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
· 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 ATTORNEY
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.
