Representatives Tom Cole (R-OK) and Sanford Bishop (D-GA) have introduced legislation, called the FDA Deeming Authority Clarification Act. Often called “Cole-Bishop,” the bill would fill the gaps left by the FDA’s rules on e-cigarettes, require common sense regulations, and provide clarity for manufacturers, retailers, and consumers.
A current FDA rule would require that every product that came to market after 2007 must go through a lengthy, expensive, and burdensome approval process. This legislation would modernize this re-approval date to 2016, relieving this unnecessary burden on manufacturers and retailers, promoting innovation in the industry, and keeping products available for consumers.
Consumers want to know the products they eat, drink, wear, or use are safe. The same goes for vape products.
The Cole-Bishop Act would go further than the FDA’s current regulations to protect consumers, especially children, through stricter requirements on labeling and advertising. This includes requiring “Keep Out of Reach of Children” and “Underage Sale Prohibited” labels, restricting advertising to publications that are only marketed to adults, and mandating nicotine content be labeled on packaging. Cole-Bishop legislative language is also the only bill that demands the FDA implement new battery regulations. To date, the FDA has done nothing on this issue.
Cutting out the black market that often comes with prohibition and loopholes in regulations is also contained in the bill. This includes requiring all vape store owners to register with the FDA and providing the tools for the FDA to more consistently and comprehensively enforce current requirements, such as age restrictions.
Studies show that vapers are more likely than non-vapers to try quitting smoking, and more likely to stay smoke free longer. Many researchers note that the increase in the availability and prevalence of e-cigarettes coincides with more smokers trying to quit.
Regulations should be encouraging options for smokers who are trying to quit, not limiting their access and choice to cessation devices like e-cigarettes. However, our current regulatory framework is working against smokers who want to switch to vaping.
We do not have a good record on the harm reduction front – from the war on drugs to our current and ongoing opioid crisis, we often fail at realizing how simply reducing harm can save lives. Turns out, tobacco harm reduction is no exception. The reduction of harm should be a much bigger factor in our nation’s health care policies, and that includes supporting vaping.
A January 2018 study from the National Academies of Sciences found “conclusive evidence that completely substituting e-cigarettes for combustible tobacco cigarettes reduces users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes.” Representative Bishop said, “Vapor products offer a promising path for harm reduction for those seeking to quit or limit their smoking. This legislation would ensure the FDA’s regulatory process does not limit the availability of safer tobacco options for those seeking to make use of them.”
The current FDA regulations on e-cigarettes would be an unnecessary burden, especially to small business owners. A little-known rule from the FDA called “the deeming rule” declared any new vape products that entered the market after 2007 would need to go through a long, expensive reauthorization process.
Because of this, small vape manufacturers and vape shops would need to submit go through costly applications for re-approving products that have been on the shelves for years. The application costs are estimated to range from nearly $200,000 to over $2.5 million. This will close down many small businesses, and limit access to smoke-free options for consumers.
After the State of Indiana’s own problematic 2015 legislation on regulating e-liquid, and the subsequent legislative fix last year, we need Congress to continue modernizing our approach.
Policies and regulations should be supporting innovation in the vaping industry, leading to even smarter and safer products, not hindering progress. The Cole-Bishop Act does exactly that, and Congress should support it and help small business owners.
Like cell phones, the technology of these products moves rapidly. Think back to an iPhone five or ten years ago – a completely different product. What is the public benefit of bringing an iPhone 3 to market today?
While markets in other countries make advances in innovative vapor products and consumer safety, the U.S. is getting left behind. What does this mean? No battery safety innovation, no new devices, no flavor compound development. Instead, companies are being forced to spend significantly on “pre-market approval” for existing products rather than innovating new products.