History of FDA Tobacco Law: Part One: Putting the Dog in the Doghouse with a Choke Collar.

History of the FDA - Focus: Tobacco

Pre-1996

Tobacco was not always under FDA control. Historically, Tobacco controls roots were split between ATF (Firearms, Tobacco, Alcohol) and IRS (Show me the money). These organizations were only interested in illegal trafficking, interstate commerce and taxes. 1964 was the first instance of someone other than ATF/IRS taking an interest in Tobacco and that was the Surgeon General, Luther Terry, and even he wasn't FDA. He released the Smoking and Health Report. It was this report that enabled some of the very first anti-smoking laws -  Federal Cigarette Labeling and Advertising Act (FCLAA - 1964) and the Public Health Cigarette Smoking Act (PHCLA -1970). FCLAA mandated that cigarettes packs be labeling with the Surgeon General Warning and the latter, with advice from the FCC, banned TV and Radio ads , declaring that Tobacco advertising broke the 'Fairness doctrine' which declared that all broadcasts licensed by the FCC must treat controversial subjects with fairness - airing dissent and support equality. Tobacco was too one-sided,in their opinion, with Big Tobacco the only voice heard. Other than these perfunctory laws, Tobacco enjoyed a long and lucrative unrestricted market, as long as they were not breaking trafficking rules of the ATF.

We have all seen Madmen. Everyone smoked. It was not only vogue, it was accepted. All office desks had ashtrays. You could smoke in subway cars, walking around the mall, in the movie theater and of course every restaurant or bar was full of smoke. There really were no regulations at all. Another interesting note: Age-restrictions were state rights, not federal mandate.

Enter the 80's, but even more interesting, the 1990's. During the 1980's, Nancy Regan began her crusade against drugs. Tipper Gore began her crusade against the music industry and Hollywood, labelling movies and music with age-appropriate warnings (PG-13 etc). American was in the midst of a large drug epidemic, gang-warfare and the music reflected the times. However, these crusades of "Family Values" and protecting the "nations youth" created a gestalt of government intervention and traditional cigarettes became major traget. It was this atmosphere where anti-smoking sentiment  created a national conversation on Tobacco and the winning message was that the government needed to fight Big Tobacco and smokers

The Clinton administration (1992) then asked the FDA to get involved, to draft legislation to curb smoking. The FDA did draft some legislation which proposed age-restrictions and banned advertising or other positive imagery, such as NASCAR logos or billboards with celebrities enjoying a cigarette. See, TV and radio advertising were banned in 1970, but Big Tobacco found a way around it. In response to this FDA action, Big Tobacco banded together to oppose FDA, claiming they had no jurisdiction to  implement any restrictions.

Now this is where it gets interesting. The FDA then released the '1996 rule', which not only increased the amount of restrictions, but at the same time, declared themselves full authority over tobacco et al. They would regulate it all since nicotine is a drug and a threat to Public Health. They claimed they were compromising when they asserted total legislative control over a product that until this time, was effectively regulated by *nobody.* This was their compromise: "We regulate advertising, promotion, sales and nicotine level...in exchange for keeping cigarettes on the market at all.

Some compromise, huh?

The 1996 Rule was an insanely complex and controversial subject. FDA quite literally, without Congressional approval, declared themselves the 'Regulators' just by issuing a statement of laws. Really - they just issued laws giving themselves regulatory control. This is not how law works and FDA paid dearly for it.

Now, things really get interesting. Rule-making is Administrative Law - the process in which individual agencies create legislation. We will talk more about this latter, but suffice it to say for now, the FDA created a dung-heap within which they had to operate. The 1996 Rule is easily regarded as the longest rulemaking proceeding in FDA history. This becomes extremely relevant. Upon issuance of the 1996 rule, Big Tobacco banded together and launched lawsuits challenging FDA authority over anything Tobacco. It won't be the only lawsuit as we will see.

4 years later after the lawsuit was announced, in FDA v. Brown & Williamson Tobacco Corp, the Supreme court ruled in favor of Big Tobacco, citing that Congress never gave proper authority over tobacco to FDA.

So how did we get here?? If FDA lost, how and why are we even fighting this fight today?

Simple answer: The Supreme Court forced Congress to formally give control of Tobacco to FDA. Even this was no easy task. Session after session opened and closed with Congress not agreeing to law. Congressional record will show who mucked up legislation year after year, thereby keeping tobacco relatively unregulated - that is, Until 2009, where Obama led Congress to pass the 

Family Smoking Prevention and Tobacco Control Act or TCA.

(citations and links will be added on edit)

Part Two: Current Law - Modernization of 1996 Rule

Martha Coakley tries to take credit for regulating E-cigs. The problem? They are already set to be regulated by the FDA.

Recently, Martha Coakley, Massachusetts Attorney General and Governor wanna-be, issued a statement along with 38 other Attorney Generals to pressure the FDA to regulate e-cigs. 

You can read that article here: http://www.boston.com/lifestyle/health/blogs/white-coat-notes/2013/09/24/mass-martha-coakley-urges-feds-regulate-cigarettes/WavUyqJpW98YpxcnbdgmmK/blog.html


The Problem? As we all know, the FDA has been working on regulation for 2 years and announced their intention to announce Proposed Rule in October. I will be posting more about this shortly in another article which should be finished soon. So what exactly is Coakley trying to accomplish here? It seems to be that she is trying to create a narrative for her run for Governor that she was successful in getting e-cigs regulated at the national level, which will be a complete lie.

Electronic cigarettes have been on the FDA's radar for the 5ish years that they have been in existence. They announced last month, in August, that they were finally ready to issue Proposed Rule in October and have been meeting with various interested parties, both pro Harm Reduction and Anti-Harm Reduction. Martha Coakley had *nothing* to do with the inevitable regulation of the Electronic Cigarette. Her only accomplishment here is jumping on the Anti-Harm Reduction bandwagon on the Eve of "success" - a success she had no involvement with.

After reading some of the comments on Boston.com, I see that there are still some misconception of E-cigs, or vaporizers as we prefer to call them. I will very curtly address some of them:

1. We know exactly what is in e-cigs.

There are 3-4 ingredients. (See and/or clause)

Propolyene Gycol and or Vegetable Gyclerin - both completely safe and used in Asthma inhalors and fog machines. Propolyene Gycol, while sounding like a scary name, has been studied extensively and actually shown to prevent lung infection, used in fog machines and pumped into Hospital air systems. Oh, and it is in your toothpaste - go ahead, take a look.

Nicotine Extract. Yes, this is extracted from the tobacco plant, but it is not tobacco, just as vanilla extract is not a vanilla bean. Nicotine, by itself, meaning, unattached from a burning cigarette *IS* relatively harmless, with addiction properties that resemble caffeine.

Flavoring: These are the same flavors that are in every single flavored food product we have on the market and FDA approved (though not specifically for inhalation).

2. Adults do in fact, like flavors. We are quitting a habit of bringing a burning, stinky, tar-filled cigarette up to our mouths for inhalation every hour on the hour. Quite simply, we are slowly suffocating ourselves with Carbon Monoxide poisoning while offending others wherever we are. When quitting, we want something that is enticing - something that does not taste like that burning, stinky cigarette. It seems to me that the public would want this for us....and for them. For every adult smoker who chooses e-cigs, the public is no longer exposed to offending stinky smoke.

3. Since e-cigs came to market, they have been studied extensively. We are however, in need of more studies, especially peer-reviewed. That said, every study has come back positive, with very few negatives. This is were 'Harm Reduction comes in. We know they are not completely safe. We want regulation that brings quality control along with efforts to make e-cigs as safe as possible. Despite what  Martha and other Anti-Harm Reductionists say, they are, with 100 percent certainty, a *safer alternative* to smoking cancer sticks. Regulate e-cigs out of adults hands and all you do is keep the population smoking traditional cigarettes, killing themselves and polluting your air. Give them a safer alternative that does not involve burning tar-filled smoke, and we have the biggest public health win of the century.