Understanding U.S. E-Cigarette Regulation: Who Regulates It, How It Works, and How to Comply

Recently, my country has begun to further strengthen its efforts to export.e-cigarettesOn the other hand, as the world's largest market, the regulatory agency FDA frequently affects China companies in the form of import alerts and warning letters. U.S. e-cigarette regulatory laws have become a required course for practitioners.

This tweet shared with you today was originally created by Zheng Mingwei, a lawyer team from Beijing BOC (Shenzhen) Law Firm. It explained the above issues in detail and suggested that people in the e-cigarette supply chain collect and forward this tweet for any time.

In recent years, my country has begun to pay attention toe-cigarette enterprisesand has begun to supervise the export of e-cigarettes by China companies abroad. Article 33 of the "Measures for the Administration of Electronic Cigarettes" issued by the Tobacco Monopoly Administration stipulates that they are not sold in China and are only used for export.e-cigarette products, should comply with the laws, regulations and standards of the destination country or region.

Article 14 of the "Guidelines on Promoting the Construction of a Quality Assurance System for Export E-Cigarette Products"(hereinafter referred to as the "Export Guidelines") issued by the Tobacco Monopoly Administration on July 20, 2023 stipulates that exported e-cigarette products have been approved by international organizations due to quality and safety issues. If notified by overseas government agencies, the enterprise shall immediately report to the local Tobacco Monopoly Bureau, and relevant enterprises shall accept the verification and handling organized by the Tobacco Monopoly Bureau in accordance with the law. Abroad, as the world's largest e-cigarette market, the United States has repeatedly issued enforcement actions such as warning letters and import alerts against China e-cigarette companies. New York City recently filed a lawsuit against e-cigarette products produced by China companies sold by local distributors (see "How should China e-cigarette companies respond when U.S. distributors are prosecuted for illegal sales?"). These should be enough to enable my country's e-cigarette companies to establish a compliance awareness.

Whether it is necessary for my country's e-cigarette companies to report quality and safety issues to the Tobacco Monopoly Administration as stipulated in the Export Guidelines or face enforcement actions of the U.S. FDA, it is necessary for my country's e-cigarette companies to have an understanding of U.S. e-cigarette regulatory laws.

Zheng Mingwei's legal team organized Master's and Doctor's in British and American Laws to carefully study and sort out the main regulatory laws on e-cigarettes in the United States as follows for reference by e-cigarette companies.

1. Introduction to the U.S. federal government e-cigarette regulatory agency

The U.S. Food and Drug Administration (FDA) is a federal government agency under the U.S. Department of Health and Human Services with authority to regulate tobacco products under the authority of the Federal Food, Drug, and Cosmetic Act (FDCA).

The FDA conducts regular compliance inspections of tobacco manufacturers and retailers. If a company produces or sells tobacco products that violate the FDCA or related regulations, the FDA's Center for Tobacco Products (CTP) will issue a warning letter to the offending company.

In addition, the FDCA grants the FDA the authority to detain any imported tobacco product for which there appears to be or may be a violation. The main measure for the FDA to manage imported products is to issue import alerts to prevent potentially violating products from entering the U.S. market. Products included in the import warning will be subject to "Detain Without Physical Examination"(DWPE). In other words, the FDA has the right (or a customs representative) to directly detain all products from a particular product or company without inspecting the goods until the importer or carrier certifies that the goods comply with relevant regulatory requirements, i.e., detain first and then inspect.

What has troubled China e-cigarette companies recently is the FDA's warning letters and import alerts. (For details, see "Three Questions FDA's" E-Cigarette Warning Letter ": Why was it issued? Send it to whom? How to deal with it?", "U.S. FDA Import Alerts and Removal Applications Guidelines for E-Cigarette Companies (1) and (2)")

2. Key legal provisions of the U.S. federal government on e-cigarette supervision

1. Submit health and safety information

The Federal Food, Drug, and Cosmetic Act (FDCA) requires each tobacco product manufacturer, importer (or its agent) to submit health and safety information to the Secretary of Health and Human Services (hereinafter referred to as the "Secretary"), including (1) a list of raw materials;(2) nicotine content;(3) a list of hazardous substance compositions; and (4) all documents related to product health, toxicity, behavioral and physiological effects. In addition, the FDCA requires manufacturers or importers of tobacco products to submit documents on research activities and findings on product health, toxicity, behavioral and physiological effects, reduction of product health risks, etc., when requested by the Minister. E-cigarette companies can refer to the guidance document "Requirements for Tobacco Products to Submit Health and Safety Information" issued by CTP (Health document #p#pagination title #e#Submission Requirements for Tobacco Products) to learn how to submit health and safety information.

(2) Licensing

Because e-cigarettes are regulated by the FDCAnew tobaccoProducts, so e-cigarette products need to submit a Premarket Tobacco Product Application (PMTA) in accordance with the FDCA and Chapter 21 of the Code of Federal Regulations (CFR) to obtain marketing approval issued by the FDA.

According to the FDCA and the Requirements for Premarket Applications and Record Keeping of Tobacco Products, The information to be submitted in the PMTA includes (1) basic information;(2) descriptive information;(3) samples that may be required by the Minister;(4) labeling and marketing plan;(5) environmental assessment;(6) product formulation;(7) production method;(8) Health risk investigation (which should include the health risks of the product, the impact on the tobacco use behavior of tobacco product users, and the impact on non-smokers, especially adolescents, etc.);(9) The impact on the overall residents (which should include a health impact assessment on the overall population), etc.

As of July 2023, only 23 e-cigarette products and devices have passed the PMTA and obtained marketing licenses. In addition to the PMTA that is still under review, other PMTA faces refusals, refusals and marketing refusals. According to the "Refuse to Accept Procedures for Premarket Tobacco Products Submissions", the reasons for refusal include that the application content is not in pure English, the application does not provide the applicant's contact information, the foreign applicant does not provide information on the U.S. agent, the application does not use the official application form, and the product information description in the application is not enough. The main reason for refusing to submit was the insufficient information contained in the PMTA, especially regarding health risk investigations.

According to the FDCA, reasons for rejecting PMTA include:

(1) The applicant cannot prove that allowing the tobacco product to be put on the market is beneficial to the protection of public health;

(2) Failure to comply with the FDCA requirements on production specifications during the production, processing and packaging of the tobacco product;

(3) Incorrect or misleading labeling;

(4) The tobacco product does not comply with the FDCA's product standards and there is no valid reason for deviating from the standard. In addition, e-cigarette companies can also refer to the document "Premarket Tobacco Product Applications for Electro" published by CTPnic Nicotine Delivery Systems), this document is a guidance document written by CTP in accordance with relevant laws and regulations to help companies understand how to submit PMTA for e-cigarette products.

In addition to PMTA that are refused to accept, refused to submit, or issued marketing refusal orders, in practice, if the PMTA is still under review and the PMTA submitted by the company indicates to the FDA that the product will not attract young people, it will generally be tacitly sold.

(3) Sales restrictions (taste, age, sales method, etc.)

1. Taste

The FDCA prohibits the sale of specialty flavored cigarettes. Federal law does not prohibit flavored e-cigarettes. However, laws and regulations of states, counties, and cities in the United States have varying degrees of restrictions or bans on flavored e-cigarettes. Among them, New York, California, Massachusetts, New Jersey and Rhode Island have completely banned the sale of flavored e-cigarettes. According to the guidance document issued by the CTP,"Enforcement Priorities for Electro for Electronic Nicotine Delivery Systems and Other Products on the Market Without Marketing Authorizations"nic Nicotine Delivery System and Other Deemed Products on the Market Without Premarket Authorization, FDA will mainly crack down on flavorsthe cartridgeE-cigarettes, e-cigarette products that do not take measures to prevent contact with minors, and e-cigarette products that are aimed at or promote their use by minors. In individual warning letters, the FDA has made it clear that the reason for the crackdown is to attract minors to use it.

2. Age

The FDCA makes it illegal for retailers to sell tobacco products to people under the age of 21. Under the Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco and Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Co#p#Page Title #e#ntrol Act), retailers must verify that buyers are of legal age through photo identification.

3. Sales method

Title 21 CFR restrictions on sales methods include

(1) Retailers cannot use vending machines to sell tobacco products unless the vending machine is located in a place where the retailer can determine that people under the legal age cannot enter;

(2) Manufacturers are not allowed to use the brand name of non-tobacco products as the brand name of tobacco products;

(3) Manufacturers, distributors and retailers are prohibited from distributing free samples except in situations where entry is only allowed to persons above legal age;

(4) Prohibition of labeling tobacco brands in promotional products of non-tobacco products; prohibition of using tobacco brands to sponsor sports events, but allowing sponsorship in the name of the company.

(4) Warning label

Under the Federal Tobacco Labelling and Advertising Act Federal Cigarette Labeling and Advertising Act and Restrictions on the Sale and Distribution of Tobacco Products and Warning Statements Required on Tobacco Products Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, tobacco product packaging and advertising require warning labels, such as "Warning: This product contains nicotine; nicotine is an addictive chemical"; And warning labels must comply with the format requirements in the above laws and regulations.

conclusion

Judging from the trend of traditional cigarettes being gradually replaced by e-cigarettes, e-cigarette companies are likely to become the main force of my country's export earnings in the future. Facing the new situation and new opportunities that may come, my country's e-cigarette companies are scientifically understanding and correctly grasping domestic e-cigarette regulatory policies. At the same time, they should also understand and abide by foreign e-cigarette laws, regulations and policies, and increase investment in legal compliance of export destinations. Only in this way can we smoothly cope with the storms brought about by major changes unseen in a century in the rolling economic wave.

The author is:

Zheng Mingwei holds a master's degree in international law from Shenzhen University, director of the Company's Comprehensive Business Committee and equity partner of Beijing BOC (Shenzhen) Law Firm.

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 Qualification Examination.

The U.S. regulatory laws and regulations covered in this article are as follows:

Federal Food, Drug, and Cosmetic Act (FDCA) Sections 904, 906, 907, and 910

Section 4 of the Federal Tobacco Labeling and Advertising Act

Refuse to Accept Procedures for Premarket Tobacco Products Submissions (21 CFR 1105)

Premarket Tobacco Applications and Recordkeeping Requirements (21 CFR 1114)

Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco (21 CFR 1140)

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Co.ntrol Act)(21 CFR 1140)

Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products (21 CFR 1143)