The day the vaping community had anticipated finally arrived. On May 10th, 2016, The Food and Drug Administration (FDA) released what they titled “Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act”. The FDA CTP (Center for Tobacco Products) has regulated Cigarettes, Roll-Your-Own Tobacco, as well as Smokeless Tobacco since 2009 (The last amended date before 2016). Now, they have included E-Cigarettes, Dissolvables, Pipe Tobacco, Hookah Tobacco, Cigars, as well as Novel and Future Products within their scope of regulation.
The FDA considers “this action a milestone in consumer protection” as they will now be able to review new tobacco products before they hit the market using PMTA’s (Pre-Market Tobacco Authorizations) as well as help prevent claims by manufacturers which may or may not have been misleading. This will also allow the FDA to evaluate the individual ingredients being used in the newly regulated products, primarily e-liquid. Finally, the FDA’s hope/goal is to better communicate the potential risks of tobacco products to prospective and current consumers while combatting underage use of these products at the same time.
Unfortunately, these regulations affect the vaping industry in its entirety including Manufacturers, Distributors, Vapor Shop Owners, as well as the end-user (consumer/vaper). Manufacturers of e-liquid and other electronic cigarette accessories will have a certain amount of time to get their products that aren’t currently “in-commerce” onto store shelves as well as comply with the new regulations set fourth concerning the overall contents of their juice (ex. VG, PG, Flavors, and Nicotine) as well as their current or future packaging (ex. CRC Caps with Shrink Wrap). Distributors will also face many challenges as much of their current stock won’t be in compliance with the new regulations; although they still have time to continue their distribution efforts, a loss will be more than likely be incurred.
Vapor Shop owners may face the most detrimental of these regulations as not only will they have a certain amount of time to ensure that their current stock of e-liquid is in compliance, the regulations also prohibit in-store sampling after a certain date which will more than likely discourage consumers from purchasing flavors they are unsure of, which could lower revenue for the vapor shop (see below for time frames). Finally, the consumer will suffer as many of their favorite brands will disappear from store shelves depending on whether or not the company has the capacity to meet regulations and continue production.
The dates in which the new regulations take effect, as well as what is required of those participating within the industry are as follows:
August 8th, 2016
The official effective date of the new rules. All manufacturers must have new e-liquid lines on the market by this date, as well as proper labeling outlining the new rules regulating sales to those under the age of 18.
August 8th, 2016 to August 8th 2018
By this time, manufacturers who were unable to meet the initial August 8th 2016 deadline will have two years to submit their PMTA’s (Pre-Market Tobacco Authorization). Also, Vapor Shops that feature tasting bar’s or sampling areas will have to discontinue providing that as an added-value to their customers.
The question came up as to whether or not anyone within the industry will benefit from these regulations vs. facing the coming hardship that many will undoubtedly endure. The answer is unfortunately yes. Companies who have dominated the industry with their brands, or increased their reach by saturating the market with many brands will undoubtedly have an advantage regardless of whether or not they meet the initial August 8th deadline due to their multiple revenue streams and capital resources. Professionals have speculated that those who can’t meet the deadline may face a fee of up to $1.5 Million dollars per product SKU in order to submit a PMTA. For e-liquid manufacturers, this means not only each flavor, but each nicotine level. If the line has 3 flavors, with 4 nicotine levels, that equals out to 12 SKU’s or $18 Million dollars in fees in order to submit an application that may or may not be approved at the discretion of the FDA. Among the larger dominating companies exists what many refer to as “big tobacco” meaning the larger tobacco companies who have ventured into the vaping industry by releasing cartomizer type e-cigarettes that are readily available wherever cigarettes and other tobacco products are sold. Using their current resources, they were able to secure shelf space in retail locations that smaller manufactures were unable to acquire due to size, volume, and/or capital restrictions.
At this time, we as industry professionals have no choice but to play the waiting game and comply. It has been speculated that the FDA doesn’t have the power to enact such strict restrictions, but that is to be determined by members of congress and information won’t be readily available until a decision has been made. As manufacturers, vapor shop owners, and distributors, there are things that you can do to ensure that your voice is heard. For example, becoming a member of the SFATA (Smoke Free Alternatives Trade Association) has many benefits within the association as well as enables you to provide support for those advocating for the industry as a whole. Another association worth joining is CASAA (The Consumer Advocates for Smoke-free Alternatives Association) who provide up to date information on FDA regulations as well as other worthwhile information for those who may be interested in becoming more aware of the coming changes. Vapor shop owners are encouraged to pass relevant information along to their customers and make them aware of how they may be affected as consumers because they also have an opportunity to voice their opinion by reaching out to their local legislators and relaying their thoughts on the new regulations. SVBS
Below are two sources in which to consider when looking for up to date information:
The SFATA –
(Smoke Free Alternatives Trade Association)
(The Consumer Advocates for Smoke-free Alternatives Association)
Editorial by Matthew C. Ball.