Companies importing dietary supplements, cosmetics, and drugs may think primarily about FDA requirements at the border. But some FDA-regulated products are also subject to the Poison Prevention Packaging Act (PPPA), administered by the U.S. Consumer Product Safety Commission (CPSC). If a product is subject to a PPPA special-packaging requirement, its importer may also be required to electronically file CPSC certificate data at entry.
We previously wrote in detail about CPSC's mandatory eFiling requirements. These requirements took effect for most imported products on July 8, 2026. Importers of products subject to a CPSC certification requirement, including products required to be in special packaging under the PPPA, must electronically file the required certificate data. Products entered from a Foreign Trade Zone become subject to the requirement on January 8, 2027.
For a product subject to a CPSC-enforced mandatory standard, the manufacturer or importer generally must issue a General Certificate of Conformity or Children's Product Certificate, as applicable, certifying compliance with the applicable CPSC requirements. One such requirement is special packaging, commonly referred to as child-resistant and senior-friendly packaging. That has not changed.
For imported products, however, that certification obligation now carries an additional step. As of July 8, 2026, importers subject to CPSC's certification requirements generally must eFile certificate data with U.S. Customs and Border Protection through the Automated Commercial Environment.
Examples of dietary supplements, cosmetics, and drugs that require special packaging under the PPPA include the following, subject to the specific conditions and exceptions set forth in the PPPA regulations:
- dietary supplements containing 250 mg or more of iron per package
- mouthwash containing 3 grams or more of ethanol per package
- products containing more than 50 mg of fluoride, 5 mg of lidocaine, 0.5 mg of dibucaine, or 14 mg of minoxidil per package
- liquid products containing more than 5% methyl salicylate (wintergreen) by weight
- drugs and cosmetics containing 10% or more hydrocarbons by weight
- ·oral prescription drugs and
- many oral OTC drugs
Companies that import supplements, cosmetics, or drugs should take this opportunity to confirm whether any of their products are subject to the PPPA. If so, they should not only ensure that their packaging is compliant—which requires testing to specific CPSC protocols—but also that they are prepared to eFile the required certificate data.
Failure to eFile can result in import delays, and failure to comply with the packaging requirement can result in a consumer-level recall and civil or criminal penalties.
If you have any questions about eFiling or CPSC compliance, we are happy to help.