On Tuesday, May 10, 2016, The U.S. Food and Drug Administration (FDA) officially published the new e-cig deeming regulations that will effectively and systematically eradicate the entire vaping industry within the next two years. The deeming regulations are published in a lengthy 500-page document that many in the vaping community find difficult to understand. As a result, the FDA has established a National Hotline for answering any questions or concerns.
Some of the common questions that vapers and vape shop owners are asking include:
- I was planning to release a new e-liquid next month. Will I be breaking any laws if I still release it for sale?
- I have a home-based business. Do I need to register as a tobacco manufacturer?
- My product has zero nicotine in it. Do the new deeming regulations apply to me?
- Is the ingredient vegetable glycerine considered a “tobacco product?” I make my own e-liquid at home.
- I sell cotton material for wicks. Is the FDA telling me that cotton is now a tobacco product?
- How much will the Pre-market Tobacco Application (PMTA) cost me? How long does it take to get approval?
- Can I still sell my vaping products after I submit the PMTA application? Or do I have to wait for an official approval or rejection? If so, how long does it take?
- And many others.
For questions related to
FDA deeming regulations or clarification
Please contact the FDA Hotline:
Since the original announcement of the new FDA deeming regulations on May 5, 2016, advocacy organizations such as the Smoke-Free Alternatives Trade Association (SFATA) and The Consumer Advocates for Smokefree Alternatives Association (CASAA) have been receiving thousands of calls and emails from citizens. Many are from vape shop owners and online retailers asking about the specifics of the new legislation. While these advocacy groups are always happy to help, they are also posting in their newsletters and websites that the FDA hotline might provide a faster and more informed answer to these types of questions.
The important thing is to get the answers that you need. Even if you think that you have an expert understanding of the new FDA deeming regulations, please contact the FDA Hotline for any clarifications that you need, no matter how small.
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