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News: FDA Commissioner’s Resignation Could Have Big Implications for Cigar Regulations

6 Mar 2019

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Late yesterday reports broke that U.S. Food & Drug Administration (FDA) Commissioner Scott Gottlieb would be resigning his position next month. The move comes less than two years after Gottlieb was confirmed to the position in May 2017.

According to a Washington Post report, Gottlieb’s resignation didn’t come at the request of the the White House. President Trump tweeted praise of Gottlieb’s job at the FDA. “Scott has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things.”

Gottlieb, who had been commuting from Connecticut weekly, told the Post it was a difficult decision. “This is the best job I will ever have. I’m leaving because I need to spend time with my family. I get home late Friday, work on weekends, and come back to Washington on Sunday.”

Gottlieb’s confirmation was supported by cigar industry groups based on his prior writings questioning the logic of FDA tobacco cigar regulations. But his time at the FDA was a mixed bag for cigars. Gottlieb came into the job known for a “harm reduction” approach to tobacco regulations.

One of Gottlieb’s first acts was to delay upcoming deadlines for implementing the FDA’s Deeming Rule, which included new cigars. He later initiated another round of rule-making on whether the FDA should adopt an exemption for premium cigars. Later, Gottlieb pushed for a ban on flavored tobacco products.

Next Commissioner Faces Big Decisions on Cigar Regulations

Gottlieb’s departure leaves the next head of the FDA to make major decisions regarding the FDA’s oversight of premium cigars. A permanent replacement for Gottlieb would need to go through a Senate confirmation process, which would take months given the backlog of other nominees awaiting confirmation votes. An acting commissioner could be named more quickly, but no decisions have been made about who would fill the post.

The FDA could issue a final rule on the premium cigar exemption any day now and, unless it comes in the next month, it may be one of the first big decisions made by the next commissioner. If a final rule isn’t issued before late spring 2020, the rule can be overturned using the Congressional Review Act by a new Congress and president after the 2020 elections.

The next commissioner would also be primed to make final rulings on flavored tobacco products and on an FDA initiative for reduced nicotine tobacco products. Cigar industry groups would do well to lobby the White House for a nominee who is likely to issue premium cigars a long sought-after exemption from FDA rules.

Patrick S

photo credits: Stogie Guys

News: Tampa Looks at Protecting Historic Cigar Factories

14 Jan 2019

Tampa, which calls itself “Cigar City” for its long-ago role as the hub of the industry in the U.S., may again consider officially protecting the historic factories that remain.

Designating the old facilities as historic landmarks, which restricts some changes, was rejected a few years ago. Many of the two-dozen or so remaining buildings still dot Tampa’s Ybor City neighborhood, which is also home to numerous cigar shops, small rolling operations, and a giant annual cigar festival.

The only full-fledged factory still operating is J.C. Newman’s (pictured above). Others sit empty or have been converted to different uses. Some already have the historic designation.

New interest in the factories was spurred recently when the city said it had ordered a halt to remodeling work on the Santaella Cigar Factory building because of permit issues. One city councilman told the Tampa Bay Times that it was important to protect the old factories: “They are the castles of our neighborhood.”

According to the Times, Tampa council members considered the historic landmark designation in 2006 but were dissuaded by owners who viewed it as a potential restriction of their property rights.

The Santaella is a three-story building constructed in 1904, one of more than 200 cigar factories that operated at one time in Ybor City. Babe Ruth was said to stop by Santaella for cigars when the Yankees held spring training in the area.

In recent years, the building has been home to local artists. It was sold last year, and the permit flap flared as the new owner was renovating.

We’ve written about Tampa’s cigar history in the past, including a 2015 piece that included a reference to a terrific resource, Tom Ufer’s seminal guide to the factories in Ybor City. If you don’t find live links at Tom’s site, be sure to check back; he recently told me he’s working to restore much of the great information he compiled.

George E

photo credit: J.C. Newman

News: New Congress Means Renewed Effort to Exempt Cigars from FDA Regulations

9 Jan 2019

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Every two years, a flurry of new bills are introduced in Congress and, as has been the case every two years since 2011, a bill was again introduced in the Senate to protect handmade cigars from damaging Food and Drug Administration (FDA) regulations.

Senate Bill 9, the “Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2019,” was introduced January 3, 2019, by Florida Senator Marco Rubio. Five Senators signed on as original co-sponsors: Cory Gardner (R-CO), Joe Manchin (D-WV), Tom Cotton (R-AR), Robert Menendez (D-NJ), and Joni Ernst (R-IA).

In the previous Congress, Florida Senator Bill Nelson introduced the legislation, while longtime-supporter Rubio had been an original co-sponsor who supported the bill from its initial introduction. The change takes place after Nelson, a Democrat, was defeated in November by then Republican Governor Rick Scott.

Although Scott is not one of the original co-sponsors, as governor he did send a letter to the FDA Commissioner opposing FDA regulation of handmade cigars. A later report claimed Scott personally lobbied Vice President Mike Pence about the issue of how FDA regulations would be applied to cigars already on the market. The discussion was revealed in a report that noted that Swisher, which now owns Drew Estate, had made significant contributions to Scott’s campaign.

Other past supporters who were defeated in November include Senator Dean Heller (R-NV) and Joe Donnelly (D-IN), though many others were re-elected. Cigar industry groups will now have to build support for the legislation in both the Senate and House.

According to Congress.gov, a companion House bill has not yet been introduced to protect handmade cigars from the FDA. Florida Republican Bill Posey, who easily won re-election in November, has traditionally introduced that bill.

Despite the House changing hands in the 2018 elections, most previous supporters of the bill survived re-election. The cigar industry did lose some champions, including Florida Representative Ileana Ros-Lehtinen, who retired after being a longtime advocate for cigar rights.

Trump-appointed FDA Commissioner Scott Gottlieb was initially seen by many as a positive change when it came to FDA policies towards cigars compared to the Obama FDA. However, despite delaying the implementation of some cigar regulations, some experts worry his subsequent actions are step towards a stealth ban on tobacco products, including cigars.

Patrick S

photo credits: Stogie Guys

News: Judge Rules Against Industry Challenge to FDA Cigar Regulations

16 May 2018

Judge Amit P. Mehta of the U.S. District Court for the District of Columbia issued a 70-page decision yesterday in CAA v. FDA, largely ruling against the cigar industry groups that brought the legal challenge to the U.S. Food and Drug Administration’s (FDA) regulation of premium cigars and other tobacco products.

The Cigar Association of America, International Premium Cigar & Pipe Retailers Association, and Cigar Rights of America filed the legal challenge last year claiming the FDA’s move to extend tobacco regulations to cigars and other tobacco products violated the Administrative Procedures Act, as well as the First and Fifth Amendments to the Constitution.

The one win for the industry groups relates to pipe tobacco. The Obama-appointed judge found the FDA was “arbitrary and capricious” when it designated tobacco retailers who blend pipe tobaccos in-store as domestic manufacturers under that Tobacco Control Act. That issue was remanded back to the FDA for further consideration.

The judge rejected claims that the FDA violated the Administrative Procedures Act when enacting the deeming rule, putting cigars under the Tobacco Control Act. He also rejected claims that the large cigar warning labels violate the Constitutional rights of cigar manufacturers who were required by the law to put health warnings on products and advertisements for cigars. (The picture above is of required warning labels in France, which are only slightly larger and more colorful than what is required under the FDA.)

Although the judge noted the “basic unfairness” of enforcing the warning labels and associated costs while the FDA was reconsidering the regulations and may soon change them, he ultimately deferred to the agency’s authority.

Judge Mehta’s decision can (and very likely will) be appealed to the U.S. Court of Appeals for the District of Columbia Circuit. An adverse ruling by a three-judge panel of that court could then be petitioned for review “en banc” by the full court, after which the U.S. Supreme Court could be asked to review that decision.

Analysis

Legal precedent is stacked against those challenging executive agency rules. The “Chevron Doctrine” gives wide deference to executive branch agencies when it comes to interpreting the law. As a result, an agency like the FDA gets the benefit of the doubt in the eyes of federal courts when it comes to interpreting the limits of its authority.

The good news is, in addition to a likely appeal, this isn’t the only legal challenge to the FDA rules. A lawsuit filed by Global Premium Cigars in Florida includes additional claims that the FDA’s actions violate the Regulatory Flexibility Act, designed to protect small businesses from over-burdensome regulations. And an additional lawsuit brought by El Cubano Cigars and the Texas Cigar Merchants Association in Texas challenges the regulations including the warning label requirements.

If any of the various appellate courts split on an issue, it increases the likelihood the U.S. Supreme Court could weigh in on the issue. Although the odds are still long, legal experts believe there is an increasing skepticism on the Supreme Court for the deference afforded executive branch agencies under the Chevron Doctrine.

Ultimately, though, the best hope for stopping FDA regulations of cigars remains outside the courts. Short term, the FDA’s restarted rulemaking process could provide relief for the cigar industry, as the Trump-appointed FDA commissioner has already initiated a new direction for tobacco regulations.

The more fundamental, if difficult, solution is to repeal the FDA’s authority over premium cigars. Once the FDA was granted the power in 2009 to extend its authority over cigars, it was inevitable that eventually the agency would exercise that power.

Back in 2009, some in the cigar industry weren’t particularly worried about the FDA’s new powers over tobacco because the law’s primary target was cigarettes. While it may have been true that cigarettes were the primary target, it was short-sited to think FDA regulation wouldn’t eventually expand to cigars.

Cigar maker Steve Saka provided his reaction to yesterday’s ruling in a Facebook post: “Basically the court is saying that what the FDA is doing is wrong and unjust, but legal… This is a byproduct of an inept Congress that lacks the moral fortitude to fix the colossal mistake they created and bureaucracy run amok. It is beyond frustrating and infuriating.”

In short, if you’re looking for someone to blame for yesterday’s ruling, don’t focus on the judge, but on the Congress that authorized the FDA’s regulation of cigars in the first place. And don’t forget: Today’s Congress still has the power to repeal it.

Patrick S

photo credit: Stogie Guys

News: FDA Again Considers Premium Cigar Exemption

26 Mar 2018

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Handmade cigar industry groups supported President Trump’s appointment of Dr. Scott Gottlieb as the head of the U.S. Food & Drug Administration (FDA). Now they will see if that support was deserved.

On Friday, the agency announced its intent to seek comments about reconsidering existing regulations of premium cigars. The 90-day comment period opens today (Monday, March 26) and runs through June 25.

Here is the FDA’s summary of its action:

The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of premium cigars under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and regulations regarding the sale and distribution of tobacco products. Specifically, this ANPRM is seeking comments, data, research results, or other information that may inform regulatory actions FDA might take with respect to premium cigars.

In the notice, the FDA asks for “comments, data, research results, and other information related to the following topics: (1) definition of premium cigars, (2) use patterns of premium cigars, and (3) public health considerations associated with premium cigars.”

The request for comments also zeros in on an issue regarding the definition of youth (something we raised about the original 499-page deeming document): “Please provide any evidence or other information supporting your comments. Also, provide the definition of ‘premium cigar,’ ‘youth,’ and ‘young adult’ used for the studies, information, or views provided in your responses.”

The document specifically asks for additional research that might not have been considered when the FDA made the decision to not exempt premium cigars from their deeming rules in 2016. It specifically notes the PATH study published last September that reinforced the idea that different types of cigars have vastly different usage patterns.

Simply considering a premium cigar exemption, of course, doesn’t guarantee that the FDA will ultimately adopt one. The FDA notably considered and rejected such an exemption in its original regulation of cigars.

However, the willingness of the new FDA leadership to spend time and resources considering rolling back its regulations is a good sign for those who make, sell, and enjoy handmade cigars. Over the next 90 days, expect a big push from the handmade cigar industry for comments urging the agency to adopt a premium cigar exemption.

Patrick S

photo credits: Stogie Guys

Quick Smoke: Partagas Ramon y Ramon Robusto

17 Dec 2017

Each Saturday and Sunday we’ll post a Quick Smoke: not quite a full review, just our brief verdict on a single cigar of “buy,” “hold,” or “sell.”

About a year ago, both of my colleagues praised the Robusto (5.5 x 50) from the new (at the time) Partagas Ramon y Ramon line. This cigar sports a Cameroon wrapper around a Dominican binder and filler tobaccos from Nicaragua (Jalapa) and the Dominican Republic (Piloto Cubano). The profile starts mild and ramps up to medium-bodied with flavors of sweet cream, cedar, oak, toast, and melon. Construction is solid. This is an easy recommendation at about $8.

Verdict = Buy.

Patrick A

photo credit: Stogie Guys

Quick Smoke: Paul Garmirian Soiree Belicoso

24 Sep 2017

Each Saturday and Sunday we’ll post a Quick Smoke: not quite a full review, just our brief verdict on a single cigar of “buy,” “hold,” or “sell.”

It’s not widely known, but when PG was creating a cigar to celebrate its 15th Anniversary, the decision came down to two final blends. The runner-up became the PG Soiree. Although I think they made the correct decision, the Soiree is also a very fine cigar. It starts out with intense black pepper and wood spice and soon develops an almost maple sweetness to go along with dry oak, hay, and some mushroom-y funk. Not as balanced as the the PG 15th Anniversary cigar, but a blast of enjoyable medium- to full-bodied flavors with flawless combustion.

Verdict = Buy.

Patrick S

photo credit: Stogie Guys