[PUBLISHER"S NOTE: This is an article about the effects of the pending ruling by the FDA on the inclusion of new tobacco products subject to its approval. It was originally posted on Facebook and written by none other than Lew Rothman, the legendary cigar expert and former owner of JR Cigars, one of the world's largest cigar distributors. He has graciously allowed us to repost his work here.]

A lot of people on the various cigar sites (Herfers Paradise, Cigar Weekly, Cigar Aficionado, Cigar Family, etc., have posted information that is somewhat correct, somewhat incorrect, or somewhat incomplete. So I figured I would just post the ruling as it actually is.

These rulings will have dramatic implications for both the consumers and the manufacturers and importers.

Here it is:
FDA Final Rule Details

• The FDA's final rule, "Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act," extends the agency's current authority to regulate cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and smokeless tobacco to products that meet the statutory definition of "tobacco product," except accessories of the newly deemed tobacco products, under the Federal FD&C Act, as amended by the Family Smoking Prevention and Tobacco Control Act. It takes effect on August 8, 2016, or 90 days after the final rule is officially published in the Federal Register on May 10th. "Deeming" all tobacco products to be subject to the FD&C Act "will result in significant benefits for the public health," FDA said. 

The final rule has two main sections. The first section on "deeming provisions" clarifies that the rule will cover all cigars, rather than a subset, and include other currently marketed products like dissolvables, gels, waterpipe tobacco, electronic nicotine delivery systems, pipe tobacco, and any current and future products that meet the statutory definition of "tobacco product." The second section on "additional provisions to protect public health" bans the sale of "covered tobacco products" to anyone under 18, requires the display of health warnings on product packages and advertisements, and prohibits vending machine sales of tobacco products unless the machine is located in a facility that bans minors from entry. The health warnings are required on cigarette tobacco, RYO tobacco, and covered tobacco product packages. FDA also announced that it intends to issue, "in the future," a proposed product standard that would "eliminate characterizing flavors in all cigars including cigarillos and little cigars." 

Manufacturers of newly deemed products that are "new tobacco products" will be required to obtain premarket authorization of their products through substantial equivalence (SE), exemption from SE, or premarket tobacco product applications. For newly deemed products that are on the market as of the effective date of the final rule but were not on the market on February 15, 2007, manufacturers have a 12-month initial compliance period to submit an SE exemption request, an 18-month initial compliance period to submit SE applications, and a 24-month initial compliance period to submit premarket tobacco applications (PMTA). The "continued compliance period" (the time during which FDA does not intend to enforce the premarket review requirements" will close 12 months after the initial compliance period closes [NOTE: See table for a clarification of these application deadlines.] (FDA 5/5).

• During a media briefing, Center for Tobacco Products Director Mitch Zeller said among other things that: the final deeming rule is a "foundational step" to regulate currently unregulated products; FDA took over 135,000 public comments into ed-inform.net; ENDS are most likely to go through the premarket tobacco application pathway given the relative newness of their technology; and the approval of eight new products [Swedish Match's General snus product] through the premarket tobacco application shows the viability of the pathway. Zeller also said that the FDA's "review of scientific evidence" determined that there is no public health justification to exclude premium cigars from the deeming rule, and that excluding it would be "neglecting FDA's duty to protect public health." The FDA estimates the PMTAs to cost "several hundred thousand dollars" per application, but there will be subsequent "improving efficiencies" that allow companies to use a "master file" with information on specific components of a product. On the two riders in HR 5054, which would exempt premium cigars from FDA regulation and change the predicate date of February 15, 2007, so that products on the market as of the effective date of the final rule would be grandfathered, Zeller said they "would have an adverse impact on public health," and the Obama administration "opposes the two riders." It is unknown whether President Obama would veto HR 5054 if the bill contained the two riders and reached his desk for approval (FDA media briefing 5/5).

During the "industry" briefing, Zeller pointed out that the final rule has a provision for "small-scale tobacco product manufacturers," defined as a manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5 million or less. Those small-scale manufacturers would have additional time to comply with certain provisions, such as additional time to respond to SE deficiency letters, an additional six-month compliance period for the tobacco health document submission requirements, and additional time to submit ingredient listing. They will also receive additional assistance with their marketing applications, including a designated "Regulatory Health Project Manager" who will be the single point of contact at FDA CTP Office of Science to help them navigate through the regulatory process. FDA said it slightly revised the nicotine warning statement to read: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." [NOTE: The already-deemed tobacco products, cigarette tobacco and roll-your-own tobacco are also subject to the nicotine warning statement.] For products that do not contain nicotine, the warning statement will read: "This product is made from tobacco."

Zeller also highlighted additional documents accompanying the final rule on www.fda.gov/tobacco, including a Guidance for Industry on tobacco product master files, a Draft Guidance for Industry on the FDA's current thinking on premarket tobacco product applications for ENDS, a Final Rule on submission of data needed to calculate user fees for domestic manufacturers and importers and Small Entity Compliance Guides for the deeming rule and data submission. FDA also updated its page on CTP Office of Small Business Assistance (OSBA) for small tobacco product manufacturers (FDA industry briefing 5/5).

DEEMING REGULATION – INDUSTRY DEADLINES
(As of August 8, 2016)

Large Manufacturers Small-Scale Manufacturers:

HPHC Reporting 36 months (August 2019) 36 months (August 2019)

Substantial Equivalence Stop-Depression-Now 12 months to submit (August 2017); plus 12 months to approval 18 months to submit (February 2018); plus 12 months to approval

Substantial Equivalence Reports 18 months to submit (February 2018); plus 12 months to approval 24 months to submit (August 2018); plus 12 months to approval

Pre-Market Product Applications (PMTA) 24 months to submit (August 2018); plus 12 months to approval 30 months to submit (February 2019); plus 12 months to approval

A "Small-Scale Tobacco Product Manufacturer" is a manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5,000,000 or less.