# FDA prevented from regulating e-cigs 10 years ago



## Hooked (9/11/19)

Hmmmm.... interesting!

https://epuffer.com/rules-and-regulations/fda-loses-appeal-cant-regulate-e-cigarettes-as-drug
*14 Jan. 2010
*
*WASHINGTON - January 14th, 2010 *- The *Food and Drug Administration ( FDA )* has no authority to regulate electronic cigarettes and cannot block the importation and sale of this battery-powered device.

In granting a temporary injunction blocking the FDA from confiscating or preventing the importation of e-cigarettes, U.S. District Judge Richard J. Leon ruled that the devices are essentially a modern-day tobacco product. He found that the FDA had overstepped its authority in trying to block their importation.

"This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices," Leon wrote. "Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable."

The controversy over the regulation of electronic cigarettes has resulted in difficulty to import these revolutionary nicotine delivery devices to many places in the United States and Canada. The FDA has taken an aggressive position against the sale and importation of these devices, seizing shipments as they enter the U.S. borders. The decision made by Judge Leon will make electronic cigarette manufactures such as UK and American based ePuffer International Inc., ensure their products are once again getting in time to its distributors, resellers and consumers.

*About EPUFFER Electronic Cigarette:* EPUFFER is a battery-powered electronic nicotine delivery device developed to help smokers quit or provide clean alternative to smoking. It contains no carbon monoxide, no tar, or any other cancer-causing chemicals. Smokers are still smoking like they do normally, and they still getting a nicotine dose, while at the same time eliminating cancer causing carcinogens, and other 4000 chemicals found in regular tobacco cigarettes.

Reactions: Like 2


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## RichJB (10/11/19)

This is why vaping is now classified as tobacco products. The FDA only had the power to block drug delivery devices back then. They seized a shipment of Njoy e-cigs claiming that they were "drug delivery devices" and Njoy argued in court that they weren't drug delivery devices but tobacco products. The judge accepted their argument that vaping devices are tobacco products, and ruled that the FDA had no jurisdiction over it. That established the legal precedent that vaping is tobacco products.

The FDA's role was changed by Congress in 2010 following a lawsuit by big tobacco. From Wiki:



> In 1996, the FDA issued the "FDA Rule," which asserted its authority over tobacco products and issued a rule intending to prevent and reduce tobacco use by children. The intended regulations included prohibiting non-face-to-face sales of tobacco products, prohibiting outdoor advertising of tobacco products near schools or playgrounds, imposing more stringent advertising regulations, and prohibiting brand-name sponsorship, among other things.
> 
> After the regulations were issued in 1996, tobacco companies sued. In the 2000 Supreme Court case _FDA v. Brown & Williamson Tobacco Corp._, the court ruled that Congress had not given the FDA authority over tobacco and tobacco marketing.
> 
> As a result, Congress was forced to provide explicit FDA authority to regulate tobacco and this was finally accomplished via the passage of the Family Smoking Prevention and Tobacco Control Act in 2010.

Reactions: Informative 4


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## Hooked (10/11/19)

So when FDA is challenged - and loses - they simply make a new rule. 

I still find it unbelievable that something which contains no tobacco can be classified as tobacco.

Reactions: Agree 3


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## RichJB (10/11/19)

It was a complicated issue. Every statutory body has its role and responsibilities set out in the Act that governs it. So, for example, the SABS is governed by the terms of the Standards Act of 2008. Historically, the FDA had the power to regulate food and pharmaceuticals since 1906 when the Pure Food and Drug Act was passed. In 1938, that was replaced by the Food, Drug and Cosmetic Act or FDCA. The FDCA gave the FDA the power to regulate drugs and the devices used to deliver them, along with their historical mandate for food and pharmaceuticals. 

However, it was never clarified whether tobacco was included among "drugs" or not. The FDA interpreted the FDCA to include tobacco. They interpreted nicotine to be a drug, and cigarettes, pipes, e-cigarettes etc as the devices used to deliver nicotine. So they assumed control over tobacco and issued their "FDA Rule" in 1996, which tackled various aspects of tobacco marketing.

Big tobacco objected and sued the federal government, claiming that the FDCA gave the FDA no regulatory authority over tobacco. The lower courts were divided on the issue, some ruling in favour of the FDA and others in favour of big tobacco, so it went all the way up to the Supreme Court. Big tobacco argued in the SC that even after the FDCA came into effect, it was state governments and Congress - and not the FDA - who formulated and enforced new regulations on tobacco. It was a very close call but the SC accepted big tobacco's argument and found in favour of them by 5-4 majority, reversing the FDA Rule and ruling that big tobacco did not have to abide by it. 

The various court cases around this issue also established the legal precedent that vaping is not "drug delivery devices" but "tobacco products". It was big tobacco and vaping who argued in court that vaping is "tobacco products". They did this because, at the time, the FDA had the authority to regulate "drug delivery devices" but not "tobacco products". This is why they cannot argue against vaping being "tobacco products" now. It was their lawyers who set the precedent and slim het sy eie baas geword.

Naturally, Congress had to tackle the dilemma of who actually has regulatory authority over tobacco, which the Obama administration did by promulgating the new Family Smoking Prevention and Tobacco Control Act in June 2009. This doesn't replace the FDCA but works alongside it, specifically giving the FDA the authority to include tobacco among the various products that it regulates. The new Act established the Center for Tobacco Products (CTP), which is the branch of the FDA that is tasked with tobacco regulations. Their mandate, as set out in the Act, is to:

Set performance standards
Review applications for new tobacco products and modified-risk claims before they reach the market
Require and control warning labels, and

Establish and enforce advertising restrictions
So unless Congress decides to change the laws again, the FDA are acting within their statutory mandate.

Reactions: Like 1 | Informative 3


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