Amend FDA Deeming Rule:
Change Predicate Date to August 16th, 2016
Proposal: The FDA Deeming Rule currently requires products not brought to market before February 15, 2007 (the "predicate date") to submit a premarket tobacco application (PMTA). This amendment would change this date to August 8, 2016, the same day the rule became effective.
Rationale: The e-vaping/e-cigarette industry developed their products with certain regulatory expectations in mind. Backdating the application requirements to 2007 unfairly imposes compliance burdens on existing products, and will force small businesses unable to afford the application process out of business. This proposed change would prevent the shutdown of 99% of e-vaping businesses, but would have no effect on the FDA’s ability to protect consumers and regulate vapor products, including safety standards, marketing, sale to minors, and batteries. Manufacturers would still be regulated under the Deeming Rule and would have to abide by FDA standards for their products to remain on the market. Finally, e-cigarettes are 95% safer than cigarettes, and there is no evidence that they act as a route into smoking for children. Moreover, e-cigarettes are more effective at helping smokers quit relative to nicotine patches or no alternative, and are an accepted medical option for smoking cessation. Unless amended, this rule will make e-cigarettes more expensive and reduce product variety, negatively impacting public health.
- TechFreedom: "The FDA’s Deeming Rule, which took effect August 8, 2016, requires e-vapor product manufacturers to endure a lengthy and expensive pre-market tobacco application process for all products not brought to market before the predicate date of February 15, 2007. Unless a product is “substantially equivalent” to decade-old products, the FDA estimates that a single application will take 5,000 hours and cost $330,000. The FDA estimates that companies will need to file 20 applications for each product within the first two years of regulation, setting the cost around $6 million per product. Even that would be enough to exclude all but the largest companies, but the National Center for Public Policy Research estimates the real cost will be closer to $1 million per application. The industry has seen massive growth and innovation in the last decade. By setting the predicate date well before the introduction of most modern vapor products, the FDA has ensured that most manufacturers will be forced to shut down, as 99% of products will not go through the required process. The tens of thousands of U.S. shops that sell e-vapor products shouldn’t be punished because the FDA was asleep at the wheel for almost ten years. The Amendment would change only the predicate date, not the FDA’s rules themselves." See letter to Congress.
- Steven Turner, Vapewild Co-Founder. "They placed regulations on us that imposed pretty major hurdles on our ability to stay in business. We spent over $100,000 just on registering the company and the products as they demanded and that was before we had to deal with the pre-market tobacco application." Read More
- Francesca Gettler, Director of Operations at Vapor Source “We have literally come from a mom-and-pop shop to 5 stores, another one in the making and 30 employees and it’s our livelihood." Read More
- Frank Blankenship, Lucky Ruckus Vape Shop. "Blankenship's shop sells roughly 2,000 products. If the application cost $300,000 for each product, that's $600 million coming out of his pocket. That, or, close the doors for good." Read More.
- Madvapes LLC. "Madvapes LLC is not aware of any e-cigarette or e-liquid product that was commercially marketed on February 15, 2007. Because there are no viable predicate products that were on the market on that date, no e-cigarettes or e-liquids products would be considered grandfathered. Recognizing the difficulty that imposing the statutory Grandfather Date will cause the industry, FDA has proposed a compliance policy in the NPRM that would delay enforcement of the premarket authorization requirements for the newly deemed products.27 This two year post- effective date compliance period buffer, however, does nothing but delay the complete collapse of the e-cigarette/ARPV and e-liquid industries as they exist today. Requiring all e-cigarette and e-liquid products to obtain premarket authorization by way of a PMTA will result in these products eventually being removed from the market and effectively banned, even though this was never intended by Congress. While such a result would undoubtedly be disastrous for the public health, as millions of former smokers would likely turn back to harmful tobacco-leaf and combusted products, it may be prevented if the Agency utilizes a more appropriate grandfather date for these novel, significantly less risky products." Details
- Chris Goodwin, Southern Clouds Ejuice. ""We're going to see companies going to one or two products, the regulations are going to divert people from a healthy alternative to smoking by taking the variety out. Variety is very important to smokers that start vaping, you have options. You're not just stuck with a tobacco or a cigarette flavor. Our whole purpose of being here is to help people quit smoking and to save lives. The quit-rate from vaping is 85 percent, 85 percent of the people that vape instead of smoke quit smoking cigarettes. People that use Nicorette, Chantix, and other patches...only 8 percent of those people quit smoking. This is the public health miracle we've been looking for the last 30 years." Read More
- R-Street - TechFreedom Coalition
- Competitive Enterprise Institute - TechFreedom Coalition
- Freedom Works - TechFreedom Coalition
- Americans for Tax Reform - TechFreedom Coalition
- Log Cabin Republicans - TechFreedom Coalition
- Citizens Against Government Waste - TechFreedom Coalition
- National Center for Public Policy Research - TechFreedom Coalition
- Taxpayers Protection Alliance - TechFreedom Coalition
- HighTech Forum - TechFreedom Coalition
- Free the People - TechFreedom Coalition
- Campaign for Liberty - TechFreedom Coalition
- The Heartland Institute- TechFreedom Coalition
- National Taxpayers Union- TechFreedom Coalition
- Zach Cummings, Individual Consumer. "I am a 25 year old male who has been smoking cigarettes and using tobacco products since I was 17 years old smoking about a pack or two everyday . I found out about E-cigs about 4 months ago and instantaneously switched due to the cost of cigarettes and the effects I was noticing from smoking. It has been almost 4 months since my last cigarette and the improvements in my breathing and the way I feel now are drastically improved. Also using e-cigs has killed any urge to have a cigarette since I have started vaping. I think i would accredit that to the flavor selection that is available. I currently have a rotation of flavors that range from apple and cinnamon, pear strawberry, waffle, marshmallow and custard. If the flavors were limited to tobacco i probably would have never switched. If I no longer had access to this type of product I would either go to the black market to buy adequate e-cig product, rather than buy the low quality products that are available at gas stations which are mostly produced by the tobacco industry."
- Dr. Michael Siegel, Professor, Boston University. "The current FDA regulations will decimate the electronic cigarette industry, removing 99 percent of vaping products from the market and eliminating much of the competition faced by cigarettes for the nicotine market. This is all to the advantage of real, maximum harm, tobacco cigarettes." Read more.