Electronic Mail 

cc: 

GoDaddy.com, LLC 

abuse@godaddy.com 

6 

Sincerely, 

tb~~ 

Ann Simoneau, J.D. 

Director 

Office of Compliance and Enforcement 

Center for Tobacco Products 

Ma~K.En 

Associate 

Division of 

Director 

Advertising 

~ ~ Practices 

Federal Trade Commission