Sunday, November 03, 2019

Why I Think the FDA's Imminent Ban on Flavored E-Cigarettes is Unlawful

I expect the FDA to announce soon that it is banning the sale of all flavored e-cigarettes, with the exception of tobacco and probably mint and menthol as well.

As you know, when an executive agency issues a regulation, it is required by the Administrative Procedures Act (APA) to go through a formal rule-making process, which at a minimum requires that the agency publish the proposed rule in the Federal Register, allow public comment on the rule, and then respond to the comments before actually issuing the rule. This process can take one to two years.

The question you may be asking is: How can the FDA ban flavored e-cigarettes without issuing a rule that bans flavored e-cigarettes and that goes through the required APA process?

I expect that the FDA is going to use its enforcement authority, rather than a formal rule-making process, to "promulgate" a de-facto ban on the sale of most flavored e-cigarettes, exempting only tobacco, mint, and menthol flavors.

I believe they will attempt to escape the required public input and due process requirements of administrative rule-making by issuing a "guidance" regarding its enforcement of the pre-market tobacco application (PMTA) requirement, whose enforcement it is currently holding off on until May 2020.

So what the FDA will likely do is to issue a guidance announcing that it is going to use its enforcement authority to enforce the PMTA requirement "immediately" for all flavored e-cigarettes. This means that any flavored e-cigarette that has not yet submitted a PMTA (which is every flavored e-cigarette) will have to be taken off the market until they submit and gain approval of a PMTA (which will be never for almost all companies except for the cigarette companies and perhaps a few of the largest independent companies). So not only will most flavored e-cigarettes have to come off the market but what does remain of the market will be handed over to the tobacco companies.

So the following question arises:

Is It Legal for the FDA to Ban Flavored E-Cigarettes By Issuing a Guidance and/or Using Its Enforcement Authority Regarding PMTAs?

The answer, I believe, is no, for three major reasons.

1. Such a guidance would violate the Executive Order on Promoting the Rule of Law Through Improved Agency Guidance Documents and the Executive Order on Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication

On October 9, 2019, the president issued an executive order that requires for any significant guidance document:

"a period of public notice and comment of at least 30 days before issuance of a final guidance document, and a public response from the agency to major concerns raised in comments, except when the agency for good cause finds (and incorporates such finding and a brief statement of reasons therefor into the guidance document) that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest."

The rationale for this executive order seems to perfectly describe what the FDA is doing here and why it is not appropriate or legal:

"Agencies may clarify existing obligations through non binding guidance documents, which the APA [Administrative Procedures Act] exempts from notice-and-comment requirements.  Yet agencies have sometimes used this authority inappropriately in attempts to regulate the public without following the rulemaking procedures of the APA.  Even when accompanied by a disclaimer that it is non-binding, a guidance document issued by an agency may carry the implicit threat of enforcement action if the regulated public does not comply.  Moreover, the public frequently has insufficient notice of guidance documents, which are not always published in the Federal Register or distributed to all regulated parties.

Americans deserve an open and fair regulatory process that imposes new obligations on the public only when consistent with applicable law and after an agency follows appropriate procedures.  Therefore, it is the policy of the executive branch, to the extent consistent with applicable law, to require that agencies treat guidance documents as non-binding both in law and in practice, except as incorporated into a contract, take public input into account when appropriate in formulating guidance documents, and make guidance documents readily available to the public.  Agencies may impose legally binding requirements on the public only through regulations and on parties on a case-by-case basis through adjudications, and only after appropriate process, except as authorized by law or as incorporated into a contract."

An "enforcement authority"-imposed ban on flavored e-cigarettes also appears to violate a second emergency order, also issued on October 9 of this year.

That executive order states that:

"When an agency uses a guidance document to state the legal applicability of a statute or regulation, that document can do no more, with respect to prohibition of conduct, than articulate the agency’s understanding of how a statute or regulation applies to particular circumstances.  An agency may cite a guidance document to convey that understanding in an administrative enforcement action or adjudication only if it has notified the public of such document in advance through publication, either in full or by citation if publicly available, in the Federal Register (or on the portion of the agency’s website that contains a single, searchable, indexed database of all guidance documents in effect)."

Since I do not believe that the FDA notified the public of this new enforcement approach through publication, it seems that it would violate this executive order.

2. Such a guidance and/or new policy on enforcement action would violate the Congressional Review Act.

The Congressional Review Act (5 U.S. Code 801-808) requires that a federal agency submit any rule to Congress prior to its issuance. Congress has an opportunity to disapprove the rule via a joint resolution. While it may seem that a guidance or a new policy on enforcement action is not a "rule," the definition of "rule" in the Congressional Review Act is quite broad, being defined as:

"the whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy."

In addition, this past April the Office on Management and Budget issued a memorandum explaining that in its view:

"The CRA applies to more than just notice-and-comment rules; it also encompasses a wide range of other regulatory actions, including, inter alia, guidance documents, general statements of policy, and interpretive rules."

The imminent ban on flavored e-cigarettes would appear to fit under this definition.

3. Such a guidance and/or new policy on enforcement action would violate the Administrative Procedures Act because it represents "Rule-making by enforcement."

I believe there is a legitimate argument that what the FDA is attempting to do represents rule-making by enforcement action. It is generally held that rule-making by enforcement is not permissible because it circumvents due process.

Finally, even if it were lawful for the FDA to promulgate a rule banning flavored e-cigarettes merely by announcing a new enforcement action policy, I do not think it is an appropriate action. A policy of this magnitude, which is going to affect the national economy in a major way, is going to shut down almost an entire industry, is going to create new black markets, and is going to cause severe public health consequences, should not be implemented by enforcement action, but by a formal rule-making process.

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