May 2016

FDA rocks vapor industry with sweeping regulations

FDA 2016 E-Cigarette RegulationBy COREY NOLES

The Food and Drug Administration this morning gave the vapor industry a rude awakening when it issued sweeping regulations that deemed vapor products to be tobacco products.

>> read the full FDA regulatory document.

The 499-page document places all vapor products under the jurisdiction of the Tobacco Control Act of 2007. Under the changes, vapor products including e-liquid containing no nicotine, will be held to the same requirements.

Numerous vaping advocacy groups have already denounced the regulations. The American VapingAssociation, in a statement, referred to the regulations as “downright prohibition.”

On Twitter this morning, AVA President Greg Conley noted that the regulations effectively freeze the market to new products 90 days after they are published. Any product moving forward that is not already on shelves, would have to go through theprocess immediately, as opposed to being allowed two years for compliance.

SFATA also weighed in on the discussion earlier this morning

“Our industry has a long history of supporting sensible science-based regulations, including license requirements, as well as banning sales to minors and adopting child-resistant packaging,” according to SFATA President and Executive Director, Cynthia Cabrera. “Today’s final rule pulls the rug out from the nine million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses.”

The regulations include federally requiring age identification, banning of vending machines, free samples and a laundry list of other items. As we at VAPE Magazine are still investigating the documents, more will come in the near future.

Specific warning label instructions are included in the regulations as well, with active manufacturers having 24 months to come into compliance.

In addition, all products — hardware and e-liquid — will have to go through one of two processes to reach the public. The pre-market tobacco application would have to be completed; otherwise manufacturers will be required to show substantial equivalence to a product on the market prior to February 15, 2007.

SFATA is challenging this date with the idea that virtually no products were on the market at that time.

“Although the FDA states it has found a vapor product on the market in 2006, it has yet to be determined whether the far more technologically advanced vapor products on the market today can be considered substantially equivalent to that product,” Cabrera said in a statement. “These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers. It also limits access to the 40 million adult smokers in the U.S. yet to make the switch to vaping and cripples a multi-billion dollar job-creating industry, the majority of which are made of small businesses.”

More information, reaction and specific requirements will be posted later today.

Corey Noles is the managing editor of VAPE Magazine. He has worked as a journalist for more than a decade and is the founder, owner of Inked Up E-Liquid Co.