Understanding the FDA August 8th, 2016 Regulations

Understanding the FDA August 8th, 2016 Regulations

Updated: 8/10/2016

As requested here is a breakdown of what everyone can expect as regulation kicks in starting Monday, August 8th. (These are current regulations and not future. That would require another post) It’s taken quite some time for myself and the Vapor Talk team to wrap our heads around the amount of data the FDA released. (Then understanding it well enough to easily explain to everyone. So I appreciate the patience) I’m working on a visual timeline to make it even easier for vendors & members which should be completed shortly.

August 8th – What Regulations Take Effect:

Manufactures must register with the FDA – If you manufacture a finished tobacco product (eliquid or any kind vaping hardware) You must register with the FDA. The Center of Tobacco Products (CTP) will soon start conducting facility inspections. If you mix or create your own liquid, create or manufactures mods, it’s time to get your ducks in a row. The requirement starts August 8th, the deadline is December 31, 2016.

On Site Rebuilding (Retail stores making coils) –  If retailers have a documented catalogue of every type of coil they are building and can prove that each one was manufactured, marketed, and sold prior to 8/8/2016 and can demonstrate that these coils are made the same way, consistently after 8/8/2016, then it is possible that the shop may decide to continue to offer coils built in­house. However, installing these coils on a customer’s device adds another variable that may need to be accounted for. (Updated thanks to TYJ Blog)

For example, if a retailer has documented installing a coil on several atomizers prior to 8/8, in theory, they should be able to continue installing coils on those same atomizers after 8/8. But, if a customer comes in with a device they’ve never seen before and asks to have a coil installed, staff may, effectively, be manufacturing a new tobacco product. Because of the wide range of variables here, many shops will simply decide to stop rebuilding for customers to avoid the potential problems. We expect that many shops will decide to instead instruct customers on how to rebuild.

Assembling Products for Customers – Retail staff can instruct and even demonstrate how a device is assembled or a tank is filled or how eliquid is dripped. They cannot assemble products for customers. That would qualify them as a manufacturer. To that point, repairing or adjusting a customer’s device is also considered manufacturing. The range of possibilities alone makes it virtually impossible to file the appropriate number of PMTAs to continue offering this service (Updated thanks to TYJ Blog)

List your products with the FDA – You will need to provide the FDA (manufactures/mixers) with a list of products that you manufacture. Additionally you’ll need to provide your labeling process and samples of your marketing materials. If you make a change to your product, you must notify the FDA. Additionally, this will become a bi-annual process moving forward. The requirement starts August 8th, the deadline is December 31, 2016.

Testing for PMTA compliance – While there is some time to complete this, it’s a lengthy process. Mixers and manufactures will need to supply the FDA with testing results as per the PMTA application guidelines. (The testing requirements are strict and cumbersome) Mixers and Vendors will need to reach out to their respective legal team and consulting firms to assist with this process. (I cannot legally provide advice here on the forum) To put things into respective, Roger works with a company who’s currently undergoing the PMTA process, they just submitted a 120,000 page set of documents….The requirement starts August 8th, the deadline is August 8th, 2019.

Note on “Finished Tobacco Products”– Finished tobacco products include (but are not limited to): e liquids, tanks, atomizers, batteries, cartomizers, clearomizers, vaping software, bottles. There’s no getting around this, if you sell flashlights for example and plan to sell them with 510 fitted bulb connectors…, the FDA simply needs to prove your item is being used for tobacco purposes. Likely, at that point you can either attempt to mitigate this with features preventing a user from converting your product into a vaping device or apply for PMTA application. The estimated cost is roughly $900k – 1.5 million per SKU depending on your particular situation. US customs, like pre 2011+- will also likely monitor incoming merchandise at some point. If any of you remember ordering from China way back when, while they don’t catch all of the products coming through the border, they do catch 95%. Those products will fall under PMTA requirements. I can’t stress this enough, the FDA is absolutely serious about these requirements. They’ve spent years monitoring the market. They can (and have) read the forums too.

Age Verification – Vendors must ensure vaping or “finished tobacco products” aka ENDS are sold to persons over 18 years of age. Effective: August 8th, 2016. Your local or state law may require higher age restrictions.

Free samples prohibited – You may not provide free samples to consumers after August 8th. That includes reviewing, testing, contests etc. This includes 0mg liquids as believe it or not, the FDA is still considering this a “Finished tobacco product.” There doesn’t seem to be a clear guideline on what constitutes “not free”. This is where each vendor will need to hire their own legal person(s) to assist.

Misbranded products – The FDA will take immediate action on vendors/retailers who sell products with mislabeled products. If a product is produced under what the FDA deems unsanitary conditions and/or contains statements/misleading safety claims, that retailer will be subject to seizure and court ordered injunction. Advertising cannot contain false or misleading information. Liquids must contain the correct nicotine % provided on the label as well as company name, place of business etc

No vending machine sales – Self explanatory. Starts August 8th, 2016. Exception rule: Adult only facilities.

Choose your wording correctly – While this won’t become effective immediately, you cannot use terms such as “low, light, mild” etc as way to describe your eliquid strength or product aspects. Deadline for safety descriptions: August 8th, 2017.

Modified Risk Claims without MRTP application – (This covers all “ENDS” or finished tobacco products as mentioned in the examples above) The FDA will take action against e-cigarette manufacturers and vendors who use the terms “natural” or “additive-free” in labeling and advertising their products. Vendors, this is a big one as I know quite a few do this now – You cannot claim your e liquid is Diacetyl, Acetyl Propionyl, Acetone free etc without first obtaining an MRTP order. Failure to adhere to this could result in a court injunction. The FDA plans to enforce this immediately.

No NEW products – Products created after 2007 and before August 8th can apply for PMTA. You can continue to sell these products until the final deadline august 2018. (2019 for a few small manufacture making under 5 million or per the PMTA guidelines) However no new products after Monday August 8th can be sold or marketed. The burden will be on the manufacturer/vendor to prove the product was manufactured prior to August 8th. So basically what you see now available on the market is it. No no products should/can be released.

I believe that covers most of it. If you believe something above has been posted in error, please Contact Me. (ATT: Chris) There are more regulations but those don’t kick in until December and February respectively. I will create another post discussing those separately.

Forum Topic & Discussion Here: http://www.vaportalk.com/forum/topic/30152-understanding-the-fda-august-8th-2016-regulations/