Enacted in 2016, the Child Nicotine Poisoning Prevention Act (CNPPA) requires “any nicotine provided in a liquid nicotine container sold, offered for sale, manufactured for sale, distributed in commerce, or imported into the United States” to utilize a packaging that meets all of the requirements of 16 CFR § 1700.15. See 15 U.S.C. § 1472a(a). The requirements of the CNPPA became effective on July 26, 2016, and means that any products manufactured, imported, or sold on or after July 26, 2016, must meet the requirements of the CNPPA.
Section 14(a) of the Consumer Product Safety Act (CPSA), 15 U.S.C. § 2063(a), requires manufacturers of consumer products subject to a regulation, standard, or ban enforced by the CPSC to certify that those products meet the requirements of all applicable regulations, standards, or bans by issuing a certificate of compliance (General Certificate of Compliance or GCC). For more information on GCCs, please visit our GCC page.
Please note that although CPSC regulates special packaging of liquid nicotine containers, it does NOT regulate liquid nicotine itself, nor does it regulate tobacco and tobacco products per section 3(a)(5)(B) of the CPSA, 15 U.S.C. § 2052(a)(5)(B), and section 2(f)(2) of the Federal Hazardous Substances Act, 15 U.S.C. § 1261(f)(2). For regulatory information related to liquid nicotine and tobacco products, visit the U.S. Food and Drug Administration’s Center for Tobacco Products guidance page.
16 CFR § 1700.15 has 4 requirements as follows:
- General requirements: the package must function for the lifetime of the product’s use, and the substance introduced to the package must not compromise or interfere with the effective specifications (see point 2).
- Effective specifications: the package, when tested by the methods described in 16 CFR § 1700.20, must be child-resistant and adult-friendly.
- Reuse of special packaging: the package must not be reused.
- Restricted flow: the package must not allow more than 2mL of the contents to be obtained when the inverted, opened package is taken or squeezed once or otherwise activated once.
For more information on the requirements of 16 CFR § 1700.15 and special packaging, visit our Poison Prevention Packaging Act (PPPA) business guidance page.
CPSC technical staff has developed test parameters which will be used by CPSC to assess compliance to the restricted flow requirement. It should be noted that rigid packages (such as those made of glass) will still be subjected to this test when determining compliance to the restricted flow requirement.
No. A GCC can cover all lines of varying nicotine strengths and flavors (even product lines) provided they use the same packaging and closure (similar packaging and closure from different manufacturers are NOT considered the same for the purposes of certification). The section on the GCC must specifically identify a description of the products covered under the GCC (type of bottle, item codes from package/closure suppler or manufacturer, nicotine strengths). If a bottle comes in different sizes or uses a different cap, dropper, etc., then a separate GCC would be required.
The CNPPA includes some exclusions. Containers where the liquid nicotine is inaccessible (e.g., sealed, pre-filled, disposable cartridges intended for use in e-cigarettes or other similar devices) are exempt from the requirements of the CNPPA.
The U.S. Food and Drug Administration (FDA) issued a deeming rule in 2016 (81 FR 28973) which includes electronic nicotine delivery systems (ENDS), such as e-cigarettes and vaporizes, and components of ENDS, such as e-liquids, as tobacco products and, as such, are subject to FDA’s tobacco product authorities. For regulatory information related to tobacco products as a whole, please see this guidance page from FDA’s Center for Tobacco Products. In addition, Division P of Pub. Law No. 117-103 (HR 2471) enacted in 2022 clarified that FDA can regulate tobacco products containing nicotine from any source.
Packagers (entities that take liquid nicotine and mix with flavors and solvents to fill retail packaging) and repackagers (entities that take bulk e-liquid and repackage into smaller bottles) are considered manufacturers and are responsible for generating a GCC when providing liquid nicotine products to retailers and redistributors. Retailers and redistributors should exercise due diligence and request a GCC be supplied when ordering liquid nicotine products and maintain copies of all GCCs they receive.
Not necessarily. It is the responsibility of the final manufacturer of the product (in this case, the entity introducing the liquid nicotine to the empty package) to certify that the product meets the requirements of the CNPPA by generating a GCC based on supporting information. Package manufacturers often test their empty package to the special packaging requirements to advertise their product as special packaging. The manufacturer may obtain a copy of the protocol data (or GCC for the empty package) from the manufacturer and generate the GCC for their own product based on this information.
Distribution of noncompliant product (including retail sale) is a prohibited act under the CPSA. Retailers, and other parties involved in the commerce of liquid nicotine products that are not the responsible party, should exercise due diligence and request a GCC be supplied when receiving liquid nicotine products and maintain copies of all GCCs they receive.