What to Expect from the FDA's New "Deeming Rule"

Vapechemist.com | Deeming FDA Rules

Last year, the regulations around tobacco and tobacco products changed. The Food and Drug Administration enacted a new rule extending its authority over a wide range of tobacco products, commonly called the “Deeming Rule.” Before enacting the rule, the FDA already regulated cigarettes, cigarette tobacco, “roll-your-own” tobacco (RYO), and smokeless tobacco. The Deeming Rule also allows the FDA to regulate cigars, electronic nicotine delivery systems (such as e-cigarettes), and waterpipe or hookah tobacco. The new rule, initially proposed in April 2014, also added new regulations regarding the sale and distribution of such products.

So what exactly does this mean for you?

The Deeming Rule has a pretty significant impact for anyone involved with tobacco or tobacco-related products. This includes manufacturers, retailers, and consumers, and the changes will come in phases. But exactly what should people expect? And when do the changes need to happen?

Manufacturers

According to the FDA, manufacturers include entities that do any of the following:

  • Mixing e-liquids
  • Making and modifying any type of device for vaping
  • Mixing loose tobacco that is intended for use in a pipe
  • Rolling or blending tobacco for cigars
  • Manufacturing “roll-your-own” tobacco for consumers to make their own cigarettes
  • Importing tobacco products from other countries
  • Manufacturing any sort of tobacco product

Since August, tobacco manufacturers have been required to stop distributing tobacco products with modified risk claims other than “light,” “low,” or “mild.” In addition to this, they will be required to submit tobacco health documents and ingredient lists for their products in 2017. For most manufacturers, the deadline for these submissions is February 8. The deadline is August 8, 2017 for small-scale manufacturers. If a manufacturer does not have an MRTP order in place by September 8, 2017, the descriptors “light,” “low,” and “mild” will also need to be removed.

Manufacturers will need to register their companies and submit a list of the products they offer, including the labels they use for those products and any advertising materials by June 30, 2016. Any “new” products—that is, any product that entered the market after February 15, 2007—will require a premarket application to the FDA.

By May 10, 2018, manufacturers will need to include warning statements on the packages and advertisements of any “covered” tobacco product. Finally, by August 8, 2019, they will need to submit a list, including quantities, of any harmful or potentially harmful ingredients in the product.

According to the FDA, they intend to limit their enforcement of these new requirements to e-cigarettes, cigars, and other tobacco products added by the Deeming Law. For more information, you can view the FDA’s compliance guide for manufacturers.

Retailers

The FDA’s website defines tobacco retailers as any entity that does any of the following:

  • Selling cigars
  • Selling tobacco for use in a water pipe or hookah
  • Selling e-cigarettes or e-liquids
  • Selling any sort of tobacco product

For retailers, the main change is that the restrictions they are currently under for cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco will extend. The new regulations will include cigars, hookah tobacco, e-cigarettes and vape juices. Starting on May 10, 2017, retailers will not be allowed to sell the products to anyone under 18 and must check ID for anyone under 27. They also will not be allowed to sell these products without a warning label on the package and on any advertisements.

For more information, see the FDA’s compliance guide for retailers.

Consumers

The changes for consumers mostly come from the new regulations for manufacturers and retailers. As of August, distributors are no longer allowed to offer free samples of e-cigarettes and related products, nor can they sell in vending machines. The August 8 deadline also prohibits the sale of e-cigarettes to people younger than 18. This only really affects Michigan and Pennsylvania, however, as the other 48 states already had their own legislation in place with the same effect.

For a more complete guide on what to expect, visit the official FDA page discussing the new regulations.

Guest Post by Kenneth Overton



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