FDA Deeming Rule - Important Dates
August 8 2016
Deeming Rule goes into effect.
Compliance period begins for manufacturers to submit a substantial equivalence exemption request, substantial equivalence application or premarket tobacco product application (PMTA) for new, newly deemed finished tobacco products.
NO free samples of nicotine products.
December 31 2016
Deadline for registration of establishment engaged in the manufacture, preparation, compounding, or processing of tobacco product and product listings.
February 8 2017
Manufacturers need to submit an ingredient list and tobacco health documents to FDA for all products manufactured. *
August 8 2017
Small scale tobacco product manugaturers must submit an ingredients list and tobacco health document to FDA for all products manufactured.
Compliance period for manufacturers to submit and FDA to accept a substantial equivalence exemption request.
All required label and labeling statements must be prominently and conspicuously placed on tobacco products.
February 8 2018
Compliance period for manufacturers to submit and FDA to accept a substantial equivalence application.
May 10 2018
Tobacco products will be considered misbranded unless they bear a label containing 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
Product packaging and advertising warning labels go into effect.
June 11 2018
Manufacturers cannot distribute products with non-compliant packaging.
August 8 2018
Deadline for manufacturers to submit and FDA to accept a premarket tobacco product application (PMTA).
August 8 2019
HPHC (Harmful and Potentially Harmful Constituents) submissions are due. *
All products on the market must have been grandfathered or the subject of an FDA marketing authorization order.
* = For products entering the market after August 8, 2016, ingredient list and HPHCs must be submitted to FDA 90 days prior to marketing.
Need more info? Go to fda.gov to find details on compliance deeming dates.
Please visit www.SFATA.org for more information.