Business Guidance FAQ

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:

1. 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).
2. Effective specifications: the package, when tested by the methods described in 16 CFR § 1700.20, must be child-resistant and adult-friendly.
3. Reuse of special packaging: the package must not be reused.
4. 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) has 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.

The PPPA requires several household substances to be packaged in special packaging, also referred to as child-resistant/senior-friendly packaging. The purpose of the PPPA is to protect children under 5 from poisonings and deaths that can occur when children access the contents of containers with hazardous products.

The requirements for special packaging are codified at: 16 CFR part 1700.

“Special packaging” is defined as a package that is significantly difficult for children under 5 to open (a.k.a. child-resistant) but is relatively easy for an adult to open (a.k.a. senior-friendly or adult-friendly). For a package to be child-resistant, at least 85% of tested children must not be able to open the package during the first 5 minutes of the test, and at least 80% of tested children must not open the packaging during the full 10 minutes of the test. For a package to be adult-friendly, at least 90% of adults must be able to open a package within 5 minutes and, if applicable, properly resecure a second package within 1 minute. The protocols to be followed for testing children and adults can be found at: 16 CFR § 1700.20.
 

There are some additional requirements for special packaging that may apply: (1) the package must continue to effectively function for the life of the product; (2) the package must not be rendered ineffective due to interference or reacting with the enclosed substance; (3) the package must not be re-used; and (4) the package must include a restricted-flow mechanism. These requirements are outlined at 16 CFR § 1700.15, and the applicability of each requirement is stated explicitly under each regulated substance listed at: 16 CFR § 1700.14. 

The PPPA allows CPSC to set rules requiring special packaging for certain household substances if the CPSC determines:

• That those substances present a risk of serious injury or illness to children under 5 years of age who are able to open packages of such substances and possibly drink, eat, or handle its contents; and
• That technology exists or can be developed to produce special packaging for such substances, the packaging can be used with modern mass production and assembly techniques, and the packaging will adequately protect the integrity of the substance and not interfere with intended storage or use of the substance.

A “household substance” is defined as a substance:

1. that is customarily produced or distributed for consumption or use, or customarily stored, by individuals in or about the household; and,
2. that is
   1. a “hazardous substance,” as defined in section 2(f) of the Federal Hazardous Substances Act, 15 U.S.C. § 1261(f);
   2. a “food,” “drug,” or “cosmetic,” as defined in section 201 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321; or,
   3. a substance intended for use as fuel (heating, cooking, or refrigeration system) when stored in a portable container.

The list of substances that require special packaging can be found at: 16 CFR § 1700.14. CPSC adds new substances or updates the requirements from time to time; therefore, we recommend that you check periodically for new or revised rules.

Yes. Except for prescription drugs and drain cleaners containing 10% or more sodium/potassium hydroxide, firms may package one size of a regulated product in conventional packaging. To take advantage of this option, firms must also provide popular sizes of the regulated product in special packaging and must label the conventional package with the statement: “This package for households without young children” or, for small packages, “Package not child resistant.” For more information, see: 16 CFR § 1700.5.

The test protocols for the various tests (child test, senior-adult test, and younger-adult test) are outlined at 16 CFR § 1700.20. As long as these test protocols are followed, anyone can conduct the tests. If you choose not to test a package yourself, CPSC has compiled a list of testing facilities that have informed CPSC that they conduct such testing. CPSC has also compiled a list of consultants who have informed CPSC that they can provide services related to the development or manufacture of special packaging in accordance with the PPPA. Note that CPSC does not approve, certify, or endorse any firm/consultant or their services.

Due to key differences in the test methods, CPSC does not accept alternative tests when certifying to the special packaging requirements.

Due to the extraordinary circumstances caused by the SARS-CoV-2 (COVID-19) pandemic, CPSC staff issued a notice of enforcement discretion on June 25, 2020, which allows for certain deviances from the regulation:

• Acceptance of alternative test methods (ISO 8317, ISO 14375, EN 632, CSA Z76.1, CSA Z76.2)
• Use of transparent barriers between tester and test subjects, and between children
• Use of single site (site restriction noted in the protocols applies to zip codes instead)
• Use of resecuring data to support compliance to child test

Packages that initiated testing during the enforcement discretion period do not need to be retested once the enforcement discretion period ends.

The enforcement discretion ended as of June 30, 2022. Any packages initiating testing for compliance to the special packaging requirements after June 30, 2022, are no longer allowed the deviances noted above.

CPSC does not perform pre-market approval of special packaging. Note that CPSC does not approve, certify, or endorse any specific package or design.

Special packaging is not intended for children and, therefore, special packaging does not require third-party testing under the Consumer Product Safety Improvement Act (CPSIA); however, certificates of compliance are still required. Certification of a special package must be done by the manufacturer of the end product. The manufacturer must ensure that the packaging meets the requirements of the special package under 16 CFR § 1500.15 and generate a General Certificate of Conformity (GCC) for the end product. For more information on GCCs, please visit www.cpsc.gov/GCC.

As long as the protocols outlined in 16 CFR § 1700.20 are followed, anyone can perform the test to determine if a package is considered special packaging. CPSC is aware of firms that conduct tests in accordance with 16 CFR § 1700.20 and has compiled a list. Note that CPSC does not approve, certify, or endorse any particular testing facility or its services.

According to the PPPA, the manufacturer of the end product is responsible for ensuring or certifying that the end product meets the special packaging requirements. Note that the manufacturer of an empty package is not considered the manufacturer of the end product and would not be considered the responsible party. Under the PPPA, the entity that fills the package with the regulated substance is considered the manufacturer.

Yes. CPSC does not prohibit the use of special packaging for unregulated substances.

As long as the tested package adequately reflects the package being used in the end product, retesting or recertification is not required. If there is reason to believe the effectiveness of the package has changed, the manufacturer should retest and recertify. CPSC staff recommends that retesting and recertification be conducted whenever there is a change in the packaging material, a change in the manufacturing process, a different substance will be inserted, or a different combination of closure and package is used. CPSC staff also recommends that retesting and recertification be conducted when incident reports and/or complaints are received or when a manufacturing or materials defect becomes evident.

The practice of testing intervals of package sizes, as opposed to every single size, is commonly referred to as bracket testing. The PPPA does not specifically address bracket testing, nor does CPSC provide any guidance on the subject; however, CPSC staff may accept bracket testing if the manufacturer is able to make an informed determination (based on other testing of similar products, trends, or information from other manufacturers) on how certain sizes will perform.

CPSC staff generally recommends testing the two extremes (e.g., the smallest and largest sizes) along with some intervals between the extremes (e.g., if you have 5 different sizes you should test the 1st, 3rd, and 5th sizes). If the compliance of a certain size that did not undergo the full testing was ever to be called into question, CPSC staff would evaluate the rationale and supporting information used to certify that size.

The Child Nicotine Poison Preventing Act (CNPPA), Pub. L. No. 114-116, requires liquid nicotine to use special packaging as of July 26, 2016. For more information, visit our liquid nicotine page.

Section 3 of Reese’s Law, H.R. 5313, requires button cell or coin batteries use special packaging as of February 12, 2023.