Manufacturers Allowed To Continue Selling, Marketing Products In Interim
The chaos caused by the coronavirus had led to mass delays and cancellations throughout the world. While obvious candidates such as sporting events and concerts have been pushed back or outright ended, less obvious events such as governmental reviews are being moved as priorities rapidly shift.
The Food and Drug Administration announced a delay in the federal premarket review process for vapor products and devices. The delay further sets back what would be essentially a full federal ban on most vapor products, unless they meet strict FDA criteria for public health that many cessation aids simply can’t meet.
The previous deadline for manufacturers to submit applications for their products to the agency for review was May 12th, after anti-vaping activists had sued the FDA to expedite its review process. The new deadline is now set for September 9th, although that may easily be delayed further as the pandemic rages onward.
The premarket review process for vapor products and devices represents a portion of the FDA’s larger efforts to regulate the vapor industry. The regulatory crackdown came after vocalized concerns by anti-vaping activists over youth access to vapor products and questionable marketing practices by companies such as Juul.
The United States Food and Drug Administration has announced it will delay the application deadline for its premarket review process for vapor products and devices. While manufacturers previously had until May 12th to submit applications for their products to the FDA for review and approval, companies will now have four additional months, until at least September 9th, to conduct the necessary research and paperwork.
The commissioner for the agency has stated that priorities have shifted in the wake of the outbreak, and that staff who would have previously worked on the premarket review process are currently assisting with the agency’s pandemic response. In addition, many companies involved in the review process have reported a series of difficulties with completing research due to various travel restrictions and limited lab access.
The FDA premarket approval process for vapor products and devices requires companies to submit detailed information on the design and effects of their products to determine their risks and benefits to public health at large. As a form of enforcement discretion, the agency is allowing products subject to review to continue to be sold and marketed illegally.
Many companies are viewing the delay as a promising sign for the industry, who is struggling to adapt to a rapidly shifting and increasingly hostile regulatory landscape, alongside the basic challenges posed by an unfolding global pandemic and the economic fallout that follows it. This delay also gives retailers a bit of reprieve, allowing them to adjust their business strategies as the economic environment continues to evolve.
Misinformation spread by anti-vaping activists, as well as agencies such as the FDA, have led to an unearned negative public perception regarding vapor products. A national survey conducted in September found that as many as 58% of adults believed EVALI outbreaks were caused by nicotine-containing vapor products, with only 22% of respondents believing that vaping is less harmful than smoking.
This directly contradicts the current scientific consensus surrounding vaping, as there is an extensive body of research noting the reduced harm e-cigarettes pose compared to cigarettes. A groundbreaking study conducted by Public Health England found vaping to be 95% safer than smoking, a figure the country’s top public health agency continues to defend and stand behind.
Not only has vaping been proven to be less harmful compared to smoking, but research also shows that it may be our greatest tool in smoking cessation and combating the very real smoking epidemic. Research from the University of Louisville found vaping to be the most effective smoking cessation device available, more than going cold-turkey or even prescription options such as Chantix.
Furthermore, there is no evidence noting any long-term harm or risk to users of e-cigarettes and other vapor products. A report released by the National Academy of Sciences found that not only is vaping safer than smoking but that there are no long-term health effects associated with prolonged use.
The FDA delay is beneficial not only for the agency, whose priorities should solely focus on the pandemic response but to a vaping industry that has largely been under siege by regulators as well. The anti-vaping activist crusade against the so-called vaping “epidemic” has been dwarfed by the very real threat the pandemic poses to the public.
The vaping industry has been involuntarily and inadvertently extended a lifeline during its darkest hour. Manufacturers and retailers alike must take advantage of this time to develop new strategies to be able to adapt to the rapidly changing regulatory and economic landscape surrounding it.
What are your thoughts regarding this FDA delay? How do you think it will affect vaping companies and retailers moving forward? Let us know what you think in the comments below, be sure to like us on Facebook and follow us on Twitter to receive all the latest vaping news!
(Image Credit – Pixabay – https://pixabay.com/images/id-4508934/)