FDA should take Puff Bar at its word that it is not a tobacco product … and ban them as illegal drug delivery devices

The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA jurisdiction to regulate tobacco products, defined as products “made or derived from tobacco.”

This means that any product that includes nicotine derived from tobacco is subject to FDA jurisdiction.

There has been discussion in academic circles about nicotine delivery products being made from nicotine not “made or derived from tobacco” even though there is small amounts of nicotine in other plants (including eggplants and potatoes) and it is possible to manufacture synthetic nicotine.  These non-tobacco sources for nicotine are, however, much more expensive than to simply extract the nicotine from tobacco plants.

Now that has changed.

After the FDA clamped down on sales of Puff Bar, a disposable e-cigarette popular with youth, Puff Bar now claims that it is no longer a “tobacco product” because it is not “made or derived from tobacco.”

Specifically, on its website (accessed 9 Mar 2021), Puff Bar says

As a demonstrated pledge to premium quality, Puffs nicotine-based products are created with tobacco-free nicotine. Our nicotine-based products are crafted from a patented manufacturing process, not from tobacco. The result? A virtually tasteless, odorless nicotine without the residual impurities of tobacco-derived nicotine. This dramatically improves flavor while still maintaining the same satisfaction smokers are seeking from their nicotine. [emphasis added]

According to  a Wall Street Journal article, “Puff Bar Defies FDA Crackdown on Fruity E-Cigarettes by Ditching the Tobacco,” Puff Bar made this change after the FDA cracked down on sales in July 2020 because of flavored Puff Bar’s popularity with youth. 

The WSJ quotes language from Puff Bar’s website that is specifically designed to allow it to argue that it is not a “tobacco product” and so not subject to regulation as a consumer product by the FDA Center for Tobacco Products (CTP):

Puff Bar’s website now says its products “contain nicotine but do not contain tobacco or anything derived from tobacco.” It adds that they “are not intended for use with any tobacco product or any component or part of a tobacco product.”

The second disclaimer is also important because FDA considers non-tobacco components of tobacco products – such as the IQOS holder that heats tobacco sticks – under its jurisdiction.

While FDA could argue with Puff Bar about whether the nicotine is truly not “made or derived from tobacco,” a more productive pathway would be to just take Puff Bar at its word and ban the product as an unauthorized drug deliver device.

 FDA has already completed most of the foundational work for this approach back in the 1990s when then-commissioner David Kessler tried to regulate cigarettes and other tobacco products as drug delivery devices.

Under Kessler’s leadership, the FDA argued that nicotine is a drug (“articles (other than food) intended to affect the structure or any function of the body”) and that cigarettes and other tobacco products were intentionally designed to addict people so they would keep purchasing the products.

In 2000, the Supreme Court (in a 5-4 ruling) struck down the regulations on the grounds that the FDA did not have jurisdiction over tobacco products.  If Congress wanted FDA to regulate tobacco it would need to enact legislation giving FDA that authority, which eventually led to the 2009 law granting FDA authority over tobacco products.

But this decision does not apply to Puff Bar because it says it is not a tobacco product.  The FDA’s underlying scientific reasoning that nicotine is a drug, however, does.

The second relevant court case is the 2009 Sotera case in which the courts held that FDA could not seize e-cigarettes because it tried to do so on the basis that they were illegal medical devices.  As the Public Health Law Center summarizes,

Background

On April 15, 2009, the FDA denied the import into the U.S. of e-cigarettes and accessories made by two companies called Smoking Everywhere, Inc. and Sottera, Inc., doing business as NJOY. According to the FDA, these products appeared to be unapproved drug-device combination products that were intended to help treat the withdrawal symptoms of nicotine addiction. In other words, the FDA was using its authority to regulate drugs under the Food, Drug, and Cosmetic Act (“FDCA”) to regulate e-cigarettes.

District Court Proceedings

Smoking Everywhere filed suit in the United States District Court for the District of Columbia, claiming that electronic cigarettes are not intended to help treat withdrawal symptoms of nicotine addiction but, rather, that they are for smoking enjoyment, similar to conventional cigarettes. Therefore, the companies asserted, the products could not be regulated by FDA as drug-device combination products under the FDCA, and FDA could not enforce its import ban.  …

On January 14, 2010, the court granted the companies’ motion for a preliminary injunction [to block the FDA] … Judge Richard Leon reasoned that … Congress did not intend tobacco products to be “drugs” merely because they deliver nicotine  …

Sotera would not apply because Sotera applies to tobacco products and Puff Bar claims not to be a tobacco product.

Puff Bar’s website also includes a warning that it delivers nicotine “an addictive chemical;” and addiction occurs when the chemical changes “the structure or function of the body.” 

Puff Bar also includes the following legal language on its website in an effort to head off FDA action against its new tobacco-free nicotine product:

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.

None of this changes the fact that Puff Bar is an unauthorized drug delivery device.  As noted above, Puff Bar’s website says that its non-tobacco nicotine “dramatically improves flavor while still maintaining the same satisfaction smokers are seeking from their nicotine.” “Satisfaction” is an industry euphemism for “nicotine hit” to bind to receptor sites and depress nicotine withdrawal.

Indeed, Patricia J. Zettler, Natalie Hemmerich, and Micah L. Berman wrote an excellent law review article on synthetic nicotine explaining why such declarations by a manufacturer do not change the fact that non-tobacco-derived nicotine is a drug. 

They also explain how Puff Bar’s long statement later in the warning, supports the conclusion that the non-tobacco nicotine in Puff Bar is a drug because it affects the “structure and function” of the body:

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 difficulty breathing. Do not use PuffBar products if you are taking theophylline, ropinirole, or clozapine. As with other nicotine products, use of PuffBar products can increase your heart rate and blood pressure and may cause nausea or dizziness or aggravate existing respiratory conditions.

These statements are not being made as therapeutic smoking-cessation claims; they support the conclusion than the non-tobacco nicotine in Puff Bar affects “the structure or function of the body.” 

So, FDA should take Puff Bar at its word and block and further import or sales of its drug delivery system.

March 30, 2021 update

On March 18, 2021 several health groups, including Tobacco Free Kids, the American Academy of Pediatrics, Parents Against Vaping and the major voluntary health associations wrote Acting FDA Commissioner Janet Woodcock making the case that the law requires FDA to ban Puff Bar whether it is a drug delivery system or a tobacco product.

They also resent a 2018 detailed legal analysis of synthetic nicotine showing that it is a drug under the Food, Drugs and Cosmetics Act.

Both are worth reading and are available here.

Published by Stanton Glantz

Stanton Glantz is a retired Professor of Medicine who served on the University of California San Francisco faculty for 45 years. He conducts research on tobacco and cannabis control and cardiovascular disease/

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