August 8, 2016 Deeming Day & The Future of Vaping

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Today is Deeming Day: What Does This Mean For the Future of the Vaping Industry?

 

August 8, 2016 has earned the moniker Deeming Day as it marks the day that the FDA asserts its authority over electronic cigarettes and vapor products to treat them exactly as tobacco products.

Though no one is sure yet, but it may be the beginning of the end of vaping as we now know it—though this all does depend on if the vapor industry’s legislative efforts fail or if they succeed. Either way, it is the beginning of new territory for all things vaping related as starting today there are many new additional rules that all retailers in the industry now have to follow in order to continue to operate.

There is a lot of confusion out there at the moment on the regulations, so here is a quick list for all those interested in learning exactly what is set to happen for the future of vaping. For your own reference, here is the full document of the FDA’s Deeming Regulations.

 

What Happens After Deeming Day--August 8, 2016

 

- No new vapor products can be introduced into the market unless the FDA has given their approval on the product. This approval requires the product to go through the Premarket Tobacco Application (PMTA) or Substantial Equivalence approval.

- Vendors who sell vapor products can only sell to customers who are legally old enough to use tobacco products. The common age is 18 or older, where some states like New Jersey the age is 19 and others like Hawaii and California the age is now 21. Vendors MUST check the valid photo ID of everyone who looks like they can be 27 years old or younger. Online sales require proper age verification before being fulfilled.

- Stores who mix their own e-liquids or make/modify mods and other vapor devices are now considered tobacco product manufacturers. All manufacturers must now comply with the FDA’s legal requirements, read them here. In a nutshell, these requirements include the following:

       Manufacturing facilities must be sanitary to prevent contamination of products that could become a health risk beyond the regular use of the products.

       Businesses that decide to stay as manufacturers must register as a manufacturer with the FDA no later than December 31, 2016 and must provide the FDA with a full list of their products.

- Free samples are no longer allowed. Vendors have opted to interpret this rule as simply to charge a small fee in order to allow their customers to sample products. It would also allow them to have proof of their compliance with the regulation.

- Selling vapor products in a vending machine is no longer allowed. Unless the facility the vending machine is in caters solely to those over the legal age to smoke in that state.

- The FDA will be cracking down on “misbranded” products, items that have misleading claims on advertising and labels. Vapor manufacturers and vendors are not allowed to make claims to customers that indicate vapor products are less harmful or have fewer risks than tobacco products.

 

The Rest of the Timeline:

 

December 31, 2016

 

- Businesses that manufacture, prepare or process tobacco products are required to register with the FDA by this date. Down the road, the FDA will also require international businesses who sell their products in the US to register.

- The FDA must be provided a list of ALL products that a company manufactures or sells. This includes proper labeling and advertising. Product listings will be required to be updated every June and December.

 

February 8, 2017

 

- By this date all e-cig manufacturers must provide the FDA with a list of ingredients along with Tobacco Health Documents (view here). This doesn’t apply to “small-scale” manufacturers, which are businesses that have less than 150 employees and an annual total revenue that is less than $5 million.

 

August 8, 2017

 

- Products that contain the descriptions “Light”, “Low”, “Mild” or other similar descriptors on the labeling will be prohibited. Advertising of products without a modified risk tobacco product order in effect and no distribution is allowed after September 8.

- “All required label and labeling statements must be prominent and in such terms that render it likely to be read and understood”

- Compliance period for e-cig manufacturers to submit substantial equivalence exemption requests. This most likely will not be applicable to vapor products.

 

February 8, 2018

 

- The compliance period for manufacturers to submit a substantial equivalence application to the FDA. Very unlikely that this will apply to vapor products unless a product passes the PMTA screening.

 

May 10, 2018

 

- Product labels and advertisements MUST contain the addictiveness warning statement:

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

This warning has a specific font and format size requirement that must be followed. Businesses cannot manufacture products without the properly compliant packaging beginning on May 10, 2018 and won’t be allowed to distribute non-compliant products starting on June 11, 2018.

- Vapor product packages and ads of covered tobacco products can use the following alternative warning statement:

“This product is made from tobacco.” Manufacturers are required to submit to the FDA a self-certification that these proper labels are in use.

 

August 8, 2018

 

- This is the deadline for all vapor companies to submit PMTA’s for all products that were on the market prior to this date. Vapor products are allowed to remain on the market for one year or until the FDA denies the product’s application.

 

August 8, 2019

 

- Products that have not been issued a marketing order by the FDA can no longer be sold.

- Businesses are required to report all harmful or potentially harmful constituents (HPHCs) for their FDA approved products.

 

Our Fight Is Not Over Yet!

 

Don’t give up; there is still hope for our industry. Go through this list below, participate in all of them or at least do one thing—as vapers, we need each others’ support now more than ever.

 

1. Join SFATA – Become a member and stay informed with the largest leading association in the vapor industry that's committed to help save the vapor industry. As a member you’ll have access to the latest information and knowledge for the goings-on with vapor legislation and it will help you connect with other vapers in your neighborhood and all over the country.

2. Join CASAA – This free membership gives you access to the vaping community in your town and nationwide. It will sign you up for their newsletter that will keep you up to date on the latest in legislation for the vapor industry and it will also give you a list of things you can do now to help save vaping.

3. Join the American Vaping Association – Their newsletter list will keep you up to date on the latest news in the vaping industry and what you can do to help our cause.

4. Check out August8th.org – Via CASAA, this url links out to an easy to fill form that you can use to quickly find our who the Representatives are in your state. It will also give you talking points on what you can say in your phone call or email to your state Representative in an effort to have them support a change in the predicate date stated in the Tobacco Control Act (HR 2058 and the Cole-Bishop amendment).

5. Support the Right to be Smoke-Free Coalition Lawsuit by sending in a quick contribution.