Seems this has turned into an ECA thread lately.
Sun:
What do you think Judge Leon is going to question the parties about tomorrow? The plaintiffs claim e-cigs are a tobacco product and if Judge Leon finds that they are - very doubtful. Even if he does, the recent legislation gives the FDA the right to regulate them - and control the still unknown ingredients due to the manufacturer's failure to have sufficient independent testing done.
This would mean that every product sold would have to independently tested and the results submitted to the FDA for approval. The same holds true if they are found to be a "reduced harm" device - testing must be done to prove reduced harm.
The worst case would be if the FDA is allowed to consider them an NRT, a position which I think is untenable. Intended Use by most vapers is NOT to treat the "disease" of nicotine addiction - it is to find a safer alternative to tobacco cigarettes. So we're back to a reduced harm product.
So what do you see as the possible/likely rulings that Judge Leon could make?
Lotus--the Judge is going to what to hear arguments about the two differnent statutory schemes that he could rule under. Judge Leon is can rule under either or a combination thereof.
Remember the standard for a preliminary injunction:
There must be a demonstration all four elements here:
- That there is a substantial likelihood of success on the merits of the case,
- That they face a substantial threat of irreparable damage or injury. if the injunction is not granted,
- That the balance of harms weighs in favor of the party seeking the preliminary injunction
- That the grant of an injunction would serve the public interest.
The "balance of harms" refers to the threatened injury to the party seeking the preliminary injunction as compared to the harm that the other party may suffer from the injunction.
In the instant case, SE and NJOY have the tall order of establishing that they are likely to succeed on the merits, and that they are
likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in their favor, and that an injunction is in the public interest
Based on the facts, Counsel for SE and NJOY have a steep hill to climb to meet the first, third, and fouth prongs.
Futhermore, the "indented use' for the e-cig is to mitigate the damage of using tobacco--------and mitigation means regulation.
Sun
