E-Cig Rule Practical Guide

FDA E-Cig Rule Practical Guide

Now that the shock of the new FDA E-Cig rule (Deeming Rule) is settling in it is time to get practical about compliance. This post is meant to be a practical guide to the e-cig rule. Below are key dates to keep in mind. One of the big keys in the FDA e-cig rule is the two compliance periods for newly deemed tobacco products (cigars and hookahs included). Any product marketed prior to 2007 subject to criteria is grandfathered and exempt. For newly deemed tobacco products that were on the market as of the effective date of the Deeming Rule (August 8), but that were not on the market as of February 15, 2007 (i.e., are not grandfathered), FDA is providing two compliance periods: one for submission and FDA receipt of applications and one for obtaining premarket authorization. During these compliance periods, FDA does not intend to take enforcement action for products remaining on the market without authorization, as set forth below.

The compliance periods for submission and FDA receipt of applications for newly deemed tobacco products under the three premarket pathways are as follows:

• SE Exemption Requests – 12 months from the effective date of the Deeming Rule

• SE Reports – 18 months from the effective date of the Deeming Rule

• PMTAs – 24 months from the effective date of the Deeming Rule

New products for which no application has been submitted by 24 months from the effective date of the Deeming Rule will no longer be subject to this compliance policy, and will be subject to enforcement.

The above makes REGISTRATION and Premarket Tobacco Product Applications (PMTAs) critical. Firms avoiding these deadlines place their operations at risk.

If a PMTA is intimidating, then the Center for Tobacco Products is offering meetings. Only TWO meetings will be granted per company. The meetings may be requested based on a detailed submission compliant with the Guidance on meetings.

The new FDA e-cig rule is dense with details, but for next steps look at the compliance periods and plan accordingly.

FDA E-Cig Rule Practical Guide Timeline

  • See Table A and Table B for FDA Timeline
  • August 8, 2016 Deeming rule is Effective starting the clock on pre-market pathways and changing marketing and labeling**
  • December 31 2016 The first biannual (December and June annually) that manufacturers (as defined in the rule) must submit a list of all the products made
  • February 2017 Manufacutreres will need to submit an ingredient list of all products manufacted.
  • August 8, 2018 premarket tobaccao product application (PMTAs) are due (YES, it will take this much time to be ready!)
  • August 8, 2019 – final compliance deadline – all PMTAs must be in and approved.

**This is the day the “automatic provisions” go into effect. This includes:

  1. Adulterated or misbranded tobacco products;
  2. Required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs);
  3. Required registration of tobacco product manufacturing establishments and product listing;
  4. Prohibition against sale and distribution of modified risk tobacco products unless FDA issues an order authorizing their marketing;
  5. Prohibition on the distribution of free samples (same as cigarettes); and
  6. Premarket authorizations/orders for new tobacco products.

Contact our Washington D.C. or Charlotte NC office with any questions.

 

 

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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