Appeals Court May Sidestep E-Cig Key Issue - ARGUMENT THURS - Reports ASH

Although the e-cig industry is eagerly awaiting oral argument Thursday before the U.S. Court of Appeals, hoping to get some inkling of how the court will rule concerning the FDA's power to regulate their product, the court may sidestep that issue
By: Action on Smoking and Health (ASH)
 
 
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Sept. 21, 2010 - PRLog -- Although the e-cigarette [e-cig] industry is eagerly awaiting oral argument Thursday before the U.S. Court of Appeals, hoping to get some inkling of how the court will rule concerning the Food and Drug Administration's [FDA] power to regulate their product, the appellate court may sidestep that key issue and postpone judgment by focusing on procedural problems with the case, says public interest law professor John Banzhaf, who was a party to the proceeding in the lower court.

Instead of deciding whether the FDA must regulate e-cigs as "tobacco products" or as a "drug-device combination," the court may well conclude that this issue is not properly raised in these convoluted and long delayed proceedings, especially since the FDA has just created several new proceedings in which the legal issue is more properly raised, and has been ruled upon in a more final proceeding at a much higher agency level.

The case, now called Sottera, Inc. v. FDA [10-5032], was originally brought by another company known as Smoking Everywhere. It challenged the authority of the FDA to prevent imports of its e-cigarettes. Under the then-existing law, the FDA could do this only if e-cigs were drug-device combination devices since the agency, under a prior U.S. Supreme Court decision, had no jurisdiction over tobacco products like cigarettes, chewing tobacco, etc.

However, Congress subsequently passed the Family Smoking Prevention and Tobacco Control Act which gave the FDA authority to regulate tobacco products. Thus, all parties now agree that the FDA has the authority to regulate e-cigs; the only legal issue is under what category they fall. As drug-device combination devices they must meet difficult regulatory hurtles, while as "tobacco products" they would be less strictly regulated.

Also, because Smoking Everywhere is no longer a party to the case, there may be much less reason to rule on the central legal issue.

Before appellate courts rule on -- much less decide to reverse -- a decision by a major federal regulatory agency, they usually want to be sure that the agency itself has in fact already decided the precise legal issue, and that it did so finally and at a very high level in the agency not likely to be changed later.

Here, Sottera, the only company remaining in the case, may have had some e-cig imports interfered with, but only at the most preliminary level -- a notice of "Detention" -- which is only the first of many steps to the process towards a final agency decision. Moreover, any such interference occurred long before the Tobacco Control Act became effective, so it is not at all clear that the FDA made a determination about how such products would be regulated under the Act, or that the decision which was made was sufficiently final,or made at a sufficiently high agency level, to warrant judicial review.

Thus, says Prof. Banzhaf, who teaches Administrative Law, the court may decide that the issue of how e-cigs should be regulated by the FDA under the Act is not ripe for review at this time because the agency has either never ruled on this legal issue, or did so only in a very preliminary fashion and at a very low agency level.

In sharp contrast, and perhaps not just by coincidence, the FDA has just sent letters on the eve of oral argument to several e-cig companies. These letters assert that their products must, under the Act, be regulated as drug-device combination devices rather than as tobacco products.

These letters appear to be far more conclusive than the notice of Detention which may have been applied to Sottera under the old law, and is signed by a high agency official: Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research.

These letters might have been sent by the FDA, just prior to the oral argument, to help convince the court that a law suit based upon the actions taken with regard to these companies, rather than the doubtful action taken almost two years ago regarding Sottera, provide a much better legal basis for judicial review.

In other words, the court might find that it can dispose of the Sottera situation without reaching the key underlying issue based upon common administrative law principles like lack of ripeness, failure to exhaust the administrative remedies which the FDA provides, the absence of final agency action, and even mootness.

"Any such attempt by the court to dispose of the case without reaching the issue of the FDA's jurisdiction over e-cigs under the newly-passed statute would be very disappointing to the many e-cig companies following this proceeding, but it is consistent with a court's reluctance to overrule an agency, especially on a matter related to the public health, before it is necessary to do so, and then only if the record is complete," says Banzhaf.

This proceeding, Sottera, Inc. v. FDA [10-5032], will be argued before the U.S. Court of Appeals for the District of Columbia Circuit shortly after 10:00 AM on Thursday, September 23, 2010, in Courtroom 11 on the fifth floor of the E. Barrett Prettyman United States Courthouse at Third Street and Constitution Avenue, NW, Washington, D.C. It is located one block west of the United States Capitol.

The building faces Constitution Avenue where Constitution and Pennsylvania Avenues have merged.

The appellate court panel hearing this case consists of judges Merrick B. Garland, Brett M. Kavanaugh, and Stephen F. Williams.

PROFESSOR JOHN F. BANZHAF III
Professor of Public Interest Law at GWU,
FAMRI Dr. William Cahan Distinguished Professor,
FELLOW, World Technology Network, and
Executive Director and Chief Counsel
Action on Smoking and Health (ASH)
America’s First Antismoking Organization
2013 H Street, NW
Washington, DC 20006, USA
(202) 659-4310 // (703) 527-8418
Internet: http://ash.org/
Twitter: http://twitter.com/AshOrg

# # #

Action on Smoking and Health (ASH), America's first anti-smoking and nonsmokers' rights organization, serves as the legal action arm of the anti-smoking community. It is supported by tax-deductible contributions.
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Tags:E-cigarette, E-cig, Fda, Court Of Appeals, Banzhaf, Ash, Ripeness, Tobacco Product, Drug Device Combination, Sottera
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