FDA’s New Health-Warning Rules for Covered Tobacco Products

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New Health-Warning Rules for Covered Tobacco Products

The U.S. Food and Drug Administration has issued updated guidance pertaining to health-warning rules as they pertain to covered tobacco products. These products include cigarettes, cigars, RYO, pipe tobacco and hookah. In a document titled “Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule,” the FDA outlines requirements and compliance deadlines for these tobacco products. This includes:

Manufacturers must include a new warning statement pertaining to the addictiveness of these covered tobacco products. This goes into effect after Sept. 11, 2018. No covered product can be distributed without this statement after the given date. This impacts manufacturers who both distribute and manufacture these products.

As of Aug. 10, 2018, all advertisements relating to covered tobacco products must include the warning statement about the product’s addictiveness.

As another part of these new requirements, retailers cannot distribute, sell any covered tobacco product without the warning statement about its addictiveness included in its packaging. This goes into effect Aug. 10, 2018 and the only exception is if the covered tobacco product falls within a “safe harbor,” which is a statute or regulation that specifies that certain actions won’t violate the statue or regulation. For this to happen:

  1. The covered tobacco product’s package must include a health warning
  2. Covered tobacco product was supplied to the retailer by a manufacturer, distributor or importer that has a required state, local, or federal Alcohol Tobacco Tax and Trade Bureau (TTB) issued license or permit.
  3. Health warning wasn’t altered by the retailer

The FDA also has very specific requirements for the warning statements including where on the packaging it must appear, how much of the packaging must be devoted to the display of the warning statement, and how the font must be displayed in the warning statement. The warning statement must be included on promotional materials, posters, placards, brochures, and emails. It also includes advertisements sent out through social media, video, photography and mobile phones.

To read the full document from the FDA, click here. For all the latest legislation and FDA news impacting the tobacco industry, click here.

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