The undersigned organizations submit these comments in the above referenced Docket on the Draft Guidance for Industry on the Food and Drug Administration’s (FDA) proposed Modifications to its Compliance Policy for Certain Deemed Products, issued in March 2019 (Draft Guidance).

The Draft Guidance can be a step forward if it reduces youth access to the flavored products that have contributed so significantly to the problem of youth tobacco use. However, unless strengthened, the Draft Guidance falls short of the forceful action needed to address a public health crisis of this magnitude.

As explained in detail below, on balance we believe the Draft Guidance to constitute an insufficient response to the current crisis of youth e-cigarette use, as well as to the continuing adverse public health consequences of youth cigar smoking, for the following reasons:

  • The Draft Guidance will allow flavored e-cigarettes, with great appeal to young people, to remain on the market for years to come without FDA public health review.
  • The restrictions on youth access to flavored e-cigarettes at retail stores and on-line proposed in the Draft Guidance are likely to be inadequate to address the youth e-cigarette epidemic.
  • The special treatment given to menthol and mint-flavored e-cigarettes in the Draft Guidance has no public health justification and leaves widely available products that the latest survey data shows are commonly used by youth.
  • As FDA recognizes, action is needed to curtail advertising and marketing that makes these products attractive to young people, but the proposed prioritization of enforcement against the advertising and promotion of ecigarettes targeting youth appears insufficient to address the kinds of targeted advertising and promotion most responsible for fueling the current youth e-cigarette epidemic.
  • The Draft Guidance lays the appropriate groundwork for action against flavored cigars, but expedited action should be taken to take them off the market and to move toward a rule prohibiting characterizing flavors in cigars.

Read Full Comments of Public Health Groups on FDA Draft Guidance Modifying Compliance Policy for Certain Deemed Tobacco Products