06/19/2018 - New FDA Label Requirements.

"Covered" Tobacco Product and Roll-Your-Own/ Cigarette Tobacco Labeling and Warning Statement Requirements

Nicotine Addictiveness Warning Statement

Beginning August 10, 2018, you cannot manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States roll-your-own, cigarette tobacco, or "covered tobacco products" without the required warning label statement on the tobacco product package, per 21 CFR § 1143.3(a)(1). (Cigar required warnings are described under 21 CFR § 1143.5.)1

For the following products, including components and parts, that are sealed in final packaging intended for consumer use and are made or derived from tobacco, package labels and advertisements must bear the nicotine addictiveness warning statement:

  • hookah
  • pipe tobacco
  • vaporizers, e-cigarettes, and other electronic nicotine delivery systems (ENDS)
  • dissolvables
  • gels
  • roll-your-own and cigarette tobacco
     

"WARNING: This product contains nicotine. Nicotine is an addictive chemical."


This required warning statement must also meet certain requirements, with respect to font, text, size, placement and formatting  of the warning statement on the package labels. That is, the required warning statement on package labels must also appear directly on the package, and be clearly visible underneath any cellophane or other clear wrapping, per 21 CFR § 1143.3(a)(2), as follows:

  • Be located in a conspicuous and prominent place on the two "principal display panels" of the package;
  • Comprise at least 30 percent of each of the principal display panels (warning label area);
  • Be printed in at least 12-point font size and must occupy the greatest possible proportion of the warning label area set aside for the required text;
  • Be printed in conspicuous and legible Helvetica bold or Arial bold type or other similar sans serif fonts and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other printed material on the package;
  • Be capitalized and punctuated as indicated above; and
  • Be centered in the warning area in which the text is required to be printed and positioned such that the text of the required warning statement and the other information on the principal display panels have the same orientation.

Zero-Nicotine: Self-certification and Alternative Required Warning Statement

If the product does not contain nicotine and is made or derived from tobacco, the tobacco product manufacturer may display the alternative warning statement, instead of the nicotine addictiveness warning statement.

The manufacturer must mail a confirmation statement to FDA's Document Control Center, addressed to CTP's Office of Compliance and Enforcement, certifying to be true and accurate that the product does not contain nicotine and that the tobacco product manufacturer has data to support that assertion. If you have any questions on the self-certification, you can contact FDA.

The alternative warning statement, under 21 CFR § 1143.3(c), for applicable package labels and advertisements reads:

"This product is made from tobacco."


Products that are not made or derived from tobacco do not meet the definition of "covered tobacco product" and are not required to carry any of the required warnings or to submit a self-certification.

Packages that are Too Small to Display the Required Warning Statement

A "covered tobacco product" that is too small or otherwise unable to accommodate a label must contain the required warning statement on one of the following, per 21 CFR § 1143.3(d):

  • Carton
  • Outer container
  • Wrapper
  • Tag firmly and permanently affixed to the tobacco product package.

Other Labeling Requirements

There are other labeling requirements that must appear on tobacco product package labels if the product is manufactured, packaged, sold, offered for sale, distributed, or imported for sale or distribution within the United States. The following statements must appear on roll-your-own, cigarette tobacco, and "covered tobacco product" package labels per Section 903(a)(2) of the Tobacco Control Act:

  • the name and place of business of the tobacco product manufacturer, packer, or distributor;
  • an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;
  • an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and
  • the statement: “Sale only allowed in the United States” on labels, packaging, and shipping containers of tobacco products


References

1 FDA does not intend to enforce these three warning statement requirements for products that were manufactured before the effective date (August 10, 2018) of the new required warning statement for covered tobacco products, cigarette tobacco, and RYO tobacco. For important details about required warning statements, please see the small entity compliance guide. 

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