Today, the U.S. Food and Drug Administration (FDA) issued its regulations on tobacco products. The regulations issued include premium cigars for which there is no exemption from FDA regulation, nor revised predicate date. In addition to premium cigars, the new regulations include pipe tobacco, hookah, and electronic cigarettes. The timetable for the new regulations to take effect is 90 days from today.
In a press release from the FDA, “The actions being taken today will help the FDA prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, as well as communicate their potential risks”
The new regulations set to go into effect on August 3rd will have some drastic effects for premium cigars. In a nutshell, the cigar industry as we know it will change.
- Unless the product was on the market before February 15, 2007, Cigar manufacturers will now be required to submit information to the FDA “to show that the products meet the applicable public health standard” and get approval from the FDA.
- For products currently on the market introduced after February 15, 2017, cigar manufacturers will be given a two year window while they submit products for approval, and an additional year while the FDA review the tobacco product application.
- Elimination of free samples
- Requiring warning labels on packaging and advertising
- Age verification for anyone under the age of 27 who attempts to purchase cigars.
A premarket review and authorization of new tobacco products will need to be performed by the FDA. As for what is required to be submitted to the FDA:
- Manufacturing establishments will need to be required to register with the FDA and provide associated product listings to the FDA;
- Submitting a list of ingredients used in premium cigars.
- Requiring premarket review and authorization of new tobacco products by the FDA;
- “Modified risk tobacco products” ( those described as “light,” “low,” or “mild”) will require approval unless authorized by the FDA.
The FDA was granted the authority to regulate tobacco products, including premium cigars when the Family Smoking Presentation and Tobacco Act was passed into law back in 2009. In 2014, the FDA issued its Deeming Document with its intent to regulate premium cigars. This included an option for an exemption for premium cigars. Following a period of public comment, and then a review by the White House Office of Management and Budget, the exemption was not implemented.
While the regulations are set to go into effect in 90 days, there currently a proposed Appropriations Bill in U.S. House of Representatives that could withhold federal funding to implement these regulations. There is separate language in that bill that also revises the predicate date to when the regulations are issued. This bill is still pending a House vote and also needs to go through the Senate before being signed off by the President. Meanwhile, there exists the possibility of litigation through the court system on this ruling. Meanwhile S. 441 and H.R. 662 are still pending bills in Congress that would put into law a cigar exemption for regulation of premium cigars.
Following the news from the FDA, Cigar Rights of America Glynn Loope commented, “the inclusion of premium cigars in the final rule by FDA is yet another clear indicator that the agency never intended on complying with the Congressional mandate in the 2009 Act, and that the agency is clearly overstepping its authority in its zealous pursuit of unjustified regulations. Due to today’s actions by FDA, CigarRights of America will continue concentrating its efforts on the pursuit of the legislative exemption adopted by the U.S. House of Representatives Committee on Appropriations, and CRA is calling on Congress to act this year to protect the premium cigar retail community, the availability of legal products to America’s adult consumers, and to address the political and economic threat that this regulation posses throughout Latin America.”
Wil,
A lot of information here. I will call our Montana congressmen and urge them to vote for these 2 pending bills.
Thank you.
What ever happened to the land of the free…. We have been over run by the nanny state
Will online retailers discount cigars now, or will they want top dollar? This will be a paradigm shift. Brick and Mortar will suffer as well. We can thank the vapers for this. Premium cigars have never been marketed to the underaged. This is bad news.
Here’s the one that keeps getting me. There’s a part in the 499 pages of this crap that states there will be a federally mandated minimum age of 18 to buy any tobacco products. DOSN’T THAT ALREADY EXIST!!! And here in this article they state again, “Age verification for anyone under the age of 27 who attempts to purchase cigars.” Well duh, the minimum age is already 18. And why put an arbitrary age number of “27” here. If you know the person is under the age of 27, you already know how old they are, so you already know if you can sell them something or not. It is a bunch of hot air wind bags speaking and writing something overly complicated for no other reason than they can.
For the love of God, can’t the government find something better to do with our tax dollars? Like maybe hire competent people so you don’t dump toxic waste in a river? If someone derives pleasure from something the government seems to find a way to regulate it.
Feature Story: Understanding the Impact of FDA Regulations on Post-Embargo Cuban Cigars – HNM Trademark Law
[…] be lifted. However, this answer is now more complicated by the recent announcement of the U.S. Food and Drug Administration’s new regulations that affect premium cigars. In a nutshell, even if the green light were in place to sell Cuban cigars tomorrow, the fact now […]
The government should use all their resources to fight a clear and present danger like ISIS. Tobbaco already has warnings by the surgeon general, and a law to restrict minors from buying tobbaco products. 499 pages…what a waste of oxygen -producing trees! Premium cigars are natural, and handmade not man-made, what is there to dissect?
FDA sucks, another waste of Tax paying dollars get them off our backs write you senators and reps let them know they are overstepping again and need to change the regulation.