NEW FDA REGULATIONS

For the past few years, there has been a lot of talk about the FDA’s Center for Tobacco
Products making a move to regulate the manufacturing and distribution of all tobacco products which includes e-cigarettes, pipe tobacco, dissolvables and hookah or waterpipe tobacco. In April, a Social Smoke representative went to Washington to speak before members of the proposal in a public forum discussion. You can read more about that in a previous post, Social Smoke Goes to Wasington.

This month, May 5th, 2016, the FDA’s CTP division finalized and passed the proposal. This post is meant to provide a very surface level overview of the new regulations and not the possible changes Social Smoke or other manufacturers will have to make in order to be in compliance of the guidelines or gain approval from the FDA.

According to the FDA’s website, http://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/default these are the new guidelines all manufactures of hookah tobacco will now have to adhere to:

(the following is copied verbatum from the FDA’s website)

  • Submit an application and obtain FDA authorization to market a new tobacco product (for timelines and more details please see Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act)
  • Register establishment(s) and submit product listing to FDA by December 31, 2016 (this currently only applies to domestic manufacturers)
  • Submit listing of ingredients
  • Submit information on harmful and potentially harmful constituents (HPHCs)
  • Submit tobacco health documents
  • Do not introduce into interstate commerce modified risk tobacco products (e.g., products with label, labeling, or advertising representing that they reduce risk or are less harmful compared to other tobacco products on the market) without an FDA order
  • Manufacture your tobacco product with the required warning statement on packaging and advertising
  • Market your tobacco product in compliance with other applicable statutory requirements, rules and regulations

While all these regulations seem to be straightforward there are a lot of gray areas that the FDA has yet to address. The biggest and one not mentioned on this page of their website is the Grandfather Clause.

This clause states that any and all tobacco that was produced and marketed before or on February 15th, 2007 could be eligible to continue to be manufactured and distributed without required compliance to the new regulations. The catch is that companies would have to be able to prove that the product was on the market before February 2007 and that it’s still an active product today

Every other product produced and distributed after that date is required to adhere to the new guidelines and companies must submit an application to the FDA for approval. Since most US based hookah tobacco companies are fairly new or active within the past five to ten years, this clause pretty much subjugates all domestic tobacco while giving free reign for foreign hookah tobacco companies that have a lengthier history of manufacturing to distribute without penalty.

As of now, there is no fee attached to the application, but scientific testing of the product is required and it’s still unclear whether each blend will require testing or if it’s all inclusive. Such tests could cost companies upwards of a million dollars with no guarantee of approval. An exact timeline of the actual approval process has not been made clear but it could take an application about two years to receive approval.

On May 10th, 2016 the first known lawsuit against the FDA regulations was filed by a vapor company and I’m sure many more will follow. But without an injunction granted by court, which will delay these regulations, the FDA intends to continue the regulatory process even while the lawsuit is pending.

At the moment, Social Smoke is in a wait and see mode. Many of the new regulations will not affect the way we do business. We have always labeled our products with the standard tobacco warnings required of cigarette companies and making a list of our ingredients is not an issue.

However, all of the Social Smoke Tobacco line was produced and marketed after 2007 and is ineligible for distribution under the  Grandfather Clause.

So as more information comes out about the application process, and costs, Social Smoke will comply with the FDA’s new guidelines while determining if registering for FDA approval is feasible and in our best interests.

We will continue to keep you updated regarding this issue in the next few months. Please feel free to message or comment any questions you have.