E cigarette FDA Status

How Did the E Cigarette and the Current Status of the Federal Law Evolve?

The definitive interpretation of a law, statute, or regulation is the judiciary.  Whether it be a court of original jurisdiction (a court designated to be the first court that hears the case), or a court of appeals (a court that reviews the record and makes a determination to approve, overturn, or remand —send the case in whole or in part to the previous lower court).  In the US, when the Supreme Court makes a ruling, only new legislation or an amendment to the constitution can change the decision.

Currently, the legal status of the e cigarette as it pertains to governmental oversight occurred in the spring of 2011 when a three-judge panel of the U. S. Court of Appeals in Washington ruled that the FDA had overstepped its authority and that e cigarette and other similar products are not drugs/devices unless they are marketed for therapeutic purposes.

Why is the Federal Government Even Concerned about E Cigarette Usage?

Until January 11, 1964, the United States government’s control of the tobacco industry was limited to collection of taxes.  On that date, the Office of the Surgeon General of the U. S. released a report on the harmful effects of cigarette smoking. This report acted like a detonator on a bomb, with the e cigarette and e cigarette manufacturers eventual victims of the explosion.

However, the constitution of the US enumerates the powers of Congress as to category of laws it can pass.  Trying to include e-cigarettes as protecting the health of the citizenry, which is what the concern of the Office of the Surgeon was, is not on that list.  The problem of including e-cigarettes being covered is by using the tactic of the Commerce Clause…once something is transported across state lines, then Congress can legislate.  E cigarette distribution crosses state lines.

During the intervening years, the federal government, fuelled by additional information provided by the Office of the Surgeon General has engaged literally a war against cigarette smoking, or anything that could be considered similar to cigarette smoking.  The e cigarette falls into the latter category.

Several laws were passed by Congress with the goal of thwarting cigarette sales—the 1965Cigarette Labeling and Advertising Act, followed in 1970 by the Public Health Cigarette Smoking Act.   Interestingly, although passed in 1970, this act did not go into effect until January 1972 so that tobacco companies could advertise during the telecasts of the college football bowl games.

Developed by Hon Lik, a Chinese pharmacist, the e cigarette avoided coming under either of these laws both by intent and definition.

The FDA Decided to Extend Existing Law to Cover the E-Cigarette

Since the available cigarette laws did not cover the e cigarette or the manufacture of e cigarettes, the Food and Drug Administration (FDA) determined to extend the Federal Food, Drug, and Cosmetic Act (FD&C) to cover the import of the e cigarette by designating them as drug delivery devices.  The misplaced logic the FDA used to justify the attack strategy against e cigarette manufacturers was that e-cigarettes should be regulated as a nicotine replacement failed.

In its April 25, 2011 Letter to Stakeholders, (http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm), the FDA announced that it would not appeal the court’s decision regarding e-cigarettes.

The FDA, not to take defeat easily, is not done using the FD&C. Most recently, the FDA is attacking e cigarette manufacturers alleging producing defective products and contaminated tobacco.

What will come of this newer approach against e cigarette manufacturers? As long as the e cigarette manufacturers make a quality product, the FDA will probably not succeed.  If e cigarette manufacturers make an inferior product, the public will buy alternative brands of e cigarettes.  In either instance, the e cigarette consumer will be the ultimate adjudicator on the quality of the product, not FDA legal gyrations.

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