-~ 11 U.S. FOOD & DRUG 1.z~ ADMIN I STRATION 

May1 , 2018 

VIA USPS and Electronic Mail 

Fog It Up 

P.O. Box 9418 

Fountain Valley, CA 92728-9418 

admin@foqitup.com 

WARNING LETTER 

Dear Fog It Up: 

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

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

http://www.fogitup.com from which you take orders for VNilla Cookies & Milke-liquid products. 

FDA has determined that thee-liquid products listed there are 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 eliquids, are subject to FDAjurisdiction undersection 901(b) ofthe FD&C Act (21 U.S.C. 

§ 387a(b)). The FTC reviewed your marketing for VNilla Cookies & Milke-liquid under Section 

5 of the FTC Act, 15 U.S.C. § 45. . 

FD&C Act Violations 

1. False or Misleading Violation 

FDA has determined that your VNilla Cookies & Milke-liquid is misbranded under section 

903(a)(1) ofthe 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. 

FDA's investigation of the website http://www.fogitup.com revealed that it sells or distributes 

VNilla Cookies & Milk e-liquid with labeling and/or advertising that causes it to imitate food 

products, particularly onesthat are marketed toward, and/or appealing to, children (see Exhibit 

A). Specifically, the labeling and/or advertising ofthe product looks very similar to cookies that 

are marketed toward children, such as Nilla Wafers cookies and Golden Oreos cookies (see 

Exhibit B) . For example, the labeling and/or advertising for VNilla Cookies & Milke-liquid 

includes statements and representations, such as: "VNilla," "Cookies & Milk," and an illustration 

depicting cookies dunked in a glass of milk. In addition, the labeling and/or advertising for 

VNilla Cookies & Milk e-liquid includes the appearance of a package of cookies that is 

substantially similar to the packages in which cookies are sold, and displays a product name 

and color scheme that are substantially similar to the cookies in Exhibit B. This labeling and/or 

advertising causes the productto imitate food products, particularly ones that are marketed 

toward, and/or appealing to, children and is therefore misleading. 
Page 2-Fog It Up 

COOKIES & MILK 

6MG 60ML 

Exhibit A Exhibit B 

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 thee-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 vvell as seizure, coma, and respiratory arrest. 

Given that the labeling and/or advertising ofVNilla Cookies & Milke-liquid describes its nicotine 

content as 6mg/ml, 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 VNilla Cookies & Milk 

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 903(a)(7)(A) of the FD&C Act. 

2. Sales to Minors Violation 

Additionally, FDA has determined that yourVNilla Cookies & Milk 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. 

FDA's investigation of http://www.fog itup.com revealed that you sold an e-liquid product to a 
Page 3 -Fog It Up 

minor. Specifically, during our investigation of http://www.fogitup.com, a person younger than 

18 years of age purchased VNilla Cookies & Milke-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 (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 cigarettetobaccowere 

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 IXand its implementing 

regulations. The product cited in this violation is a "covered tobacco product." Under section 

903(a)(7)(B) ofthe 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) ofthe FD&C Act (21 U.S.C. § 387c(a)(7)(B)). 

The FD&C Act 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. 

Unfair or Deceptive Marketing 

In addition , the Federal Trade Commission has reviewed the on line marketing ofVNilla 

Cookies & Milke-liquid. Section 5 ofthe FTC Act prohibits unfair or deceptive acts or 

practices in or affecting commerce. This prohibition includes practices that present 

unwarranted health or safety risks. Commission Policy Statement on Unfairness, 104 

F.T.C. 1070, 1071 (1984) (appended to Int'/ Harvester Co., 104 F.T.C. 949 (1984)), 

available at https://www.ftc.gov/public-statements/1980/12/ftc-policy-statement-unfairness. 

Preventing practices that present unwarranted health and safety risks, particularly to 

children, is one of the Commission's highest priorities. FTC Strategic Plan for 2018-2022, 

at6; Philip Morris, Inc. , 82 F.T.C.16 (1973). 

As noted above, VNilla Cookies & Milk e-liquid is marketed in packaging that resembles 

Nabisco NiIla Wafers and Golden Oreos cookies, brands that are easily recognized by and 

popular with young children. Nilla Wafers cookies have been marketed on Facebook and 

other social media platforms through campaigns targeted to mothers. Oreo is the top 

cookie brand, and some marketing research indicates that it is the favorite brand among 
Page 4-Fog It Up 

children ages 6 through 12. VNilla Cookies & Milke-liquid has a scent very similar to 

vanilla cookies, and the odor is detectible without opening the packaging. Given the 

significant number of serious child poisonings due to the ingestion of liquid nicotine, 

packaging VNilla Cookies & Milke-liquid in a manner that is likely to be particularly 

appealing to young children could present an unwarranted risk to health and safety. 

The FTC strongly urges you to review your marketing, including packaging, for VNilla 

Cookies & Milk e-liquid and similarly marketed products and to take swift and appropriate 

steps to protect consumers, especially young children. 

Conclusion and Requested Actions 

With regard to the F D&C Act violations discussed in th is 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, RW1800857, in your response and direct your response to 

the following address: 

DPAL-WL Response, Office of Compliance and Enforcement 

FDA Center for Tob~cco Products 

c/o Document Control Center 

Building 71, Room G335 

10903 New Hampshire Avenue 

Silver Spring, MD 20993-0002 

If you have any questions, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at 

CTPCompliance@fda.hhs.gov. 

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 ofthe 

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

Sincerely,~ 

~?V ,tl.-t--c_ 

Ann Simon au, J.D. 

Director 

Office of Compliance and Enforcement 

Center for Tobacco Products 

'fl!\ aAYl,,, ~ ~~ Mary K. Eq~e 0 

Associate 9 frector 

Division of Advertising Practices 

Federal Trade Commission 
Page 5 -Fog It Up 

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