Puff Bar, once the best-selling disposable vape in the United States, has been in an ongoing battle with federal regulators since 2020. The brand received its first FDA warning letter in July 2020, briefly shut down U.S. sales, then attempted a legal workaround using synthetic nicotine before Congress closed that loophole in 2022. The company has never received FDA authorization to sell its products, and most Puff Bars found in stores today are counterfeits.
The 2020 FDA Warning Letter
In July 2020, the FDA sent a warning letter to Cool Clouds Distribution, Inc., the company operating under the Puff Bar name. The letter cited two major violations. First, Puff Bar products were “new tobacco products” that had never received marketing authorization from the FDA. Flavors like Cool Mint, Mango, Blue Razz, Banana Ice, and Sour Apple were all listed as illegally sold products. Second, the FDA found that Puff Bar’s website made claims suggesting its products were safer or less harmful than other tobacco products, which requires a separate FDA order that the company didn’t have.
Days later, on July 13, 2020, the company posted a statement on its website saying it had stopped all online sales and distribution in the United States. Behind the scenes, this triggered an internal split. Some shareholders wanted to shut the company down entirely. Two co-founders, Nick Minas and Patrick Beltran, wanted to keep the brand going. They took full ownership of the restructured company that summer.
The Synthetic Nicotine Loophole
Rather than submitting the lengthy application the FDA requires for tobacco-derived nicotine products, Puff Bar found a creative workaround. In early 2021, the company switched its formula to laboratory-made nicotine, which is not derived from the tobacco plant. At the time, the FDA’s authority over nicotine products was tied specifically to tobacco-derived nicotine. By using synthetic nicotine, Puff Bar argued its products fell outside the FDA’s jurisdiction entirely. The company’s marketing materials stated its products “do not contain tobacco or anything derived from tobacco.”
This strategy worked, at least temporarily. Puff Bar resumed sales, and other vape companies followed the same approach. The move drew sharp criticism from public health groups, anti-tobacco advocates, and members of Congress who saw it as an obvious attempt to dodge regulation.
Congress Closed the Loophole
The synthetic nicotine strategy lasted about a year. On April 14, 2022, a federal law took effect granting the FDA authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine. Congress passed the provision specifically in response to companies like Puff Bar exploiting the regulatory gap.
With synthetic nicotine now under FDA oversight, Puff Bar and similar companies were required to submit premarket tobacco product applications or stop selling. In October 2022, the FDA issued a second warning letter, this time addressed to EVO Brands, LLC and PVG2, LLC (the restructured entities operating under the Puff Bar name). The letter noted that PVG2 was receiving products from a foreign manufacturer and distributing them to U.S. retailers listed on the Puff Bar website, all without the required FDA authorization.
What’s Actually in a Puff Bar
Lab analysis published in Chemical Research in Toxicology found that Puff Bar devices contained nicotine concentrations averaging 44.8 mg/mL, with some devices reaching as high as 52.4 mg/mL. That’s a high concentration, roughly equivalent to what you’d find in nicotine salt pods marketed for heavy smokers.
Researchers identified 126 different flavor chemicals across the products tested, with 16 of those present at concentrations above 1 mg/mL. Common flavoring agents included ethyl maltol (a sweetener), menthol, and vanillin. Every product tested also contained a synthetic cooling compound that creates the icy sensation in flavors like “Ice” variants, with concentrations ranging from less than 1 mg/mL to over 45 mg/mL depending on the flavor. The long-term inhalation safety of many of these flavoring and cooling chemicals remains poorly understood.
The Counterfeit Problem
Perhaps the most significant part of the Puff Bar story is what happened to the brand in the marketplace. According to Puff Bar’s own estimates, 95% of all vapes sold under the Puff Bar name were counterfeits. Independent retailers had strong financial incentives to stock fakes, which cost up to 50% less than authentic products from the company’s supply chain.
This means that for years, most people buying a “Puff Bar” at a gas station or convenience store were getting a device manufactured by an unknown factory with no quality controls, filled with unknown chemicals. The company eventually introduced a verification system using a circular authentication label, but by that point the counterfeit market had already overtaken the legitimate one. If a Puff Bar doesn’t have that specific authentication sticker, the company says it’s a fake.
Where Things Stand Now
Puff Bar has never received FDA marketing authorization for any of its products. The company has received two formal warning letters and operates under constant regulatory pressure. The brand’s website still exists and lists retail locations, but the legal status of its products in the U.S. remains unresolved. No version of Puff Bar, whether made with tobacco-derived or synthetic nicotine, has cleared the FDA’s review process.
Meanwhile, disposable vapes from other brands (many manufactured in China) have flooded the U.S. market in flavors and formats that closely resemble the original Puff Bar. The brand essentially created the template for the disposable vape category, then lost control of it to counterfeiters and competitors while fighting regulators. What you’re likely to find in stores today carrying the Puff Bar name is almost certainly not made by the actual company.