August 8, 2016
No new products (or changes to existing products) can be introduced to the market until the FDA authorizes such sales through a “marketing order” based on successfully completing either the SE or PMTA pathways.
All “covered tobacco products”.
Retailers, Manufacturers, Importers, Distributors.
None.
You can only sell to customers age 18 or older and you need to check a photo ID of everyone under age 27.
All “covered tobacco products”.
Retailers.
None.
You are no longer allowed to give away free samples.
All products.
Retailers, manufacturers, importers, and distributors.
None.
You are no longer allowed to sell products in a vending machine.
All “covered tobacco products”.
Retailers.
Unless the vending machine is in a facility where those under the age of 18 are not present or permitted.
You must prevent “product adulteration” by operating your facility in a sanitary manner to avoid contamination (of manufactured or shopped products) that could pose a risk to public health beyond the risk of the product itself.
All products.
Manufacturers.
None.
You must avoid any and all misbranding of products as the FDA will start enforcement on false or misleading labeling and advertising. This includes “modified risk claims” (see notes).
All products.
Retailers, Manufacturers, Importers, Distributors.
You are not allowed to make any claims through advertising or other public statements, to consumers and customers, that your product may be less risky, less harmful, have fewer or no additives, when compared to other tobacco products.
December 31, 2016
You must register your business if you prepare, manufacture, compound, repackage, relabel or process tobacco products.
All “covered tobacco products”.
Finished Tobacco Products of all “establishments” (i.e. domestic facilities) that prepare, manufacture, compound, relabel, repackage, or process tobacco product.
This is an annual registration that is required and foreign establishments shall be required to register through additional regulation that will be presented in the future. At some point in the future the FDA will issue revised guidance to provide clarity to the scope and timing of requirements for registration and listing for newly deemed products.
You must list your products, in detail.
All “covered tobacco products”.
Finished Tobacco Products of all “establishments” (i.e. domestic facilities) that prepare, manufacture, compound, relabel, repackage, or process tobacco product.
When first registering your business you must list all your “covered tobacco products) including any and all labeling and associated advertising. These product listings need to be updated every June and December, at which point you will have the opportunity to remove discontinued products or add new products to the list. At some point in the future the FDA will issue revised guidance to provide clarity to the scope and timing of requirements for registration and listing for newly deemed products.
February 8, 2017
If you are a large-scale manufacturer, you must submit your ingredients, by quantity, brand, and sub-brand.
All “covered tobacco products”.
Large-Scale manufacturers.
For products introduced after the effective date, ingredient listings need to be provided 90 days before marketing of such products.
If you are a large-scale manufacturer, you must submit your Tobacco Health Documents (developed after June 22, 2009) relating to “health, toxicological, behavioral, or physiologic effects” of products, constituents (including smoke constituents), ingredients, components and additives.
All “covered tobacco products”.
Finished Tobacco Products of Large-Scale manufacturers. Importers.
None.
August 8, 2017
Your Substantial Equivalence Exemption Requests are due.
New, newly deemed finished tobacco products that were on the market as of August 8th 2016.
Manufacturers, Importers.
This covers all requests for exemption from the Substantial Equivalency (SE) pathway for any additive in products or minor modifications to existing ones, as of August 8th 2016. If you file it will allow your product(s) to remain on the market until, at least, August 8th 2018. However, considering that there is no predicate product from before February 2007 that will be substantially equivalent to yours, you will be unlikely to use the application for exemption.
If you are a small-scale manufacturer, you must submit your ingredients, by quantity, brand, and sub-brand.
All “covered tobacco products”.
Small-Scale manufacturers.
For products introduced after the effective date, ingredient listings need to be provided 90 days before marketing of such products.
If you are a small-scale manufacturer, you must submit your Tobacco Health Documents (developed after June 22, 2009) relating to “health, toxicological, behavioral, or physiologic effects” of products, constituents (including smoke constituents), ingredients, components and additives.
All “covered tobacco products”.
Finished Tobacco Products of Small-Scale manufacturers. Importers.
None.
You are not allowed to use “modified risk” language on your labels.
All “covered tobacco products”.
Retailers, Manufacturers, Importers, Distributors.
Your product(s) are not allowed to use terms like “light”, “mild”, or “low” or similar reduced risk descriptors on your labels. If you’re a manufacturer, you must quit with the production of all products if the packaging contains any reduced risk claim. You can continue to distribute those products for an additional 30 days until September 7th, 2017. If you are a retailer you can continue to sell those products until your stock is gone.
February 8, 2018
Your Substantial Equivalency (SE) Applications are due.
New, newly deemed finished tobacco products that were on the market as of August 8th 2016.
Manufacturers, Importers.
Your applications for substantial equivalency authorization (products that were on the market as of August 8th, 2016) must be filed. This will allow your product(s) to remain on the market until, at least, February 8th, 2019. There may be additional time granted to small-scale manufacturers but those will be handled by the FDA on a case-by-case basis. However, considering that there is no predicate product from before February 2007 that will be substantially equivalent to yours, you will be unlikely to use the application.
May 10, 2018
You have to comply with labeling and advertising requirements.
All “covered tobacco products”.
Retailers, Manufacturers, Importers, Distributors. Cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars and those covered tobacco products that do not contain nicotine).
All covered vapor products must have “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” on all their labels, packaging, and advertising.
Warnings on your packaging must cover 30% of each of the two main display panels but there will be alternate means to comply for small(er) packages. Warnings on advertisements (print, web, e-mail, social media, video, etc.) must cover 20% of the top.
If you manufacture a non-nicotine product, you may certify to the FDA that your product(s) contain no nicotine. Be prepared to have the data to prove that. In this case the wording required is “This product is made from tobacco”, using the same format and size as the above mentioned nicotine warning.
Products that were manufactured before May 10th, 2018, and that do not carry these statements may still be distributed until June 9th, 2018.
All your labels must contain:
- Name and location of manufacturer, packer or distributor.
- Net quantity of contents by weight, measure or count.
- Percentage of tobacco used in the product that is domestic, percentage foreign.
- “Sale only allowed in the United States” which must also appear on packaging and shipping cartons.
Retailers can not offer for sale, sell, distribute, or import products with non-compliant packages beginning May 10, 2018 unless the retailer falls within the safe harbor.
Manufacturers can not manufacture products with non-compliant packages beginning May 10, 2018 and cannot distribute such products beginning June 11, 2018, irrespective of the date of manufacture.
Manufacturers, importers, distributors, and retailers who direct their own advertising: Advertisements must bear the alternative warning beginning May 10, 2018,
August 8, 2018
Your Premarket Tobacco Applications (PMTA) are due for all products that were on the market as of August 8th, 2016.
New, newly deemed finished tobacco products that were on the market as of August 8th 2016.
Manufacturers.
If you file your product(s) are allowed to remain on the market until, at least, August 8th 2019.
August 8, 2019
You have to report Harmful and Potentially Harmful Constituents (HPHC).
All “covered tobacco products”.
Manufacturers and Finished Tobacco Products.
You have to provide reports on the required testing of Harmful and Potentially Harmful Constituents (HPHCs). Regulation guidance will be provided by the FDA at a later time. Note that this may also be requires as part of the SE review if you decide to attempt that pathway and as such this requirement may be implemented at an earlier date. For products introduced onto the market after August 8th 2019, all HPHC’s must be reported no later than 90 days before the product is introduced.