Mr Fog is not FDA approved, nor is it FDA authorized. The company has no marketing authorization order from the FDA for any of its products. In September 2024, the FDA issued a formal warning letter to Mr Fog stating that its products are being sold unlawfully in the United States.
What the FDA Warning Letter Says
On September 12, 2024, the FDA sent a warning letter directly to Mr Fog identifying specific products sold without required authorization, including the Mr Fog Max Air 3000 Puffs Strawberry Peach Pear, Mr Fog Drop Blue Slushy, and Mr Fog Max 1000 Puffs Hyper. The letter declared these products “adulterated” and “misbranded” under federal law.
The FDA’s position is straightforward: because Mr Fog products were not commercially sold in the U.S. before February 15, 2007, they are classified as “new tobacco products.” That classification means they need a premarket authorization order before they can legally be sold. Mr Fog does not have one. The warning letter states that all new tobacco products on the market without this authorization “are marketed unlawfully and are subject to enforcement action at FDA’s discretion.”
Why No Vape Is “FDA Approved”
It’s worth understanding the language here, because even the e-cigarettes that have gone through the FDA’s review process are not called “FDA approved.” The FDA uses the term “authorized,” and it draws a clear distinction: authorization means a product has met a specific regulatory standard to be legally sold, but it does not mean the product is safe. The FDA explicitly states that “all tobacco products are harmful and potentially addictive.”
The FDA has authorized a very small number of e-cigarette products, mostly tobacco-flavored options from a handful of manufacturers. Mr Fog is not among them. The company does not appear on the FDA’s list of marketing granted orders, which is the public record of products that have cleared the premarket review process.
How Mr Fog Products Reach the Market
Mr Fog sells flavored disposable vapes in varieties like fruit and candy blends, with ingredients the company lists as propylene glycol, vegetable glycerin, flavors, nicotine, and “taste-improvement additives.” Despite having no FDA authorization, these products are widely available at convenience stores and vape shops across the country.
This is not unique to Mr Fog. Thousands of e-cigarette products are currently sold in the U.S. without FDA authorization. The agency has issued marketing denial orders to many manufacturers and continues enforcement actions, but the sheer volume of unauthorized products on the market means many remain available. The FDA’s warning letter to Mr Fog signals that the company is on the agency’s radar, but a warning letter is a preliminary step, not a product ban. It puts the company on notice and gives it an opportunity to respond before the FDA decides whether to take further action like seizures or injunctions.
What This Means if You Use Mr Fog
The practical takeaway is that Mr Fog products have not undergone the FDA’s scientific review process. That review evaluates things like what chemicals a product releases when heated, how much nicotine it delivers, and whether its marketing could attract young people who don’t already use tobacco. Without that review, there’s no independent verification of what’s in the product or how it performs beyond what the manufacturer claims.
Mr Fog’s own FAQ lists general ingredient categories but does not publish specific nicotine concentrations for its product lines or detailed information about its flavoring compounds. For a product that hasn’t been through federal review, that means you’re relying entirely on the company’s quality control with no regulatory oversight confirming the contents match what’s on the label.