FDA issues press release on new regulations, extension of authority over tobacco products

The U.S. Food and Drug Administration today released a 499-page document detailing an extension of its regulatory authority to all tobacco products (which includes premium cigars).

“This historic rule helps implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA to improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of these tobacco products to minors nationwide,” reads a press release announcing the changes.

Before today’s rules, there was no federal prohibition on the sale of e-cigarettes, hookah tobacco or cigars to people under age 18. The rule changes announced today change that. In addition, though, the FDA has included a rule that — though it is ostensibly designed to address youth access to tobacco products — could have a dramatic impact on the way cigars are discovered by and sod to consenting adults: the distribution of free samples will be a violation of FDA regulations when they go into effect in 90 days.

Here’s another key excerpt:

“Today’s rule also requires manufacturers of all newly-regulated products, to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The tobacco product review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit – and an additional year while the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.”

And another one:

“Today’s actions will subject all manufacturers, importers and/or retailers of newly- regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.

These requirements include:

  • Registering manufacturing establishments and providing product listings to the FDA;
  • Reporting ingredients, and harmful and potentially harmful constituents;
  • Requiring premarket review and authorization of new tobacco products by the FDA;
  • Placing health warnings on product packages and advertisements;”

As with so many other matters of bureaucratic regulation, the real meanings of all these rules will reside in the finer details. We’ll revisit them over the coming days, but at least a few things are almost certain.

First, the next 90 days in the cigar industry will bring lots of movement on the product side. Maybe that means new releases will be rushed to be ready for the IPCPR trade show in July. Maybe that means that product development slows and tobaccos currently destined for new lines are worked into existing products. Each brand will come to its own conclusion on that the best path is. No matter how those companies — especially smaller ones, which make up a sizeable chunk of the industry — decide to respond to these changes, they’ll be wise to make their moves inside of the next three months.

Second, the cost of doing business in the cigar industry (and, in turn, the cost of enjoying cigars) is on its way up. Even if it turns out to be relatively easy to clear regulatory hurdles moving forward, cigar companies will have to make compliance-related investments, and that’s all going to show up on the price tags at your local tobacconist. How steep that change will be is unclear, as the costs associated with the new regulations have not been announced.

Finally, the fight over this issue will continue, but it’s changing. Organizations like Cigar Rights of America (CRA) and IPCPR have been working on multiple fronts to avoid this scenario. The struggle to get sensible treatment of premium cigars from the FDA right out of the gate is lost. Now that we’re here, they’re sure to continue working to reverse this somehow. Maybe that’s a lawsuit. Maybe it’s heavy lobbying in Congress (for example, for language in a House appropriations bill that protects cigars by barring the funding of these regulations' enforcement). Whatever the path, this isn’t over.

Speaking of which, read CRA's statement on these changes here.