Is there a timeframe on the new regulations/exemption?
At the very least, the FDA could not issue rules until August 8, the day after the extended comment period closes—a scenario that would be extremely unlikely in our opinion.
When the FDA does issue regulations, they will be published in the Federal Register and take effect 30 days after their publishing, meaning the earliest date you could see any change would be September 7, although once again, this is very unlikely.
From there, manufacturers have two years to submit products currently on the market for compliance testing and the products get to remain on the market until the FDA rejects the application. However, ingredient disclosure will likely be due six months after the law goes into effect.
We believe this two-year window means most manufacturers will keep current product on the market through July 2016 (or whenever the two-year date would fall) before removing them, even if they have no intention of submitting for substantial equivalence testing.
Was there any mention of banning internet sales?
The word "internet" only appeared in the document three times, once to indicate explicitly that the FDA was not banning internet sales as part of the deeming regulations.
The PACT ACT, a 2009 bill banning the sale of cigarettes online, might have established precedent that Congress must act to ban online sales of tobacco products, although this has not been tested.
Given the FDA's broad authority on tobacco, it's impossible to rule anything out of their control at this moment and it's important to remember that the proposed regulations are foundational.
Were there any regulations regarding walk-in humidors?
The only change you might see would be a text-based warning label placed inside the humidor. It's not required by the deeming document, but some retailers might do so just to ensure compliance in case a box was missing a warning label.
Would the exemption (option two) be permanent?
It's our belief that it could well be in the best interest of the premium cigar industry to push the FDA to established a minimum time period for the exemption.
As it's currently proposed option two would be an indefinite exemption the FDA could rescind at any time and provides little if any stability for the industry as they look towards the future.
How is option two different than the attempts to exempt premium cigars in Congress?
If the FDA decides to exempt premium cigars under option two, it has the ability to rescind the exemption at any time.
Congress has authority over the FDA when it comes to this sort of regulation, so if Congress were to pass a bill exempting premium cigars, it would overrule the FDA's authority. This would also mean that Congress—or the courts—would have to rescind the exemption, not the FDA.
A Congressional exemption would be far more permanent than any exemption granted by the FDA.
What about pipes?
Pipes are subject to the new regulations, which means costs will go up, and products will be removed. The FDA estimates as many as 694 pipe and hookah tobaccos could disappears in the first 24 months following adoption of the new regulations. The sampling restrictions would apply, as well as the approval regulations.
Is the FDA even capable of dealing with this?
Probably not with their current staff.
The FDA has responded to 34 out of an estimated 4,000 applications since 2009. With the passage of the regulations put forth in the deeming document, they will literally open the floodgates.
The FDA estimates over 10,000 individual cigars exist on the market today.
Did the White House ever respond to that petition?
Yes. Essentially, the public comment for the deeming regulations has served as the official response.
How many cigars will die because of the regulations?
The exact number remains to be seen, but according to the FDA, as many as 2,438 individual cigars could be off the market within the first 24 months due to new regulations.