Tobacco Products Required Warnings

Tobacco Products Required Warnings

Among the key requirements of the FDA’s new Deeming Tobacco rule are that tobacco products bear the required warnings. This rule states advertising and packaging warnings for newly deemed covered tobacco products must contain one of two required warnings. The required warnings will be one of the first requirements of the rule to go into effect. Any new deemed tobacco product will need to comply with the required warnings by August 8, 2016.

Tobacco Products Required Warnings – Nicotine

Any new deemed tobacco product, except cigars, which contain nicotine must bear the warning statement from the rule. That warning statement reads, “WARNING: This product contains nicotine. Nicotine is an addictive chemical.”

There are several requirements on placement and size of the warning. In general the tobacco products required warnings must be conspicuous and appear on advertising, outer and inner packaging.

Tobacco Products Required Warnings – No Nicotine

Any new tobacco product, except cigars, which contain tobacco but not nicotine are required to use an alternative warning statement. This statement can only be used after “self-certification” is submitted to the FDA. There are several requirements on how to make the self-certification. Key among those are that the manufacturer will need data to support the declaration of no-nicotine.

The alternative warning statement reads, “This product is made from tobacco.”

There are accommodations for tobacco products with small packaging and those that contain no nicotine or tobacco. For small packages the warning may appear on the outer packaging or “on a tag firmly and permanently affixed to the package.” Tobacco products that contain neither tobacco or nicotine are regulated as ENDS components and still require a PMTA.

Tobacco Products Required Warnings – Cigars

Cigars are subject to unique warning requirements. There are six required warning statements (five specifically for cigars and the one addictiveness warning) that must be randomly displayed and distributed on product packages and rotated quarterly in advertisements in accordance with an FDA-approved warning plan submitted by the manufacturer, distributor, importer, or responsible retailer. The rule contains more details on the complex warning requirements for cigars/

 

Please contact our Washington D.C. or Charlotte NC office with any questions on the new deeming regulation or required warning statements.

 

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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