In the latest episode of The FDA Update with Frank Herrera we talk about the August 16th order issued by the judge in the case Philip Morris brought against the FDA. The opinion rendered applies to the guidance documents the FDA provided with regard to Substantial Equivalence (not the actual deeming regulations), and looks to be beneficial to cigar manufacturers. You may have heard something about it- it has to do with packaging changes and box counts. What you may not know yet is that doesn’t guarantee packaging changes are in the clear, it means the ball is back in the FDA’s court. Per the judge’s order, the FDA has to update the guidance document on the matter. (Side note, this is the same judge presiding over the CAA/CRA/IPCPR case.)

The reissuing of the guidance document creates another issue- time. Specifically the time that passes between the August 16th order and whenever the new document is presented. During this period, there is no official guidance for the regulations, and that lost time is an added burden on the cigar industry. How can you file your required reports when the official guidance is being modified? Manufacturers will have less time to file their Substantial Equivalence documentation and/or do followup filings, should they be required.

Frank goes over what is happening with a few other cases out there that may have an impact on the cigar industry. One of them is a suit filed in California by Vape company Lost Art Liquids, LLC. Another is one filed in D.C. by NICOPURE LABS, LLC. We also discuss the status of his case (representing Global Premium Cigars, aka 1502 Cigars) and the CAA/CRA/IPCPR case. (Complete case list at the end of this post.)

We also talk a little bit about how to approach Substantial Equivalence filings. How much information is too much, and how general you can reasonably go with product. Frank answers questions like “why can’t you just file for Substantial Equivalence for all new cigars on that grounds that they’re all black tobacco just like scores of existing products?” That leads to a discussion of how little the FDA truly understands the cigar industry.

As before, this post and the video you are about to watch are not legal advice. Brian is not a lawyer, nor is he a paid or unpaid spokesman for a lawyer. Brian avoids all suits as much as possible, law or otherwise. If you are need of some legal advice and/or assistance with the FDA regulations, Frank is happy to help. You can contact him at CigarLaw.com (@CigarLaw on Twitter), hnewmedia.com (@hnewmedia on Twitter) or on Facebook.

Cases Discussed:
Philip Morris: Civil No. 15-cv-1590 (APM)
Lost Art Liquids, LLC: Case # 2:16-cv-03468-SJO-FFM
NICOPURE LABS, LLC: Case # 1:16-cv-00878-ABJ
CAA/CRA/IPCPR: Case # 1:16-cv-01460-APM
Global Premium Cigars: Case # 16-cv-21967 (USDC SD Fla)

See Also
Previous FDA Update