The 'tobacco wars' go back to the 1970's and early 80’s. The tobacco industry, dominated by cigarette manufacturers was a powerful lobby and we in the public health community were naive and not well funded in those days. Organizations like the American Cancer Society (ACS), American Heart Association (AHA) and the American Lung Association (ALA) did not even have fulltime public policy offices until the 1980's and even when they were established, they were staffed with very few people working on many issues not just tobacco. During that early period there were even questions as to whether nonprofit 501(c)3 organizations (NGO's) could lobby. Yet cigarette smoking was the major preventable cause of disease and death in the nation. Something had to be done about it.

An early example of the public health community's naivety was the acceptance of the idea that 'low tar’ cigarettes were somehow going to be the 'solution' to the smoking problem. Turns out it was anything but. The idea obviously was that filters and the introduction of so-called ‘technologically advanced cigarettes’ would remove a significant portion of the deadly particulate matter that caused cancer. It turns out that people ended up smoking more, thinking the products were safer and inhaling more deeply in order to get their nicotine fix. It was a win/win for the tobacco industry. Without having to admit that their products caused disease and killed, they could provide a 'public health' solution so that people didn't quit. They could merely use these new products, which were heavily marketed with implied claims of reduced risk and safety.

Most importantly there was no FDA oversight over tobacco. As one internal industry document noted, 'it was brilliantly conceived and executed' and designed to buy the tobacco industry years of time and head off regulation. I hope you are getting the picture as to what some view are parallels to today's e-cigarette environment. And while they aggressively marketed their regular products with images of sexual attraction, sophistication (many targeted at youth), and ‘low tar products’, the industry was also working on new technological products such as Premier, Eclipse and Accord – all to be marketed and sold in an unregulated environment.

In the 1980’s, to take on the industry, these groups (ACS, AHA, ALA) established what was called the Coalition on Smoking OR Health and built a grassroots coalition around it. This Coalition was the precursor to the Campaign for Tobacco Free Kids. I was and still am proud to have been a part of those efforts.

This was being done at a time when the industry’s influence over the US Congress, the White House and various regulatory agencies was second to none. The industry also used many front groups, including retailers, wholesalers and tobacco farmers. They developed well-financed so-called education campaigns such as Helping Youth Say No, Helping Youth Decide, and We Card. They used farmers to bring the message to Congress, 'Keep FDA off the Farm'. They hired researchers to come up with scientific results that questioned the link between smoking and health and over a period of years took out advertisements indicating that if it were proven that their products caused disease they would 'do the right thing'. They were employing similar tactics in Europe as well as in the rest of the world.

In the early years our public health goal was to ‘reduce disease and death from smoking'. It evolved and turned into an all out war with the tobacco industry. And today for many in tobacco control that remains the focus - unfortunately. Anyone who sells tobacco in any form is part of the enemy. Many are probably too young to remember that image of the CEO's of the tobacco companies standing before Congress with their right hands raised, swearing that 'nicotine is not addictive' (April 1994). It said it all.

Our Coalition had filed petitions with the FDA in the 1980's seeking to regulate tobacco products as 'drugs' under the Food Drug and Cosmetic Act. They sat at the agency for some time until, at the end of Bush 1's administration, the green light was given to begin an investigation as to how cigarettes could be regulated. In February of 1994, I as Chairman of the Coalition on Smoking OR Health received a letter from FDA Commissioner David Kessler responding to our petitions. I can tell you a number of personal stories related to that but will save that for another time. I would recommend that you read former Commissioner David Kessler's book, A Question of Intent.

The Master Settlement Agreement (MSA) and the release of millions of pages of documents helped further expose the industry for its decades of deceptions. The more we read the more our distrust of the industry grew, the more the 'wars' raged. Related to this was the Justice Department law suit against the industry where industry was found culpable on many counts. The fight for FDA oversight would continue well into the first 10 years of the 21st Century. It was a justified war, entrenched in our hearts and minds. The tide was turning in favor of the public health community. We were beginning to see significant progress in the 'war' against the industry. We had learned valuable lessons along the way.

TODAY’S ENVIRONMENT- A ‘NEW ERA’

In spite of a very different environment, one in which FDA regulation is now almost universally accepted and one that recognizes that all tobacco, nicotine and alternative products should be regulated based on the continuum of risk, many of my colleagues are still fighting the 'tobacco wars'. This war goes on not just in the US but globally as well.

The World Health Organization (WHO) and the NGO coalitions that have been formed seem entrenched in an 'anti-harm reduction' and 'anti- e-cigarette' mode similar to the tobacco wars of the past. I think the 'tobacco wars' as we knew them and fought them are over even though there are and will be many battles to be fought. Clearly things are being done that should not be done in the vaping industry but we need to be careful not to 'through the baby out with the bathwater'. The challenges and opportunities that exist with respect to the manufacture, sale, distribution and marketing of e-cigarettes as a public health tool needs to be confronted head on and discussed in a civil manner. In a regulated competitive market place it is about the products and not about who makes them that is paramount. In addition we should be encouraging research and innovation not stifling it. In talking about harm reduction I have used the equation:

Regulation + Research and Science + Technology + Innovation + Incentives + Competition + Consumer Acceptability =

A means of advancing public health goals and changing the behaviors of those manufacturing and marketing tobacco, nicotine and alternative products.

People are so 'emotionally wound up’ in perpetuating adversarial and polarizing ‘wars’ that I think that they have lost sight of what they want to accomplish and can accomplish. This is not the 1980's or 90's. I do not recall a time when the public health community has been so polarized. I do not remember a time when some are looking to the future while others remain firmly entrenched in the past.

For many, it is far more convenient to merely cross out the word ‘tobacco’ and put in 'e-cigarettes’ - than it is to address the issues and seek to find common ground and a path forward. I am convinced that there is a path forward. The question is will responsible stakeholders take it or will we remain fighting the 'tobacco (vaping) wars' for the next 10 plus years?

Let me end by giving some general advice to the vaping industry, which they can take or leave.

  • Make public health a major priority in what ever you do - this is not the era of the ‘tobacco wars'. It is, as FDA/CTP Director Zeller, I and many other believe, truly a 'New Era'. Accept that you have responsibility, accountability and an important role to play;
  • Accept that the vaping industry and products it makes must be regulated but it should be done so using good science and based on the 'continuum of risk' - something FDA in the US is now giving a high priority. If it does it right then public health will benefit;
  • Accept that there must be fair but effective product standards put in place and that a great deal more needs to be done in preventing children and youth from accessing and using any and all tobacco, nicotine and alternative products. This is particularly of great importance in the low to middle income countries. I believe that there needs to be a national (international) dialogue/summit on the children and adolescents issue involving all stakeholders;
  • Practice what you preach and do what you say you will do;
  • If you have bad apples in your ranks, get rid of them because a few bad apples can give everyone a bad name;
  • When you believe you are right, stand your ground. There is a lot of disinformation out there;
  • Actively participate in the legislative and regulatory processes;
  • Listen and learn and don't be afraid to engage with others - you might be surprised just how much you have in common. Let's take the emotion and rhetoric out of the discussions. These are different times with tremendous opportunities. I say that directed at all stakeholders including my public health colleagues and to governmental agencies such as the FDA, CDC, and the World Health Organization (WHO).

Lastly, if you believe that transparency and civil dialogue are an important part of the process for moving forward, I call on all of you to read the University of Virginia's Core Principles document on harm reduction and consider signing on to them. They can help serve as guidance for moving forward in these rapidly changing times. The document can be accessed at:

http://www.virginia.edu/ien/tobacco/?p=407

Once you access the document you can then click on the Survey Monkey link (found at the bottom of each page) to add if you wish your name or organizational support.

*These comments are revised from a presentation made at the Smoke Free Alternatives Trade Association Meeting - May 4, 2015

Contact Information:
Scott D. Ballin, JD
Health Policy Consultant
Mobile: 202 258-2419
Email: [email protected]