FDA Deeming Regulations: An Updated Timeline and FAQ
On July 28, when FDA commissioner Scott Gottlieb announced a four-year delay for the final deadline to submit premarket tobacco applications (PMTA’s) for vapor products (and other newly deemed “tobacco” products), it created some confusion among vapers and vape vendors. We created this timeline to offer an easy-to-understand timeline of deadlines that remain in the deeming process. It is up to date as of Dec. 18, 2017 — and we’ll keep it that way if additional changes happen.
Deeming rule changes - FAQ
Can a new product now be introduced without submitting a PMTA?
No. The delay for PMTA submission allows products that were already available before August 8, 2016 to remain on the market until August 8, 2022. Any products introduced after August 8, 2016 must have a marketing order from the FDA before sale. That means all new products require a PMTA to be filed and approved.
Has the February 15, 2007 “predicate date” changed? Do we still need to support HR 1136?
That date can probably only be changed by Congress. Vapers should not forget about HR 1136, the most-recent Cole-Bishop bill. This legislation would change the predicate date from 2007 to August 8, 2016, which would allow all current products to remain on the market without a PMTA.Many vapers assume that the new four-year delay for PMTA submission will solve our problems, but it won’t. Unless the FDA changes the entire playing field for tobacco product approval, we still need Congress to eliminate this concern by amending the Tobacco Control Act (which HR 1136 does).HR 1136 still needs support to make headway in this session of Congress — or to be inserted into the 2018 budget bill. Please continue to ask your U.S. House member to support HR 1136. Visiting August8th.org is so simple and fast, there’s no excuse not to do it right now!
Is the FDA changing the requirements for a PMTA?
Nothing has changed yet. But the Gottlieb announcement included the promise that the agency would make some big changes.According to the agency’s July 28 press release, “the FDA plans to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission.“Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to demonstrate Substantial Equivalence (SE). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS.”
Is the FDA going to ban flavors?
Not immediately, but they’re planning on starting the process to address the issue very soon. The FDA has the authority to ban or restrict the availability of flavors in all deemed products. In fact, they originally planned to ban flavors, but were prevented after review by the White House Office of Management and Budget (OMB).
In December 2017, a preliminary version of an FDA Advanced Notice of Proposed Rulemaking (ANPRM) surfaced, indicating that the agency would soon ask for public comment on flavors. “In this notice, FDA would request information on how best to regulate flavors in tobacco products to limit appeal to youth and prevent youth initiation and use of tobacco products,” says the notice. Vapers and especially manufacturers need to be ready to send thoughtful, persuasive comments to the agency. Vapers need to be involved in this process in a much more serious and organized way than we were during the 2014 preliminary deeming announcement. In fact, we should already be preparing our comments on why flavors are important. Let’s be ready this time!
Is the FDA planning on reducing nicotine content in vapor products?
The FDA says no. The most-discussed part of Gottlieb’s announcement — for everyone but vapers, that is — was his suggestion that the FDA would reduce the nicotine in cigarettes to eliminate their “addictive potential.”“Armed with the recognition of the risk continuum, and the reality that all roads lead back to cigarettes as the primary cause of the current problem, we need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels,” said Commissioner Gottlieb. “And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them.”That seems to indicate that vapor products with “satisfying levels” of nicotine will still be around. BUT…who knows what the FDA will decide to do if and when they are able to reduce the nicotine in cigarettes? Having fulfilled the fantasy of many tobacco control zealots, who can say they won’t continue and try to create a nicotine-free world?However, the process of showing that “Very Low Nicotine Cigarettes” (VLNC’s) can be effective in reducing smoking, and that they won’t simply create the biggest black market for any product ever, will be a long and tedious one for the agency. So if the FDA ever gets around to trying to reduce or eliminate nicotine in vapes, it will be many years down the road.
September 30, 2017
- Establishments engaged in the manufacture, preparation, compounding, or processing of a tobacco product must register with the FDA. (Future regulation will require registration of foreign establishments.)
- Provide the FDA a list of all products. The list must include all labeling and advertising. Product listings are updated every June and December
November 8, 2017
- Small-scale manufacturers must provide “Tobacco Health Documents” notification (if applicable). Large-scale manufacturers were required to submit these by Feb. 8, 2017. Note that this is an arcane requirement that will probably apply to very few vapor products manufacturers.
*FDA considers “small-scale tobacco product manufacturers” to be manufacturers of any regulated tobacco product with 150 or fewer employees, and annual total revenues of $5 million or less. All others are considered large-scale manufacturers
- “All required label and labeling statements must be prominent and in such terms that render it likely to be read and understood”
- Prohibition on the manufacture of products that contain “light,” “low,” “mild,” or other similar descriptors in the label, labeling, or advertising of such products without a modified risk tobacco product order in effect
May 8, 2018
- Submit ingredient listings for all products. (Large-scale manufacturers only. This deadline was originally Nov. 8, 2017. The deadline for small-scale manufacturers in now Nov. 8, 2018.)
August 10, 2018
- Product packages and ads must contain the addictiveness warning statement “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” The warning must follow size and format requirements. Distribution of products without the required warning must end by September 10, 2018)
- Product packages and ads of covered tobacco products that do not contain nicotine may bear an alternative warning statement: “This product is made from tobacco.” (Yes, even though e-liquid without nicotine positively does not contain tobacco.) Manufacturers must submit to FDA a self-certification
- Labels must include the following information:
- The name and place of business
- Quantity of the contents
- Percentage of domestic and foreign- grown tobacco
- The statement: “Sale only allowed in the United States” on labels, packaging, and shipping containers of tobacco products
November 8, 2018
- Submit ingredient listings for all products. (Small-scale manufacturers only. This deadline was originally May 8, 2018.)
November 8, 2019
- Submit lists of harmful and potentially harmful constituents (HPHC’s)
August 8, 2022
- PMTA’s or SE reports due for all products that were on the market August 8, 2016 or before.
Commissioner Gottlieb announced on July 28, 2017 that the agency would amend the one-year limit for products to remain on the market while submitted PMTA’s are reviewed. Products will be allowed to be sold until the FDA reaches a decision to approve or deny the application.
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