What does fda certification of american e-cigarettes need to check? In order to sell e-cigarettes in the United States, the first step is to obtain FPD certification for e-cigarettes. The FDA of the United States began requiring companies that export foreign food (and animal food) to the United States on December 12, 2003 to register with the FDA. Without registration, the products of these companies cannot be landed in the United States. The companies referred to here include product production and production companies, packaging companies, wholesale companies, and repackaging companies. Electronic cigarettes sold in the United States must obtain an FDA certificate and belong to the food grade FDA registration.

1. Electronic Product Attributes

It shall comply with FCC regulatory requirements, and the corresponding certification procedure is FCC SDOC.


2. Attributes of consumer goods

Shall comply with CPSC regulatory requirements, the most common being 16 CFR part1303. If there is a coating on the surface of the product, it is prohibited to contain lead in the coating.


3. Packaging materials

TPCH (Toxics in Packaging Cleaning House, formerly known as CONEG, the Northeast Governors Association) is a coordinated regulation in the United States aimed at reducing the content of certain harmful substances in packaging materials, which was implemented in 1989. It requires that the total content of lead (Pb), cadmium (Cd), mercury (Hg), and hexavalent chromium (Cr VI) in packaging materials and individual packaging components should not exceed 100 ppm.


4. Battery

The 1996 federal decree, the "Mercury Containing Batteries and Rechargeable Pools Management Act" (US PUBLICLAW 104-142), came into effect on May 13, 1996.

It is prohibited to add mercury to alkaline manganese batteries and carbon zinc batteries;

The use of mercury containing batteries is prohibited in stages.

5. FDA Food Contact Material Requirements

The oil storage bin for electronic cigarettes is in long-term contact with electronic cigarette oil, which can be atomized and inhaled by consumers. Therefore, the materials in contact with cigarette oil in the oil storage bin need to meet the standard requirements for food contact materials.

6. Tobacco Product Attributes

On May 10th, 2016, the FDA issued the Deeming Regulation, which took effect on August 8th, 2016, and included electronic atomization products in the scope of regulated tobacco products.

Through the FDA Deeming Regulation, FDA can legally regulate the manufacturing, import, packaging, labeling, advertising, promotion, sales, and distribution of Electronic Nicotine Delivery Systems (ENDS). ENDS includes but is not limited to Vaporizers, Vapor pens, Hookah pens, Electronic Cigarettes (E-Cigarettes), and e-pipes

Tobacco extract/nicotine containing products or products that may be used with nicotine/tobacco extract are subject to FDA control.

Products that do not contain nicotine or tobacco extract and are unlikely to be used with nicotine/tobacco extract are not subject to FDA control.

At the same time, the regulatory object also includes the components and components of ENDS, but does not include accessories.

The FDA closely monitors retailers, manufacturers, importers, and distributors' compliance with federal tobacco laws and regulations, and takes corrective action when violations occur.

The FDA takes a three-pronged approach to helping the industry comply with the law by:

Develop and provide compliance training and education

Monitor legal compliance in regulated industries through supervision, inspection, and investigation

Take action as necessary, including:

Warning letter

Civil Penalty (CMP) Complaints

Non Tobacco Sales Order (NTSO) Complaints

Seizures, bans, and criminal prosecutions

Production site registration and product list

Only for US based ENDS product manufacturers

The term "manufacturing" refers to the manufacturing, preparation, assembly, or processing of ENDS products, including repacking or otherwise replacing the containers, packaging, or labels of any ENDS product packaging.

"Importing ENDS products for sale or distribution in the United States is not considered an ENDS product manufacturing enterprise.".

New ENDS product manufacturing enterprises established after August 8, 2016 must immediately complete the registration of production sites and upload the product list.

Health Documents

For manufacturers or importers of ENDS products, if the product is imported from abroad into the United States, the manufacturer and importer of the product should jointly ensure that the health documentation is submitted in accordance with FDA requirements.

Key content of health documents:

Health, toxicology, behavioral, or physiological effects

Tobacco product identification, components, ingredients, components, additives

Newly launched products must be submitted 90 days before their launch

List of ingredients

For manufacturers or importers of ENDS products, if the product is imported from abroad into the United States, the manufacturer and importer of the product should jointly ensure that the ingredient list is submitted in accordance with FDA requirements.

Only for ENDS products that are ultimately sold to consumers, there are no requirements for ENDS products used for reproduction.

Components requiring submission of ingredient lists:

Made from or derived from tobacco,

Or contains components that burn, atomize, or ingest during the use of ENDS products.

E-liquids√，Cartomizers╳，Coils ╳ ，Wicks ╳ ，Tanks ╳ ，Electrical components ╳

Changes in the composition of the product must be submitted within 60 days (reducing or adding harmless ingredients) or 90 days (in other cases) before the product is launched after the change.

Newly launched products must be submitted 90 days before their launch

Hazardous and Potentially Hazardous Substances Report (HPHC)

FDA believes that the term "hazardous and potentially hazardous substances" includes any chemical or chemical compounds in ENDS products or their smoke:

A. Is or may be inhaled, ingested, or absorbed into the body, including as aerosols (vapors) or any other emissions; and

B. Causes or is likely to cause direct or indirect harm to users or non users of ENDS products. Examples of ingredients that have a "potential to cause direct harm" to users or non users of ENDS products include ingredients that are toxic, carcinogenic, and addictive chemicals and chemical compounds. Examples of ingredients that have a "potential to cause indirect harm" to users or non users of ENDS products include ingredients that may increase the harmful effects of ENDS product ingredients by:

I. May be helpful to start using ENDS products;

II. May hinder the discontinuation of the use of ENDS products;

3. May increase the intensity of use of ENDS products (e.g., frequency of use, consumption, depth of inhalation).

4. Another example of ingredients that have a "potential to cause indirect harm" is ingredients that can enhance the harmful effects of ENDS product ingredients

Products launched after August 8, 2016, and products launched for sale after the release of the final guidance document of the HPHCs report, shall be submitted within 90 days before the product is launched for sale

Pre Marketing Authorization (PMTA)

On July 11, 2019, the Maryland District Court of the United States issued a final ruling on the lawsuit "The rising prevalence of electronic cigarette use among young people is an increasingly serious public health crisis", and requested the FDA to:

The FDA should require that new tobacco products ("new products") that enter the market before August 8, 2016 must be submitted to the PMTA before May 12, 2020 (within 10 months after the issuance of the memorandum and order on May 15, 2019);

B. For new products that have not submitted an application during this period, FDA shall take mandatory measures according to FDA's decision;

C. For new products that have submitted applications in a timely manner, when the application is being evaluated by FDA, they can continue to be sold on the market for a period not exceeding one year from the date of application, without being subject to FDA enforcement measures;

D. FDA should have the ability to evaluate each product on a case by case basis and exempt new products from the PMTA filing requirements with sufficient justification.

On April 27, 2020, the FDA issued a further statement requesting manufacturers and retailers to withdraw certain electronic cigarette products targeted at young people from the market. The FDA also stated that it would continue to conduct inspections to ensure that unauthorized flavored electronic cigarette products intended to attract young people meet specifications. Finally, manufacturers who intend to continue selling any recognized new tobacco products (including ENDS products) on the market before August 8, 2016 must submit an application to the FDA before September 9, 2020 to demonstrate whether the product meets applicable legal standards, such as whether the product is suitable for protecting public health. Due to the impact of the coronavirus pandemic, this date has recently been extended (originally dated May 12, 2020).

"Products that enter the market after August 8, 2016 must obtain the approval of the PMTA before they can be sold in the market.".


PMTA includes the following main contents:

A. HPHCs analysis report

B. Toxicological analysis report

C. Clinical analysis report

D. Behavioral analysis report

E. UL Listed

F. Market Planning

G. Environmental Assessment Report

H. GMP quality management system