FDA Releases Regulations for Vapor Industry



May 5th, 2016


FDA Releases Regulations for Vapor Industry

After years of deeming federal regulations, the FDA has released the industry rulings


Honolulu, Hawaii - The FDA issued its final Deeming Regulations rule[1] today, bringing all tobacco products under its control, including those made or derived from tobacco and which are not a drug, device, or combination product. The rule goes into effect August 8, 2016 and will immediately impact E-cigarettes, cigars, pipe tobacco, and other tobacco products.

Included in the regulations are rules that restrict access to minors under the age of 18, require specific warnings to be placed on the product labels, and require all products that were introduced to the market after February 15, 2007 (the predicate date established in the Family Smoking Prevention and Tobacco Control Act) to go through a pre-market or substantial equivalence application and review process. 

The arduous application and review process which is estimated by the FDA to take nearly 5000 man hours and $330,000 to produce for each and every product or variation thereof, will be nearly impossible for the 95% of small businesses operating in the vapor industry to comply with. Most of those companies could ultimately be shutdown creating a serious threat to the estimated 3.5 billion dollar industry.

“A growing body of evidence has shown that e-cigarettes are up to 95% less harmful than traditional tobacco cigarettes and it is essential that Congressional action be taken so that vapor products can remain on the market” said Cory Smith, CEO and Co-Founder of VOLCANO eCigs. The Royal College of Physicians, one of the world’s leading medical associations, recently released its historic report endorsing vaping as a harm reduction option, stating that regulations should not inhibit the development or use of vapor products.

“The only viable option at this time is to change the predicate date with federal legislation so that products that are already on the market can continue to stay on the market without having to go through the onerous and financially burdensome application and review process.  Bills such as H.R. 2058 (aka the Cole Bill), as well as a recent bi-partisan amendment introduced by U.S. Representatives Tom Cole (R-OK) and Sanford Bishop (D-GA) that recently passed the House Appropriations Committee are a step in the right direction so that a more reasonable substantial equivalency pathway to market can be created” said Cory Smith, CEO and Co-Founder of VOLCANO eCigs.

“We support sensible science based regulations including child resistant packaging, labeling requirements, banning sales to minors and instituting good manufacturing processes. The deeming regulations as they stand pose a serious threat to the vaping industry and could reduce the availability of modified risk products to consumers that create a public health win.” Smith stated.



Scott Rasak

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