Friday, November 8, 2013

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