FDA Announces Proposed Record-Keeping Rules for Substantial Equivalence

Yesterday, the U.S. Food & Drug Administration (FDA) published proposed rules for the process of applying for agency approval of e-cigarettes and vaping products. Almost none of the more than 300 pages of the proposed rule have anything to do with cigars—though some of the proposed process could eventually make it into the process for applying for approval for cigars in the future—other than a small notice about the agency’s expectations for how cigar companies keep records of their products.

In short, companies that apply for substantial equivalence—one of the two main pathways cigar companies will seek to get FDA approval for their products—will be expected to keep records of communication with FDA, testing data, examples of product labeling, advertisements of the products and others for four years after FDA has acknowledged it has received the documents.

For grandfathered products, companies will be expected to keep most of the same records, though notably those products won’t need testing data as grandfathered products won’t be required to be tested.

The rest of the document deals with a process known as a premarket tobacco product application (PMTA). While it is expected that this is how most, if not all, e-cigarette and vaping products get FDA approval, FDA has repeatedly stated that it does not believe this will be an approval process that will be necessary for any cigars.

There are parts of the PMTA proposal that will likely be of interest to cigar companies. The document outlines how FDA will view the timelines for the submission process—including what were to happen if a company were to submit an application and then modify the application or product—as well as potential penalties for violations.

FDA is still finalizing the substantial equivalence process, so more guidance will be needed from the agency before a complete set of rules are created for cigar companies. It is possible that some of those minor details might be different between the PMTA process and the two cigar companies will use for FDA approval.

None of what FDA published on Friday is law yet. The agency will formally file the proposal on Wednesday, Sept. 25, and there will be a comment period of at least 90 days for interested parties to submit their thoughts. From there, the agency will need to review and respond to comments meaning that these changes won’t go into effect until 2020 at the earliest.

You can view the proposal here.