FDA Delays Additional Packaging Requirements

FDA Delays Additional Packaging Requirements

In light of the recent injunction postponing the FDA’s warning label requirements, the agency has agreed to stay additional package and labeling laws that were set to go into effect next month until after the appeal process in the ongoing cigar industry lawsuit has been completed. 

The additional packaging requirements fall under section 903(a)(2) of the Family Smoking Prevention and Tobacco Control Act. These regulations require that tobacco product packages contain the following labels: 

  • 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 Federal Food, Drug, and Cosmetic Act).

These requirements were scheduled to go into effect on August 10. 

According to the Cigar Association of America—one of the three organizations representing the cigar industry in its lawsuit against the U.S. Food And Drug Administration—the agency does not intend to enforce these labeling requirements for cigars while the injunction is in effect, so manufacturers can “make the required label changes at one time.”

Instead, the FDA says it will not implement these requirements until 60 days after a final decision has been reached on the appeal. Industry insiders don’t expect the appeal to be complete for a year or more.