Smokeshop October 2014 - Regulation Focus - Premium Cigars Face Regulation Strangulation under FDA

Sep 27, 2026

Smokeshop October 2014 analyzes how FDA “deeming regulations” and pre-market review requirements could restrict the premium cigar industry. The discussion outlines current pathways to approval, including Substantial Equivalence, Exemption, and Pre-market Tobacco Applications, and explains how new or modified products may be treated as new products requiring FDA approval. It highlights planning uncertainty, potential exemption proposals, and burdens for small makers, especially due to product variability and costly testing demands.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages4

Reading Time10 min

AccessFree to download

Regulation Focus

Premium Cigars Face Regulation Strangulation under FDA

Overview of Current Premarket Review Requirements

Relevant Considerations for the Cigar Industry

What Are Deeming Regulations?

Pre-Market Review is Disproportionately Burdensome for Cigar Manufacturers

T H E I N D U S T R Y A U T H O R I T Y O N T O B A C C O R E TA I L I N G Official Publication of the International Premium Cigar & Pipe Retailers Association (IPCPR) October 2014 TESA CIGARS Self-Taught Blender Chris Kelly Produces Cigars at his Family’s Nicaraguan Factory for His Chicago Cigar Shop & Lounge Plus: > WHAT THEY SAID: Industry Comments on FDA Deeming Regulations > M&R HOLDINGS: U.S.A.’s Largest Private Label Tobacco Producer Keeps atthe Forefront of Trends > DREW DIPLOMATS: Innovative Cigar Maker Drew Estate Adds a New Twist to Incentive Program |
REGULATION FOCUS | | | | --- | --- | --- | |
Premium Cigars Face Regulation
Strangulation under FDA
The potential impact ofFDA pre-market review requirements on the premium cigar industry can be underestimated: small makers and small batch releases would be in jeopardy unless separate rules are implemented for cigars. > BY NANCYELLEN KEANE, ESQUIRE | | OVERVIEW OF CURRENT PREMARKET REVIEW REQUIREMENTS
Current pre-market review requirements apply to manufacturers of cigarettes, smokeless, roll-your-own, and cigarette tobacco. The purpose behind pre-market review of new tobacco products is to confirm that new products are not more dangerous than grandfathered or provisional products.“Grandfathered”products may be introduced into U.S. commerce without prior approval from FDA, as these were in U.S. commerce as of February 15, 2007. Any of these products changed or introduced after February 15, 2007 is considered a new product. Those introduced between February 15, 2007 and March 22, 2011 are given an intermediate “provisional”status by FDA, allowing them to remain in commerce until approved or denied by FDA. After March 22, 2011, any change to an existing product results in anew product requiring pre-market review and approval by FDA before introducing the product into commerce. New tobacco products that are sold without the required FDA order are deemed to be adulterated and cannot be legally sold. Thus far, pre-approval by FDA is not a simple concept and has not proven to be quick or inexpensive.
RELEVANT CONSIDERATIONS FOR THE CIGAR INDUSTRY
For planning purposes, cigar manufacturers should prepare as if the current regulations will apply, although it is not yet clear whether they will apply without changes. There is a proposal pending to exempt a defined category of premium cigars from regulation, and if accepted, then these products would not be regulated. If the very same regulations were to apply, then cigar makers should expect most of the same requirements as currently exist for pre-market review of new products. Pre-market review will pose unique burdens for cigar manufacturers. | | I
n the five years since the Tobacco Control Act was enacted in June 2009, giving the United States Food
and Drug Administration (FDA) regulatory authority over certain tobacco products, very few new tobacco products have been approved under any of the three pathways to approval: Substantial Equivalence, Exemption, or Pre-market Tobacco Application.
The results of passing this law have been to limit product innovation, prevent changes that could benefit public health, and to place a significant barrier to entry into the portions of the industry related to cigarettes, smokeless, roll-your-own and cigarette tobacco. Despite few approvals and relatively few actions taken by FDA on enforcement matters for the products it currently regulates, and a lengthy back-log of existing premarket review applications in the existing tobacco categories, the agency is pressing forward with its request to add more products to its purview via deeming regulations. | WHAT ARE DEEMING REGULATIONS?
FDA seeks to expand the definition of tobacco products to add such products as cigars, pipe tobacco, and e-cigarettes to its portfolio. The agency recently received over 50,000 public comments about this proposed regulation and is reviewing those at

FAQs

What are the current FDA pre-market review requirements mentioned in the document?

The document explains that pre-market review applies to cigarettes, smokeless tobacco, roll-your-own, and cigarette tobacco. It aims to ensure new tobacco products are not more dangerous than grandfathered or provisional products.

How does the document describe “grandfathered” and “provisional” products?

“Grandfathered” products can enter U.S. commerce without prior FDA approval if they were in commerce as of February 15, 2007. Products introduced between February 15, 2007 and March 22, 2011 receive a provisional status until FDA approves or denies them.

What burdens does the document attribute to pre-market review for cigar manufacturers?

It notes that cigars are artisanal and not homogeneous, creating many products with slight variances. Under the interpretation that virtually every change is a new product needing prior FDA approval, requirements could be costly and disproportionate, especially with extensive testing demands.

Sep 27, 2026

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