August 2016

The First Deadline: Is your shop ready for the FDA on August 8?

By Corey Noles

By the time you read this, the FDA’s regulations will be days from taking effect in your shop. Hopefully, you’ve spent the previous 90 days planning and making preparations for the future.

With a number of different rules becoming official, many are common sense and have been enforced by most reputable shops for years already.

This article will walk you, the store owner or curious consumer, through the list of items that must be taken care of ahead of the effective date.

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  • ID checks become law for any customer under the age 27 – just as the cigarette retail system has done for years. This should be an easy fix and should already be taking place in most stores.
  • Sales are now prohibited at the federal level for anyone under 18 years of age. Most states had already made this particular provision law, but the regulations make it a uniform law across the nation.
  • Free sampling is a thing of the past – in shops, at expos and giveaways are all a thing of the past. Shop owners across the nation have been developing systems to ensure customers will continue to be able to sample before buying full bottles. The ideas range from monthly or annual membership plans to charging a set fee per individual sample. There remains considerable dispute over which method would be in compliance while still providing the customer the best experience.
  • Vending machine sales are now illegal in any place other than an adult only facility.
  • Shops that continue to manufacture their own e-liquid, will be treated as manufacturers – not simply stores. Over the long term, this could be catastrophic for stores with house juices.  By December 31, 2016, they will have to file a report detailing every juice they make, like all other manufacturers. They will then also be subject to the Premarket Tobacco Application (PMTA) process, likely with hundreds of applications per store given the nearly infinite number of flavors and nicotine levels.
  • Product labels may not contain any statements that electronic nicotine delivery systems (ENDS) can be used to help a person stop smoking.

The next deadline of concern applies to manufacturers and importers of ENDS products and E-Liquids. By December 31, 2016, establishments engaged in the manufacture, preparation, compounding, or processing of a tobacco product and product listings must be registered with the FDA.

An ingredient listing of all products is required by February 8, 2017. Small-scale manufacturers, any manufacturer with less than 150 employees and (a key word) $5 million in annual revenue, will have until August 8, 2017 to file their ingredient listings. Any product introduced to the market after August 8, 2016, will have to file the listing 90-days prior to marketing.

The same deadlines apply to the filing of Tobacco Health Documents to the FDA, which will also require rather expensive testing.

Look for more information on how the process will affect manufacturers, importers and distributors in our special September issue.

Corey Noles is the managing editor of VAPE Magazine. He has worked as a journalist for more than a decade and is the founder, owner of Inked Up E-Liquid Co.