FDA Flavor Ban

The FDA flavor ban was announced today through a new Guidance document (link here). It is important to emphasize that this is not a new law. FDA guidance documents are not a source of law but an interpretation of existing law (1). Also, the Guidance Document makesclear that the FDA through this flavor ban is lifting its previous decision.

The preamble to the May 10, 2016, final deeming rule explained that FDA intended to defer enforcement for failure to have premarket authorization during two compliance periodsrelated to premarket review..Accordingly, FDA is issuing this Final Guidance to communicate its enforcement priorities with respect to ENDS products. FDA’s decision to exercise its enforcement authorities with respect to particular products will be determined on a case-by-case basis, informed by the enforcement priorities described in this Final Guidance and any other relevant factors.

The FDA flavor ban is not a new law but is an enforcement of the 2016 law (the Deeming Regulation) due to changes the FDA has seen in the market (“In late 2017, FDA started to see a marked increase in complaints about ENDS products. FDA
initiated an investigation of these complaints, the majority of which pertained to minors’ access to and use of these products”). Now the FDA’s not worried about market disruption but about enforcement. The Agency, however, cannot enforce everywhere and everyone at the same time and so the guidance document set forth enforcement prioritization scheme. That privatization is as follows:

Specifically, FDA intends to prioritize enforcement against:
(1) Flavored, cartridge-based ENDS products (except for tobacco- or menthol-flavored
products);
(2) All other ENDS products for which the manufacturer has failed to take (or is failing to
take) adequate measures to prevent minors’ access; and
(3) Any ENDS products targeted to, or whose marketing is likely to promote use by,
minors.

(4) In addition, FDA intends to prioritize enforcement of any ENDS product that is offered for sale
in the United States after May 12, 2020, and for which the manufacturer has not submitted a
premarket application (or after a negative action by FDA on a timely submitted application)

The FDA flavor ban will place all flavors as a top priority in enforcing the PMTA requirement.

It’s important to note the flavor ban is broad:

Given the urgent need to address the dramatic rise in youth use, this Final Guidance prioritizes enforcement with respect to any flavored, cartridge-based ENDS products (other than a tobaccoand menthol-flavored ENDS product) without regard to the location or method of sale.

Also important is the definition of a cartridge, which is defined as:

Cartridge-based ENDS products are a type of ENDS product that consists of, includes, or involves a cartridge or pod that holds liquid that is to be aerosolized through product use. For purposes of this definition, a cartridge or pod is any small, enclosed unit (sealed or unsealed)
designed to fit within or operate as part of an electronic nicotine delivery system.

At 53 pages the guidance document contains a wealth of detail that cannot be covered in full on this post. Also, there may be a case by case situations that are not addressed by the guidance document. For more more information please contact my office for a consultation.

(1) See FDA link here (Guidance documents represent FDA’s current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.).

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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