August 15, 2020

Stanton A. Glantz, PhD

FDA’s warning letters to tobacco companies look like puffery

Companies that violate laws intended to protect kids from nicotine addiction, tobacco-related diseases and death can face penalties ranging from a slap on the hand to seizure and removal from the market.

The FDA Center for Tobacco Products has several options for enforcing against tobacco companies that violate the law.  They can assess civil money penalties, obtain injunctions, impose no-tobacco sales orders, or seize and remove products from the market.

The first step is for FDA to issue a warning letter.

Most recently, on July 20, 2020, FDA sent a warning letter to Cool Clouds Distribution, Inc. dba Puff Bar for marketing Puff Bar without the required premarket authorization and making unauthorized modified risk claims, and warning letters to nine other e-cigarette companies for violations of tobacco laws and regulations. FDA proudly announced these actions with great fanfare, stating in its press release that it notified Puff Bar and nine other e-cigarette companies “to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market,” and touted this action as part of “FDA’s ongoing, aggressive effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use in America.”

FDA gave Puff Bar and the other companies 15 working days (until August 10, 2020) to respond with details about how each company would discontinue the sale or distribution of their illegal products and address other violations. FDA correctly pointed out, “Failure to correct violations may result in further action such as a civil money penalty complaint, seizure or injunction. In addition, misbranded or adulterated products imported into the U.S. are subject to detention and refusal of admission.”

We don’t know if or how Puff Bar and/or the other companies responded.  Although FDA’s warning letters are made publicly available on its website (and FDA provided a link to that website in its press release, FDA refused to respond to a written request asking whether it has received a response to the Puff Bar warning letter, let alone what that response might have been, saying that its investigation related to the warning letter was still ongoing and therefore FDA could not comment.

This is surprising considering FDA’s Center for Tobacco Products claims to endorse FDA’s overall transparency goals and to be dedicated to fostering transparency and protecting citizens’ right to know.  

But absent a clear answer from FDA and using available resources, we are left to surmise that FDA’s warning letters are not followed up with meaningful action, and are mere puffery.

FDA’s compliance actions are publicly available on this website. It shows that between 2009 and 2020, FDA issued 98,922 tobacco warning letters. That’s an impressive number, and dwarfs the 2,581 warning letters issued for food/cosmetics (the next largest category). However, despite the threat made in FDA’s July 20 press release that a company’s failure to address violations could result in further actions including injunction or seizure, it appears that FDA has never taken either of these actions against tobacco products.

In contrast, FDA imposed 85 injunctions and 41 seizures for food/cosmetics violations, so the total number of these enforcements was 4.9% of the number of warning letters.  If FDA was as vigorous in going after tobacco companies, CTP would have issued 4829 injunctions and seizures against tobacco products.



FDA must not only send warning letters, but must follow up with meaningful action that removes from the marketplace products that are dangerous to kids and that violate laws and regulations.  Without these actions, FDA is not protecting the public health.  And FDA must be transparent about all of its, and its regulated companies’ actions (and inactions).

The legal details:

E-cigarettes are tobacco products subject to FDA regulation and enforcement. All e-cigarettes being sold in the US today are illegal because they have not obtained the required premarket review and authorization (PMTA) and are therefore “adulterated” under section 902(6)(A) of the FD&C Act.  Additionally, any e-cigarette sold with unauthorized modified risk claims (MRTP, labelling or marketing that explicitly or implicitly represents that the products are less harmful than others on the market or contain reduced levels of dangerous substances) violates section 911 of the FD& C act and is adulterated under section 902(8).  Any e-cigarette that uses false or misleading labelling or advertising is “misbranded” under section 903. Further, any e-cigarette sold in violation of FDA regulations prescribed under section 906(d), such as those targeting youth with product designs and flavors that imitate kid-friendly candies, cereals and juice-boxes, and products with advertising that targets kids, are adulterated under section 903. E-cigarettes that are sold with cessation claims are unauthorized drugs/devices that also violate FDA law. These violations are subject to penalties (e.g., civil money penalties, injunction, seizure) laid out in 21 USC 333.

Note:  These comments refer to the tobacco companies.  FDA has imposed some money fines and other actions against retailers.

This blog post was drafted by Lauren Lempert.

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