March 18, 2021

Dr. Janet Woodcock

Acting Commissioner

US Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

RE: Synthetic nicotine and Puff Bar

Submitted via e-mail

Dear Dr. Woodcock:

because the nicotine it contained was derived from tobacco, forcing the manufacturer to

remove Puff Bar from the market.

2

Whether Puff Bar is under the jurisdiction of the Center for Drug Evaluation and Research

(CDER) as a drug or the Center for Tobacco Products (CTP) as a tobacco product, it is critical that

FDA take action and not permit this company and this product to escape regulatory oversight.

Puff Bar has neither been approved as a drug nor received a premarket tobacco product order.

The agency should not allow any perceived regulatory “gap” to enable this company or any

other company to market new addictive nicotine products without going through the legally

required FDA review by either CDER or CTP.

immediately through enforcement action.

In a letter to FDA dated November 6, 2018, the Campaign for Tobacco-Free Kids demonstrated

that synthetic nicotine products are drugs. We incorporate that letter by reference here and

include it as an appendix to this letter. Under the Federal Food, Drug and Cosmetic Act (FDCA),

a product delivering nicotine that is not derived from tobacco (and therefore is not a tobacco

product under the definition of tobacco product in the FDCA) is a drug because it is intended to

affect the structure and function of the body.

FDA must not lose sight of the real-world public health consequences of regulatory inaction

over these synthetic nicotine products. As FDA is well aware, the most recent NYTS data show

that in 2020 youth use of disposable e-cigarettes increased 1000% over the previous year.

has replaced JUUL as the most popular e-cigarette brand among youth and young adult past 30-

day e-cigarette users. Puff Bar was preferred by 24% of users ages 16-19 vs 21% for JUUL.

Further, 72.6% of disposable e-cigarette sales during that time period were for flavors that

were otherwise banned in pod-based e-cigarettes.

FDA sent a warning letter to Puff Bar in July 2020, after which the company claims to have

stopped online U.S. sales. Nonetheless, Nielsen data still show Puff Bar products have

continued to capture a significant portion of the disposable market. There is some dispute

which are harmful to children.

Rarely is an effort to escape FDA jurisdiction so blatant. Puff Bar previously sought to evade

regulation as a tobacco product by withdrawing from the market because it could not meet

FDA’s public health standard for tobacco products. Now the manufacturer claims to have

reformulated the product so that it contains synthetic nicotine. Thus, by marketing its product

without authorization of any type, it is acting in a manner that is inconsistent with the rules

consumers announcing its new product leaves no doubt that Puff Bar seeks to avoid CTP

jurisdiction: “THIS PRODUCT IS NOT DERIVED FROM TOBACCO OR INTENDED TO BE USED WITH

ANY TOBACCO PRODUCTS”.

It repeats this theme on its website: “All PuffBar products listed on

At the same time, the company seeks to avoid FDA’s regulatory oversight as a drug, stating on

WARNING: PuffBar products are not intended to diagnose, treat, cure or prevent

any disease, condition, or disorder and are not smoking cessation or nicotine

replacement therapy products. The FDA has not reviewed these products, nor has

it evaluated their safety or any of the statements made regarding these products.

PuffBar products contain nicotine, which is a highly addictive substance, and are

cigarettes or other tobacco or nicotine vaping products. Do not use PuffBar

products if you are pregnant or nursing, if you have heart disease, high blood

pressure, diabetes, ulcers, liver or kidney disease, throat disease, asthma, or

including aldehydes, volatile organic compounds, and metals.

The definition of a drug under 21 U.S.C. § 321(g) includes, inter alia, “articles (other than food)

intended to affect the structure or any function of the body of man or other animals.” Here,

there is no doubt that Puff Bar’s manufacturer is aware of nicotine’s pharmacological effects.

The warning quoted above states this, and indeed, producing those effects is the entire

purpose of Puff Bar. And while the presence of nicotine alone is sufficient evidence of the

manufacturer’s intent, the company’s website states plainly that Puff Bar delivers “the same

Bar could delay regulatory enforcement action and invite copycat products. Both in response to

questions at the recent SRNT annual conference, and from the press, FDA spokespeople have

indicated that FDA is aware of the issue of synthetic nicotine, and Puff Bar products specifically,

but must conduct a case-by-case review to determine whether they are a tobacco product.

The lack of a clear position on the regulatory status of synthetic nicotine creates a dangerous

loophole that will enable this manufacturer to market these addictive products to youth and

young people. Under the current statutory regime, FDA should conclude that these synthetic

nicotine products are drugs. Therefore, CDER should regulate them under the rules governing

drug products, including the requirement that FDA approve a new drug application (NDA)

before the product may be marketed. Under the regulatory structure for drugs, these products

must necessarily and immediately be removed from the market as adulterated products, as

they do not have an approved NDA.

Even if FDA determines that Puff Bar is a tobacco product, it should still be subject to

immediate removal from the market. As the manufacturer has indicated, the product has not

own admission, it is a “new” product, and was introduced to the market after February 15,

decision clear to the public, consumers, manufacturers, and retailers. FDA must not allow

products, with demonstrably adverse public health consequences to children. Any failure of

FDA to act promptly puts our nation’s children at risk.

Sincerely,

American Cancer Society Cancer Action Network

American Heart Association

American Lung Association

Campaign for Tobacco Free Kids

References

1. PuffBar. About. https://puffbar.com/pages/about. Published 2021. Accessed March 8,

2021.

2. US Food and Drug Administration. Warning Letter to Cool Clouds Distribution, Inc. d/b/a

Puff Bar. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-

investigations/warning-letters/cool-clouds-distribution-inc-dba-puff-bar-608526-

07202020. Published July 20, 2020. Accessed March 8, 2021.

data-flavored-e-cigarettes-continue-drive. Published September 15, 2020. Accessed.

Emerging Public Health Challenge. The New England journal of medicine. 2021.

5. Hammond D, et al. Trends in smoking and vaping among youth and young adults in

Canada, the US, and England. Presented at the Society for Nicotine and Tobacco

Research Annual Meeting 2021. February 25, 2021.

6. Maloney J. Puff Bar Defies FDA Crackdown on Fruity E-Cigarettes by Ditching the

Tobacco. The Wall Street Journal. https://www.wsj.com/articles/puff-bar-defies-fda-

March 2, 2021. Accessed March 2, 2021.

7. Herzog B. Goldman Sachs Equity Research. Americas Tobacco: Tobacco Nielsen Data.

February 16, 2021.

11. Society for Research on Nicotine and Tobacco Annual Meeting 2021. FDA CTP Director

Mitch Zeller's Response to a Question at FDA Special Session on February 24, 2021.