Tobacco Products Labeling Compliance. Another Deadline is Approaching – August 10, 2018

Nicotine Addictiveness Warning Statement

Beginning August 10, 2018, FDA will enforce a new nicotine warning Statement. Manufacturers and distributors cannot 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:

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. The alternative warning statement, under 21 CFR § 1143.3(c), for applicable package labels and advertisements reads:
• “This product is made from tobacco.”

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.
• an accurate statement of the quantity of the contents.
• an accurate statement of the percentage of the tobacco used in the product
• the statement: “Sale only allowed in the United States” on labels, packaging, and shipping containers of tobacco products

Call J&J Compliance Consulting Group at 949-735-6224 to schedule a free consultation