The FDA Facts As I See Them – A David Garofalo Editorial

Here it is… short and sweet…THE FACTS AS I SEE THEM
A Summary of FDA Regulations on Cigars

The FDA adopted restrictions on the sale and distribution of cigars including advertising and promotion restrictions. All cigars (premium and domestic) are now subject to regulation by the FDA.

Manufacturers of cigars must comply with the following regulations:

  • Submission of ingredient lists for each cigar and reporting of harmful or potentially harmful constituents.
  • Registration of cigar manufacturing establishments and a list of all cigars manufactured.
  • Prohibition of descriptions against the sale and distribution of cigars with modified risk (such as; light, low, mild).
  • Premarket review requirements for products introduced in the marketplace after the predicate date (grandfather date) of February 15, 2007.
  • No Free Samples allowed which prohibit manufacturers, wholesalers and retailers from giving out free samples of cigars.
  • Requiring a new health warning on the packaging and on advertisements for cigars as follows: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.”

This warning must appear on at least 30 percent of the two “principal display panels” of Cigar Box or Bundle and at least 20 percent of the area of any advertisement of the cigar. “Principal display panels” are panels of a cigar box that are most likely to be displayed, presented, shown or examined by the customer. The health warning statement must be printed in at least 12-point font size. The effective date for this new health warning is August 8, 2018. Distributors and retailers can sell through the tobacco products that were manufactured before the August 8, 2018 effective date.

Six health warnings for cigars is as follows:

  • WARNING: This product contains nicotine. Nicotine is an addictive chemical.
  • WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
  • WARNING: Cigar smoking can cause lung cancer and heart disease.
  • WARNING: Cigars are not a safe alternative to cigarettes.
  • WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
  • WARNING: Cigar use while pregnant can harm you and your baby.

For advertisements of cigars, the warnings must be rotated quarterly in alternating sequence for each brand of cigar in accordance with a warning plan submitted to, and approved by the FDA. Manufacturers, distributors and importers must submit a warning plan for cigar health warnings by August 8, 2017. Retailers that create their own cigar advertisements must also draft and submit a cigar health warning plan to the FDA by August 8, 2017. The same warning statement will apply to cigars sold individually and not in product packages, however, instead of being required to place warnings directly on the cigars sold individually, retailers are required to post signage at the point of sale listing all six warnings on a sign that measures at a minimum 8.5 inches x 11 inches. It is required that the sign be placed on or within 3 inches of each cash register where payment is made, unobstructed and easily read by consumer making a purchase. These advertising health warning requirements will take effect on August 8, 2018.

Advertisements which are subject to displaying a cigar health warning include promotional materials, magazines, catalogues, brochures, direct mail, shelf-talkers, display racks, websites, Internet web pages, television, e-mail correspondence, and also include advertisements communicated via mobile telephone, social media websites, or other programs that allow for the sharing of audio, video, or photography files.

A manufacturer can submit an application if a cigar introduced to the market after February 15, 2007 is substantially similar to a cigar that was already on the market. If there were no substantially similar products for a manufacturer to rely on, then the manufacturer would need to file a Pre-Market Tobacco Application (PMTA) with the FDA. The FDA estimates that the time burden per application would on average be 1,713 hours with some requiring as many as 5,000 hours for early applications that involve complex products and for which the company has no experience conducting studies or preparing analysis of public health impacts. The FDA estimates that an application will cost $330,000.00.

The definition of “tobacco product manufacturer” includes “any person, including any repacker or relabeler who manufactures, fabricates, assembles, processes or labels a tobacco product.”

FDA will regulate the manufacture of all newly deemed tobacco products, including those products manufactured at the retail level. This means that tobacco retailers that blend pipe tobacco meet the definition of a “tobacco product manufacturer” and will be regulated by the FDA as a manufacturer. As of August 8, 2016, persons who own or operate a domestic establishment engaged in the manufacture, preparation, compounding, or processing of tobacco products will need to comply with the manufacturer requirements.

According to the FDA, the regulations enable the FDA to issue further regulations related to cigars that are appropriate for the protection of the public health. The FDA states that asserting its authority will enable them to propose further regulatory action in the future, and those actions will have their own costs and benefits.

FDA also has the authority to restrict or ban ingredients in all tobacco products or tobacco smoke. Although the regulations do not ban self-service displays, the FDA will continue to monitor this issue and, if it determines that it is appropriate for the protection of public health to extend the self-service display prohibition.

The FDA is not banning flavored cigars, however, the FDA states that it intends in the future to issue a proposed product standard that would eliminate characterizing flavors in all cigars including cigarillos and little cigars.

The FDA states that the regulations are severable, meaning that if the courts strike down one regulation, the other regulations remain in force.

Previous Post Next Post

You Might Also Like

%d bloggers like this: