The FDA has issued new draft guidance clarifying requirements for vape shops. While this is encouraging, it’s important to remember the recommendations are still nonbinding and will need your support.
The idea is that vape shops would be able to provide a wider range of services to customers without either being classified as a manufacturer or subject to costly pre-market authorization. According to the FDA’s published document, available here, vape shops could:
Refill tanks for customers, within certain restrictions
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 Can You Do?
The FDA is accepting public comments on the new draft guidance through February 16 and will issue final guidance at a later date. It’s crucial that we take the opportunity to explain to the FDA how current restrictions affect us. Click here to submit your comment now.