GCC : the new certification required for e-liquids
Last week we reported on the new regulations in compliance with the Child and Nicotine Poisoning Prevention Act that were inadvertently put into effect, taking the vaping world by surprise. In addition to complying with these new child resistant packaging standards, and being subjected to regular inspections by the CPSC, now all manufacturers selling vaping liquids require a General Certificate of Compliance (GCC), to prove their adherence with the new requirements. The GCC must be provided with every shipment of e-liquids.
FDA’s deeming rule to be enforced next week
One cannot but mention that the toughest regulation to decode and therefore to comply with, the deeming rule, comes into effect next week, on the 8th of August. Amongst many requirements aimed for tobacco products and regulations to limit the access of young adults to vaping products are the below:
- E-cigarette manufacturers and distributors will be prohibited from distributing free samples of their products;
- E-cigarette manufacturers and distributors will be required to register their manufacturing establishments with FDA and list their products;
- Manufacturers will be required to submit ingredient lists to FDA and report harmful and potentially harmful constituents; and
- New warning label statements about tobacco-addictiveness will be required on packaging and in advertisements. Those warning statements apply only to “covered tobacco products,” which excludes any component or part that is not made or derived from tobacco.
In addition, as from the 8th of August vaping products will require a premarket authorization (PMTA) by the FDA that goes as follows:
- Tobacco products that were on the market prior to Feb. 15, 2007 are grandfathered in and do not require any sort of premarket authorization.
- Tobacco products that were on the market before the Effective Date (Aug. 8, 2016) but were not on the market as of February 15, 2007 are required to obtain premarket authorization. For these products, FDA has provided two compliance periods – the first is a deadline for an application to be submitted and the second is a deadline for receiving authorization. FDA has no plans to take enforcement action against any products that remain on the market during these compliance periods provided that applications are submitted; the Agency also has stated its intention to review all these incoming applications expeditiously.
- Tobacco products that were not on the market as of the Effective Date cannot be introduced without marketing authorization from FDA and will be subject to enforcement if distributed and sold without authorization after August 8th.
Currently the FDA will be enforcing the above regulations on finished tobacco products such as ENDS or e-cigarettes, which means that components that are distributed separately for the further manufacturing of any vaping product have further time to ensure that the stock they produce is compliant with the FDA’s specifications.
What can be done?
In article published yesterday on The National Law Review, Joanna S. Hawana, who is experienced in US federal drug regulations, including premarket and postmarket requirements, and restrictions on advertising and sampling, and counsels clients on the impact of the U.S, federal and state actions, offers a word of advice : “Even entities not directly affected by the new rules should consider, for example, whether they need to add more specific reps and warranties related to regulatory compliance in their supply agreements with ENDS manufacturers.”
Get involved in the vaping industry and community
There are various organizations that are taking action to save the vaping industry and ensure the consumers have access to vaping products. The Smoke-Free Alternatives Trade Association for instance, which represents e-cigarette companies, is seeking legal advice on the implications of enforcing such a regulation without warning, and Ms.Cabrera, who is former executive director for the organization, suggests that more people and organizations in the industry should file law suits against the FDA.
Also worth mentioning is The Vapor Technology Association, (VTA) which is an organization promoting ”entrepreneurship, responsible public policies, and a high standard of safety for the vapor industry”, through representing its members, all contributors to the vaping industry, encourages membership from all businesses in the industry, whether large or small.
The VTA has additionally always been open to joining forces with other organizations who share the same vision, infact recently it has joined forces with Sevia USA, so that together they can fight the “unfair and burdensome FDA regulations”.
Besides joining the above, vaping business owners could benefit by following pages by vaping experts such as Dimitris Agrafiotis, Stefan Didak or Gregory Conley, president of the American Vaping Association to name a few, in order to be always updated with the latest news and armed with the accurate information so to be able to take steps in the right direction.