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Product Approval

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The most challenging and costliest part of FDA's deeming regulations is the requirement for product approval.

Every cigar sold will be required to gain approval from FDA in order to be sold in the U.S. There are two important differences between the American form of product approval and that used by most other countries.

  1. None of the Approval Costs are Paid to FDA — In many other countries, companies have to pay to register and have their brands tested by government-approved labs, that's not how it works in the U.S. Instead, there is no fee for registration of cigars, instead there are user fees paid on all cigars, new or otherwise.
  2. It is Not a Standardized Form — This isn't like applying for a driver's license or loan, instead, it's more akin to a book report. FDA gives guidance about what it is looking for, but each company can decide what to include in a submission.

There are three main pathways for product approval for cigars, though FDA only expects two to be used.

Grandfather/Predicate Products

For Cigars Introduced Prior to Feb. 15, 2007

The easiest, clearest and cheapest pathway to approval is something known as grandfathering.

Any product that was commercially marketed prior to Feb. 15, 2007—the day the Tobacco Control Act was introduced for the first time—is eligible for approval. FDA's rules argue that these products are guaranteed approval so long as companies file for the actual approval.

While they aren't required to go through advanced testing like the other methods, they are still subject to the basic FDA rules: ingredients must be disclosed, user fees must be paid and—at some point—warning labels will likely be required.

FDA estimates that 60 percent of the cigars on the market would be eligible to be approved under this pathway. It's unlikely FDA's estimation of how many cigars are on the market was accurate, so it's likely the percentage is effectively less than 60 percent.

In order to prove that a product was commercially marketed prior to Feb. 15, 2007, a manufacturer could provide the following evidence:

  • dated copies of advertisements
  • dated catalog pages
  • dated promotional material
  • dated trade publications
  • dated bills of lading
  • dated freight bills
  • dated waybills
  • dated invoices
  • dated purchase orders
  • dated customer receipts
  • dated manufacturing documents
  • dated distributor or retailer inventory lists
  • any other document you believe demonstrates that the tobacco product was commercially

FDA keeps a database of all approved grandfathered cigars here.

Substantial Equivalence

For Most Other Cigars

Substantial equivalence is a process by which a manufacturer argues that their cigar is substantially equivalent to an already-approved or grandfathered cigar and poses no additional health risks and does not market to children.

How a manufacturer goes about doing that isn't clear as of now.

FDA has issued some guidelines for how a cigar manufacturer could file a substantial equivalence report. However, the agency has also delayed substantial equivalence submissions by three years, asked for comments about how to improve its substantial equivalence process in the spring of 2019 and still has indefinitely delayed its requirements for testing until after it figures that out.

Some manufacturers have filed for substantial equivalence but none have been approved yet and it seems unlikely that will change until FDA figures out the above.

In 2016, FDA estimated that a full substantial equivalence filing would cost a company $22,787. However, some companies would be able to file for modified versions of substantial equivalence because products contained the same characteristics ($3,570) or were in a bundled substantial equivalence report ($6,836), but until the agency determines its procedure for the regular substantial equivalence, it's unclear if any of these estimates are accurate.

Furthermore, the Maryland court case could change the timelines for FDA to update its substantial equivalence process.

PMTA

The Expensive Pathway

FDA has stated that it does not believe any cigar will be required to go through the process known as Premarket Tobacco Product Application (PMTA).

This pathway is by far the most expensive, with estimates stating it will cost over $1 million. If a product applies for PMTA, it will almost certainly be an e-cigarette or vaping product where substantial equivalence is not an option. PMTAs would include far more testing than substantial equivalence, potentially including a clinical study of the product.

Other Paths

There are other pathways for approval that some cigars will use.

  • Substantial Equivalence Exemption — Manufacturers could apply for a substantial equivalence exemption if their product is simply a minor modification to an already-approved product from the same manufacturer. FDA's original comments seemed like these would be relevant to things like packaging changes, but that's no longer under FDA control due to a 2016 court decision.
  • Private Labels — FDA also has a different pathway for products that are considered private labels. If a manufacturer has an already approved product and sells the identical tobacco product to other companies with different packaging as a private label, that manufacturer could apply for a private label approval which would be far cheaper than substantial equivalence.

 

Last Updated: May 23, 2019.

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