07/26/2018 - FDA Label requirements REMINDER!!!

REMINDER: Upcoming Compliance Date for Labeling and Advertising Requirements for Certain Tobacco Products
 
 
 
Beginning Aug. 10, 2018, “covered” tobacco products, as well as roll-your-own and cigarette tobacco products, manufactured on or after Aug. 10, 2018 are expected to include the required health warning statement on packages and advertisements. “Covered” tobacco product means any tobacco product deemed by the deeming final rule to be subject to FDA’s tobacco authority (including ENDS, cigars, and pipe tobacco), but excludes any component or part that is not made or derived from tobacco. The required statement reads: "WARNING: This product contains nicotine. Nicotine is an addictive chemical."

In addition to this statement, packages and advertisements must also bear the following label requirements under section 903(a)(2) of the FD&C 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;
  • the statement: “Sale only allowed in the United States” on labels, packaging, and shipping containers of tobacco product (required under section 920(a)(1) of the FD&C Act.)
A recent court order, however, enjoins FDA from enforcing health warning requirements for cigar and pipe tobacco product labeling and advertising until 60 days after a final decision on appeal. In addition, the agency does not intend to enforce the labeling requirements under section 903(a)(2) for cigars and pipe tobacco while the injunction is in effect so that firms may make the required label changes at one time. For more information, please contact FDA/CTP Office of Small Business assistance at smallbiz.tobacco@fda.hhs.gov.

FDA remains committed to warning the public about nicotine tobacco products. “Nicotine is central to the issue of addiction, with both the potential to lessen or prevent tobacco use, and also the danger of fueling it. It’s imperative that people are adequately informed of the presence of nicotine in tobacco products and understand the risks – especially kids, who research shows are misinformed,” said FDA Commissioner Scott Gottlieb, M.D.

To assist manufacturers and retailers, FDA has developed several visual examples of the health warning statement on different tobacco product packaging. For example:
 
To see additional examples, please click below.
 
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