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.”