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FDA拒绝美国最大电子烟申请

FDA rejects America's largest e-cigarette application

中國基金報 ·  Sep 11, 2021 13:28

China Fund News Amman

Last night, the e-cigarette industry was full of blood!

FDA rejects US largest e-cigarette application

Distributors' shares plummeted by more than 40%

After a year-long review of millions of e-cigarette-related products, the US Food and Drug Administration (FDA) said it had rejected 946000 related e-cigarette products and banned them from being marketed or sold, according to foreign media reports.

So far, no e-cigarette product has passed the PMTA (application for pre-listing of tobacco products). According to FDA's statement, it has reviewed 93 per cent of applications.

On September 10th, FDA Tobacco products Center updated the latest marketing refusal order (MDO) list, and the well-known Apollo apollo e-cigarettes appeared on the rejection order list, causing an uproar in the market.

According to public information, Apollo E-cigarette was founded in 2008. It is the earliest e-cigarette oil manufacturer in the United States, and it has branches in some European capitals and China.

Affected by this news, e-cigarette distributor Kaival Brands Innovations Group Inc. The share price plunged 43.27% last night.

In addition, US-listed RLX Technology Inc. also fell 16.81 per cent last night.

It is worth mentioning that the popular e-cigarette brands in the American market are basically Chinese brands, so whether they can pass the PMTA also has a great impact on China's e-cigarette industry. In addition, SMOK, Si Moore and other smoking brands have applied for smoking PMTA, which also need to be legally authorized.

Earlier, the FDA website revealed that the agency withheld some domestic nicotine e-cigarettes that entered the US market but lacked pre-market authorization on July 20. The products of the following four Chinese companies will be denied entry into the United States: Huizhou Taoker Technology, Magic Flute, Hua Yucheng and Jin Yida.

Hong Kong to legislate to completely ban e-cigarettes

Coincidentally, the Bills Committee on the smoking Amendment Bill of the Hong Kong Legislative Council held a meeting on 10 September to complete the scrutiny of legislative amendments to prohibit heating cigarettes and electronic cigarettes. The second Reading of the Ordinance will be resumed in the Legislative Council next month. The Hong Kong Government expects to pass the Bill before the end of the current legislative session in October.

Once the bill is passed, it is very likely to affect Hong Kong's transit function as an e-cigarette exported overseas.

Affected by the news, Hong Kong stock e-cigarette index fell more than 4% on the 10th, of which Smoore International Holdings Limited fell 5.45% and China Bolton fell 4.65%.

As early as October 2018, Hong Kong Chief Executive Carrie Lam said in his policy address that the Hong Kong SAR Government was drafting a bill to ban the import, manufacture, sale, distribution and promotion of e-cigarettes. Previously, the Hong Kong government only restricted the sale of e-cigarettes to minors.

Carrie Lam said that in recent years, electronic cigarettes and other new smoking products have become more and more popular, bringing new health risks and challenges to the public. These products are often packaged as less harmful alternatives, and promotion methods are targeted at young people and non-smokers, enticing them to try or even switch to traditional cigarettes. In fact, these new tobacco products are hazardous to health and produce "secondhand smoke", and there is not enough evidence to show that these products can help quit smoking.

It is mentioned in the policy address that since the Hong Kong Government proposed to legislate to regulate e-cigarettes and other new smoking products, the medical profession, the education sector, parents and many members of the public have expressed concern about dealing with this issue in the form of regulation. They are worried that allowing e-cigarettes and other new smoking products to be sold on the market to a limited extent will not be sufficient to protect public health, especially on children and young people.

Therefore, the Hong Kong SAR Government has decided to give top priority to the protection of public health and will propose legislative amendments in this legislative session to prohibit the import, manufacture, sale, distribution and promotion of e-cigarettes and other new smoking products.

In the following year or so, the Bills Committee held 12 meetings on the Bill, but there was no result. The Bills Committee subsequently decided to suspend its scrutiny of the Bill and report to the House Committee on 3 July 2020, which agreed to dissolve the Bills Committee.

The proposal became one of four bills that the Legislative Council of the Hong Kong Special Administrative region (LegCo) suspended its work in June last year. The Legislative Council said at that time that it would not ban ENDS (atomized / steam e-cigarettes) because these products provided smokeless alternatives for smokers.

However, a new bills committee was set up in November last year after Beijing approved the Hong Kong government's request to extend the term of office of the Legislative Council by one year. It last met in June to discuss the bill. The government plans to ensure that the bill, which ends in October, is passed during the current term of the Legislative Council, according to the Hong Kong Food and Health Bureau.

China: e-cigarettes are proposed to refer to cigarette regulation

In the past two years, governments of various countries have realized the harm of e-cigarettes to people's health, and the world has begun to strengthen the supervision of e-cigarettes, and China is no exception.

On March 22 this year, according to the website of the Ministry of Industry and Information Technology, in order to strengthen the supervision of new tobacco products such as electronic cigarettes, the Ministry of Industry and Information Technology and the State Tobacco Monopoly Administration studied and drafted the decision on revising the regulations of the people's Republic of China on the implementation of Tobacco Monopoly Law (draft for soliciting opinions). The deadline for feedback is April 22, 2021.

The draft for soliciting opinions proposes to add an article to the regulations of the people's Republic of China on the implementation of Tobacco Monopoly Law as Article 65: "Electronic cigarettes and other new tobacco products shall be implemented with reference to the relevant provisions on cigarettes in these regulations."

At present, the policy rules have not yet been finally landed.

RLX Technology Inc. 's share price fell nearly 50 per cent on the day. Since then, RLX Technology Inc. 's share price has fallen 90 per cent to around $3.70, down 90 per cent from the year's high of $35.

On June 18, 2021, the State Tobacco Monopoly Administration and the State Administration of Market Supervision and Administration issued a circular jointly issuing a special action plan for protecting minors from tobacco.

The circular stresses that all localities should implement the requirements of the CPC Central Committee and the State Council on promoting the legalization of e-cigarette supervision, gradually establish and improve the e-cigarette supervision system, enhance the efficiency of supervision, and standardize e-cigarette production and management activities. to prevent the "resurgence" of the e-cigarette market, and at the same time carry out a three-month special campaign.

The translation is provided by third-party software.


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