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FDA FAQ

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Yes. Altria published this document supporting FDA’s regulation of all cigars, including premium cigars. Including premium cigars under the deeming regulations likely would reduce Altria's user fees.

There’s no evidence that suggests that any cigar companies pushed for these regulations in broad terms. Imperial Brands, formerly Imperial Tobacco, is the parent of Altadis U.S.A. also owns Blu, one of the preeminent e-cigarette brands, who publicly spoke against the deeming regulations.

While it’s unlikely that any premium cigar company actively pushed for regulation, some certainly petitioned FDA to look at certain provisions in a specific manner. For example, certain manufacturers with no flavored cigar products were unwilling to fight against the flavored tobacco provisions contained in the proposed Option 2.

Not specifically.

If a factory is not listed as a U.S. importer of cigars, it's unlikely the factory will have to file any paperwork with FDA.

If the factory is a U.S. importer of cigars, it is required to comply with all regulations for importers, i.e. cigar companies, but it is not subject to the rules regarding domestic manufacturing.

(Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act…, 117)

FDA will instruct U.S. Customs & Border Protection to seize the products on import. If the product was already in the market, FDA would issue an NSE order instructing retailers to stop selling the product. Fines could be issued to distributors, manufacturers and retailers for failure to comply.

While some product has been delayed by customs, there is little to no evidence indicating FDA has begun to crack down on non-compliant product.

 

Yes. FDA has stated that even those serving under 18 are barred from purchasing tobacco products. Futhermore, over a dozen states and hundreds of cities and counties have passed laws requiring individuals to be at least 21 to purchase tobacco in their jurisdictions. With little exception, those rules apply to those, even if a person is 18-20, serving in the military.

(Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act…, 320)

No. FDA specifically states this regulation "does not ban cigar trade shows." (Final Regulatory Impact Analysis, 49)

Yes.

The first lawsuit filed by a premium cigar company was filed by Global Premium Cigars, Inc., the parent of 1502 Cigars. Ultimately, that lawsuit was halted by the company in the summer of 2017.

In addition, there have been a number of lawsuits filed by different e-cigarette companies regarding the deeming regulations.

Cigar boxes might have warning labels for three different reasons.

  1. FTC Consent Decree — In 2000, a variety of companies including Altadis U.S.A., General Cigar Co., Swisher International and Altria voluntarily agreed to place warning labels—smaller than those which are to be required under FDA's deeming regulations—on their products as part of an agreement with the Federal Trade Commission (FTC). Because Swisher owns Drew Estate and Altria owns Nat Sherman, it means a variety of brands are already federally required to have warning labels on their boxes.
  2. California — California's Proposition 65 requires all cigars sold in the state to carry a warning label. Cigar makers have chosen to place the warning label on all boxes, not just the cigars specifically sold in California.
  3. Early Compliance — The decision to delay the warning labels came barely a month before the new warning label rules were set to take effect. As such, some manufacturers—most notably Drew Estate and General Cigar Co.—had already begun applying warning labels to its product. Ultimately, both companies stopped placing warning labels on boxes, but not after tens of thousands of boxes had entered the market.

There are other reasons, including some smaller companies copying larger companies, which explains why companies like Maya Selva have FTC warning labels, even though the company is not a signee to the FTC consent decree.

Last Updated: March 11, 2019.

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