Upcoming FDA Pre-Market Tobacco Application Deadlines
August 8, 2016 has come and gone. The compliance requirements are in effect for prohibition of sales to minors, prohibition of free samples, misbranding, child proof packaging, adulteration of product, . What is next on the e-cig and e-liquid PMTA compliance date schedule?
December 31, 2016
- By December 31, 2016, manufacturers must complete and submit their manufacturing registration per FDCA §§ 905(b), (c), (d), (h), and (i).
Establishment Registration and Product Listing.
Any establishment engaged in the manufacture, preparation, compounding, or processing of a tobacco product must register with FDA the name, places of business, and all such establishments of that person.
Every person who registers shall, at the time of registration, file a list of all tobacco products which are being manufactured, prepared, compounded, or processed for commercial distribution. An owner or operator may authorize a third party agent to register and submit product listing information on its behalf.
February 8, 2017
- By February, 8, 2017, manufacturers must complete and submit their comprehensive list of ingredients as required under FDCA §§ 904(a)(1),(c)(1).
(a)(1) Each tobacco product manufacturer or importer, or agents thereof, shall submit to the Secretary a listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and sub brand. Products entering the market after the effective date must provide the list in 904(a)(1) 90 days before delivery for introduction into interstate commerce.
- By February, 8, 2017, manufacturers must complete and submit their “Health Document Submission” by February 8, 2017 as required under FDCA § 904(a)(4)
Each tobacco product manufacturer or importer, or agents thereof, shall submit to the Secretary all documents developed after such date of enactment that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.
The e-cig/e-liquid attorneys at Brown & Charbonneau, LLP are up to date on all the issues that affect your industry. For immediate help, call us today at 714.505.3000 or email inquiries@bc-llp.com to set up a consult to learn more about how we can help you. For more information about the e-cigarette, e-liquid and ENDS industry, click here
With knowledge of the FDA, TPD and ENDS industry, we represent industry clients on a wide variety of areas affecting their business, including:
- PMTA Process & Compliance
- European Union Tobacco Product Directive (TPD)
- Contract, fraud, shareholder and other business litigation
- Manufacturing & Related Contracts & Agreements
- Manufacturing requirements, including:
-Current Good Manufacturing Practices (cGMP)
-International Organization for Standardization (ISO)
-US Dept of Labor OSHA
- Products Liability & Related Issues
- Product Labeling & Warnings
- Human Resources Issues