When the U.S. Food & Drug Administration (FDA) announced its intention to regulate a variety of tobacco products, including cigars, it issued a variety of documents highlighted by a 499-page read explaining the new rules and its intentions. Despite the literal pounds of paper released in May, the agency acknowledged that there were gray areas and that in some cases, it was still deciding exactly how to regulate these products. In some of the more complex parts of the rule, FDA said it would issue guidance at a later date.

Yesterday came word that guidance would be issued on at least one major topic: warning labels and advertising.

As part of the new regulations, oftentimes described as the deeming regulations, the packaging cigars come in—boxes and bundles—along with advertising will be subject to warning labels.

Draft guidance is non-binding and is said to describe the agency’s current thinking. In short, FDA could change its mind and introduce binding rules that are less or more restrictive than those published today.

FDA is asking for comments from the public on the guidance document, with the submission for comments window open for the next 30 days.

Very little of what’s in the 14-page document is new or revealing with one exception: FDA has produced an example of what it believes a cigar warning plan submission will look like.

A cigar warning plan is a document submitted to FDA that outlines how a manufacturer plans to comply with the aforementioned requirements requiring labels on both packaging and advertising.

Manufacturers and/or importers will be required to submit the document no later than May 10, 2017 for existing products and at least 12 months before any new product is scheduled to be marketed for the first time.

The document will explain how the manufacturers plan on using the six—or in some cases seven[ref]Altadis U.S.A, General Cigar Co. and Swisher International/Drew Estate are subject to a previous agreement with the Federal Trade Commission (FTC) that currently requires them to display warning labels. These companies will have the option to continue using the current language, meaning they have seven potential warning messages. Regardless all companies must adhere to the same rules regarding usage and rotation.[/ref]—warning labels. These warning labels must be used evenly on boxes produced for a specific cigar and rotated quarterly in advertising.

As such, if a manufacturer produced 600 boxes of a particular cigar, 100 boxes would have to display one label, another 100 would have to display the second label, etc.

While the submissions are due by May 10, 2017, boxes won’t be required to have these warning labels until May 10, 2018.

FDA states that it believes it will take up to 12 months to approve warning labels plans, particularly the initial round, which will require every single cigar manufacturer doing business in the U.S.  to submit a warning plan.

As for retailers, most will not have to submit a warning plan. FDA has stated that retailers will need to have an 8 1/2 x 11 sign with the six warning messages placed near the point of sale, i.e. the cash register, and retailers will need to ensure that any advertisement or package has the required warning labels once the rules go into effect, i.e. May 10, 2018.

In addition, retailers cannot modify or cover up any warning labels.

The document provides no clarification as to what warning labels will be required for retailers who sell cigars online, in catalogues or other non face-to-face transaction. FDA has previously stated that retailers who ship individual cigars to consumers should place a warning label on the outside of the shipping box to satisfy warning label requirements (Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act…, 356).

It remains to be seen how warning labels will be required in regards to the pages of catalogs and online storefronts. Under the harshest of requirements, the warning statement on an individual page would likely not be the largest issue for retailers, but rather a requirement to submit individual pages as part of a warning plan 12 months in advance.

Finally, the guidance document made no clarification to the question of selling samplers, or even a collection of loose cigars, by a retailer. Some believe that FDA might interpret the act of placing loose cigars into a bag and/or advertising a five-pack sampler by a retailer might constitute the sampler as a new product. If it was considered a new product, it would be required to be approved by FDA and the retailer would have to register as a manufacturer. It should be noted, FDA has made no public statement about this.

Samplers that come pre-packaged by a manufacturer are considered their own SKU and subject to applicable FDA rules that apply for all cigars.

Despite the attempts at clarification, the guidance document provided little new information. In addition to some of the above topics, it didn’t clarify about how FDA plans on regulating social media accounts for cigar companies and retailers and/or individuals who work for cigar companies and retailers.

In many instances, there’s very little precedent for how the agency will decide these issues. The cigarette and smokeless tobacco industries are regulated by a series of rules, almost all of which cigars aren’t privy to, and many of which were not implemented by FDA.

There have been those falsely claiming that the regulations extend beyond what is described above. Some have claimed that warning labels will be required for all apparel and promotional items—a restriction that applies to certain manufacturers[ref]Altadis U.S.A, General Cigar Co., Swisher International/Drew Estate.[/ref] due to a previous agreement with FTC. FDA has stated that it is not extending any restrictions to these items at this time.[ref]These restrictions, as well as a plethora of others, exist for the cigarette industry due largely to rules and regulations agreed upon with agencies other than FDA. The most restrictive of which is the Master Settlement Agreement.[/ref]

Others have claimed that individual cigars wrapped in cellophane would be required to have warning labels on each individual cellophane. This is something the FDA has consistently stated is false. The draft guidance reiterates this point, “Cigars that are sold individually, without any packaging, are exempt from the packaging requirements.” (Submission of Warning Plans for Cigars, 3)

For more information, please visit halfwheel.com/fda.

Charlie Minato

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I handle the editing of our written content, the majority of the technical aspects of the site and work with the rest of our staff on content management, business development and more. I’ve lived in most corners of the country and now entering my second stint in Dallas, Texas. I enjoy boxing, headphones, the Le Mans 24-hour, wearing sweatshirts year-round and gyros. echte liebe.