FLOW-wrap: break-word !important"> This tweet I shared with you today Beijing BOC (Shenzhen) Law Firm Zheng Mingwei's lawyer team Original creation. In this article, Zheng Mingwei's legal team discussed the FDA's actions in the paste-cigarette enterprisesThe warning letters issued constantly are interpreted, including What is a warning letter, The reason for receiving the warning letter, Response to receiving warning letters has been interpreted in a focused manner, Recommendatione-cigarettesSupply chain people collect and forward this tweet for anytime review.

1. What is a warning letter

The Federal Food and Drug Administration (FDA) has the authority to regulate tobacco products under the authority of the Federal Food, Drug, and Cosmetic Act (&FDC). The FDA conducts regular compliance inspections of tobacco manufacturers and retailers. If a company produces or sells tobacco products that violate the Federal Food, Drug and Cosmetic Act or related regulations, the FDA's Center for Tobacco Products (CTP) will issue a warning letter to the offending company.

Warning letters usually contain: Laws and regulations violated; time when stores were inspected; illegal activities discovered by inspectors and relevant evidence; guidelines for companies to correct illegal activities;A warning that enforcement measures can be taken without notice if illegal activities are discovered in the future; a written response is required within 15 working days of receiving the warning letter.

Enterprises should promptly take measures to correct illegal behaviors after receiving a warning letter, and seek the assistance of professional legal personnel to respond to the warning letter in accordance with their attitude towards judicial procedures. Otherwise, they will face penalties such as fines, bans on the production and sales of tobacco products, or even entry into the FDA import alert list.

2. Reason for receiving the warning letter

(1) Inspection priorities given by the FDA

In April 2020, the FDA issued a policy fore-cigarette productsA guidance document on law enforcement priorities, which declares priority enforcement for flavored e-cigarette products, e-cigarette products that do not warn minors, and e-cigarette products whose target market is identified as teenagers.

10 warning letters were issued on April 27, 2020. The products targeted include schoolbags and sweatshirts with invisible pockets that can be used to hide e-cigarettes, atomized e-cigarettes shaped like smart watches, and e-cigarette products shaped like toys, food or cartoon characters.

On October 7, 2021, the FDA issued a warning letter to 20 companies because they continued to sell atomized e-cigarettes on the market after their Premarket Tobacco Product Application (PMTA) submitted to the FDA was rejected.

On November 16, 2022, the FDA issued a warning letter to 15 e-cigarette products from five companies because the design or packaging of these e-cigarettes resembles toys, food or cartoon characters. Such products will induce teenagers to increase the use of e-cigarettes, which runs counter to the FDA's original intention of protecting the health of young people.

On May 31, 2023, the FDA issued a warning letter to 30 retailers, mainly to crack down on popular among teenagerse-cigarette brands, thereby achieving the goal of keeping young people away from tobacco products.

On June 22, 2023, the FDA issued 189 warning letters, mainly targeting flavors that will appeal to teenagers (chewing gum,marshmallowFlavor) e-cigarette products.

From January 2020 to July 2023, the FDA issued more than 780 warning letters based on companies 'lack of marketing licenses.

Based on the above information, we can summarize the reasons for FDA issuing warning letters The main reasons are the lack of marketing licenses for companies and the appeal of products to young people, which increases their use of e-cigarettes.

(2) Reasons why China companies received warning letters

As of July 20, 2023, a total of 9 China companies have received warning letters from the FDA Tobacco Products Center. The specific information is as follows:

The common reason why nine companies were issued warning letters was that the company did not obtain marketing permission under FDC Article 910(c)(1)(A)(i) and was therefore considered adulteration as defined in FDC Article 902(6)(A). Three of the companies 'illegal activities also include design to attract young people: Shenzhen Quawins' products look like light sticks or carry cartoon patterns that attract young people, which may help young people conceal their use of tobacco products from their parents; Shenzhen Fumot's products are printed with popular TV or movie images, which may promote the use of e-cigarette products by teenagers; Shenzhen Youwei Technology (U#p#paginated title #e#Well)'s products have a smartwatch-like appearance and will induce teenagers to hide tobacco products.

3. Response to receiving a warning letter

For companies that receive warning letters, the FDA's standard response is to respond in writing within 15 days and correct the illegal behavior in a timely manner. The written reply should include:

(1) Next measures to correct illegal activities;#p#pagination title #e#

(2) How to prevent future violations (such as employee training, removal of problematic products);

(3) Enterprise contact information.

Companies should pay enough attention to the issuance of warning letters. Although it is an email, it is not our daily chat and should respond in accordance with judicial procedures. For example, when responding to a warning letter, we must ensure that the statements contained therein are supported by evidence. The opportunity to respond to a warning letter will not be unlimited. The situation should be similar to a reply to a query about the withholding of goods by British Customs, with generally two opportunities to respond. If there are no professionals with relevant experience in the company, it is the right solution to seek guidance from a professional Chinese and American lawyer team to formulate recovery documents and organize evidence.# p#pagination title #e#

The company's statement that corrective actions have been implemented or will be implemented is not sufficient to convince CTP. After receiving the company's reply to the warning letter, CTP will actually verify whether the company has corrected the illegal behavior. If the company provides sufficient information in its response to the warning letter to prove that the violation has been corrected, and the CTP believes that the company has implemented appropriate corrective measures and there are no other violations during subsequent inspections, the CTP will issue a close-out letter to end this enforcement.

According to official statistics from the US FDA, only 23 e-cigarette products and equipment have passed the PMTA so far, and none of them directly involve China companies. Although the review time for PMTA is long, companies should still make timely corrections after receiving the warning letter, such as submitting the PMTA in a timely manner and receiving acceptance, and paying attention to the product design to avoid violating the FDA's policy of protecting young people from tobacco hazards.

Companies that do not respond to FDA warning letters may face further penalties. If the company continues to violate the law, the FDA will file a civil fine complaint with the court (civil money penalty (CMP), companies will face fines. If a company commits more than five consecutive violations within three years, the FDA will file a complaint with the court to issue a no-tobacco-sale order (NTSO) or a complaint with the court to issue a permanent injunction (permanent injunction) on the production and sale of tobacco products. At that time, the company will face penalties for being unable to carry out tobacco business. If a company is an importer of tobacco products, it may even enter the FDA's import alert list.

Conclusion

In recent years, my country has paid more and more attention to the supervision of domestic e-cigarette companies, and has begun to supervise the behavior of China companies exporting e-cigarettes abroad. According to the "Guidelines on Promoting the Construction of a Quality Assurance System for Export E-Cigarette Products"(hereinafter referred to as the "Export Guidelines") newly issued by China's Tobacco Monopoly Administration on July 20, 2023, enterprises should pay special attention to the quality and safety issues of exported e-cigarette products. Article 13 of the Export Guidelines stipulates that if exported e-cigarette products have quality and safety problems that have caused or may cause damage to human health, enterprises shall immediately stop the production of relevant products, take corresponding measures to avoid and reduce the occurrence of damage, and report to the local Tobacco Monopoly Bureau. Article 14 of the Export Guidelines stipulates that if exported e-cigarette products are notified by international organizations or overseas government agencies due to quality and safety issues, the enterprise shall immediately report to the local Tobacco Monopoly Bureau, and the relevant enterprise shall accept the verification organized by the Tobacco Monopoly Bureau in accordance with the law.# p#pagination title #e#

If China companies continue to carry out illegal activities in defiance of foreign laws and regulations on e-cigarettes, it will surely damage the international reputation of China's e-cigarette companies, and may even lead to the United States 'criticism of China's entiree-cigarette industryImplementing import controls has forced the e-cigarette industry chain to transfer to other countries and regions. China e-cigarette enterprises shall establish compliance awareness as soon as possible, increase compliance investment, and timely and effectively respond to FDA warning letters and other regulatory measures by prudent and professional means (such as seeking the assistance of a team of Chinese and American lawyers with relevant experience).

The author of this article is:

Zheng Mingwei, Master of International Law from Shenzhen University, Director of the Corporate Comprehensive Business Committee and Equity Partner of Beijing BOC (Shenzhen) Law Firm.# p#pagination title #e#

Lin Hongping, Master of Civil and Commercial Law, Huazhong University of Science and Technology, Master of Advanced Accounting, Chinese University of Hong Kong;

Jiang Yubin, Master of Laws, University of Birmingham, UK;

Yang Aoyu, LL. B. from the University of Hong Kong, LL. D. from the University of California, Irvine, passed the California Bar Examination.& nbsp;

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