Federal Court Upholds Cigar Labeling Requirements — Why and What This Means

Cause of Action Institute (“CoA Institute”) has been active as an amicus curiae (friend of the court) in an ongoing federal lawsuit regarding cigars and other tobacco products.  Meaning, while we don’t represent any of the parties, we have been submitting briefs to help the Court reach its final decision. The Food and Drug Administration (“FDA”) originally proposed a burdensome tobacco-safety regulation that would have effectively crippled the premium cigar market, putting countless American small businesses out on the street.  After the 2016 election, however, new FDA leadership delayed that rule with the intent to change it. This was a wonderful development for both cigar companies and hobbyists alike. However, the FDA kept pushing a scaled-back rule that would require large, intrusive warning labels on premium cigar products.  We submitted a brief opposing that rule.

CoA Institute did not take a position on the efficacy or utility of tobacco warning labels.  Our concern was, as it frequently is, that agencies must show their work when they enact a new regulation.  The governing statute here, the Family Smoking Prevention and Tobacco Control Act (“FTA”), required the FDA to show that any new regulations would be appropriate for the protection of the public health.  Plaintiffs, as well as CoA Institute, argued that the FDA had not done its work and, indeed, had conceded it had no real quantitative data or analysis for the efficacy of these new warning labels for cigar products.  Regulatory action for the sake of regulatory action is bad policy.

Unfortunately, the Judge disagreed, finding that the FDA had done its due diligence in determining that the warning labels would be effective.  He held that the FDA’s statements connecting the labels to public health, as well as their citation of certain data, such as the overall addictiveness of nicotine, was enough.  Furthermore, he found that the agency’s concession that it had no data available was merely an admission of the “agency’s inability to quantify the benefits of the Deeming Rule’s requirements prior to their implementation date.”  He held that a mere connection, quantifiable or not, between smoking prevention and the larger warning labels is enough.  He cited the agency’s prior work with other tobacco products, singling out cigarettes, as the foundation for the FDA’s contention that the new health warnings were appropriate and would affect cigar and pipe tobacco usage.

As any cigar aficionado knows, cigars and cigarettes are distinct products.  I regularly enjoy cigars, but I never touch cigarettes.  Why?  Because, in my opinion, the health risks are profoundly different for the two products.  More importantly, the addictive nature of the two is incomparable.  I regularly smoke cigars during the summer—which, for me, is 1-3 a week—and completely stop for the long winter months with no undesired effects or feelings of withdrawal.  That, to put it lightly, is not the usual experience with cigarettes.  Aficionados know: these are two different worlds.

Some might criticize me for relying on personal anecdotes to argue a federal regulation is unfounded.  I agree!  And that’s why the FDA should have conducted quantitative studies specific to premium cigars, rather than just relying on general science on nicotine addiction and the agency’s experience with a totally different product, cigarettes.  I suspect this is why Congress included language in the statute mandating that a “finding as to whether such regulation would be appropriate for the protection of the public health shall be determined[.]”  Of course, we live in the era of Chevron deference, where the Supreme Court has instructed the lower courts to defer to an agency’s interpretation of a statute and, sometimes by extension, the agency’s own science (or lack thereof).  Accordingly, the agency’s own statements in support of the rule were given enormous deference by the Court.

The Plaintiffs in the case argued that it was ridiculous for the FDA to claim to not have access to quantitative data, since they’ve had “sixteen years and an entire nation’s worth of data to examine the efficacy of the [prior-implemented] FTC warnings.”  After all, most of the cigars produced and sold in the United States are subject to an FTC consent decree that requires these companies to put warning labels on their products.  The FDA could have studied the efficacy of the FTC warnings on cigar use, but failed to do so.  In rejecting this argument, the Judge made an interesting comment: “Plaintiffs, however, have identified no requirement, statutory or otherwise, that compelled the FDA to undertake such studies to make the findings required by [the statute].”  CoA Institute, as amici, did just that though.  We contended that Chamber of Commerce of the United States v. Securities & Exchange Commission, which applied to similar statutory language in the financial sector, was controlling here.  The SEC made basically the same claim the FDA did, arguing “it was without a reliable basis” to determine costs associated with a regulation.  In Chamber, the D.C. Circuit recognized that limitations on data cannot “exclude the Commission from its statutory obligation to determine as best it can the economic implications of the rule it has proposed.” In its decision upholding the labeling rule, the District Court did not cite Chamber.

If this case were to be appealed—and, again, CoA Institute was just amici and did not represent any of the parties—we believe the D.C. Circuit would be faced with two interesting questions.  First, is the statutory language enforced by the Court in Chamber similar enough to the FTA that the case controls here?  And second, if Chamber does apply, can the FDA comply by simply reaching back and pointing to data based on cigarettes and other general science on tobacco?  We, of course, would argue no, given the distinct differences between premium cigars and cigarettes.

What does this all mean for cigar smokers?  Probably not that much, at least for now.  The original rule would have rocked the market, cutting off competition, reducing quality, and increasing prices exponentially.  The new, cutback rule might result in some increase in price, given the labeling costs cigar companies will now need to endure, but the same quality and quantity of cigars should be available for purchase.

But here’s the important point: there’s nothing preventing a future administration from bringing back the original rule.  And, given the Judge’s opinion in this case, the FDA would not have to reach a high bar to “deem” and regulate cigars the same way it does cigarettes.  This could be a death knell for the pastime.  The Courts and Congress must act to hold agencies accountable to good science and, most importantly, to doing their job.

*There were many other strong arguments made by the Plaintiffs, including Administrative Procedure Act and constitutional claims.  These were similarly rejected by the Court. For this blog post, I concentrated only on the arguments CoA Institute highlighted in our amicus brief.  The Court did vacate one part of the rule, which defined retailers who blend pipe tobacco in their stores as “manufacturers,” asking the agency to justify its reasoning.*

Make the FDA small again

FDA regulation doesn’t just inconvenience Americans – it puts their lives at risk

Back in January, President Donald Trump vowed to cut the Food and Drug Administration’s (FDA) regulations by 75-80 percent, a dramatic policy shift from his predecessor who oversaw regulatory costs skyrocket to more than $100 billion annually. As debate centers on Dr. Scott Gottlieb, the president’s nominee to be the next FDA commissioner, Americans should follow this process closely.

No drug can be marketed in the United States without FDA approval. Over the years, the FDA kept numerous drugs off the market that were approved in other developed countries. According to an article published by the CATO Institute, one doctor estimates that these drugs could have prevented 200,000 American deaths over the last 30 years. One example is pirfenidone, a drug to treat pulmonary fibrosis, which didn’t get approved in the United States until 2014 even though it was marketed in Japan in 2008, Europe in 2011, and Canada in 2012. The FDA was advised by its own advisory committee to approve the drug in 2010, but the agency waited another four years after demanding yet another study on the matter.

Between 2010 and 2014, 150,000 Americans died from idiopathic pulmonary fibrosis, a disease that may have been treatable with this drug. Patients should not be banned from trying experimental medication if they and their doctors believe it is the best choice. The best way to speed up the process is for the FDA to allow the free market to function. The more power we give the FDA, the higher the risk of the agency cracking down on states that allow more freedom to terminally ill patients to make decisions for themselves.

This isn’t a conservative or liberal issue. This is an issue of saving lives and allowing sick Americans the right, with appropriate counseling on the risks, to make informed choices about trying experimental therapies.

The Boston Globe reported a troubling story about a woman who had two sons, both diagnosed with the terminal disease muscular dystrophy. The FDA allowed one of her sons to improve with the help of an experimental new drug, while forcing her to watch idly as her other son’s condition continued to worsen. Her younger son, Max, nine years-old at the time, qualified for a clinical trial of the experimental drug eteplirsen, while her older son, Austin, 12 at the time, did not. After 16 weeks, Max began to improve, which caused her to try to speed the FDA’s approval process for the drug.

The mother submitted an application for Austin again in 2013, and he was finally allowed to participate in a trial beginning in 2014. The FDA, however, didn’t approve the drug for everyone else for another two years.

Americans want safe drugs, but no one wants a bloated bureaucracy at the FDA to decide which terminally ill patients can and cannot benefit from a medicine that seems to be working. Giving this medicine to both sons earlier would have allowed them to improve together, but FDA regulators took away the right of this family and their doctor to make that decision.

There are many more examples. As the CATO article reports, individuals with Alzheimer’s were denied THA, individuals with cardiac problems had to wait for beta-blocker approval, individuals with kidney cancer were denied Interleukin-2, and AIDS patients died while the FDA debated whether AZT was cost-effective.

Multiple surveys by the Competitive Enterprise Institute show that medical professionals disapprove of the FDA’s slow pace in approving promising new drugs. A majority of Orthopedic Surgeons have said FDA’s approval process is too slow and hurts patients. A staggering 70 percent believe the current law should be changed to allow physicians access to unapproved therapies.

This debate is over whether individuals should have autonomy to make informed decisions about medical procedures, or whether an overly cautious federal agency can prevent them from trying what their doctor thinks is best. The solution is to get the federal government out of people’s lives and drastically cut the FDA’s role. Unelected bureaucrats who don’t know the individuals involved or the unique circumstances of the impacted families should not be making life-and-death decisions.

President Trump has signaled he wants to reform and streamline agencies’ regulatory power. In February, the president signed an executive order that requires all federal agencies to create a task force to help “alleviate unnecessary regulatory burdens placed on the American people.” The FDA is a prime target for such reform.

In 2012, Dr. Gottlieb, said that the review culture at the FDA needs to change to encourage innovation. He has also long been supportive of deregulation. Let’s hope he follows suit with what President Trump has promised to do and implements common sense reforms at FDA to give patients more freedom to make decisions for themselves.

FDA is Trying to Snuff Out America’s Cigar Industry

New rule would cripple a $20 billion industry and put thousands of American jobs in danger

Washington, D.C. – Cause of Action Institute (“CoA Institute”) today filed an amicus curiae brief in support of Plaintiffs the Cigar Association of America, the International Premium Cigar and Pipe Retailers Association, and Cigar Rights of America in their lawsuit against the Food and Drug Administration (“FDA”) challenging a new regulation with far-ranging, negative economic impacts on consumers and small businesses engaged in the premium cigar industry. The new regulation finalized by FDA unfairly targets America’s smaller-scale cigar manufacturers, trampling on a proud American heritage and eliminating economic opportunity for many small businesses.

“Common sense appears to be dead at the FDA,” said Patrick Massari, Assistant Vice President at CoA Institute. “Inexplicably, the FDA ignored tens of thousands of comments from the premium cigar industry, Congress, local government, media, and the citizens of the United States, particularly those affected in ways large and small by FDA’s power grab. Under this new rule, the tradition of premium, hand-rolled cigars handed down by generations will turn into a corporate profit mill.”

In its brief, CoA Institute argues that FDA failed to conduct a legally sufficient cost-benefit analysis, as required by federal law and Executive Orders issued by President Clinton and President Obama. Specifically, President Clinton’s 1993 EO 12866 requires that “[e]ach agency shall tailor its regulations to impose the least burden on society, including individuals, businesses of differing sizes, and other entities (including small communities and governmental entities), consistent with obtaining the regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations.” [emphasis added].

The limited analysis FDA produced either omitted or glossed over several important costs:

  • First, premium cigar prices will substantially increase for all consumers as a result of the rule;
  • Second, the sheer compliance costs of FDA’s regulation will be so high that smaller, family-owned businesses will no longer be able to comply;
  • Third, the resulting government-defined marketplace will cripple consumer choice and bar future innovation.

Many companies will likely have no choice but to sell out to larger corporations, which will then dominate the market as regulation-protected monopolies.

The FDA itself admits that it failed to do any analysis on consumer choice, saying: “We lack a baseline estimate of consumer valuation of tobacco product variety, making it impossible to estimate how consumers who continue to use tobacco products would value the potential loss of variety due to product exit under this final rule.” Instead, the FDA ignored this essential element of cost-benefit analysis by pretending that such data does not exist.

In its brief, CoA Institute calls on the Court to order FDA to reopen its cost-benefit analysis and to vacate and remand the final rule.

The full amicus brief can be found here

About Cause of Action Institute:

Cause of Action Institute is a 501(c)(3) non-profit working to enhance individual and economic liberty by limiting the power of the administrative state to make decisions that are contrary to freedom and prosperity by advocating for a transparent and accountable government free from abuse.

For information regarding this press release, please contact Zachary Kurz, Director of Communications at CoA Institute: zachary.kurz@causeofaction.org

CoA Institute Investigates Red Tape Limiting Access to Zika Testing

Washington D.C. – Cause of Action Institute (“CoA Institute”) today sent a Freedom of Information Act (“FOIA”) request to the Food and Drug Administration (“FDA”) to examine its role in regulating laboratory developed tests (“LDTs”), including tests for the Zika virus. This investigation comes on the heels of the FDA’s post-election decision to indefinitely postpone guidance documents the FDA had issued in an attempt to regulate LDTs. 

This year, the FDA took steps to enforce its guidance against labs that had developed Zika tests. The FDA’s actions would further limit patients’ access to testing for the Zika virus, which can cause serious birth defects. The FDA and the Centers for Disease Control and Prevention (“CDC”) have already put in place a policy limiting the availability of Zika tests to only pregnant women and individuals who were exposed to Zika and are experiencing symptoms. In other words, unless pregnant, an asymptomatic person who has traveled to a country with known Zika transmission prohibited from being tested for the virus. This policy prevents couples who are trying to conceive from information that would help them make personal healthcare and family planning decisions. 

CoA Institute Vice President John Vecchione: “The FDA needs to explain its actions. After 40 years of allowing laboratories to innovate freely and offer patients a variety of tests that often meet unique healthcare needs, it is troubling that the FDA has chosen to crack down just as the Zika virus started to spread. Couples exposed to Zika who are trying to conceive should not have to face bureaucratic hurdles to obtain testing. Instead, they and their doctor should have access to testing services that meet their unique needs. Such decisions cannot be made at a bureaucracy’s pace.” 

Due to the rapid onset and spread of the Zika virus, there is still no test that has undergone the FDA approval process for in vitro laboratory developed tests (meaning laboratory tests performed in a test tube, culture dish, or elsewhere outside a living organism). Rather, the Zika tests currently available for use were all approved by the FDA pursuant to an “Emergency Use Authorization,” which comes with strict limitations.

Clinical laboratories that perform testing services were historically regulated solely by the Centers for Medicare and Medicaid Services. However, beginning in 2014, the FDA asserted that it, too, has regulatory authority over laboratory developed tests. The FDA has authority to regulate manufactured drugs and “medical devices” pursuant to the Federal Food, Drug, and Cosmetic Act. In 2014, the FDA issued draft guidance documents that assert sweeping authority to treat laboratory developed tests as “medical devices.” Accordingly, the FDA asserted authority to regulate LDTs as “medical devices” under this updated guidance.   

In addition to a CDC-developed test, private laboratory companies have developed Zika tests and obtained approval to administer the tests pursuant to the Emergency Use Authorization. However, even these tests developed by private companies are subject to the CDC’s policy limiting the test to pregnant women or symptomatic individuals who were exposed to Zika.     

CoA Institute is interested in learning more about the FDA’s attempts to regulate these tests and the impacts such regulation may have on the ability of patients and doctors to access testing services.

The full FOIA is available here


Amber Abbasi: The Curious Case of Trent Arsenault: Questioning FDA Regulatory Authority Over Private Sperm Donation

Amber Abbasi, chief counsel for regulatory affairs at Cause of Action, wrote an article for the Annals of Health Law, the Health Policy and Law Review of Loyola University of Chicago School of Law:


The Curious Case of Trent Arsenault: Questioning FDA Regulatory Authority Over Private Sperm Donation


CoA Joins Coalition of Government Accountability Advocates in Asking FDA to Revise FOIA Policy

Earlier this week, Cause of Action was proud to join a number of other transparency organizations in sending a letter to the FDA concerning their FOIA deletions policy. Read more below from Open the Government and follow this link to see the letter.



Groups to FDA: Make FOIA Process More Accountable

“On Tuesday, March 8 OpenTheGovernment.org and 16 other organizations dedicated to openness and accountability filed a comment on a public petition urging the Food and Drug Administration (FDA) to you revoke the its Freedom of Information Act (FOIA) “deletions policy.” Public Citizen originally filed the petition in September 2012.

Under the FDA’s current FOIA policy, the agency redacts portions, referred to by them as “minor deletions,” of documents released without giving requesters an immediate right to appeal within the agency. The agency instead requires requesters to make a second request for “reconsideration” of any deletions before being allowed to appeal. If a requester does not do so, the FDA administratively closes the FOIA request without ever making a final determination. The agency does not define “minor deletions,” but in practice it relies on the policy to delete substantial portions – sometimes full pages – of documents.

As described in the comment, we strongly believe the policy violates both the letter and spirit of FOIA and casts serious doubt on the accuracy of FOIA performance data that FDA provides to Congress and the public. Public Citizen’s citizen petition on this matter has been pending for more than five months and alleges a serious violation of the law; it is high time for the agency to respond to it.

Find out more about the petition, and submit your own comment, here.”

Doe v. Hamburg Amended Complaint and Exhibits

Amended complaint in Doe v. Hamburg et al. case filed on January 11th, 2013 in the US District Court for the Northern District of California.

Amended Complaint

Exhibit 1

Exhibit 2