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Vapers and producers alike feel the burn after San Francisco passed Proposition E, which reportedly bans retailers from selling flavored e-liquids to stop rising teenage consumption of vape products. Once major companies caught wind of the possible flavoring ban, they launched a $12 million-dollar campaign to sway voters against passing the proposition, but despite their efforts 68-32, Proposition E passed.
In response, industry organizations such as the American E-Liquid Manufacturing Standards Association (AEMSA) continue to steadfastly lobby officials to amend the Deeming Regulations to a more reasonable set of standards.
The beginnings of Proposition E
Rumblings of Proposition E first started following a press release from the Food & Drug Administration (FDA) commissioner Dr. Scott Gottlieb. From there, it picked up steam after health advocates voiced their concerns about the increase of teenage vapers that, in their opinion, are drawn to fruity and dessert-themed e-liquids. Advocates also believe that these products specifically target a younger demographic to get them addicted to traditional tobacco products.
In March, Food and Drug Administration (FDA) commissioner Dr. Scott Gottlieb released a statement explaining that the agency would explore possible regulations for delicious sounding e-liquids and nicotine levels. Critics see reasonable new restrictions as a crackdown on companies in non-compliance with components of the Deeming Regulations that set strict labeling guidelines and started a prohibition on selling products to consumers under 21.
Dr. Gottlieb praised e-cigarettes for being a viable option for adult smokers looking to quit the habit and for those transitioning from traditional tobacco to a less harmful alternative. Despite this, Dr. Gottlieb opines that for younger consumers, the opposite is true and that e-cigarettes may be putting kids and teenagers on a lifelong path of smoking.
Political concerns heating up
Worried that flavored e-liquids are targeting a younger demographic, Senator Dick Durbin (D-IL) and 13 other Senators penned a letter to the FDA calling for the agency to reverse a decision to delay review of products. Senator Durbin noted that according to a US Surgeon General study, youth vaping increased 200% between 2011 to 2015.
Flavor restrictions are not the only concern for the FDA, as officials are exploring regulations to control nicotine levels and the availability of menthol options because of health concerns. Additionally, Dr. Gottlieb introduced an advance notice of proposed rulemaking (ANPRM) that is seeking to research the role of flavors in smoking cessation and smoking initiation.
One part of the Deeming Regulations released in 2016 established regulations for product flavorings, however, the FDA delayed the flavored product review from 2018 to 2022. Because of this delay, products can remain on the market without the immediate threat of FDA regulations.
Continued industry efforts
On the other hand, some critics believe the Deeming Regulations create significant burdens for small to medium companies, and that further restriction of the industry is a violation of both the rights of producers and consumers. The industry should allow consumers to remain in control of their purchasing decisions, and besides that, the tax revenue generated by e-cigarettes is beneficial to municipalities.
Recently, AEMSA met with the Center for Tobacco Products (CTP) to express their concerns with the flaws of the Deeming Regulation and to introduce workable, cost-effective alternatives. In a summary of the meeting, they suggested the regulations should:
- Base regulations on the Continuum of Risk and Harm Reduction (a scientific concept that while vaping is less harmful than smoking, e-cigarettes are inherently less safe than non-use)
- Promote innovation for newer products
- Reduce possible harm
- Encourage smoking cessation through e-cigarettes
- Certify manufacturers with high-quality standards
- Provide a quicker, cost-effective path to market
- Increase consumer trust that products are quality and safe
- Inspire consumer trust through batch and quality management
Despite popular belief, ISO (International Standards Organization) certification does not provide or reinforce the processes necessary to create or improve existing quality assurance system or come into compliance with regulations – another solution is necessary.
Used by industry trailblazers and popular brands, InstantGMP™ Vape takes companies to another level through comprehensive and interactive workflows to better manage and organize batches and drastically elevates product quality and consistency. Structured like TurboTax, InstantGMP™ Vape does not require users to be familiar with the ins and outs of Good Manufacturing Practices (GMPs) for compliance, the workflows are built into the software. Get in touch to learn more and see InstantGMP™ Vape in action in a live demo.