The FDA’s Deeming Regulations are now in full swing, and several deadlines have come and gone since its implementation on August 8, 2016. Currently, the tobacco industry is working hard to comply with the imminent deadlines in connection to the FDA’s new labeling requirements. Manufacturers/importers of cigars are required to submit a rotational warning plan in compliance with FDA regulations by May 10, 2017, and the new labels must be implemented and in commerce no later than May 10, 2018.
The material aspects of the new FDA warning plan are fairly straightforward. Manufacturers and importers of cigars must rotate six warnings:
- WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale;
- WARNING: Cigar smoking can cause lung cancer and heart disease;
- WARNING: Cigars are not a safe alternative to cigarettes;
- WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers;
- WARNING: Cigar use while pregnant can harm you and your baby; or SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth, and Low Birth Weight; and
- WARNING: This product contains nicotine. Nicotine is an addictive chemical.
These rotated warnings must be permanently affixed to the cigar packaging and advertisements. For packaging, the warning must encompass no less than 30 percent of the two principal display panels of the product’s packaging (a principal display panel being defined by the Deeming Regulations as the panels of the package that are most likely to be displayed, presented, shown or examined by the consumer) and no less than 20 percent of the total display area of the advertisement, with the caveat that the warning on advertisements appear in the upper portion of the advertisement within the trim area of the advertisement. The warnings have some other requirements such as font size, capitalization and color.
Although the rule is relatively straightforward, the industry still remains confused in connection with two looming issues: First, how will this warning coalesce with California’s current Proposition 65 warning requirements? Second, how will the timing of selling through products with older warnings on them work?
Prop 65 vs. FDA Warning
For Prop 65, certain industry groups are working to devise a plan. The purpose of California’s Proposition 65 is to warn the consumer and the public at large that tobacco products contain toxic chemicals. The new FDA warning plan achieves California’s objective and does so in a meaningful manner such that 30 percent of the principal display panels of the product’s packaging will notify the consumer of the health warnings of the tobacco product. In terms of size and visibility, the FDA’s rule goes above and beyond what is required by California’s Proposition 65. Therefore, a proposed and reasonable outcome is that California determines that the additional Prop 65 warning is unnecessary, duplicative and may cause customer confusion in light of the new federal guidelines that require such a clear and conspicuous warning. In either event, hopefully the State of California will provide clarity in connection with this issue.
Products Already in the Retail Pipeline
Another common concern is that the May 10, 2018 deadline for implementing the new warning scheme may create challenges in light of the fact that product can sit in a warehouse or on a retail shelf for extended periods of time. This may result in the sale of product without the adequate warning to the consumer after the May 10, 2018 deadline, which would not be the fault of the manufacturer/importer or the retailer. While the answer is not crystal clear yet, the Deeming Regulations appear to have considered this issue and provide a safe harbor to both the manufacturer/importer, as well as to the retailer. The manufacturer and importer appear to be allowed to introduce product without the current warning requirements into commerce up until May 10, 2018. They then have an additional 30 days after this deadline as a safe harbor to continue selling the last of the product.
In addition, retailers appear to be provided a safe harbor as long as the retailer purchased the product from a licensed manufacturer, the packaging contains some type of health warning, and the retailer has not altered the packaging. Both the FDA and the industry want to provide clear and conspicuous warnings so that consenting adults may make informed decisions. With time, the new FDA warning plan will be further clarified.
This story first appeared in the May/June 2017 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.