What should we pay attention to when exporting infant products to the United States?

Bringing a newborn into the world is a time of both joy and preparation. While parents carefully select every item to ensure their baby’s safety and comfort, manufacturers bear a critical responsibility to meet stringent quality standards. In the United States, the regulatory environment for baby products is comprehensive and unforgiving, reflecting the high stakes involved in protecting our youngest consumers.

In this guide, we’ll unpack basic regulatory requirements, explore product-specific requirements, and provide actionable insights to help you ensure your infant products meet the highest safety benchmarks.

The importance of regulatory compliance

In the U.S., regulatory compliance for infant products is more than just a legal requirement; it plays a vital role in protecting the well-being of children. Regulations established by regulatory agencies such as the Consumer Product Safety Commission (CPSC), the Food and Drug Administration (FDA), and ASTM International are designed to identify and reduce risks at every stage of the product life cycle, from design and manufacturing to distribution and use.

Compliance with these standards has a dual benefit. For consumers, it ensures that baby products meet safety benchmarks, thereby reducing the likelihood of injury or death; for companies, compliance is a strategic necessity. Adherence to these standards minimizes the risk of product recalls, litigation, and reputational damage, which can have devastating financial and operational consequences. In addition, it demonstrates a company’s commitment to safety and reliability, building trust in high-quality products among parents and caregivers.

Core regulations and standards system

Consumer Product Safety Improvement Act (CPSIA)

CPSIA is the cornerstone of U.S. children's product safety regulations. The act requires all children's products to be tested and certified by a third party to ensure that the products meet strict safety standards before entering the market. This requirement is non-negotiable and covers a wide range of safety issues, including lead content, phthalate restrictions, and mechanical safety. The act also stipulates clear and accessible labeling requirements to ensure that consumers understand the correct use of products and potential dangers.

For manufacturers and importers, CPSIA compliance means investing in accredited testing agencies and maintaining detailed certification records. The act also places special emphasis on traceability, requiring companies to attach tracking labels to products to indicate the date and location of production. This traceability is essential for managing recalls and addressing potential safety issues in a timely manner.

ASTM International Standards

ASTM International provides voluntary performance and safety standards for a wide range of infant products, including strollers, cribs and toys. These standards are developed by industry experts, regulators and consumer representatives, making them both comprehensive and practical.

While ASTM standards are technically voluntary, they often become de facto requirements due to adoption by regulatory agencies such as the CPSC. For example, ASTM F833 details strict safety specifications for strollers, covering stability, durability, and mechanical integrity; similarly, ASTM F963 is the gold standard for toy safety, covering hazards such as choking, toxic substances, and flammability. Manufacturers who align with ASTM standards can benefit from this structured risk mitigation framework, which improves product reliability and consumer confidence.

FDA Guidance

FDA's role in regulating baby products mainly involves food contact items such as bottles, pacifiers and feeding utensils. These guidelines are based on scientific research and focus on eliminating the risk of exposure to harmful chemicals. For example, FDA has banned BPA (diphenylmethane A) from use in baby bottles and leak-proof cups due to potential health risks.

Manufacturers must conduct rigorous migration testing to ensure that materials used in food contact products do not release harmful substances. Complying with FDA guidelines is not only a legal requirement, but also an important factor in assuring parents that feeding products are safe.

16 CFR Regulations

Title 16 of the Code of Federal Regulations (CFR) covers federal regulations for a range of safety issues for infant products. Key areas include:

• Hazardous substances : Limits on toxic chemicals, such as lead and phthalates, to protect children from long-term health risks.
• Flammability standards : Require materials to resist ignition of fire, reducing the risk of fire-related injuries.
• Machinery Safety : Specifies specific requirements for preventing choking, entanglement and sharp edge hazards.

The 16 CFR regulations are strictly enforced, and the CPSC conducts regular inspections and imposes penalties for non-compliance. For companies, complying with these regulations requires proactive measures in design, material selection, and quality assurance processes to eliminate potential hazards.

Compliance and standards for certain infant products in the United States

Cribs and Sleeping Products

Cribs, bassinets, and other sleep products are among the most strictly regulated infant products due to key safety risks such as entrapment, suffocation, and structural failure. Federal regulations such as 16 CFR Part 1219 for full-size cribs and 16 CFR Part 1220 for non-full-size cribs establish mandatory requirements to ensure these products provide a safe sleep environment.

Key requirements:

• Crib rail spacing : Crib rails should be spaced no more than 2 3/8 inches apart to ensure that an infant’s head or limbs cannot become trapped, leading to serious injury or death.
• Mattress fit : The mattress must fit tightly against the crib frame, with a gap of no more than two fingers wide to prevent the baby from being trapped between the mattress and the crib frame and suffocating.
• Structural Integrity : Cribs must pass durability tests that simulate long-term and repeated use without showing signs of loosening, collapse, or structural damage.
• For inclined sleeping products (which undergo the most stringent regulatory scrutiny), they must comply with ASTM F3118. These standards address specific risks posed by inclination angle and stability, ensuring that the product minimizes suffocation hazards while maintaining structural integrity when in use.

Baby strollers and baby carriages

Strollers and baby carriages are essential items for parents every day, and their safety and ease of use are of utmost importance. The ASTM F833 standard specifies safety specifications for these products, focusing on mechanical durability, stability, and normal function under stress. Given their high frequency of use and the variety of terrains they face, rigorous testing to identify potential hazards is essential.

Key requirements :

• Effective braking : Parking brakes must be tested to ensure that they remain in a braking state even when subjected to large external forces, especially on slopes to prevent sliding and causing serious accidents.
• Stability : Products must pass a tilt test to ensure they remain upright when weight is unevenly distributed or when accessories such as diaper bags are attached.
• Durability : Folding mechanisms and other components are tested through repeated use to ensure they do not wear out or fail prematurely, thereby preventing hazards such as sudden collapse during use.
• Anti-pinch design : Design features are analyzed to ensure there are no gaps that could trap a child’s fingers, limbs or clothing. This includes testing of all moving parts and adjustable features.

In addition, the law requires clear instructions and warnings to educate parents on how to properly use, assemble and maintain the product. Unclear labeling often leads to misuse, resulting in avoidable injuries.

Toys and small parts

Toys intended for young children, especially those under three, are subject to strict safety regulations under ASTM F963 and the Federal Hazardous Substances Act (FHSA), which are designed to reduce choking risks, avoid exposure to toxic chemicals, and prevent fire hazards.

Key requirements :

• Small Parts Hazard : Toys intended for infants and young children must not contain parts that can break off and must meet the dimensions of a small parts test tube, which simulates the size of a child's airway to prevent choking accidents.
• Lead and Toxic Substances : Materials must not contain more than 100 ppm of lead and must meet strict limits for phthalates and other hazardous chemicals. These limits help reduce the potential harm to children’s development from long-term exposure.
• Flame retardant properties : Toys must be made of materials that are not easily ignited and can slow the spread of fire. This is especially important for plush toys and toys used near heat sources.

These comprehensive requirements ensure toys are safe for everyday use, reduce preventable injuries, and provide peace of mind for parents.

Feeding products

Bottles, pacifiers, and other feeding products are regulated by FDA guidelines because they come into direct contact with food and liquids. These products must not only be physically safe, but must also avoid releasing chemical hazards that could leach into food during use.

Key requirements :

• Material safety : BPA and other harmful chemicals are prohibited in the materials used in feeding products. Products are subject to chemical migration testing, especially under heating conditions, to ensure that they meet FDA safety standards.
• Sterility and hygiene requirements : Manufacturing processes must follow strict sterility standards to prevent bacterial contamination, and testing must ensure that the product is free of harmful microorganisms throughout its life cycle.
• Migration testing : Products are subjected to thermal and chemical exposure tests to ensure that no harmful substances migrate into liquids or food during use.

These standards ensure that feeding supplies are not only durable but also safe under conditions of frequent daily cleaning and disinfection.

Dining chairs and booster seats

High chairs and booster seats are regulated by ASTM F404, which sets detailed safety requirements for their stability, structural integrity, and safety restraint systems. These products must be able to support active infants and toddlers, even with uneven weight distribution or vigorous movement, and must not tip over or collapse.

Key requirements :

• Stability test : The high chair must remain upright when subjected to changes in weight or external forces, ensuring that the child's natural movements will not cause it to tip over and cause injury.
• Durability of the safety restraint system : Seat belts and buckles are tested for repeated use to ensure they do not wear out or break due to prolonged use. The safety restraint system is critical in keeping children safe during mealtimes.
• Assembly and use instructions : Clear and concise instructions must be provided to help parents assemble and use the product correctly. Unclear instructions can lead to improper use, which can lead to accidents, and proper education can prevent such situations.

Manufacturers must devote sufficient testing resources to identify potential weaknesses in the design and provide products that are consistently reliable during their intended use.

Chemical Safety Standards for Infant Products

Chemical safety is the cornerstone of quality control for baby products, reflecting both regulatory requirements and public health concerns. Children are particularly sensitive to exposure to chemicals due to their small size, developing systems, and tendency to put things in their mouths. To address this risk, U.S. regulations strictly limit hazardous substances in baby products and require manufacturers to meet strict standards.

Lead and heavy metals

Exposure of children to lead can cause serious developmental and neurological problems, even at low doses. To reduce this risk, the United States has implemented strict limits under 16 CFR 1303, capping lead content at 100 ppm in surface coatings. This regulation applies to paint, finishes, and all accessible parts of baby products. Manufacturers must regularly test for lead during production to ensure compliance, especially when raw materials are sourced from regions with different regulatory standards. Failure to meet these standards can result in severe penalties, recalls, and reputational damage.

Phthalates

Phthalates are a class of plasticizers commonly used to make materials flexible, but studies have linked these chemicals to hormone disruption and developmental problems in children. The Consumer Product Safety Improvement Act (CPSIA) limits six specific phthalates, including DEHP and DBP, to a concentration of no more than 0.1% in any accessible part of children's products. This limit is particularly important for products such as teethers, pacifiers, and soft plastic toys that are often chewed by babies.

Manufacturers must establish rigorous testing protocols to measure the concentration of phthalates in raw materials and finished products. A third-party laboratory approved by the CPSC is essential to ensure the accuracy of the testing, as phthalates can sometimes migrate from packaging or adjacent materials during storage.

Flame retardants

Flame retardants are a class of chemicals used to reduce the flammability of materials, particularly in textiles and foams. While these substances can reduce the risks associated with fire, certain flame retardants, such as polybrominated diphenyl ethers (PBDEs), have been linked to cognitive and behavioral problems in children. Many U.S. states, including California, have imposed additional restrictions on specific flame retardants in baby products.

Manufacturers are encouraged to use non-toxic alternatives or explore inherently flame retardant materials to meet these standards. For example, textiles with naturally flame retardant properties, such as wool, are emerging as safer alternatives compared to chemically treated foams. Thorough testing must be performed to confirm that these alternative materials meet both safety requirements and the expected performance standards.

Quality Control and Certification Requirements for Baby Products in the United States

Testing and certification are critical steps to ensure that baby products meet strict U.S. safety standards. These processes are designed to identify and eliminate potential hazards, verify product compliance with regulations, and provide peace of mind for manufacturers and consumers. Every stage from product development to final production must be thoroughly evaluated.

Testing and certification requirements

To sell baby products in the United States, manufacturers must test them in laboratories approved by the CPSC. These laboratories are equipped to conduct comprehensive evaluations to ensure that products meet safety, durability, and chemical standards. Approved laboratories follow standardized procedures to ensure that the results are reliable and reproducible, giving manufacturers confidence in their product safety claims.

Key stages in the testing process :

• Prototype testing : The first step in testing is to evaluate the product prototype. During this phase, engineers and safety experts analyze the design to identify potential hazards such as sharp edges, entrapment risks, or structural weaknesses. For example, cribs are tested to ensure that the rail spacing prevents heads from getting entrapped and that the structure remains stable under repeated forces.
• Batch testing : Batch testing is performed during the production process to ensure that all product units are consistent in quality and safety. This step is critical to discovering manufacturing defects or material inconsistencies that may not have been caught during the prototype testing phase. Regular batch testing helps maintain compliance and minimize the risk of recalls.
• Label verification : Clear and accurate labeling is not only a regulatory requirement, but also an important part of consumer safety. Labels must include warnings, instructions for use and safety guidelines and ensure they are easy to understand. Testing ensures that these labels remain legible and durable under conditions such as heat, humidity or frequent contact.
• Children's Product Certificate (CPC) : CPC is a legally required document that proves that a product complies with all applicable U.S. safety standards. This certification must be based on testing conducted by a CPSC-accepted laboratory. CPC provides detailed information about the product, including production date, batch number, and specific standards met, ensuring transparency and accountability tracking.