The FDA Deeming Rule

Summary: This rule deems cigars, pipe tobacco, water pipe tobacco, electronic nicotine delivery systems (including e-cigarettes), and other novel tobacco products subject to regulation by the Food & Drug Administration. Any of these products placed on the market after February 15th, 2007 is required to submit a premarket tobacco application (PMTA) to the FDA for approval. The per product application cost is estimated between $117,000 and $466,000, based on an average of 1,500 hours required to submit an application.

Industries Impacted: E-vapor, premium cigar, and specialty tobacco product manufacturers and retailers

UPDATE: As of May 3, 2017 the FDA is delaying enforcement of this rule in order to collect more information on its impacts. If your business is subject to this rule, now is the time to share your feedback. 

Should the FDA change this rule?


Regulation Details

Benefits

  • Product standardization Details
  • Prevents new products from entering the market that have higher health risks than currently available products Details
  • Transparency in ingredients labeling Details
  • Potentially reduce youth tobacco use by limiting access to e-cigarettes, warning labels will help consumer better understand and appreciate the risks of using tobacco products Details

Costs

  • Application and Paperwork Costs - estimated $817-$988 million over 20 years  Details
  • Potentially drive e-vaping products off the market due to higher operation costs Details
  • Increased cigarette use because of higher cost of tobacco alternatives 
  • Loss of jobs due to increased operation costs in newly regulated products Details
  • Increased use of illegal alternatives due to higher product costs (Reference 1Reference 2)

Original Text: 81 FR 28973
Code of Federal Regulations: 21 CFR 1100, 21 CFR 1140, 21 CFR 1143
Economically Significant: Y (Learn More)
Regulatory Impact Analysis: Read Cost-Benefit Analysis

Enforcing Agency: Food and Drug Administration
Effective Date: August 8th, 2016
Regulation Statutory Authority: Federal Food, Drug, & Cosmetic Act of 1938
Public Comments: 119,031 comments received
Regulation Tags: Health & Safety

Key Players

  • Large tobacco manufacturers
    • Can afford application costs, but oppose the rule on the grounds that stifles product innovation
  • Nicotine patch and gum pharmaceutical manufacturers
    • Will benefit from rule if competing e-cigarette products are eliminated or become more expensive  
  • E-cigarette/vapor manufacturers (3,500-7,000 American companies)
    • Employs 70,000 American workers - mostly comprised of small businesses - will be hard hit by the cost of new application requirements. Generally encourage FDA oversight of product ingredient listing but not the high-cost product application process
  • Premium cigar importers and manufacturers (329 American companies)
  • E-vapor retailers

Compliance Resources

Determine if you need to submit a premarket tobacco application (PMTA):
https://www.fda.gov/TobaccoProducts/Labeling/default.htm

FDA Compliance Guides: