Earlier in the year, the Food and Drug Administration announced a new set of FDA regulations for all tobacco-based products nationwide.
The sale of tobacco products and like-tobacco products to any persons under the age of 18 has been banned, and any customers under the age of 26 will be required to provide identification. Free samples will be strictly prohibited as well. These sweeping regulatory changes will be formally enacted on Monday the 8th of August.
In its announcement of the changes to come, the FDA outlined a number of specific objectives that the new regulations are intended to facilitate. With the regulations in effect, the administration will have more leeway to thoroughly inspect any tobacco products that are still in the development phase, before they are released to the public.
The administration hopes to use the opportunity as a countermeasure against misleading tobacco manufacturer claims and negligent quality control. The FDA anticipates that its more direct involvement in all levels of the tobacco production industry could serve to more clearly illustrate the inherent health risks of its products to the public.
How will these new FDA regulations affect e-cigarettes?
The new federal regulations will extend the current age restrictions and sampling bans on tobacco products sales to e-cigarettes as well. Any and all businesses that sell any form of e-cigarette, eLiquid or vapor-related apparatus will be required to comply with the same federal regulations applied to the solicitation of tobacco or face the risk of penalization.
Will vaping devices that were made available before the FDA’s new regulations be treated any differently than vaping devices produced after August 8th?
As all vaping devices will have tobacco regulations immediately applied on the 8th of August, any unreleased e-cigarettes or other vaping devices currently in development will be subject to a Pre-Market Tobacco Application (PMTA) before the can be released, essentially “freezing” the market.
As for the vaping devices that have already been made available for sale on the market, a two-year grace period after the May 8th publication has been given. Manufacturers may continue to sell their products within the grace period, but a PMTA must be submitted before two years from May 8th, 2016 have elapsed.
PMTA fees for vaping devices are currently the subject of speculation. The FDA’s small business PMA fees and standard PMA fees for medical devices are approximately $65,000 and $261,000 respectively, but there has not yet been a clear answer to just how much PMTA fees for vaping devices could be.
After manufacturers have submitted their PMTA for a fee that has yet to be determined, a yearlong grace period after the date of the submission will be allowed for consideration. Approval is not guaranteed.
Do these regulations pose a threat to manufacturers and the growth of the vaping industry?
While the full scope of changes will be formally put into effect on August 8th, 48 states (excluding Michigan and Pennsylvania) have already issued bans on sales to minors. On the 8th, providing free samples to customers of any age will be outlawed.
The public perception of distinctions between e-cigarettes and tobacco products has consistently been the subject of controversy, particularly in regard to e-cigarette use by middle and high school students. For years, the debates between proponents and detractors of e-cigarettes have surrounded everything from its health implications to its potential as an alleged “gateway” into tobacco.
Aside from the risks of excessive regulatory enforcement, many vaping manufacturers and vapers alike are concerned about the potential of these regulations to empower social stigma and misinformation surrounding their products. As the national tobacco smoking rate has fallen to record lows, the superficial association between tobacco smoking and vaping remains.
Vaping businesses that have been in operation for years before these regulations were created may or may not have the ability to meet the undetermined PMTA fee within the grace period. Unestablished sellers with products that are still in development will likely have less of an ability to manage the PMTA fee than sellers who have already been in business for some time. The exact cost of the fee, and the level of discretion that the FDA exhibits in approving manufacturers that do complete their PMTA applications, will be paramount in determining the future of the vaping industry.