How To Make Safe Baby Products

Starting a baby or kids' brand is exciting, but it also comes with big responsibilities. The U.S. has strict rules to make sure baby products are safe for children. These rules exist because babies and children are more vulnerable to harm, and in the past, unsafe products have caused serious injuries or health issues. Following these regulations protects kids and gives parents confidence in the products they buy. This blog will help you understand what you need to know to create safe, reliable, and legally compliant products for the baby and children’s U.S. market.

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1. Key Baby Products Rules and Certifications You Need to Know

The U.S. Consumer Product Safety Commission (CPSC) is the main organization that ensures children’s products are safe. Their rules set the standard for manufacturers to prevent dangerous or faulty products. Some of the key baby product certifications include:

• Children's Product Certificate (CPC): Every baby product must have a CPC. This certificate is based on lab testing from a CPSC-approved facility and confirms that your product meets safety standards
• ASTM Standards: These are guidelines created by ASTM International for different products. Key standards include:
   
  • ASTM F963 for toys. It ensures toys are free from hazards like sharp edges and small parts
   
  • ASTM F406 for baby cribs and play yards. It checks for stability and prevents collapses
 
• Federal Hazardous Substances Act (FHSA): Ensures that products are free from harmful materials like lead, phthalates, and other toxins
• Flammable Fabrics Act (FFA): Requires that clothing, blankets, and sleepwear meet flammability standards to protect children in case of fires

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NOTE: It’s best to test your baby product during prototyping and then again after manufacturing to ensure it is compliant. Your factory or manufacturing partner should be able to help guide you on this vital step. Make sure testing is planned for to avoid delays at the factory.

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2. When Do FDA Rules Apply?

Some baby and kids’ products fall under the U.S. Food and Drug Administration (FDA) regulations, especially those related to food or medical use. Here are some examples:

• Baby Bottles and Feeding     Products: Must be made from FDA-approved food-grade materials to ensure no harmful chemicals leach into food or drinks
• Pacifiers and Teethers: These must meet FDA and CPSC safety standards to avoid choking hazards and ensure safe materials
• Over-the-Counter Products: Items like diaper cream, baby sunscreen, and teething gels require FDA approval and proper labeling to guide safe use

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NOTE: The FDA does not explicitly“approve” factories. Instead, manufacturers must comply with Good Manufacturing Practices (GMPs) or specific FDA requirements based on the product category. Search for factories that are certified in Current Good Manufacturing Practices (cGMP) and request NSF certifications forfood-contact safety. All food grade plastics, coatings, etc., must comply with 21 CFR 177. Again, your factory or manufacturing partner should be able to consult with you on the best course of action to ensure you are FDA compliant.

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3. Prioritize Safety in Your Baby Products

Safety should always come first when making baby and kids’ products. For instance, in 2020, over 200,000 children were treated in emergency rooms for toy-related injuries. These risks highlight why safety is so important. Here are key steps to follow:

• Use Safe Materials: Choose non-toxic, durable, and allergy-friendly materials. Avoid banned substances like lead, phthalates, or rough surfaces that could harm children
• Rigorous Testing: Test your product for durability, choking hazards, and sharp edges. Babies and toddlers often put items in their mouths, so these tests are essential
• Clear and Informative Labels: Include warnings, age recommendations, and instructions. For example, state if the product is for children ages 3 and up
• Plan for Recalls: Understand how to handle recalls and report safety issues to the CPSC if needed. Being prepared can help you respond quickly and responsibly

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NOTE: Safety labels are required by law on all baby and children’s products in the US. Fines, penalties, or recalls can happen if not compliant.

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4. Materials and Substances to Avoid in Baby Products

Certain materials are banned in children’s products because they can harm kids’ health. For example:

• Lead and Heavy Metals: Lead levels must be below 90 ppm in paint and 100 ppm in other materials, as it can cause serious developmental issues
• Phthalates: These chemicals, often found in plastics, are banned above 0.1% in children’s products due to their impact on hormonal health
• Flame Retardants: Some flame-retardant chemicals are restricted because they can harm children’s long-term health, even though they’re designed to prevent fires

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By avoiding these materials, you can ensure your products are both safe and compliant.

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5. Steps to Get Baby Products Certified

Follow these steps to legally sell your baby and kids’ products in the U.S.:

1. Understand the Regulations: Check CPSC guidelines for your product type to know what tests and certifications are needed
2. Test Your Product: Use a CPSC-approved lab to ensure your product meets all safety standards
3. Register Your Product: If required, register your product with the CPSC and add tracking labels to make it easy to identify
4. Add Proper Labels: Include warnings, age recommendations, and your company’s contact information so consumers can use the product safely

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NOTE: All products for children 12 years old and under must undergo third-party testing by a CPSC-accepted laboratory. To find an accredited CPSC testing lab, search the CPSC's database on their website. Based on the testing results, you can create a CPC certificate, which includes the following information:

·       Product identification

·       Citation of applicable regulations/standards

·       Test results from the accredited lab

·       Manufacturer's contact information

·       Date and location of manufacture

·       Date and location of testing

·       Name and address of the testing laboratory

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Your factory or manufacturing partner can also help you find the right testing facility.

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6. Additional Baby Product Considerations

Here are a few more things to think about as you build your business:

• State-Level Rules: Some states, like California, have extra regulations such as Proposition 65 warnings for specific chemicals. Make sure you’re following rules in every state you sell in
• Eco-Friendly Materials: Many parents prefer sustainable and eco-friendly products. Highlight these features if your materials and packaging meet these standards
• Insurance: Get product liability insurance to protect your business in case of accidents or legal claims

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Final Thoughts - Baby Product Certifications

Making baby and kids’ products for theU.S. market can be incredibly rewarding, but it takes dedication to meet safety and legal standards. staying informed about regulations, testing your products,and prioritizing safety, you can build a successful business that parents and children will love. Always seek expert advice when needed and stay updated on changing rules to stay ahead in this dynamic industry. With a focus on quality,safety, and sustainability, you’ll be on the path to long-term success.

Citations:

·  U.S. Consumer Product SafetyCommission (CPSC) - https://www.cpsc.gov
Information about children's product certifications, safety standards, andrecalls.

·  ASTM International - https://www.astm.org
Details on ASTM F963 (toy safety) and other standards for children’s products.

·  U.S. Food and Drug Administration(FDA) - https://www.fda.gov
Guidance on FDA regulations for baby bottles, pacifiers, and over-the-counterbaby products.

·  Federal Hazardous Substances Act(FHSA) -https://www.cpsc.gov/Business--Manufacturing/Business-Education/Federal-Hazardous-Substances-Act-FHSA
Explanation of hazardous substances rules for children’s products.

·  Flammable Fabrics Act (FFA)-https://www.cpsc.gov/Business--Manufacturing/Business-Education/Flammable-Fabrics-Act-FFA
Details on flammability requirements for clothing and textiles.

·  Proposition 65 - California Office ofEnvironmental Health Hazard Assessment (OEHHA) -https://oehha.ca.gov/proposition-65
Information about state-level chemical warnings and requirements.

·  National Electronic InjurySurveillance System (NEISS) -https://www.cpsc.gov/Research--Statistics/NEISS-Injury-Data
Statistics on injuries related to children’s products, such as toys.

·  Environmental Protection Agency (EPA)- https://www.epa.gov
Rules on hazardous materials like lead and phthalates in consumer products.

·  Small Business Administration (SBA)- https://www.sba.gov
Guidance on insurance, branding, and compliance for small businesses.

·  Safe Kids Worldwide - https://www.safekids.org
Educational resources on child safety and injury prevention.

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