FDA Update: Hopeful News for Retailers, and a Call to Actionjwyland
The FDA has issued new draft guidance clarifying its requirements for vape shops. While we at Nicopure Labs see this development as an encouraging sign, it’s important to remember the recommendations included in the draft are still nonbinding and will need broad support from the retail community.
What This Could Mean for Retailers
The upshot is that, should the recommendations be implemented, vape shops would be able to provide a wider range of services to customers without being classified as a manufacturer or subject to the costly premarket authorization process.
According to the FDA’s published document, available from their website here, vape shops could be permitted to:
• Refill tanks for customers, provided the shop does not make any further modifications to the device or to the e-liquid before, during, or after the refill, that are either outside the marketing authorization order or, if there is no marketing authorization order, inconsistent with the original manufacturer’s specifications
• Demonstrate the use of a product without assembling it, including providing instruction designed to assist users on its correct usage
• Maintain a product by cleaning or tightening fixtures
• Replace the coils in a device with identical coils (e.g., same ohm and wattage rating)
• Assemble a final product from a kit or from components and parts sold individually or from multiple kits if the final assembled product consists of components and parts that are also available in a single kit
What Retailers Need to Do Now
The FDA is accepting public comments on the new draft guidance through February 16, 2017 and will issue final guidance at a future date. Nicopure Labs strongly urges all retailers to take this opportunity to tell the FDA how current restrictions affect their businesses, as well as to encourage their customers to submit their own comments.
All comments should be submitted here by February 16.