E-cigarettes Now Listed Tobacco and the Costly PMTA: Breathe Easy Alliance of Alabama’s Opinion on FDA’s New Regulation

vapor-vs-tabacco

“We are being painted as big tobacco, and that is the complete opposite of what is true. We are just small companies who feel passionately about helping people quit smoking in the best and safest way possible.”

– Stacey Hamilton, Vice-President of Breathe Easy Alliance of Alabama

We’ve had the privilege of interviewing the advocate and expert of the Breathe Easy Alliance of Alabama’s (BEAA) Vice-President. Stacey Hamilton weighs in on the PMTA (Pre- Market Tobacco Application) and the unfavorable possibilities that new and very stringent regulations may bring to the industry, to business owners and consumers.

BEAA is a paid membership of vape/e-cig business owners and individuals seeking to protect vaping in Alabama. BEAA supports the vaping industry as a reduced harm alternative for adult tobacco users as well as the 200 small businesses that employ over 2000 people in Alabama through its direct legislative influence, public awareness, local and state level calls-to-action and data collection. BEAA is the only vape and e-cig lobby group in Alabama who successfully suspended two vape tax bills in 2015.

Founded in March 2015, the organization aims to protect the right of adult consumers to vape by opposing or supporting statewide and local legislation that affect the vaping industry and its consumers. Together with other e-cigarette support group associations, it actively supports widespread information dissemination efforts. One of the many important BEAA advocacies is opposing the declassification of e-cigarettes as a tobacco product.

The Premarket Tobacco Application (PMTA), Store Inspections and Non-disclosure of Possible Benefits of Vaping

The Food and Drug Authority’s (FDA) ruling over requires e-cigarettes and other electronic cigarette products be classified and labeled as “tobacco products.” This regulation took effect last August 8, 2016. Not only did this move cause a stir to the vaping community, but it also created a lot of worry and fear across the entire vaping industry, particularly the small-owned, independent and booming vaping business-owners in the US.

The Tobacco Control Act defines the term “tobacco product” to mean “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” Products that meet the statutory definition of “tobacco products” can include currently marketed products such as certain dissolvable, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco.

Under the new ruling, the FDA subjects the tobacco products and their manufacturers to:

  • Enforce action against products determined to be adulterated and misbranded;
  • Require submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products;
  • Require registration and product listing for all tobacco products;
  • Prohibit against use of modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors) and claims unless FDA issues an order permitting their use;
  • Prohibit on the distribution of free samples (same as for cigarettes); and
  • Premarket review requirements

Additional provisions are also put in the regulation:

  • Requirement for a minimum age of purchase;
  • Health warnings on product packages and advertisements (which FDA is also proposing to apply to cigarette tobacco and roll-your-own tobacco); and
  • Prohibition of vending machine sales, unless the vending machine is located within a facility where the retailer ensures that individuals under 18 years of age are prohibited from entering at any time.

Furthermore, the new rule says that the tobacco products that were not on the market as of February 15, 2007, will have to undergo the PMTA and show that these products met the applicable public health standard set by the law. The manufacturers are also required to have marketing authorization from the FDA.

A PMTA is required for new tobacco products to ensure that it is beneficial to both the users and non-users. The application process would require submission of relevant documents and papers before the introduction of the new product. The FDA estimates the processing of a single application to cost an average of $300,000, but insiders estimate the actual amount to cost an average of $1,000,000. Each flavor and each nicotine strengths for e-liquids require individual applications. As a consequence, it is predicted that vapes will become more expensive, juice options will become limited, and vape mods will no longer be allowed in the market.

NicMaxx (N): BEAA is actively involved in various protest movements against this new FDA rule. Can you please give us an overview of the current regulation and policies covering vapes in the US which you think is most significant to your state?

Breathe Easy Alliance of Alabama (BEAA): All products on the market as of August 8, 2016, must undergo a very costly PMTA. The estimated cost will be approximately $1 million just to apply with no possible assurance that it will be approved. This single regulation will eliminate 99.8% of all vapor products on the market today simply because the FDA refuses to budge on an arbitrary grandfather date of Feb 15th, 2007. I would invite anyone to go back to 2007 and start using the cellphone they had then and see if they are satisfied with it. All the innovations and advancements that have been made over the past several years will go out the window to include safety features.

No new products may be introduced to the market without going through the costly PMTA first after August 8. This also means that products currently on the market cannot be improved upon nor safety concerns addressed.

Vape shop owners and staff may not tell the customer of the benefits to vaping versus smoking even though there is strong evidence demonstrating that it is (according to the Royal College of Physicians) conservatively 95% safer. This is in direct conflict with our constitutional right to freedom of speech.

Stores that sell electronic cigarettes will be subject to inspection. The deeming regulations offer no clear guidance on the purpose of these inspections. The regulations are so completely ambiguous that they leave interpretation wide open to whoever happens to be assigned to inspect a particular shop.

N: How important are reduced harm alternatives to public health, especially to tobacco smokers?

BEAA: The World Health Organization estimates that smoking-related illness will kill 1 billion people this century. There are 42 million people currently using vapor products to include an estimated 9 million in the US alone. The vast majority of these vapors are former smokers, more than 98%. Vaping offers a viable alternative to smoking and is beyond a shadow of doubt, the most effective way to assist smokers in quitting smoking to date.

N: How do you think should the government and health agencies view the emergence of e-cigarettes?

BEAA: The government and health agencies view electronic cigarettes with a jaundiced eye. They claim that vaping is just another means of addicting a new generation of people to nicotine. They have ignored the positive scientific research to the contrary. They have ignored their own official reports that nicotine does not kill, that the tar and carcinogens in combustible cigarettes are what kill smokers. Nicotine itself is no more harmful than caffeine. This disruptive technology emerged and flourished among small privately funded businesses. Entrepreneurs and visionaries have elevated the vaping industry to where it is today. Let’s face it, if a drug came on the market today, that was even half as effective at helping smokers kick the habit it would be touted as a miracle drug.

N: What are the major obstacles you’ve faced in your advocacy as an organization that supports vapers and businesses?

BEAA: The nonsmoking general population does not know or care to know what vaping is. Because vapor resembles smoke, vapers must be smoking. Legislators are lobbied by big tobacco and big pharmaceutical companies who have much more power, money and influence than do the small businesses of this fledgling industry. We deal with out and out misinformation being spread by health organizations who choose to ignore the facts and studies. These same organizations claim that the industry is attempting to appeal to children. I am an adult, and I like sweet, fruit and candy flavors. Our own company, as well as every other company that I am aware of, set a minimum age to purchase before it was even law. Most of us have used child resistant caps from the get go. Advocacy groups have encouraged everyone in the vape industry to do everything within its power to ensure these products are not falling into the hands of minors. We are being painted as big tobacco, and that is the complete opposite of what is true. We are just small companies who feel passionately about helping people quit smoking in the best and safest way possible.

N: Vaping has been around for some years, but many people are yet to understand what it’s about. What do you think is the biggest myth about vaping?

BEAA: Those in opposition say that “Vaping is worse than smoking” but the Royal College of Physicians says vaping is conservatively 95% safer. “Vaping causes popcorn lung” The name “Popcorn Lung” comes from the fact that the people who developed it worked in a popcorn factory and were exposed to extremely high doses of the chemical called diacetyl found in the powdered butter flavoring. Cigarettes have 100 to 750 times the amount of diacetyl as e-liquid products, and there has never been a confirmed case of “Popcorn Lung” from smoking cigarettes. “Vapor produces formaldehyde” If you manage to get a coil hot enough to produce formaldehyde then it is not inhalable and therefore represents an implausible scenario.

N: Many studies are coming out on the hazards of vaping to the body, among other health concerns. What is your take on these scientific studies?

BEAA: First and foremost people should consider who performed these studies and what was their intended outcome. Who commissioned these studies and what are their affiliations or biases? Most of these studies do not represent actual plausible scenarios therefore little credence should be lent to them. The production of formaldehyde and popcorn lung are two prime examples. It amounts to banning bottled water because someone could possibly use it to fill a container large enough for a baby to drown in.

N: What is your general advice on the use of e-cigarettes by teens and younger people?

BEAA: Vapor products should only be used by adults and only then to assist them in their efforts to quit smoking. Why buy a habit you do not already own? Vape shop owners should be held accountable for ensuring they do not sell to minors. Once it leaves their shop, and is in the hands of an adult, we can no more control what that adult does with that product, than tobacco companies and the liquor industry can. Parents must parent and ensure their children do not gain access to these adult products. As for online sales, I believe true age verification with adult signatures upon delivery should be required.

N: What is your message to the organizations or institutions that support vaping? How about those that oppose vaping?

BEAA: I believe the deeming regulations are far overreaching, and together we can fight them. We built this industry, and we have to stand and prepare to defend it to the very last. There are literally a billion lives at stake here. It will be worth it in the end.

We as an industry are not opposed to fair and rational regulation. We do not want children to gain access to our products, but we do not want to lose ground with the variety of equipment and flavoring on the market, after all, there are millions of smokers each one is different with different needs. Fair and rational discussion can result in compromise and a win for everyone.

BEAA has partnered with various lobbyists and plaintiffs as they move to the next steps in their opposition against the new FDA ruling. With this, more aggressive efforts and active involvement from them can be expected as the organization continues to push for tobacco smoking alternative options for adult consumers.

BEAA needs support in their ongoing battle with the FDA regulations. Commit to BEAA if you are one with the vaping industry and e-cigarette consumers in Alabama. Get to know more about BEAA and its advocacy by signing up at https://beaa-al.org/join-upport/.

Disclaimer:

Our Editorial Team is publishing the actual transcript of our email interview to accurately represent the opinion of BEAA. The opinions, beliefs, and viewpoints expressed by the various authors and advocacy segment interviewees on this website do not necessarily reflect the opinions, beliefs, and viewpoints of Nicmaxx or the official policies of Nicmaxx.

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