Posted by Mike Bartell

Effective August 10th, 2018

FDA Required Labeling and Warning Statements for Tobacco / Vapor / E-liquid Products

These new laws put to the test some of the claims other vapor e-liquid manufacturers make such as percentage of domestic (ie. USA Made) and foreign (ie. China) ingredients, Grade Level (Pharmaceutical versus Food Grade), Natural versus Artificial flavors, ingredients and more.

As always (established 2009), we are FDA compliant and our vapor brands e liquid products are 100% USA Made, with the highest purity grades (Pharmaceutical), and Natural flavors. In addition, our products have always been and will continue to be in compliance with all requirements.

In accordance with FDA Required Labeling and Warning Statements for Tobacco Products

Item 1. Nicotine Addictiveness Warning Statement

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

  • Be located in a conspicuous and prominent place on the two "principal display panels" of the package;
  • Comprise at least 30 percent of each of the principal display panels;
  • Be printed in at least 12-point font size and must occupy the greatest possible proportion of the warning label area set aside for the required text;
  • Be printed in conspicuous and legible Helvetica bold or Arial bold type or other similar sans serif fonts and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other printed material on the package;
  • Be capitalized and punctuated as indicated in 21 CFR § 1143.3(a)(1); and
  • Be centered in the warning area in which the text is required to be printed and positioned such that the text of the required warning statement and the other information on the principal display panels have the same orientation.

Item 2. Zero-Nicotine: Self-certification and Alternative Required Warning Statement

"This product is made from tobacco."

However, to avoid ANY confusion and to demonstrate best efforts to display the Nicotine Warning Statement:

  • Zero Nicotine Items will ALSO have: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." 
  • The Nicotine Level will be clearly indicated on bottle. Zero Nicotine Still Means Absolutely Zero Nicotine.
  • A supporting section has been added to the principle display panel #2.

Zero-Nicotine: Self-certification and Alternative Required Warning Statement

We feel its best to promote the FDA required language on all items in efforts to educate consumers, rather than skirt around and attempt to non-disclose required statements. We are in support of the FDA and consider them to be allies in the battle against inferior products and illegal and harmful business practices. 

Item 3. Additional Sections FDA Label Requirements and California Proposition 65

Additional FDA Label Requirements August 10, 2018 and California Proposition 65

 

  1. the name and place of business of the tobacco product manufacturer, packer, or distributor; AND an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and
  2. the statement required under section 920(a)…(section 903(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). Section 920(a) of the FD&C Act provides that the label, packaging, and shipping containers of tobacco products shall bear the statement “Sale only allowed in the United States”.
  3. Required Updated California Proposition 65
  4. an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; (similar to "20 Class A Cigarettes" on Combustible Cigarettes).

Thank you for your support and understanding of the new rules and regulations. We have spent many hours researching, testing and implementing all required items.

These new laws put to the test some of the claims other vapor e-liquid manufacturers make such as percentage of domestic (ie. USA Made) and foreign (ie. China) ingredients, Grade Level (Pharmaceutical versus Food Grade), Natural versus Artificial flavors, ingredients and more.

As always (established 2009), we are FDA compliant and our vapor brands e liquid products are 100% USA Made, with the highest purity grades (Pharmaceutical), and Natural flavors. In addition, our products have always been and will continue to be in compliance with all requirements.