August 2016

FDA Deeming Regulation: The industry’s response

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By JOHN CASTLE

Since the FDA’s finalized Deeming Regulations descended on the vapor scene last month, there has been everything from upset to anger to apprehension in the vaping community. While this has settled and calmed to some degree, many of us may still be in dark and confused about a question that is, or ought to be, at the forefront of everyone’s minds:

What are we, as an industry and as a community, going to do about it?

That question has become increasingly important since the Deeming Regulations were first announced in 2014; back then, we had years to go before the industry and the community really needed to get the lead out and get moving. Or so most thought. While some did nothing but continue on as usual with cloud competitions, vaping selfies, “hand checks”, and so on, there were businesses and business associations already taking those first steps.

Additionally, organizations were forming for the purpose of fighting for our right as consumers to choose between smoking and the less hazardous alternative we’ve all come to love. Organizations such as the Vape A Vet Project, NotBlowingSmoke.org, NoMoreCasualties.org, and Vaping Militia arose to join the ranks of groups like CASAA, SFATA, AVA, and others to form a unified force for resisting propaganda, organizing consumers, and organizing the industry in such a way that reasonable regulation could be accommodated, while unreasonable, overreaching regulation could be vocally opposed at the local, state, and national levels.

INDUSTRY AND ADVOCACY VOICES

One of the first and most powerful voices to respond to the finalized Deeming regulation was that of CASAA.org, who wrote, in a blog post dated 5 May, 2016:

…CASAA will continue to focus our efforts to develop sensible regulation of vapor products that will have maximum benefit to consumers. The most important thing to remember is that consumers will continue to have access to the wide variety of vapor products for a period of time before the regulations take effect. But, for now, vaping as we know it will continue and we are not done by any means. Keep calm.

But businesses were quick to respond, as well, as in the case of Nicopure Labs, who only five days later, announced legal action challenging the FDA on the issue:

“Back in 2009, Halo revolutionized the way e-liquid was manufactured and packaged, forever changing the Vape industry as few knew it. Today, Nicopure Labs is again at the forefront of the industry as revolutionaries, as Nicopure Labs leads the way in defense of our constitutional rights and for the future of the entire vaping industry and the American right to choose. Through one voice, Nicopure Labs has taken a stand to ensure the voices of all vapers are heard and that vapers are treated fairly and not with a single stroke of a broad brush by the FDA,” said Jeff Stamler, CEO and co-founder of Nicopure Labs. “We fully support reasonable regulation that protects consumers, accomplishes the public health priority to reduce the grave harm caused by conventional cigarette smoking, and allows businesses to survive and innovate for a greater public health vision for our society as a whole.”

Dan Corbei, speaking on behalf of Five Star Juice, LLC, had this to say:

In light of the FDA’s recent release of its deeming regulation, Five Star is further refining our facility and internal manufacturing processes to incorporate key infrastructure enhancements made in order to meet and exceed the agency’s regulatory compliance requirements for standards, safety, and traceability.

In addition to important infrastructure enhancements, our company and team is focused on building meaningful relationships with all of our political representatives, as well as any governmental or regulatory agencies involved in this industry.

Five Star’s commitment has and will continue to be producing the finest smoke-free product possible, with the highest level of quality and care available; regardless of the regulatory outcome.

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That mission will not change today, tomorrow, or on August 8th, 2016.

But not all of advocacy efforts are aimed at the FDA itself; some, such as this digital flyer, (disclosure; flyer authored by this writer and sponsored by Joe Bradley of Bradley’s Brand) are aimed at the vaping community on the consumer level and advocacy efforts alone aren’t the sum total of the industry’s response.

Many vendors are stepping forward to bring their e-liquids and hardware into conformity with the highest standards of consumer safety and top product quality.

Innokin issued the following statement on 13 May, 2016:

These FDA regulations are overreaching, costly, and place an enormous burden on an industry made up of tens of thousands of independent retailers. The regulations hamper innovation, ignore science & research data, and in their current form will prove hazardous to all of us who rely on this beloved alternative to combustible tobacco.

Innokin continues to be committed to our vision of harm reduction through advanced vaporizer technologies. We are proud to have been working with top independent American and European labs on improved aerosol emission testing protocols and the testing of our bestselling tanks. Through aerosol emissions testing we have worked to minimize any possible negative impacts of our products caused by a wide range of known toxins and metals.

Innokin is a responsible manufacturer and is committed to restricting the sales of our products to minors. All packaging has clear labels and warning information and we have worked closely with vendors to increase awareness of responsible sales. Innokin has developed and launched SecureCap child safety lock technology on our bestselling tanks for added security and peace of mind.

The FDA has proposed an obstacle — perhaps one it believed to be insurmountable. The question, “What are we going to do about it?” is one the industry has already been equipping itself to answer, and with that answer, we will answer the unspoken question posed by the FDA. Their unspoken question: “What do you think you can do about it?”

The vaping community’s answer: “Watch us and find out.”