May 29, 2020

Mr. Mitch Zeller
Director, Center For Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002

Dear Director Zeller,

We hope you, your family, and all your FDA colleagues remain healthy and safe during this difficult period. It goes without saying that we greatly appreciate all that the agency has done and continues to do on behalf of our country’s public-health. 

We take you at your word that you aim to protect minors from being courted as customers by e-cigarette companies. Therefore, we want to alert you again that Puff Bar may be engaging in the kind of teen-focused marketing behavior that you would consider predatory. While we know that disposable e-cigarettes are exempt from the latest guidance, we are concerned that Puff Bar’s promotional materials and outreach efforts as cited below are illegal and also immoral; in light of the current pandemic, this behavior is particularly dangerous and potentially lethal. 

In fact, Puff Bar appears not only to market but also to operate in multiple ways that are in direct violation of FDA’s existing policies and of the 2020 guidance.

As we discussed with you in person at our most recent public-listening session on January 14, we are deeply worried about the rapidly rising teen use of flavored disposables including but certainly not limited to Puff Bar. 

When we raised our concerns about the guidance’s exemption for flavored disposable e-cigarettes, you responded that FDA is an evidence-based agency and that the 2019 NYTS figures do not support our premise that kids are using these products. 

Our response was that while we understand and respect your position, we believe FDA must utilize alternative and interim data collection to keep up with the rapidly evolving industry and the proliferation of new flavored products that appear intended to appeal to teens.     

Based on extensive evidence from parents and teens across the country and emerging academic and investment-company research, we know that teens are migrating from pod-based e-cigarettes like JUUL to disposable products. We also know that Puff Bar, with more than 20 flavors including “O.M.G”, “Frozen Banana” and “Pink Lemonade”, as well as replication of flavors previously offered by JUUL such as “Mango”, “Cucumber”, and “Mint”, is among the most popular with youth.

As Stanford’s Dr. Robert Jackler stated in this week’s episode of our podcast “Big Tobacco Messed with the Wrong Moms”, Puff Bar “….is the new JUUL…It advertises and markets on youth-oriented social media channels. And it’s being bought by huge numbers of kids.”

In our January visit, you assured us, and you have stated publicly, including in the New York Times on February 20, 2020, that under the current guidance, “...if we see a product that is targeted to kids, we will take action.” 

We believe the time to take action against Puff Bar is now. 

As we wrote in an April 30th email to FDA Commissioner Hahn, on which you were cc’d, we reported Puff Bar’s youth marketing to CTP’s violation portal on that date, promptly receiving an email acknowledgement in response. (Violation Report ID 20D00407). (See promotional Puff Bar email attached.) 

The subject line of the promotional ad from “Team Puff Bar” reads “The first solo-spring break...with Puff Bar” and refers to customers’ receiving “parental texts” . The ad includes a photo of a very young-looking woman blowing a large cloud of vapor. The subject line, ad text, and imagery appear to merit priority enforcement based on page 24 of the guidance that refers to “Any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors.” 

Another recent promotional ad from “Team Puff Bar” declares, “May the Fourth Be With You…these are the puff-droids you’re looking for…” using graphics and verbiage that are an homage to the Star Wars films and video games:

“The force is strong with these flavors. May the 4th be with you, and Puff Bar with you, throughout our puff-facular universe. Light or Dark Side. Choose your favorite.”

On its website, Puff Bar posts recurring opportunities to win free product (“We choose 1 winner a week to receive a free PUFF Bar”) and to receive digital coupons (5% or 10%). There is no age verification required to register in either case nor is any required to access the website. When you press “Shop Now” you are asked, “are you of legal smoking age in your state?” If you respond “yes” there is no further age verification required until check out.  We believe these promotions are in flagrant violation or likely to result in violations of the Family Smoking Prevention and Tobacco Control Act and FDCA 906(d)(5) as amended by H.R.1865. 

Puff Bar also violates Section 911 of the FDCA by making unsubstantiated modified-risk claims with the following information posted on its website under the section “Quit Smoking”: 

“Quit smoking today with Puff Bar...Traditional cigarettes contain a laundry list of chemicals that are proven harmful. There is still more research to be done on the negative effects of vaping, but we believe it is the healthier alternative…”

This language actually goes further than making a modified-risk claim:  it is a therapeutic marketing claim that Puff Bar is a smoking cessation product.   And again under the section “About Us” the company implies that its product is a smoking cessation device:

“….every day, we look at ways to give you, the aspiring quitter, a reason to truly enjoy your vaping experience…We want your satisfaction and your business; but most importantly, we want you to succeed.”

Finally, Puff Bar makes no secret of the fact that it is on the market illegally. That is, the company publicly admits that it was created way beyond the August 8, 2016 cut-off as outlined by the final deeming rule. As stated on page 10 of the guidance: “The Tobacco Control Act provides that new tobacco products (I.e. non-grandfathered products) may not be legally marketed without premarket authorization. Accordingly, all deemed new tobacco products on the market without authorization are illegally marketed products.”

From the “About Us” section on the Puff Bar website: 

“Founded in 2019 in Los Angeles, CA, Puff Bar bases its company on three main values: simplicity, value and-most importantly-what we believe is a healthier alternative to smoking traditional cigarettes…Since 2019, our passion for providing the best devices and flavors made us an industry leader in disposable devices...”

What is also particularly troubling is a lack of clarity and information about Puff Bar’s ownership. As has been widely reported in the media, Puff Bar’s listed LA headquarters turned out to be a boarded-up storefront. Cool Clouds Distribution, incorporated in May, 2019 and apparently one of Puff Bar’s U.S. distributors, applied for the Puff Bar trademark on January 27, 2020. On May 18, DS Technology Licensing, described in a press release from its attorney (who also represents Cool Clouds) as owning registered trademarks associated with Puff Bar, and Puff Inc., described as an authorized US distributor, filed a $75 million lawsuit accusing over 20 Chinese and American companies of copyright infringement and selling of counterfeit devices. In a February, 2020 LA Times article, Cool Clouds CEO Umais Abubaker refers to Shenzhen-based DS Vaping as “the only manufacturer ever licensed to use” Puff Bar “marks”.)

The Puff Bar website downplays these complicated and confusing circumstances, implying that the company’s decentralized multi-nationality is a benefit, not a red flag. As it says : 

“But who makes Puff Bar? Everyone wants to know the mastermind team behind the latest craze in the world of electronic cigarettes.…Today the Puff Bar team consists of more than 100 people working together from around the world…”

It boasts that its products are designed and distributed in Los Angeles and produced in China using flavors developed in Malaysia.

As Dr. Jackler states on our podcast, “Puff Bar is a very obscure company…Until it has corporate accountability it should be taken off the market.”  In fact, it should not be on the market at all.

We urge you to immediately take action against Puff Bar. We appreciate that FDA issued warning letters just last month to a number of vaping companies and brick-and-mortar shops that the agency determined were violating policies including some of those referenced above. 

But during this unprecedented period in our country’s history, when it has never been more important to protect our kids’ public health (especially their developing lungs) we believe that warnings alone are no longer enough. Please do not allow the guidance exemptions to provide Puff Bar (and other disposable flavored e-cigarette brands) a window of opportunity to target teens and operate as they please.

Thank You for your time.

Sincerely,

Meredith Berkman & Dorian Fuhrman
Co-Founders, Parents Against Vaping E-Cigarettes