Donald Trump Can Change FDA Regulations and Save Vaping

President Elect Donald Trump is collecting guidance from US Citizens to help direct his first 100 days in office.  He could take action that saves vaping in the USA.  In its first 100 days, we need the new administration to route out the corrupt and dangerous regulations that the FDA Center for Tobacco Products, under the leadership of big Pharma lobbyist Mich Zeller has enacted.  These regulations are designed to destroy the vape industry.

Please visit the President Elect’s website and submit your  story:  https://apply.ptt.gov/yourstory/

Here is the message that I (Brendan) sent as President of Flavorah:

Please stop the FDA’s Center for Tobacco Products from destroying the vape industry. We help people quit tobacco by using technology, and the FDA has no part in our industry.  Vapor is not food, it is not drugs and it is not tobacco.

I own a business that manufactures flavoring.  My customers use our flavoring to manufacture ejuice for use with an electronic cigarettes.   For $5.49, customers purchase a .5oz bottle of concentrated flavoring, then mix it with ingredients purchased elsewhere in order to make their own ecigarette refill and help themselves quit smoking.  All my products are nicotine free, not derived from tobacco, and not used directly in an e-cigarette.

Despite the multiple steps for processing and blending our flavors, and distant—or more often non-existent linkages to tobacco—The FDA has refused to tell me explicitly if my product will be subject to their “Deeming” rules.  If they are subject to their new rules, I will be required to submit approximately $150M (according to their own figures) worth of “Pre-Market Tobacco Applications” without any guarantee that they will be accepted.

If I continue in business and assume that I am not subject to their new rules, I could face enforcement that would result in my business getting 100% shut down, and possible fines and imprisonment.

In an email correspondence with the FDA, I was told that our flavoring product could be “deemed” a tobacco product if they are packaged for consumer use.  I replied to this email with a request for clarification since my product is a raw material that must be further processed before it can be used in an ecigarette.

In Phone correspondance with the FDA, I have received continued obfuscation and lack of clarity. Since the Food Drug and Tobacco Act specifically exempts raw material that do not contain tobacco, the FDA agents can not tell me whether my product was or was not subject to their new regulations.  Instead they have been bullying us, and other members of our industry with the threat of their regulations and enforcement-new drafts of which come out every month.

Their rules, and their responses attempting to clarify them, have been impossible to follow, and their communication leaves me without a clear course of action.  Other businesses in our industry, including many of our customers, have been forced to close because they cannot afford to survive the new burden of regulations.

It is clear that the FDA director Mitch Zeller, who was a lobbyist for big pharma companies before President Obama appointed him, is trying to kill the vape industry.  On the face of it, the FDA seems like they are trying to protect tax revenues from tobacco cigarettes, and also prevent people from quitting tobacco with their own homemade mixtures of ejuice rather than a drug like Nicorette or Chantix.

The truth is, about 80% of people who use an ecigarette are able to quit smoking tobacco.  The ones who make their own refills save so much money that they rarely go back to tobacco, or commercial ejuice refills for that matter.  Ecigarettes are saving lives, even if they are causing a loss in tax revenues.

The FDA has attempted to redefine “tobacco product” so broadly in their deeming rule that it could include anything.  Literally, tap water and steel wire have the same linkages to the use of a finished tobacco product as my flavorings.

If my customers are allowed to continue purchasing flavorings from companies like mine, then they will never need to purchase tobacco cigarettes or pay taxes on newly deemed “tobacco products.” I think that scares the FDA because it makes them irrelevant.  Please send new leadership to reign in the FDA bureaucracy that threatens both jobs and lives.

Posted in Industry, Legal, News

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