Clinton Administration and the FDA Goes After Big Tobacco in 1994. In that same year, Big Tobacco lawyer, Kenneth Starr, appointed Whitewater investigator.
Starting in 1994, the FDA asserted regulatory authority over the sale of cigarettes claiming that cigarettes were a “drug delivery system” for the addictive ingredient in tobacco, namely nicotine. The FDA made the novel case that it would regulate cigarettes as a drug and a ‘medical device.’ Tobacco manufacturer Brown & Williamson sued the FDA, attempting to prevent the FDA from exercising their statutory regulatory authority. The case bounced its way up to the US Supreme Court. The majority opinion held that the FDA did not have the authority to regulate tobacco and in turn nicotine levels within cigarettes.
The question before the court was as follows: does the FDC Act (the act that gave rise to the Federal Drug Administration) grant the FDA the authority to regulate tobacco? The US Supreme Court stipulated that nicotine was addictive and that smoking cigarettes was a serious threat to the public health. However, the Court took pains to explain that had Congress intended to give the FDA this right to regulate tobacco and in turn nicotine, it would have done so. Yet, it did not do so. The dissent commented that it wasn’t clear that the Congress strictly forbade the FDA from regulating extremely dangerous chemicals, carcinogens and addictive substances. Moreover, research concerning nicotine’s addictiveness and the 4,000 chemicals used in cigarette manufacturing hadn’t been available for public scrutiny until recently. Therefore, Congress didn’t have this information available to it when the FDCA was put in place.
The Court argued that since tobacco usage has always been an important point of contention in American politics and over 50 years, Congress
US Supreme Court Justice Scalia: "They" say I was "sworn" to uphold the "Constitution..."
never saw to include that authority into the FDA’s authority. Therefore, reticence to grant authority to the FDA in previous tobacco regulatory law convinced that majority that Congress could not have intended such an important task to fall the FDA by accident. Arguably, the fact that the tobacco lobby is such a powerful force in Congress would’ve made it highly unlikely that the FDA would’ve been granted such authority without any debate on the subject whatsoever.
Through much handwringing and back and forth argumentation, the Supreme Court’s decision appears to have been, as is often the case, a political one. The court, by implication, urged Congress to pick the issue of tobacco regulation or let it lie. Since the court found that the FDA had no authority over tobacco, all of the FDA regulations affecting tobacco are now voided. The court held that the FDA could retain its authority to regulate nicotine for its therapeutic uses, but that it cannot use its authority to regulate tobacco products, per se. This case was decided prior to the advent of electronic cigarettes which can be both a therapeutic device and a nicotine delivery device such as tobacco cigarettes. Therefore, the FDA’s recent argument to regulate the use of nicotine-delivery devices has placed the conservative court and the FDA in a bit of an administrative and regulatory bind.
The case hinges on a definition: are electronic cigarettes smoking cessation therapies OR are they merely temporary tobacco substitutes?
If the court determines that the electronic cigarette device is actually a smoking cessation product, then it could argue that the FDA would maintain regulatory authority over the use of nicotine. If, however, the court determines that the electronic cigarette devices are merely tobacco cigarette augmentations (e.g. replacements when you can’t smoke real tobacco) then it is less likely it would fund that the FDA should maintain regulatory control over the units other than basic health, safety, engineering, functions. The more interesting question, however, is to what extent States can regulate the device and thus tax the device as if it were a tobacco product. In other words, if the devices offset the consumption of real cigarettes but do nothing to reduce smoking in the aggregate, then the device can be seen as simply a tax dodge and such subject to possible taxation. The answers to these questions are far from clear as there are multiple interests at work. Issue of Administrative law, Federal Trade, interstate commerce, taxation, health care and public policy and State’s Rights will all play a part in the outcome of this litigation. Suffice it to say, these series of lawsuits will hold great significance for all those involved.
Our prediction:
The courts will find that electronic cigarettes and/or any electronic nicotine delivery device marketed as a smoking alternative will eventually be subject to taxation. Congress will act on this eventual ruling and address the issue at the Federal level. This result will open the door to Big Tobacco to begin to sell competitive products on the market along with the foreign ones. Nevertheless, our prediction is that the market for these devices, however they evolve, will only increase.
|
|
| Re-Tweet | Reply | View Tweet |
|
|
|
| Re-Tweet | Reply | View Tweet |
