FDA Electronic Cigarettes Regulation Comments

Opinion IconOn Friday, 08 August 2014, the period for commenting on the FDA’s proposed electronic cigarette regulations closed. People were allowed to enter up to 5,000 words in the text box. In addition, people could attach a document. I did both. They overlap somewhat. Here are the comments I submitted in the text box.

As a former cigarette smoker, consumer of electronic cigarette devices and accessories, and a member of the Consumer Advocates for Smoke-Free Alternatives Association (CASAA), I am a stakeholder in this issue. I am very concerned these FDA proposed regulations will impact me negatively. I am deeply concerned that the primary focus of these regulations concerns the impact these regulations will have on the industry and that these regulations seem to ignore the impact they may have on the primary stakeholders, the consumers. I am also concerned that the FDA has not properly considered the impact these regulations will have on thousands of small electronic cigarette businesses across the United States. These are the businesses, brick and mortar and online, I frequent regularly to purchase electronic cigarette hardware, accessories and liquids.

I submit these arguments (more details are in the attached document):

– These proposed regulations will have devastating consequences on consumers, removing choices that may help them separate themselves from smoking, choices that can be beneficial to our health, choices that can have negative financial impacts, choices that can negatively impact our quality of life.

– These regulations are based on incomplete and outdated research, anecdotal evidence, hearsay, corporate lobbying and political maneuvering. They are not based on sound, relevant research. The FDA has not listened or solicited comment from the vast medical community. When my doctors ask me if I smoke. I tell them no, I use electronic cigarettes and have since November 2011. Every one of them is happy that I quit smoking. None of them has told me to stop using electronic cigarettes. And each of them has told me that they read the research that’s being done on electronic cigarettes. If the opinion of much of the medical community, those that see patients daily, is favorable, why is the FDA proposing regulations without due diligence and more thorough research?

– The FDA has grossly underestimated the regulatory impact on small businesses. The exorbitant initial and annual compliance costs will prevent new businesses from entering the market and force many out of business, leaving the industry to the big tobacco companies. Those same companies that fought to keep advertising cigarettes everywhere, fought to keep warning labels off of packaging, fought to suppress evidence that cigarettes do not kill or cause life threatening diseases.

Electronic cigarettes allowed me to take control of and improve my health. I do not intend to give up electronic cigarettes because the FDA intends to regulate them. I refuse to give my health back to the big tobacco companies, to the political engine, and to the FDA. And I refuse to hand over any more money to the big tobacco companies.

Here are the comments I made available in the attachment. As I mentioned, there is some overlap. I wrote the document first, then added the comments to the text box, since making an entry in the text box was required for submission.

From: William Gentry

To: FDA Center for Tobacco Products

Re: FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910-AG38

As a former cigarette smoker, consumer of electronic cigarette devices and accessories, and a member of the Consumer Advocates for Smoke-Free Alternatives Association (CASAA), I am a stakeholder in this issue. I am very concerned these FDA proposed regulations will impact me negatively. I am deeply concerned that the primary focus of these regulations concerns the impact these regulations will have on the industry and that these regulations seem to ignore the impact they may have on the primary stakeholders, the consumers. I am also concerned that the FDA has not properly considered the impact these regulations will have on thousands of small electronic cigarette businesses across the United States. These are the businesses, brick and mortar and online, I frequent regularly to purchase electronic cigarette hardware, accessories and liquids.

These proposed regulations will have devastating consequences on consumers. They will impact the health of millions of consumers that big tobacco companies do not care about. They will impact the health of millions of consumers that the FDA claims to care about yet marginalizes with these proposed regulations. They will severely limit consumer choices. Choices that can be beneficial to our health and well-being. Choices that can have a major negative financial impact. Choices that can negatively impact our quality of life. They also may also seriously compromise public health and the health of those who are not direct consumers in the industry. I cannot, in good conscience, stay silent. I cannot allow the FDA and the tobacco industry decide what is best for me based on incomplete and outdated research, anecdotal evidence, hearsay, corporate lobbying and political maneuvering.

I smoked approximately one pack of cigarettes a day from May 1987 to November 2011. From approximately 2005 until 2011, I had a very bad smoker’s cough and would become easily winded with light physical exertion. Beginning in 1993, I tried quitting many times cold turkey or using nicotine replacement therapy (patches, gum, etc.). Chantix and similar drugs were not an option for me. While some of my attempts to quit smoking were successful in the short term (1 year or less), I was not able to kick the habit permanently. That is, until I tried an electronic cigarette in November 2011. I haven’t had a real cigarette since. I am much healthier since I started using electronic cigarettes. My doctors know about my electronic cigarette use and are pleased.

Personally, returning to smoking is not really an option, but not using electronic cigarettes is not much of an option either. I refuse to use mass-produced and mass marketed electronic cigarette devices again. Nothing about them is satisfactory: poor vapor production and limited hardware and flavor selections. Most importantly, I refuse to give any more money to tobacco companies that for decades lied to the public and concealed the truth about their products.

Beyond the health benefits I’ve enjoyed, one of the most appealing aspects of electronic cigarettes for me, and many consumers, is the huge variety of flavors available. I enjoyed smoking flavored cigarettes. That choice were taken away. I do not enjoy plain tobacco flavored or tobacco and menthol flavored liquids. I like fruit and dessert flavored electronic cigarette liquids.

The FDA has grossly underestimated the impact of these regulations on small electronic cigarette businesses, whether those businesses are manufacturing companies, retailers or a combination of both. The fact that they are brick and mortar or online only businesses is irrelevant. The high initial and annual compliance costs businesses will be required to pay will prevent new businesses from entering the market and will likely force many out of business. The FDA, it appears, has not adequately complied with the Regulatory Flexibility Act, nor has it adequately explored alternatives for small businesses. These regulations will all but hand over the industry to the big tobacco companies.

In addition, the FDA proposes these regulations while stating that more research is required. I agree, some regulation is necessary: ingredient listings, barring sale to minors and safe packaging; areas, incidentally, that the industry is self-policing. But to call for sweeping regulations without fully researching the effects of the products and byproducts when these products may save lives and reduce contraction of serious, life threatening diseases is irresponsible. Regulate sales to minors. Regulate safe packaging. Regulate ingredient listings on labels. Table all other regulations until sound, controlled, repeatable research can be performed and the results accurately analyzed.

Regardless of the final regulations, one way or another, I will continue using electronic cigarettes; not the mass market varieties pushed by big tobacco companies, but the more advanced, refillable tank and high capacity, rechargeable battery electronic cigarette models I use now. I will continue, somehow, to use low or no nicotine content, flavored electronic cigarette liquids. I will continue to do this because electronic cigarettes helped me separate myself from cigarettes and big tobacco companies. Electronic cigarettes allowed me to take control of and improve my health. I refuse to give my health back to the big tobacco companies, to the political engine, and to the FDA. And I refuse to hand over any more money to the big tobacco companies.

While I have my doubts that the FDA will consider any of the narratives submitted and will simply approve the proposed regulations as is, I hope the do. Regardless, even if they are approved verbatim and without any changes, they won’t go into full effect for 2 years. In addition, I’m certain there will be litigation over the rules and regulations when they are put into effect, so they won’t take effect until 2 years after any litigation is complete.

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