The FDA’s deeming regulations are the 800-pound gorilla in the American vaping world. Everyone has heard something about them, but there are many misconceptions. Here’s the story.
With these regulations, the FDA is literally deeming (or defining) e-cigs to be a tobacco product, which allows them to then be regulated under the authority of the Family Smoking Prevention and Tobacco Control Act of 2009. Mitch Zeller, head of the FDA’s Center for Tobacco Products, has said that the deeming regulations are a “foundational” step — a basis for additional rules in the future. Once in effect, the FDA will be free to add all sorts of restrictions without real opposition.
What is in the regulations? We can’t be certain, since nobody has seen the current version. But based on what was released last year before the public comment period, we can make some educated guesses. Attorney Azim Chowdhury wrote an excellent summary of the deeming regs last year that is a good starting point. NotBlowingSmoke.org also maintains a site dedicated to the issue.
Regulation or a virtual ban?
The FDA seems determined to create requirements for manufacturers (including producers of e-liquid) that will be so expensive that no businesses except the major tobacco companies will be able to afford them. Only products that were on the market and being sold in the US before February 15, 2007 (the “grandfather date”) will be exempt from applying as new products for FDA approval.
Since virtually nothing being sold currently was on the market in 2007, that means all of the products we use now would be illegal to sell — unless the manufacturer applies for and receives approval as a new product.
Cost estimates range from $300,000 to $10,000,000 to complete a Premarket Tobacco Application (PMTA) for each product.
For e-liquids a separate application would be required for each flavor, and at each nicotine strength, and in each PG/VG mix.
By the way, applying doesn’t guarantee approval. It is quite likely that a manufacturer could spend millions of dollars and a year’s time jumping through all the hoops of submitting an application only to have it denied. The cost and the risk of denial are why many vaping advocates call the deeming regulations a virtual ban.
Where do we stand now?
Since last year’s comment period, the FDA fine tuned the regulations, and in October sent them to the White House Office of Management and Budget (OMB) for review. The OMB has just finished meeting with interested parties – including many manufacturers, shop owners, advocates, and representatives of trade associations, think tanks and consumer groups. They’ve also met with many groups that are opposed to e-cigs and want strong regulations.
Any day now, the OMB will choose to either send the regulations back to the FDA for further changes, or allow them to stand as they are. Once they make their determination, if no changes are required, the regulations will be published in the Federal Register, then go into effect after a brief public comment period.
What can we do now?
There is a legislative effort that could change the outcome to some extent. U.S. Rep. Tom Cole of Oklahoma has introduced HR 2058, which would prevent the FDA from applying the 2007 grandfather date to vapor products.
This would essentially save the whole U.S. industry — for now anyway. The bill needs co-sponsors in the House — other members to sign on to support the bill.
CASAA has an easy-to-complete form that sends a letter supporting HR 2058 to your representative just by entering your name and address. It takes just a minute to do, and could have a huge effect on the future of vaping.
While this fix would be helpful, the more likely scenario is that the deeming regs will go into effect, and then be fought in court. Who will sue? On what grounds? Who will pay for it? We don’t have answers to those questions yet. What is certain is that a legal solution will be a long, expensive and difficult process. Stay tuned!