Us e-cigarette compliance requirements

Electronic atomizer products have the attributes of both tobacco products and electronic products as well as consumer goods, and are therefore regulated by different regulatory agencies in the United States.

1. Attributes of electronic products

It must meet the regulatory requirements of the FCC. The corresponding certification process is FCC SDOC.

2. Consumer goods attributes

It should meet CPSC regulatory requirements, the most common being 16 CFR part1303. If the product is coated, lead is not allowed in the coating.

3. Packaging materials

TPCH (Toxics in Packaging Clearing House, earlier known as CONEG, or Association of Northeastern Governors) is an American harmonized regulation that has been in place since 1989 to reduce the amount of certain hazardous substances in packaging materials. It requires that the combined content of lead (Pb), cadmium (Cd), mercury (Hg), and hexavalent chromium (Cr VI) in packaging materials and individual packaging components does not exceed 100 ppm.

Step 4: Batteries

A federal statute, the Administration of Mercury-Containing Batteries and Rechargeable Batteries Act (US PUBLICLAW 104-142), was promulgated in 1996 and went into effect on May 13, 1996.

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

Phase out mercury-containing batteries.

5. FDA Food Contact Material requirements

The oil storage bin of the electronic atomizer is in contact with the oil of the electronic atomizer for a long time, and then the smoke oil will be atomized and inhaled by consumers. Therefore, the materials in the oil storage bin that are in contact with the smoke oil should meet the standard requirements of food contact materials.

6. Tobacco product attributes

On May 10, 2016, the FDA issued the Deeming Regulation, effective August 8, 2016, to include electronic fogging products in the range of regulated tobacco products.

Through FDA Deeming Regulation, the FDA can legally regulate the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS(Electronic Delivery Systems). ENDS include, but are not limited to, Vaporizers, vape 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 regulated by the FDA.

Products that do not contain nicotine or tobacco extract and cannot be used with nicotine/tobacco extract are not regulated by the FDA.

The supervised objects also include components and components of the ENDS, but do not include accessories.

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

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

Develop and provide compliance training and education

To monitor compliance with laws in regulated industries through supervision, inspection and investigation

Take action where necessary, including:

Warning letter

Civil penalty (CMP) complaint

Smokeless sales orders (NTSO) complaints

Seizure, injunction and criminal prosecution

Production site registration and product list

Only ENDS manufacturers in the United States are used

Terminology “ manufacture Means the manufacture, preparation, assembly or processing of ENDS products, including the repackaging or otherwise replacement of containers, packages or labels for any ENDS products.

ENDS products imported into the United States for sale or distribution do not belong to ENDS manufacturers.

ENDS products manufacturers newly established after August 8, 2016 must immediately complete the registration of the production site and upload the product list.

Health file

For ENDS manufacturers or importers, if the ENDS products are imported into the United States from abroad, the manufacturers and importers should work together to ensure that health documentation is submitted in accordance with FDA requirements.

Key contents of health document:

Health, toxicology, behavioral or physiological effects

Tobacco product identification, components, ingredients, components, additives

New products must be submitted 90 days prior to product launch

List of ingredients

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

Only ENDS products sold to consumers are required, and no requirements are made on ENDS products used for reproduction.

Components to submit a list of components:

Made or derived from tobacco,

Or contain components that are burned, atomized or ingested during the use of ENDS products.

E-liquids√ , Cartomizers inserts, Coils inserts, Wicks inserts, Tanks inserts, Electrical components inserts., Cartomizers, coils inserts, wicks inserts, tanks inserts, electrical components inserts

Changes to the composition of the product must be submitted within 60 days (reducing the composition or adding harmless ingredients) or 90 days (otherwise) before the product is put on the market after the change.

New products must be submitted 90 days prior to product launch

Hazardous and Potentially Hazardous Substances Report (HPHC)

According to the FDA: Hazardous and potentially hazardous substances. The term includes any chemical or chemical compound in ENDS products or in their fumes:

a. is or may be inhaled, ingested or absorbed into the body, including as an aerosol (vapour) or any other emission; and

b. Causes or is likely to cause direct or indirect injury to users or non-users of ENDS products. For users or non-users of ENDS products. May cause immediate harm. Examples of components include components as toxic substances, carcinogens and addictive chemicals and chemical compounds. For users or non-users of ENDS products. Collateral damage may result. Examples of components include components that may increase the harmful effects of ENDS product components in the following ways:

I. May help start using ENDS products;

II. May prevent the use of ENDS products;

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

4. have a/dquo; May cause collateral damage. Another example of ENDS components is components that can enhance the harmful effects of components in ENDS products

Products to be marketed after August 8, 2016, products to be marketed after the release of the final guidance document of the HPHCs report, to be submitted within 90 days before the launch of the products

Pre-marketing Authorisation (PMTA)

On July 11, 2019, the United States District Court for the District of Maryland, The rising prevalence of e-cigarette use among youth is a growing public health crisis. For a final ruling and asks the FDA to:

a. FDA, at its request, is reviewing new tobacco products that enter the market before August 8, 2016. New product ”) , must submit PMtas no later than May 12, 2020 (within 10 months of the Memorandum opinion and order issued on May 15, 2019);

b. For new products for which an application has not been submitted during this period, FDA shall, as determined by FDA, take enforcement action;

c. A new product for which an application has been submitted in a timely manner may remain on the market for a period of not more than one year from the date of application, when the application is being evaluated by FDA, without being subject to FDA enforcement action;

d. FDA should have the ability to evaluate each product on a case-by-case basis and exempt new products from the PMTA filing requirement if there is sufficient justification.

On April 27, 2020, the FDA issued a further statement asking manufacturers and retailers to remove from the market certain vaping products aimed at young people. The FDA also said that it would continue to check to ensure that unauthorized flavored electronic atomizers designed to appeal to young people comply with regulations. Finally, manufacturers who intend to continue marketing any recognized new tobacco products (including ENDS products) that are marketed before August 8, 2016, must submit an application to the FDA by September 9, 2020 to demonstrate that the products meet the applicable standards of the law, such as whether the products are suitable to protect public health. The date was recently extended (originally 12 May 2020) due to the coronavirus pandemic.

Products that enter the market after August 8, 2016, must be approved by PMTA before they can be sold on 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 certification

f. Marketing plan

g. Environmental assessment report

h. GMP quality management system