Vape Packaging Regulations

Another important date in the vape industry is fast approaching and there have been a lot of discussions of what companies are doing to prepare. In August, the FDA plans to regulate specific packaging requirements of vapor products.

Products that are manufactured after August 10, 2018 must include the following information if they contain nicotine, "WARNING: This product contains nicotine. Nicotine is an addictive chemical." Furthermore, all distribution of non-compliant packages must end as of September 11, 2018

Manufacturers, importers, distributors and retailers who direct their own advertising must also include the addictiveness warning as of August 10, 2018. Additionally, products are considered misbranded if they do not include the FDCA 903(a)(2) required labeling as of August 10, 2018.

There are other labeling requirements that must appear on tobacco product package labels if the product is manufactured, packaged, sold, offered for sale, distributed, or imported for sale or distribution within the United States. The following statements must appear on roll-your-own, cigarette tobacco, and "covered tobacco product" package labels per Section 903(a)(2) of the Tobacco Control Act:

  • the name and place of business of the tobacco product manufacturer, packer, or distributor;
  • an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;
  • 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
  • the statement: “Sale only allowed in the United States” on labels, packaging, and shipping containers of tobacco products

This required warning statement must also meet certain requirements, with respect to font, text, size, placement and formatting of the warning statement on the package labels. That is, the required warning statement on package labels must also appear directly on the package, and be clearly visible underneath any cellophane or other clear wrapping, per 21 CFR § 1143.3(a)(2), as follows:

  • 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 (warning label area);
  • 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 above; 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.

Continue to visit our blog to learn more about these upcoming changes to the industry. It's critical to everyone to be educated and up to date on these changes so we ensure the success of the industry going forward. Drip Vape Repeat