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Right to be Smoke-Free Coalition files lawsuit on behalf of vapor industry

Posted by on 6/24/2016 to General News
On June 20th, the Right to be Smoke-Free Coalition filed a lawsuit against portions of the FDA's Deeming Regulation and the Tobacco Control Act. The suit, filed on behalf of the vapor industry, challenges the FDA on constitutional and administrative grounds.

If successful, this lawsuit would protect not only the American Vapor Industry as a whole, but your right to vape.

The lawsuit focuses on the following 8 Key Points:

1. The FDA had the authority and the duty to establish a new Grandfather Date for vapor products, so that manufacturers (including e-liquid companies) "would have the opportunity to forego the Premarket Tobacco Application (PMTA) pathway", and instead have the option to "submit Substantial Equivalence (SE) Reports". Instead, the FDA kept the original Predicate Date of February, 2007, which essentially bans all vapor products currently on the market. It is therefore in violation of the Administrative Procedures Act.

2.  The FDA is using one-size-fits-all regulations in treating vapor products as cigarettes. This forces e-cigarette and e-liquid manufacturers into an unreasonably costly PMTA process, otherwise reserved for actual tobacco products. The FDA's application of the PMTA process for vapor products "will all but ban the entire e-liquid and device categories." It is also in violation of the Administrative Procedures Act.

3. The Tobacco Control Act acknowledges that different tobacco products have different risks. It makes clear that the FDA "should exercise its enforcement authority in a flexible manner". E-cigarettes are widely accepted as at least 95% safer than tobacco cigarettes, and should not be subject to the same provisions. However, the FDA argues that it is "mandated to enforce a 'one-size-fits-all' regime to all products". This would mean that Congress did not in fact give the FDA enough flexibility to regulate new, safer products. And, it makes the Tobacco Control Act unconstitutional under the Due Process and Equal Protection Clauses. 

4. The FDA's total ban on free samples is in violation of both the First Amendment and the Administrative Procedures Act. The FDA had other options in order to "(prevent) youth access while still allowing vape shops and others to market using free samples" to adult consumers.

5. E-cigarettes do not combust tobacco and do not produce smoke. The Modified Risk Tobacco Product (MRTP) provision of the Tobacco Control Act, which applies to cigarette smoke, does not apply to e-cigarette vapor. Applying the MRTP provision to vapor products constitutes a violation of the Administrative Provisions Act.

6. The classification of parts of vapor products - such as devices, coils, tanks, batteries - as tobacco products is "unreasonable and unlawful" under the Administrative Procedures Act. Such items do not contain tobacco, nor are they derived from tobacco. In other words, the lawsuit seeks to emphasize that e-cigarettes are not tobacco products.  

7. The FDA is required to consider the implications of its regulations on small businesses. The FDA "did not make a reasonable, good faith effort" to do so, instead burdening small businesses with a multi-million dollar compliance process they could not possibly afford. The FDA is therefore in violation of the Regulatory Flexibility Act. 

8. The Tobacco Control Act requires the FDA to "adequately consider the costs and benefits of the Deeming Rule". Similar to point 7 above, the FDA failed to consider alternative regulation (an extended compliance period, for example) which would increase the ability of small businesses to comply. Once again, the FDA is in violation of the Administrative Procedures Act.

You can read the full complaint over here at CASAA.

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