In 2021, Solo equipment and its tobacco flavor supplement became the first batch of e-cigarette products authorized by FDA. Solo is a primitive cigar-like electronic cigarette, which is powered by a cigarette-shaped battery and uses a spiral pre-installed atomizer.
In an announcement, the FDA explained that Vuse Solo menthol supplements did not meet the agency’s standards for protecting public health, because menthol e-cigarettes had known significant risks in attracting, absorbing and using young people.
Since rejecting the pre-marketing tobacco application (PMTA) in August, 2021, FDA has issued marketing rejection orders (MDO) for millions of flavored e-cigarette oils and pre-filling equipment, but most menthol products were still under review before Brian King was appointed.
He served as the director of the FDA Tobacco Products Center last summer.
It has been speculated that the FDA will authorize some menthol products as low-risk substitutes for people who smoke menthol cigarettes, and the agency intends to ban such products. However, since King took office, the FDA has refused to apply for menthol supplements for a number of previously authorized mass-market electronic cigarette devices, starting with the supplements of Logic Pro and Logic Power.
Logic immediately challenged the FDA’s decision in court, and was approved by the Court of Appeals for the Third Circuit to temporarily suspend the refusal order. CTP documents unearthed in Logic’s lawsuit show that CTP director’s office (before and after King took over) pressured CTP science office to refuse Logic’s menthol supplement after the science office initially recommended authorization.
In January, the agency released MDO of mint supplements for two previously authorized Vuse devices, Vuse Ciro and Vuse Vibe. On the second day after issuing the marketing refusal order (MDO), the Fifth Circuit Court of Appeals granted RJ Reynolds, a manufacturer of Vuse, the right to suspend the order temporarily.
Renault may challenge Vuse Solo menthol MDO in court.
None of these three authorized Vuse products are popular in the market, but Reynolds may be worried that Vuse Alto and its mint supplement products will be rejected in the future. Unlike the other three Vuse products, Alto is the leader in the field of convenience stores/gas stations in the electronic cigarette product market.
The PMTA of Alto e-cigarette is still under FDA review.
In its announcement, FDA mentioned that the national youth tobacco survey data shows that Vuse is the second most common brand commonly used by young e-cigarette users. All three FDA-authorized Vuse products (and their mint supplements) are not popular with users of all ages, and the agency knows this. NYTS data mainly refers to the very popular Vuse Alto.
RJ Reynolds recently asked the FDA to crack down on the popular disposable e-cigarettes that currently dominate the e-cigarette market in convenience stores/gas stations.
The following is the full text of the announcement:
Today, the US Food and Drug Administration issued a marketing refusal order (MDO) for two menthol electronic cigarette products currently sold by RJ Reynolds Vapor under the brand name Vuse Solo. At present, the products on the market include 4.8% G1 and 4.8% G2 of Vuse Replacement Cartridge Mentor. Companies are not allowed to sell or distribute these products in the United States, otherwise they will face the risk of FDA enforcement actions.
Companies can resubmit applications or submit new applications to solve the defects of products subject to these MDOs.
FDA evaluates the application of tobacco products before marketing (PMTA) according to public health standards, which consider the risks and benefits of products to the whole population. After reviewing the company’s PMTA, the FDA determined that the application lacked sufficient evidence to prove that allowing product sales would be suitable for protecting public health, which is the applicable standard control law required by the 2009 family smoking prevention and tobacco law.
Specifically, the evidence submitted by the applicant does not prove that its mint-flavored e-cigarettes provide additional benefits for adult smokers compared with tobacco-flavored e-cigarettes.
"FDA is a data-driven organization, and science is still the cornerstone of our tobacco product supervision activities. Brian King, director of the FDA tobacco products center and doctor of public health, said. "Science has guided-and will always guide-the ——FDA’s decision-making on the application of pre-marketing tobacco products, including today’s marketing refusal order. 」
Existing evidence, including data from the National Youth Tobacco Survey (NYTS) in 2022, shows that non-tobacco e-cigarettes, including mint-flavored e-cigarettes, have known significant risks in the attraction, absorption and use of young people.
In contrast, the data show that tobacco-flavored e-cigarettes are not equally attractive to young people, so they do not pose the same degree of risk. In view of these existing differences in adolescent risks, applicants need to provide strong evidence to prove that using their mint-flavored electronic cigarette products may promote complete conversion or may significantly reduce the use of combustible cigarettes by adult smokers, not just tobacco.
NYTS data also found that Vuse is the second most common brand commonly used by young e-cigarette users.
Without the risk of FDA enforcement, these products cannot be legally introduced into interstate trade in the United States. In addition to ensuring that manufacturers comply with this order, FDA also intends to ensure the compliance of distributors and retailers, just like unauthorized products. Retailers should contact RJ Reynolds Vapor Company if they have any questions about the products in stock.
Today’s action is just one of many actions taken by the FDA to ensure that any tobacco products sold in the United States have undergone science-based review and obtained marketing authorization from the agency.
So far, the agency has received more than 26 million applications as products, and 99% of them have been decided.
So far, FDA has authorized 23 kinds of tobacco-flavored electronic cigarette products and equipment, which is the only electronic cigarette that can be legally sold or distributed in the United States. This includes the Vuse Solo electronic cigarette device and two attached tobacco-flavored electronic cigarettes.
The FDA also rejected the marketing applications of millions of products that did not meet the legal requirements, including 10 kinds of non-tobacco electronic liquid cigarette bombs, 3.0% of Vuse Vibe Tank menthol and 1.5% of Vuse Solo cigarette bombs under the brand name.