Last updated on October 22nd, 2020
FDA Will Now Seek Honest Information About E-Cigarettes.
On July 28th, 2017 the FDA released a groundbreaking statement which is in support of e-cigarettes.
The FDA statement came on the heels of a new study funded by the National Institutes of Health. The study showed that electronic cigarettes can in fact, help smokers to stop smoking, and should be weighed carefully in regulatory policy.
This is great news for vapers, smokers and the vaping industry, as both the NIH study and the FDA statement acknowledges the low-risk value of vapor products.
FDA Set to Make Changes That Focus on Tobacco Harm Reduction and the Benefits of Electronic Cigarettes
The FDA admitted that regulations should encourage, rather than inhibit the development of innovative tobacco products, such as ecigs, “that may be less dangerous than cigarettes.”
New Date Set for Regulatory Submissions
The FDA’s announcement is not only a green light for smokers who were hesitant to switch to vaping, the public statement includes a reprieve for e-cigarette manufacturers and vape store owners. Previous deeming regulations required companies to submit costly product applications by Nov. 8th, 2018.
The Tobacco Control Act changed the date for submission and went into effect on 09/17/2020.
Had the original deadline remained, all but the largest ecig companies, (such as those owned by big tobacco) would likely go out of business. With the new regulatory date, e-cigarette companies can continue to do business as usual and can continue to introduce innovative vaping products into the marketplace as long as they submit a Premarket Tobacco Product Application.
HERE IS MORE INFORMATION AND A TIMELINE FOR REGULATIONS
What is PMTA?
“A PMTA (Premarket Tobacco Product Application) must provide scientific data that demonstrates a product is appropriate for the protection of public health. In order to reach such a decision and to authorize marketing, FDA considers, among other things:
– Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers;
– Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available;
– Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available; and
– The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product. “
FDA intends to enforce premarket requirements for these products after September 9, 2020. Products do not include those that were not commercially marketed in the United States as of February 15, 2007.
Back in July, 2017 the FDA announced a plan for tobacco and nicotine regulation that would include a “striking a balance between regulation and encouraging development of innovative tobacco products that may be less harmful than cigarettes.”
In late 2017 the FDA received complaints about minors' access to and use of vaping products. The FDA took measures to address the sale of ENDS products to minors, issuing warning letters to manufacturers regarding illegal sales of certain ENDS products to minors.
In May, 2018 the FDA issued 17 warning letters to manufacturers, distributors, and retailers for “selling e-liquids with labeling and/or advertising that resemble kid-friendly food products, such as juice boxes, candy, or cookies.”
In Sept. 2018 issued safeguards to prevent minors from using all ENDS products including age-verification technology to better restrict access to the manufacturer’s website and limiting quantities of purchases within a given period of time.
In April 2020 the FDA issued a revised statement regarding regulations for all vaping hardware and e-liquids that do not have PMTA.
The FDA intends to prioritize enforcement against:
- Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product)
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
- Any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors.
FDA will continue to use all available tools to prevent youth use of all tobacco products, including ENDS products.
FDA intends to enforce premarket requirements (PMTA) for these products after September 9, 2020. Products do not include those that were not commercially marketed in the United States as of February 15, 2007.
In his announcement, former FDA Commissioner Dr. Scott Gottlieb said,
“Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground.”
Vaping Advocates Remain Vigilant
The e-cigarette battle between those who support vaping and those who seek to destroy it will no doubt continue until all public health agencies and organizations recognize the common goal of Tobacco Harm Reduction – saving billions of lives.
According to CASAA.org – The Consumer Advocates for Smoke-free Alternatives:
“Too much of the current legislative and regulatory efforts are born out of fear and misinformation.”
CASAA also put out this word of caution:
“Although this is certainly positive news from the FDA, a sincere word of caution: Those who would prefer nicotine and tobacco to be regulated out of existence will be digging in. Now, more than ever, attention must be paid to policy fights in local and state government. The delay proposed by FDA means we have more time to work on sensible regulation, but it will also embolden ideologues to fight harder against us.”
What do you think? Will the recent FDA statement encourage more people to start vaping? Will opponents to vaping become more vigilant? Please leave your comments below.