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Big Companies Preparing for Regulations

As the Food and Drug Administration’s deeming rules for e-cigarettes are getting closer to being the law, some companies are preparing for the rigorous testing that their vaping products will have to go through in order to remain on the market. The companies getting ready are mostly the ones who can afford it; the testing is very costly, and some say it goes overboard and is unfair. The prohibitive cost could wipe some companies out of business.

Avail Vapor LLC is the largest e-cigarette retailer in the United States and has 100 retail stores. Avail has been planning for the FDA rules and is prepared to comply with all the testing and other regulations that will be required by mid-2018. As a manufacturer of e-liquid, the company’s primary lab is located at its corporate headquarters in Chesterfield, Virginia. The lab has been outfitted with complicated-sounding equipment such as chromatograph spectrometers, for both liquid and gas, as well as machines that mimic the act of a person using an e-cigarette. In addition, Avail has hired chemists and a regulatory compliance team. All of this is designed to ensure that the company will continue to be able to produce e-liquid and sell it in America.

Most companies that produce e-liquid are much smaller and unable to afford the type of testing the FDA rules will require. The American E-Liquid Manufacturing Standards Association says that the rules are unfair. A representative of the organization claims that the FDA rules were designed specifically so that most manufactures won’t be able to comply.

E-cigarettes are currently being regulated right and left by policy makers who cite concerns about the “unknown” health hazards of vaping as their reason. Unlike nearly all other products that exist in the U.S. market, e-cigarettes and e-liquid are being restricted despite existing testing showing them to be safe, with opponents of vaping insisting that the possibility of some harmful effect that hasn’t been found yet being enough of a reason for bans.

Avail’s CEO says that the cost for the company to comply with the FDA rules will hit about $10 million. The company’s chief operating officer speculates that smaller companies that can’t afford the cost of testing might end up asking Avail for help. Some companies do contract out lab testing, and Avail has provided lab testing services for other companies.

Efforts are currently underway to persuade the FDA to change its rules. The testing requirements will apply to all vaping products manufactured since 2007, but opposition campaigns are trying to get the date to be changed to 2016 so that most products currently on the market can stay. Even if that happens, all newly manufactured products will have to comply with the testing and other FDA requirements beginning in 2018. Small companies that can’t afford the cost may be able to save themselves by contracting testing out to other companies. Otherwise, they may have to close their doors.

Electronic Cigarettes • April 5, 2017

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