“We completed our review of your Substantially Equivalent (SE) Report submitted under section 905(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and determined that the new tobacco product is not substantially equivalent to the predicate tobacco products listed in Appendix A…..“
These are the words that start the letter from the FDA that a tobacco product has not met the requirements of the FDA for Substantial Equivalence and must be pulled from all the shelves in the USA. This is a letter, a manufacturer or brand owner does not want to receive as it will force them to remove their non-compliant product from humidors in shops across the country. Sadly, the process to get approval has not been crystal clear and requires much work from lawyers to get the paper work complete.
If such a product fails to meet the FDA requirements the letter also notes the reasons that include such statements as:
The following deficiencies are the basis for our determination:
The length of time between the manufacture of the new tobacco product and the conduct of harmful and potentially harmful constituent (HPHC) testing (18-24 months after manufacture) is approximately 6 to 12 months longer than that for predicate tobacco product 1.
Your SE Report lacks stability or shelf-life study information for the predicate tobacco products. A detailed description of stability testing, including test protocols, quantitative acceptance criteria, data sets and a summary of the results for all stability testing performed over the complete storage time of the new and each predicate tobacco product was necessary to assess the new and predicate tobacco products.
At a minimum, FDA needed measurements for all of the following for each predicate tobacco product:
b. Water activity (aw);
c. Moisture content;
d. TSNAs (total, NNN, NNK);
e. Nicotine content; and
f. Bacterial load
Ideally, measurements of these parameters should have been made at the beginning, middle, and end of the expected storage time and at the expected storage conditions of the tobacco products. If any of the measurements of stability had differed between the new and predicate tobacco products, evidence and scientific rationale demonstrating that these differences do not cause the new tobacco product to raise different questions of public health were needed.
As you can see, the process is long and if not done precisely to the needs of the FDA they can and will rule against the predicate/substantial equivalence request. When they do rule against a tobacco product the FDA will also include the following statement:
Your SE Report lacks sufficient information to support a finding of substantial equivalence; therefore, we are issuing an order finding that this new tobacco product is not substantially equivalent to an appropriate predicate tobacco product. Upon issuance of this order, your tobacco product is misbranded under section 903(a)(6) of the FD&C Act and adulterated under section 902(6)(A) of the FD&C Act. Failure to comply with the FD&C Act may result in FDA taking regulatory action without further notice. These actions may include, but are not limited to, civil money penalties, seizure, and/or injunction
The above was the case for 13 different tobacco products that the FDA ruled against and decided they were not substantially equivalent. Those products include:
- Camel Sticks Mint, Viceroy Flex, Camel Strips Mint and Camel Orbs Mint by R.J. Reynolds Tobacco Co.
- Skoal Smooth Mint Tobacco Stick, Skoal Rich Tobacco Stick, Skoal Mint Tobacco Stick and Skoal Original Tobacco Stick by U.S. Smokeless Tobacco Co.
- Union Full Flavor 100s Box, Union Gold 100’s Box, Union Platinum 100’s Box, Union Menthol 100’s Box and Union Menthol Gold 100’s Box by Heritage Tobacco, LLC.
The FDA has since ordered these products not be sold, distributed, imported, marketed or promoted in the U.S. as the FDA considers them to be misbranded and adulterated.
What does this all mean
You may be asking why do I bring this up? I bring this up because this is just the start of what will be a full fledged barrage of Substantial Equivalence (SE) orders by the FDA, as the Premium Cigar Industry must submit SE requests by September 9, 2020 or risk having products pulled from shelves.
As I write this, Attorneys for the Premium Cigar Industry and the FDA were once again presenting arguments in Federal Court regarding the FDA’s deeming regulations. You can read a re-cap of today’s hearing on Halfwheel.com where Charlie Minato breaks it down for you, but sadly no decision was made.
So here we are with the September 9 date looming and we have little to no SE applications approved and many that have yet to be submitted.
We as a combined industry of consumers, retailers, manufacturers, brand owners and farmers are all in this fight together. The Combined work of the Premium Cigar Association (PCA) and Cigar Rights of America (CRA) are fighting the battle day in and day out. We have had some court wins recently and we should applaud the work done on the industry’s behalf, but they need our help. So do your best to support these organizations and write you local, state, and federal representatives to explain how such overreaching regulations are hurting small businesses across the country. If you would liek to sign the petition, the CRA has an easy form online here.