E-cigarette products have both the attributes of tobacco products and the attributes of electronic products, and at the same time are consumer products, so they are regulated by different regulatory agencies in the United States.
1. Electronic product properties
Should comply with FCC regulatory requirements, the corresponding certification procedure is FCC SDOC.
2. Attributes of Consumer Goods
Should meet CPSC regulatory requirements, the most common being 16 CFR part1303. If the surface of the product is coated, lead is prohibited in the coating.
3. Packaging Materials
TPCH (Toxics in Packaging Clearing House, earlier called 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. It was implemented in 1989. It requires packaging materials and individual The total content of lead (Pb), cadmium (Cd), mercury (Hg) and hexavalent chromium (Cr VI) in the packaging parts of
4. Battery
The federal statute of 1996, the Mercury-Containing Batteries and Rechargeable Batteries Management Act (US PUBLICLAW 104-142), came into effect on May 13, 1996.
Prohibit the addition of mercury to alkaline manganese batteries and carbon-zinc batteries;
Phased ban on mercury-containing batteries.
5. FDA food contact material requirements
The e-cigarette oil storage tank is in contact with the e-liquid for a long time, and then the e-liquid will be atomized and inhaled by consumers. Therefore, the materials in the oil storage tank that are in contact with the e-liquid need to meet the standard requirements of food contact materials.
6. Tobacco Product Properties
On May 10, 2016, the FDA issued the Deeming Regulation, which took effect on August 8, 2016, to include electronic atomization products in the scope of regulated tobacco products.
Through the FDA Deeming Regulation, FDA can legally supervise the manufacture, import, packaging, labeling, advertising, promotion, sales and distribution of ENDS (Electronic Nicotine Delivery Systems). ENDS include but are not limited to Vaporizers, vape pens, hookah pens, electronic cigarettes (E-Cigarettes), and e-pipes.
Tobacco extracts/nicotine-containing products or products that may be used with nicotine/tobacco extracts 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.
At the same time, the object of supervision also includes the components and parts of ENDS, but does not include accessories.
FDA closely monitors retailers, manufacturers, importers and distributors for compliance with federal tobacco laws and regulations and takes corrective action when violations occur.
FDA takes a three-pronged approach to help industry comply with the law by:
Develop and deliver compliance training and education
Monitor legal compliance in regulated industries through surveillance, inspections and investigations
Take action as necessary, including:
Warning Letter
Civil Fines (CMP) Complaints
Smoke Free Sales Order (NTSO) Complaints
Seizures, Injunctions and Criminal Prosecutions
Production site registration and product list
Only for domestic ENDS product manufacturers in the United States
The term "manufacturing" means the manufacture, preparation, assembly or processing of an ENDS product, including repackaging or otherwise replacing the container, wrapper or label, etc. of any ENDS product packaging.
Importing ENDS products in the United States for sale or distribution is not an ENDS product manufacturer.
Newly established ENDS product manufacturing enterprises after August 8, 2016 must complete the production site registration and upload the product list immediately.
health documents
For manufacturers or importers of ENDS products, if the product is imported into the United States from abroad, the manufacturer and importer of the product should work together to ensure that health documentation is submitted in accordance with FDA requirements.
Key contents of the health document:
Health, Toxicological, Behavioral or Physiological Effects
Tobacco product identification, components, ingredients, components, additives
Newly marketed products must be submitted 90 days prior to product launch
Ingredient List
For manufacturers or importers of ENDS products, if the product is imported into the United States from abroad, the manufacturer and importer of the product should work together to ensure that the ingredient list is submitted in accordance with FDA requirements.
Only for ENDS products that are ultimately sold to consumers, there is no requirement for ENDS products for reproduction.
Parts that require an ingredient list submission:
made or derived from tobacco,
Or contain ingredients that are burned, aerosolized, or ingested during use of ENDS products.
E-liquids√, Cartomizers╳, Coils ╳ , Wicks ╳ , Tanks ╳ , Electrical components ╳
Changes to product ingredients must be submitted within 60 days (reduced ingredients or increased harmless ingredients) or 90 days (other circumstances) before the changed product goes into the market.
Newly marketed products must be submitted 90 days prior to product launch
Hazardous and Potentially Hazardous Substances Reporting (HPHC)
FDA considers that the term "hazardous and potentially hazardous substances" includes any chemical or chemical compound in an ENDS product or its fumes:
a. is or is likely to be inhaled, ingested or absorbed into the body, including as an aerosol (vapor) or any other emission; and
b. Causes or is likely to cause direct or indirect harm to users or non-users of ENDS products. Examples of ingredients that are "likely to cause immediate 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 are "likely to cause consequential harm" to users or non-users of ENDS products include those that may increase the harmful effects of ENDS product ingredients by:
I. May be helpful in getting started with ENDS products;
II. May prevent discontinuation of ENDS products;
III. May increase the intensity of ENDS product use (eg, frequency of use, consumption, depth of inhalation).
IV. Another example of an ingredient with a "potential for consequential harm" is an ingredient that enhances the harmful effects of an ENDS product ingredient
Products marketed after August 8, 2016, and products marketed after the publication of the final guidelines for HPHCs reporting, should be submitted within 90 days before the product is marketed
Premarket Authorization (PMTA)
On July 11, 2019, the U.S. District Court for the District of Maryland issued a final ruling on the lawsuit "Rising prevalence of youth e-cigarette use is a growing public health crisis" and asked the FDA to:
a. FDA is required to submit PMTA by May 12, 2020 for new tobacco products (“New Products”) that entered the market before August 8, 2016 (Memorandum Opinion and Order issued May 15, 2019 within the next 10 months);
b. For new products for which no application has been submitted during this period, enforcement actions shall be taken by the FDA according to the FDA's decision;
c. New products for which an application has been submitted in a timely manner, while the application is being evaluated by the FDA, may continue to be marketed for a period not exceeding one year from the date of the application, without being subject to FDA enforcement;
d. FDA should have the ability to evaluate each product on a case-by-case basis and waive PMTA filing requirements for new products with sufficient justification.
On April 27, 2020, the FDA issued another statement requiring manufacturers and retailers to withdraw certain e-cigarette products aimed at young people from the market. The flavored e-cigarette products meet the specifications. Ultimately, manufacturers who intend to continue to market any recognized new tobacco product (including ENDS products) that were on the market before August 8, 2016, must submit an application to the FDA by September 9, 2020, certifying whether the product is Compliance with applicable standards of the law, such as whether the product is suitable for the protection of public health. This date was recently extended due to the impact of the coronavirus pandemic (originally 12 May 2020).
Products entering the market after August 8, 2016 must be approved by the PMTA before they can be sold in the market.
PMTA includes the following main elements:
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
