Legal Blogs

Quick Summary of New FDA E Cig Label Requirements

Here is a Quick Summary of New FDA E Cig Label Requirements.  These apply to anyone who manufactures, packages, sells, offers to sell, distribute or import for distribution of e cigarettes, e liquid and other “tobacco products”.  For all information on FDA deeming regulations, click here.

FDA Pre Market Tobacco Applications

FDA Pre Market Tobacco Applications

·      State the name and place of business of manufacturer

·      State quantity of contents by weight, measure, or numerical

·      Statement of the percentage of the tobacco used [nicotine?]

·      Statement of the product’s name

·      Contain brief statement of the uses of product and relevant warnings, precautions, side effects, and contraindications

·     WARNING: This product contains nicotine. Nicotine is an addictive chemical.

·      Warning must be 30% of principal display panels of package

·      Must be in Helvetica bold or Arial bold type

·      Must be printed in at least 12-point font size

·      Must be black text/white background OR white/black bkgrd

·      Must be capitalized and punctuated per paragraph (a)(1)

·      Must be centered in the warning area

Per 21 Code of Federal Regulations, Title 21, Volume 8, Part 1143

LEARN MORE FROM A E-CIGARETTE ATTORNEYBrown & Charbonneau LLP: Go-To Trial Lawyers for Business & Complex Family Law Litigation

If you are in the e-cigarette/e-liquid/ENDS industry and need help navigating the stringent FDA regulations, the e-cig attorneys at Brown & Charbonneau, LLP can help. Call us today at 714 505.3000 or email for more information.