Upcoming FDA regulation puts pressure on vape industry

Upcoming FDA regulation puts pressure on vape industry



A looming Food and Drug Administration deadline for vape businesses could mean rising prices and limited selections of products for consumers.To get more news about vape manufacturers, you can visit univapo official website.

Beginning Sept. 9, a majority of vaping products will need verification through a Pre-Market Tobacco Application in order to enter the market or stay on shelves, according to the FDA website. This process stems from a 2016 ruling that classifies vapor products as tobacco products. The PMTA component requires testing to prove that a product meets an FDA standard deemed appropriate for the protection of public health.

According to the FDA website, a PMTA must include a full statement of ingredients, additives, components and properties in a product, along with other requirements.

Brian Dillon, co-owner of Velocity Vapor, said this process is going to immensely impact everyone in the industry. He said the process is expensive and was originally written for tobacco products, not vapor products.

“The paperwork that the government wants you to go through on this is so extensive, that the amount to submit this application correctly is not reachable or attainable for 99% of the industry,” Dillon said. “The PMTA process that they designed for cigarettes and cigars specifically states that if one ingredient is different, then you have to submit a new PMTA for what the FDA considers a new product.”

Dillon said in vapor and e-liquid, you have multiple strengths of nicotine and flavors. He said if you have one blueberry flavor that’s available in five different sizes and 10 different nicotine levels, that would equal 50 different application submissions in which they all have to have the same amount of paperwork and testing, which means costs could exceed $1 million just for that flavor.

“That’s not even a guarantee that you will get approved, it just means they will look at it and deem it beneficial to the public,” Dillion said. “So with that blueberry flavor with 50 different submissions, that’s $1 million just to roll the dice and see if it’s approved for sale.”

Dillon said the application requirement will likely lead to a rise in price for vapor products as companies attempt to comply with the guidelines.

“If that e-liquid sold for $15, and I just spent $1 million, I would have to raise the price to justify that,” Dillon said. “I don’t care if you’re a large manufacturer or a small manufacturer, it’s going to completely change the industry.”The price of vapor products may not rise immediately this fall, but it will likely create a more expensive market eventually, Dillon said. He said companies will likely submit incomplete applications, allowing them to keep their product on the market for two years, or until the FDA assesses a product’s application and denies them.

“A lot of companies are submitting applications which are going to be declined, because they haven’t done the extensive testing because they can’t afford it,” Dillon said. “Virtually no small vapor company can afford $1 million for one flavor to get it tested because it’s just absurd.”