FDA New Tobacco
FDA new tobacco regulation also known as the Deeming Regulation takes effect in 30-days (August 8, 2016). The regulations are broad, complex and impact every part of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco and nicotine gels, among others. This has created a great deal of confusion on timing and cost. As the FDA new tobacco regulation draws closer this post attempts to clarify parts of the Deeming Regulation.
The best place to start is with the FDA new tobacco webinars. The webinars are offered several times over the next months and provide a great overview of the rule. Links to the latests webinar’s slides can be found here.
The two biggest questions on the FDA new tobacco regulations are timing and cost. Timing is the easy part. There have been a flurry of claims that the Deeming Regulations require some action prior to August 8, 2016. This is not true. The August 8 date is simply the date when the FDA new tobacco regulations become official and effective. There are no formal activities and no benefit to any activity prior to this date. In particular there is no exemption from the rule if sales evidence is gathered to show sales prior to August 8. The exemption date is much further back (2/15/2007) and in the FDA estimation likely not to include many if any e-cigarette or e-liquids. The FDA Deeming Regulations take effect on August 8, but here are the compliance dates to mind:
- Automatic: On August 8 the new age restrictions, health warnings, registration and listing, and prohibition on vending machines takes effect.
- Staggered: pre-market approval will be required in 12 months for exemption requests, 18 for substantial equivalence requests, and 24 months for a pre-market tobacco application (PMTA).
- Extra Staggered Time: The FDA new tobacco regulations provide an additional enforcement grace period of 12 months if pre-market submissions are made in the initial compliance window provided above. This requires a complete submission to qualify.
Costs are less clear. There are figures stated that the PMTAs will cost $1 or 2million. This is purely speculative and largely based on the assumption that human clinical data will be required. The FDA in the comments to the rule addressed this concern noting flexibility and an ability to bridge with literature. The PMTA will be no cake-walk and the new tobacco regulations set a high-bar for approval, but any cost at this point is hardly an estimate. To gain a firm sense of the cost it is important to submit a pre-PMTA meeting request to the FDA. In this request details about the products, third-party testing like toxicity testing, and specific concerns or plans can be discussed. The FDA is encouraging these meetings to help ensure PMTAs are properly understood and costs better estimated. Be sure to note the FDA will only honor two meeting requests per company under the new tobacco regulation to manage demand. Make that meeting request count.
There is also discussion that litigation will stop the rule from taking effect. There are five current law suits filed against the FDA involving the new tobacco regulation. None appear ready to issue a preliminary injunction that will stop the timing of the rule from the schedule listed above. It is best not to plan based on the litigation but ensure compliance with all the relevant dates.
Please contact our Washington D.C. or Charlotte NC office for a complimentary consultation on the FDA new tobacco regulations.
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