Today’s decision is a direct result of the ongoing lawsuit brought by IPCPR, the Cigar Association of America and the Cigar Rights of America. Judge Mehta had previously ruled on this case in May – and did not endorse the Associations’ challenge to the warning labels issue. Following the ruling, IPCPR, CAA and CRA appealed and requested that Judge Mehta prohibit the FDA’s warning label requirements until a decision on the appeal is finalized.  In his order issued today, Judge Mehta agreed, recognizing the suit raises substantial and complex issues about retailers’ constitutional rights, and that the FDA was not justified to require warnings before those issues are fully resolved, “In the end, this court believes that Plaintiffs are entitled to a full hearing before an appellate court with the specter of a warnings regime going into effect.”

Scott Pearce, IPCPR Executive Director recognizes this is a positive, if not temporary development for retailers and the broader industry.  “This deadline has been bearing down on our members for some time now.  And while this is a temporary reprieve, it is a welcome development and hopefully a sign that our message is resonating. IPCPR is proud to be a party to this lawsuit, and we’ll continue to work with our great legal team and staff in DC to bring about the optimum regulatory framework for the premium cigar industry.”

*This article first appeared on an IPCPR Federal Alert 7-5-18

What are the Warning Label requirements for packaging?
Beginning on 8/10/2018, manufacturers of cigars must label product packages with six separate FDA warning statements. On the same date, manufacturers of pipe tobacco must label product packages with a nicotine-addictiveness warning. The labels must make up 30% of the two principal display panels of the package, comply with other formatting requirements, and in the case of cigars be displayed consistent with an FDA-approved warning plan.

Manufacturers have until the end of 9/10/2018 to introduce into domestic commerce any inventory of products in packaging that DOES NOT comply with the new FDA labeling requirements, AS LONG AS they were manufactured prior to 8/10/2018. (In the case of a domestically manufactured product, this could mean removal from the factory before 9/11/2018. In the case of an imported product, this could mean release of the product from customs before 9/11/2018.)

What does this mean for retailers?
On and after 8/10/2018, U.S. distributors and retailers may continue to sell, distribute or import products that do not have compliant warning labels, AS LONG AS the products were manufactured before 8/10/2018.

What happens if the FDA comes to my store? Will the Agency hold me responsible for any package labeling issue?
The labeling responsibility for packaging rests with manufacturers. And there are a series of protections under the Deeming Rule that reinforce this for retailers.

On and after 8/10/2018, retailers WILL NOT BE in violation for selling any packaged cigar or pipe tobacco product without compliant FDA warning labels AS LONG AS:

• The retailer can demonstrate or reasonably assert that the product at issue was manufactured prior to 8/10/2018 (and therefore is not subject to the warning requirements); or
• The package has some type of “health warning*”;
• The retailer obtained the product from an appropriately licensed manufacturer, importer, or distributor; and
• The retailer has not altered the product in a way that is material to the new requirements.

*It’s important to note that the regulations do not define what qualifies as a “health warning” for these purposes, but legacy FTC cigar health warnings, California health warnings, or improperly executed FDA warnings could qualify.

How do I “demonstrate or reasonably assert” a product’s manufacture date?
Ultimately, each individual supplier (including manufacturers, importers, and distributors) must determine how best to help assure its retailer customers that they may sell supplied products without FDA-compliant warning labels on or after 8/10/2018. Examples include:

• Provide a letter confirming the date on which the manufacturer began complying with the new warning label requirements;
• Include documentation confirming the date of manufacture (or the pre-8/10/2018 status) of products in a shipment;
• Include production date information on or in packaging; or
• Make such information available upon request and presentation of a labeled code.

In addition, IPCPR recommends that, as appropriate, retailers rely on their own records and inventory management practices for these purposes. For example, this could include:

• Completing a physical inventory of packaged products on hand before 8/10/2018 (and thereafter as appropriate); and either
  • Applying a sticker or other marking to help the retailer identify the date of inventory of each package; or
  • Segregating products manufactured before 8/10/2018 to allow the retailer to identify products not subject to the warning requirements.

For any additional questions or concerns regarding warning labeling requirements, please visit: http://www.ipcprlegislative.org/

*This article first appeared on an IPCPR FDA Alert 6-12-18