China officially bans fruit flavorings in e-cigarettes

China has joined a handful of countries in banning flavored vapes to combat underage use of nicotine. Starting October 1, e-cigarette companies are only allowed to sell tobacco-flavored vapes in the country, an effort by the government to “standardize” the production, sales and consumption of the novel tobacco product.

China’s e-cigarette makers had a short-lived boom before regulators began reining in the lucrative industry around three years ago. First, it was a ban on the online sales of vapes. Then in May this year, a set of comprehensive regulations went into force, effectively subjecting e-cigarettes to the purview of China’s tobacco authorities.

The ban is long in coming and investors anticipated the change. Relx, which as of 2020 commanded 70% of China’s pod vape market, has lost over 95% of its stock value since its debut on NYSE in January 2021. Shares of Smoore, a major manufacturer of vaping devices based out of Relx’s home city of Shenzhen, are down 90% since hitting an all-time high in January 2021.

A ban on flavored vapes is like a death knell to the vaping industry. Tobacco-flavored products accounted for only an insignificant amount of e-cigarette sales, according to a survey conducted by Landong, a Chinese media publication focused on the vaping industry.

Other major measures from the regulations include a tobacco tax on e-cigarette sales and stringent new requirements on how a vape is made, from its battery, ceramic coil and nicotine content to fragrance. Meeting all these criteria could cost a fortune, which means the shoddy, scruffy type of vape sellers that were crowding the market before will struggle to survive.

Well-funded Chinese vaping startups such as Relx and Myst have long begun international expansion to diversify their revenue streams. In 2020, Relx kickstarted the costly and time-consuming ordeal of obtaining FDA approval in the U.S. Myst, which was co-founded by a former Juul scientist, had entered Malaysia, Russia, Canada and the United Kingdom as of May last year.

China’s clampdown on vaping flavors stems from the same concern shared by other jurisdictions: health risks for young people. In a notice from 2019, the country’s tobacco authority had this to say:

“The current electronic cigarette market in China is chaos. The quality of products varies substantially, and a large number of them has safety issues around unsafe additives, leaky e-juice, and shoddy battery. In particular, some companies are casually adding addictives to change the flavor and color of e-cigarettes to make them more appealing, but this is causing severe damage to underage users’ mental and physical health.”

In 2019, the U.S. government was getting ready for a policy to ban flavored e-cigarette products. In June, European Union lawmakers are proposing to ban flavored heated tobacco products. As the world’s largest producer of vaping devices, China’s e-cigarette factories will likely see their demand shrink as regulators around the world continue their battle with the vaping industry.

China officially bans fruit flavorings in e-cigarettes by Rita Liao originally published on TechCrunch

The FDA proposes further restrictions to sales of flavored e-cig products

The FDA has drafted new guidance for the regulation of e-cigarettes, particularly with regards to flavored nicotine products.

The first big change is that the FDA has bumped up the application due date by one year for FDA approval of flavored products. Manufacturers of all flavored ENDS (electronic nicotine delivery system) products will now have to submit premarket applications by August 8, 2021.

The second change is introducing a new compliance policy with regards to flavored ENDS products.

At the time that the current compliance policy was enforced, in 2017, e-cigarette use among youth was leveling off. But drastic growth in the popularity of e-cigs among minors over the past two years have led to various changes in the policy, including the restriction of sales of flavored ENDS products via certain retail channels from November 2018.

“The most recent data show more than 3.6 million middle and high school students across the country were current (past 30 day) e-cigarette users in 2018,” wrote Gottlieb in the announcement. “This is a dramatic increase of 1.5 million children since the previous year. The data also showed that youth who used e-cigarettes also were using them more frequently and they were using flavored e-cigarette products more often than in 2017.”

Identifying flavored pods as a culprit was the first step, but the FDA is now introducing a policy that looks at how accessible any flavored ENDS product is to minors to determine whether or not it can stay on the market.

For online sales, retailers must have an age-verification process that connects to third-party data sources in order to sell flavored nicotine products. For physical retailers, the policy says that flavored nicotine products must be behind some sort of age-gate, whether that’s at the front door of the shop or within a different age-gated section of the store itself. In other words, there must be some barrier to entry before POS between minors and flavored ENDS products.

From the announcement:

Our proposed policy provides examples of circumstances that we’ll consider – for example, if flavored ENDS products are sold in locations where minors can enter at any time (e.g., the entire establishment or an area within the establishment); or, for online sales, if the products are sold without an appropriate limit on the quantity that a customer may purchase within a given period of time, and without independent, third-party, age- and identity-verification services that compare customer information against third-party data sources, such as public records. We’re also specifically seeking comment on, among other things, whether there are new technologies that can help prevent youth access at retail locations and intend to consider the use of those tools when we finalize the guidance.

The main point to remember is that the FDA plans to prioritize enforcement of these products based on whether they’re sold in ways that pose a greater risk for minors to access them and become addicted to them.

While this proposal includes further regulation of the budding e-cigarette industry, it could be an important step forward for the space in the long term. The e-cigarette industry won’t reach its potential as an alternative to cigarettes until the issue of underage use is solved for good.

The FDA sees flavored ENDS products as a gateway for young people, and closing off access to those products as soon as possible gives the industry, from manufacturers to retailers to regulators, the opportunity to plan for how these products can be sold and distributed in the future, or if flavored products should exist at all.

The new plan does not propose enforcement of all ENDS products — tobacco, menthol and mint-flavored ENDS products can remain on the market and keep their original 2022 deadline for premarket FDA approval applications.

Juul Labs had this to say in response to the draft guidance:

We are committed to reducing youth usage while preserving our opportunity to eliminate combustible cigarettes, the number one cause of preventable death in the world. As part of our action plan deployed in November 2018 to keep JUUL products out of the hands of youth, we stopped the sale of flavored JUULpods to retail stores, strengthened our retail compliance and secret shopper program, enhanced our online age-verification, exited our Facebook and Instagram accounts and are continuously working to remove inappropriate third-party social media content. We support category-wide action including the responsible, restricted sale of flavored products and will review today’s draft guidance as we continue to work with FDA, state Attorneys General, local municipalities, and community organizations as a transparent and responsible partner in combating underage use.

Commissioner Gottlieb announced his resignation a week ago. National Cancer Institute Director Dr. Ned Sharpless will take over as acting FDA Commissioner in April.

Gottlieb taken measured steps to keep ENDS products away from minors while still allowing adult smokers to have an alternative on the market. Whether Sharpless will thread the needle quite as well remains to be seen, but Altria stocks fell on word of his appointment.

Today’s proposal is open for public comments for 30 days.