As we have discussed in previous blog posts, the Food and Drug Administration (FDA) released its long-awaited proposed e-cig regulations earlier this year. Since releasing the draft regulations, the FDA has received over 70,000 formal comments, including a letter submitted by 29 state attorneys general seeking additional marketing regulations. Now that the comment period has ended, what’s next for the FDA’s e-cig regulations?
New E-Cig Regulations
Under the FDA’s proposed regulations, the definition of “tobacco products” has been expanded to include “dissolvables, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco.” Learning from its past mistakes, the FDA has also included a provision that would allow it to regulate future tobacco products that have yet to be invented.
By far the most important aspect of the proposed regulations involves the registration and approval process for e-cigs. As we predicted, the FDA will require that each e-cig manufacturer provide the agency with a detailed description of its manufacturing processes and ingredient lists, substantiated with verifiable scientific data. E-cig manufacturing facilities will also be subject to FDA inspections.
The draft regulations also propose to establish a nationwide minimum age requirement in order to purchase and use e-cigs. If the draft regulations are passed, no one under the age of 18 will be able to legally purchase e-cigs.
Comments to the E-Cig Regulations
Over the course of the four month comment period, the FDA has received approximately 72,000 formal comments. Not surprisingly, the majority of the comments originate from two groups: 1) health care organizations, such as the American Heart Association and the American Cancer Society; and 2) e-cig companies. In general, health care organizations are pushing the FDA to strengthen the regulations, while e-cig companies argue that the regulations are too restrictive and limit the public’s access to beneficial tobacco alternative products.
What’s Next for the E-Cig Regulations?
Now that the comment period has closed, the FDA must review all 72,000 comments, balance the competing interests at play and revise the regulations accordingly. This will obviously take several months, but if past actions of the FDA are any indication, we likely will not see the final regulations this year. Industry insiders and state attorneys general hope that the final regulations will be published within one year of publication of the proposed rule, which would be on or before April 25, 2015. Once published, the final rule will not likely be implemented or enforced for another year, in order to allow affected parties time to bring their products into compliance with the regulations.
It should be noted that drastic, substantive changes to the proposed e-cig regulations are not expected. The final regulations will most likely mirror the proposed regulations released in April, with minor changes based on the 72,000 comments received by the FDA.
The development of the FDA’s new e-cigarette regulations should be of interest to anyone involved in the e-cigarette industry.