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.