Upcoming FDA Regulations

We’ve received a lot of questions recently regarding the upcoming deadlines in the United States pertaining to the FDA and the Tobacco Control Act. We’ll highlight a few of the keys items in this blog posting but encourage everyone to reference the guidance at FDA.gov.

Packaging Requirements

All products must be manufactured with compliant packaging by August 10, 2018. That means, all tobacco products must adhere to the very specific warning labeling requirements. Furthermore, all distribution of non-compliant packaging must end on September 11, 2018. The only way a retailer can offer for sale or distribute non-compliant packaging is if they fall within the safe harbor:

“A retailer will not be in violation of this section for packaging that (i) Contains a health warning: (ii) Is supplied to the retailer by the tobacco product manufacturer, importer, or distributor who has the required state, local or Alcohol and Tobacco Tax and trade Bureau (TTB) – issued license or permit, if applicable, and (iii) is not altered by the retailer in a way that is material to the requirements of this section. 21 CFR 1143(a)(3)(ii).

Distributors and retailers may continue to sell and distribute the tobacco product packages after the effective date, but only if the products were manufacture before the effective date of the new required warning statement for covered tobacco products.”

Additionally, manufactures, importers, distributors and retailers who direct their own advertising must include the addictiveness warning by August 10, 2018.

Product Listing Requirements

All e-liquid companies that are manufacturing, mixing or developing their own liquids will have to file their formulas with the FDA in the upcoming months. For those companies that are not considered small-scale will have to file by May 8, 2018. Companies that are considered a small-scale tobacco manufacturers need to file by November 8, 2018.

“The term small-scale tobacco product manufacturer means a manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5 million or less. FDA considers a manufacturer to include each entity that it controls, is controlled by, or is under common control with.”

We here at Cali Steam are moving ahead optimistically about the future success of the industry and ask each of our customers to join us. The vaping industry as so much to offer society and smokers we can't pass up this opportunity. Drip Vape Repeat