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.

Cigar Rights of America praises House subcommittee language protecting premium cigars

Cigar Rights of America issued the following press release regarding developments on the ongoing battle over the FDA's proposed regulation of premium cigars. 

Cigar Rights of America Statement on FY 17 Agriculture Appropriations Bill

WASHINGTON, D.C. - Today, the U.S. House of Representatives Appropriations Subcommittee on Agriculture, Rural Development, Food & Drug Administration and Related Agencies released the fiscal year 2017 Agriculture Appropriations, which included language addressing the issue of premium cigars and proposed FDA regulation.

Cigar Rights of America applauds the language included by the committee that seeks to protect small businesses and the freedom of adult consumers throughout the nation.

The language contained within the bill, and supported by CRA would prohibit the use of funds for any effort "to finalize, implement, or enforce the proposed rule" [The April 25, 2014 proposed Deeming Rule, subjecting cigars and other products, to new regulations.] The language continues, "if such rule applies to traditional large and premium cigars."

J. Glynn Loope, Executive Director of Cigar Rights of America stated, "The premium cigar industry feels that enforcement of existing laws is far more important than new regulations."

Loope continued, "We commend the leadership of Chairman Robert Aderholt on this issue, as he is working to protect thousands of domestic and tens of thousands of international jobs associated with the premium cigar industry. He clearly worked for a balance with this language, that seeks to protect small businesses and traditional family owned manufacturers."

Rocky Patel, Vice Chairman of the CRA Board of Directors stated, "The inclusion of this language to protect premium cigars is a testament to the coalition the industry has built in Congress over the last several years, and to the educational process with our lawmakers on how premium cigars are a cottage industry and an art form enjoyed by adults, much like a fine wine. Premium cigars are uniquely different than other tobacco products, and hence should not be regulated as proposed by the FDA. As we may be on the eve of the issuance of regulations, this action by the subcommittee is wonderful news."

Cigar Rights of America has been working in partnership with the International Premium Cigar & Pipe Retailers Association to advance legislation to protect premium cigars from burdensome, and in fact, decimating new regulations proposed by the U.S. Food & Drug Administration.

The magnitude of the adverse economic impact was depicted by the U.S. Small Business Administration, when it estimated that at least 50% of the industry could not sustain the level of regulation outlined in the original April 2014 Deeming Rule issuance.

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Cigar Rights of America director's open letter to presidential candidates

Glynn Loope, executive director or Cigar Rights of America, issues an open letter to anyone hoping to win the 2016 presidential election.

In the letter, which you can read in full here, Glynn argues that defending the rights of premium cigar smokers to choose for themselves whether they smoke cigars has political consequences, since smokers and premium cigar industry can influence electoral outcomes.

"Florida   is   the   epicenter   of   the   premium   cigar   industry," he wrote, noting that Florida has 29 electoral votes. "There   are   over   fifty corporate headquarters locations spanning from Fort Lauderdale,   to Miami, and up to Tampa. Every premium cigar that enters the United States from Latin America enters through the Port of Miami, and the Ports of Tampa and Fort Lauderdale also represent critical pieces of infrastructure for the industry. The headquarters and logistics channels that include trucking, warehouse and distribution firms are foundations of the regional economy in Miami-Dade County, and along the I-95 corridor up  to  Fort  Lauderdale."

 

2015 brings new proposals to encroach on cigar rights

 

At the beginning of every year, state legislatures convene to discuss legislation for the rest of the year. Many of the introduced bills directly affect consumers, manufacturers and retailers of premium cigars.

A number of the bills threaten to further restrict smoking rights.

There are smoking bans and ban extensions being considered in the following states: Alaska, Iowa, Kentucky, Mississippi, New Hampshire, Oklahoma, Pennsylvania, and Texas.

Tax increases are on the table in Kansas, Kentucky, Mississippi, New York, North Dakota, Oklahoma and Wyoming.

In Oregon, legislators are considering prohibition on the imposition of local taxes on tobacco products.

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Meanwhile, other proposals offer hope for reduced government intervention in your humidor.

The definition of a premium or large cigar, as well as the tax cap, is being discussed in Hawaii.

In Washington and Nebraska, the issue of licensure for premium cigars and premium bars is also a key issue.

Finally, West Virginia has proposed a bill that allows only elected officials to regulate the use of Tobacco.

Visit the Cigar Rights of America legislation page to find proposals that affect your area and contact your lawmakers urging them to protect your right to enjoy premium cigars.