Fitness Product Regulations in the United States: An Overview

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Fitness Products Regulations in the US

Gym and fitness products imported and sold in the United States are subject to various product regulations. In this guide, we cover what you must know about FDA rules, ASTM standards, labeling requirements, lab testing, and certification when selling fitness products in the USA.

Mentioned Products

  • Yoga mats
  • Foam rollers
  • Indoor cycles
  • Dumbbells
  • Weight sets
  • Gym machines
  • Children’s exercise equipment

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Note: This article does not cover electrical or electronic fitness equipment. Click here to learn more about electronic product safety standards in the United States.

21 CFR 890 (FDA)

21 CFR 890 regulates exercise equipment imported and sold in the United States that is intended for medical purposes, with either non-measuring or measuring functionalities. Note that non-measuring exercise equipment is defined as a device that doesn’t have any without measuring instrumentation (e.g. pulse rate monitors).

For fitness equipment that can also be used for medical restoration, importers shall comply with 21 CFR 890 if they are planning to import to the United States.

Note that the FDA does not cover exercise equipment intended to use for the development of athletic abilities or general physical conditioning. You can verify whether your products are covered by the FDA in this guidance document.

Non-measuring equipment classification

FDA has classified non-measuring exercise equipment into 4 categories:

1. IOE 890.5370 – Parallel bars

2. KNL 890.5370 – Prone scooter board

3. ION 890.5370 – Exerciser table

4. IOG 890.5370 – Mechanical treadmill

Importers can identify their product category under the guidance of 21 CFR 890, and ensure all other relevant regulatory requirements.

Premarketing notification

FDA has exempted almost all non-measuring exercise equipment from premarket notifications and FDA clearance requirements. However, importers or manufacturers are still required to register their establishment.

The establishment process is known as Title 21 CFR Part 807. All registration and listing information must be submitted electronically. You can learn more about the registration procedure on the FDA website.

GMP requirements

Non-measuring fitness equipment is also exempted from the GMP regulation. However, importers still need to comply with the records and compliant files requirement stated under GMP.

Record requirement: Fitness products’ production, control, and distribution records should be retained for at least 1 year.

Compliant files requirement: All relevant compliance documents must be signed, approved and dated by authorized organizations.

Lab testing requirements

If you are not sure about the lab testing required for your medical fitness product, we suggest that you should contact reputable testing companies such as Intertek, SGS, and TUV.

Testing companies provide compliance services including conformity assessment, lab testing, certification, and other applicable services for your product.

Children’s Fitness Products: CPSIA

Fitness products and other exercise equipment intended for children aged 12 years or younger are subject to the CPSIA. Here’s a summary of the CPSIA requirements:

Note that the CPSIA doesn’t replace other product safety standards and labeling requirements in this article.

ASTM Standards

The American Society for Testing and Materials (ASTM) provides standards and test methods for many products including fitness equipment. ASTM standards are often voluntary, although sometimes compliance with the is required by a specific regulation. Here are some standards that apply to fitness products:

  • ASTM F1081-09 – Standard specification for competition wrestling mats
  • ASTM F2115-18 – Standard specification for motorized treadmills
  • ASTM F3023-18 – Standard test method for upper and total body ergometers
  • ASTM F2216-17a – Standard specification for selectorized strength equipment
  • ASTM F2810-15 – Standard specification for elliptical trainers
  • ASTM F2440-18 – Standard Specification for Indoor Wall/Feature Padding

Learn more

You can find more standards for product evaluation, testing, and use of the equipment here.

Risks

Gym equipment and other fitness products manufactured outside the United States are not exclusively designed to comply with ASTM and other standards. We recommend that you only work with overseas manufacturers that can provide existing test reports for their products.

California Proposition 65

CA prop 65 regulates all consumer products imported and sold in California. CA Prop 65 set limits to certain hazardous substances used in products such as heavy metal and chemical. As such, if you are planning to import or sell fitness products in California, you shall comply with CA Prop 65 requirement before importation.

Examples of restricted substances

  • Lead
  • Cadmium
  • Bisphenol A (BPA)
  • Mercury
  • Nickel

California Proposition 65 Lab testing

Third-party lab testing is the only possible way to verify whether your fitness equipment is compliant if your supplier cannot provide CA Prop 65 test report. We recommend importers shall instruct their supplier about the CA Prop 65 compliant, and book lab testing before mass production.

Testing costs

The CA Prop 65 lab testing cost around $200 to $300 depends on the number of the tested material. The cost could increase to a thousand dollars depends on product types.

Testing companies

CA prop 65 lab testing can also help with conformity assessment or certification service, here you can learn more.

Warning Labeling

Products containing an excessive amount of restricted substances must be attached with a warning label, otherwise, it’s illegal to import or sell in California.

Risks

Some materials used when manufacturing fitness products and other exercise equipment contain excessive amounts of substances regulated by California Proposition 65. Here are a few risk scenarios:

  • Gym machine coatings containing excessive amounts of heavy metals
  • EVA foam rollers containing excessive amounts of phthalates
  • Dumbbell PVC covers containing excessive amounts of phthalates

Country of Origin

The Federal Trade Commission (FTC) requires that all imported products must carry a country of origin label on the product and its packaging. For fitness products, the Country of Origin label must be permanently and visibly attached to the products.

Examples

  • Made in China
  • Made in Vietnam
  • Made in Germany
  • Made in France

Label file

Do not expect that your supplier will create a Country of Origin label for your fitness product. Instead, importers shall self-create a label file in .ai or .esp format, then submit to their supplier with placement information.

Product Packaging

Last but not least, importers shall also make sure to properly pack their fitness equipment according to the packaging requirement in the United States. Here is an overview of the packaging requirements for fitness products.

Heavy Metals Restrictions

Heavy metals are the most concern material used in product packaging. The US government sets limits to certain hazardous heavy metals such as lead, chrome, cadmium, and mercury.

The use of restricted heavy metals must be maintained at an acceptable level. With that said, importers shall book a third-party packaging testing companies to verify the compliance.

Labeling Requirements

All compliance marks shall be presented on the product packaging as well. The label must be visibly and permanently printed on the packaging.

Additional Resources

1. States with Toxics in Packaging Laws (Link)

  • (USA & EU)

    We Help Brands & Importers With Product Compliance (US & EU)

    • Product Requirements Lists
    • Product Certification
    • Product & Packaging Labeling
    • Lab Testing

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    Disclaimer: The content on this website is provided for general information only. The content includes summaries written by our team members based on publicly available information about product safety standards, labeling, documentation, testing, processes, and other product compliance related topics. However, we don’t guarantee that we cover every single relevant regulation/standard/requirement, or that the information is free from errors, or covering every single scenario and exemption. We do make mistakes from time to time. We never provide legal advice of any sort.

    Changes/Updates: Product standards and substance restrictions are subject to frequent updates and changes. In addition, new regulations, standards, and/or requirements may also become effective at any time. We don’t update our articles whenever new standards/regulations/rules are added or changed. We recommend that you consult a lab testing company or other professional to get the latest information about mandatory standards/regulations in your market, country, or state. Lab testing companies generally stay up to date on new and updated standards and regulations.

    National/State-Level Standards/Regulations: Many articles don't cover all European national and US state standards, regulations, and requirements. We recommend that you consult a testing company or other professional to confirm all relevant (and current) national/state level standards and regulations.
  • 1 Responses to “Fitness Product Regulations in the United States: An Overview

    1. Eloy at 9:46 pm

      Thanks for the information, it is very useful. I would like to ask you if you know if the regulation makes distinctions about products for domestic use and products for public use (for example a gym) and how it would be reflected in the requirements. Thanks a lot.

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