Vibrators containing lithium batteries, plastics containing potentially harmful chemicals, and designs that may or may not be mechanically safe. Sex toys can pose serious safety risks, which in turn requires manufacturers and importers to take steps to ensure that their products are safe and compliant.
In this guide, we explain what brands must know about sex toy safety standards, substance regulations, labeling, and lab testing requirements in the United States.
Content Overview
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ISO 3533 – Sex toys – Design and safety requirements for products in direct contact with genitalia, the anus, or both
ISO 3533 is the first international standard for sex toys in the world. ISO 3533 was published in 2021 and covers the design and safety requirements for sex toys that are designed to come in direct contact with the genitalia, the anus, or both.
ISO 3533 covers specifications such as design, materials, components, and user instructions for sex toys. It doesn’t products that are classified as medical devices or assistive products, including lubricants and massage oil.
Product scope
ISO 3533 specifies the safety standards and requirements for sex toys that are used for sexual stimulation or to enhance sexual pleasure. This standard covers sex toys that are designed to be in direct contact with the genitals and or the anus.
ISO 3533 does not cover items that are classified as medical devices or assistive products. Examples of such products are:
- Lubricants
- Massage oil
- Intimate sprays
Electrical safety requirements
ISO 3533 sets out electrical safety requirements for sex toys that fall under the scope of this standard. Importers and manufacturers of sex toys should take into account the electrical safety of the product and its batteries or charger (if any), during the usage and charging conditions.
Mechanical safety requirements
The standard also sets out the mechanical safety requirements for sex toys, which concern aspects such as the following:
- Prevention of retention
- Products for genital enclosure
- Moving parts
- Removable components
According to the standard, importers and manufacturers should design their products ensuring that they won’t harm the users in foreseeable or unforeseeable ways, from the perspective of product design, dimensions, and materials.
Labeling requirements
ISO 3533 states that the product or packaging for sex toys should contain information such as the following:
- Product information
- Product identity (e.g. SKU, lot number)
- Intended usage
- Information about the battery or charger (if applicable)
- Overview of the product’s parts and accessories
- User instructions
CPSC Standards
The United States Consumer Product Safety Commission (CPSC) is an independent agency of the US government, overseeing the safety of consumer products. It develops and enforces safety standards in the United States. It also conducts research related to hazards and risks to the public caused by consumer products.
The CPSC has not yet developed a specific safety standard for sex toys. However, importers and manufacturers are required to report to the CPSC if their product could create a substantial risk of injury to the public, for example, because of a manufacturing defect or a design issue.
In practice, an unsafe sex toy is subject to a recall, regardless of whether it is covered by mandatory safety standards. Hence, importers or manufacturers of sex toys should ensure that their products are safe, for instance by complying with relevant voluntary safety standards.
This is the case regardless of whether mandatory standards exist or not. Product safety always comes first.
Safety standards
Even if there are no specific CPSC safety rules or mandatory standards that apply specifically to sex toys, importers or manufacturers can refer to safety standards concerning aspects such as the chemical, electrical, and mechanical safety of the products, such as:
- ISO 3533 – Sex toys
- UL safety standards (e.g. electrical or battery safety standards)
- ASTM standards (e.g. ASTM F963 for sharp edges)
- 16 CFR Part 1303 – Ban Of Lead-Containing Paint and Similar Surface Coatings
UL Safety Standards
Underwriters Laboratories (UL) is a multinational corporation that develops safety standards for products, components, and materials. Some of their standards can be applied to electronic sex toys – such as battery-powered vibrators.
Importers or manufacturers of sex toys can use voluntary UL standards to ensure the safety of their products, especially when it comes down to electronic and electrical products and components.
Electrical safety standards
Below are examples of UL standards that concern the electrical safety of products. Importers or manufacturers may refer to these standards for their electronic sex toys (if applicable):
a. UL 62368-1 Audio/Video, Information and Communication Technology Equipment – Part 1: Safety Requirements
b. UL 60335-1 Safety of Household and Similar Appliances, Part 1: General Requirements
Batteries safety standards
Below are examples of UL standards that concern the safety of batteries. These standards may be applied to sex toys that are operated by batteries:
a. UL 1642 – Lithium Batteries
b. UL 2054 – Household and Commercial Batteries
Flammability safety standards
UL also develops flammability standards for devices components, such as:
a. UL 94 – Tests for Flammability of Plastic Materials for Parts in Devices and Appliances
FCC Part 15
FCC Part 15 sets limitations on the amount of electromagnetic interference emitted by electronic devices. It regulates electronic and electrical devices that operate in the radio frequency range of 9 kHz to 3000 GHz.
Hence, FCC Part 15 can be applied to electronic sex toys.
Devices Classification
The FCC mainly classifies electronic devices into two categories:
a. Unintentional radiators, that is devices that generate electrical signals within the product but are not designed to emit radiofrequency energy by radiation or induction
b. Intentional radiators, that is devices that generate and emit radiofrequency energy by radiation or induction
Importers and manufacturers of electronic sex toys should comply with the specific FCC requirements in accordance with the categories of their products.
Requirements
In this section, we briefly introduce the requirements for unintentional radiators and intentional radiators.
Unintentional radiators
Sex toys that are categorized as unintentional radiators, such as vibrators that don’t have any wireless or Bluetooth feature, should comply with FCC’s requirements on unintentional radiators, including:
- Supplier Declaration of Conformity (SDoC)
- Traceability label
- Compliance statement
- Test report
Intentional radiators
Sex toys that are categorized as intentional radiators, such as items that are operated with Wi-Fi or Bluetooth, should comply with FCC’s requirements on intentional radiators, including:
- Certification (granted by an FCC-recognized telecommunication certification body)
- Traceability label (including FCC ID)
- Compliance statement
- Test report
ANSI Standards
The FCC Knowledge Database provides guidance and examples of testing standards for electronic devices, including:
a. ANSI C63.4 Methods Of Measurement Of Radio-Noise Emissions From Low-Voltage Electrical And Electronic Equipment In The Range Of 9 KHz To 40 GHz (for unintentional radiators)
b. ANSI 64.5 Unlicensed Wireless Devices Compliance Testing (for intentional radiators)
Importers and manufacturers of electronic sex toys can refer to ANSI standards to demonstrate compliance with FCC requirements.
FDA (CFR Title 21)
If your products are designed to be in contact with the genital parts for therapeutic purposes, they might be regulated as medical devices by the FDA. Examples of such products include:
- Kegel balls (used to tighten the muscles of the pelvic floor and improve incontinence)
- Genital vibrators (use in the treatment of sexual dysfunction)
Personal lubricants are also classified as medical devices by the FDA as they are used to enhance the comfort of intimate sexual activity and supplement the body’s natural lubrication.
Devices classification
The FDA classifies medical devices into three classes:
- Class I (low to medium risk): subject to General Controls
- Class II (medium to high risk): subject to General Controls and Special Controls
- Class III (high risk): subject to General Controls and Premarket Approval (PMA)
Importers and manufacturers of lubricants, vibrators, and other products that might fall under FDA regulations should contact a testing company or consultant to confirm whether their products are classified as medical devices.
Requirements
FDA’s requirements for medical devices might include:
- 510(k) submission
- Labeling
- Good Manufacturing Practices (GMP)
- Device registration and listing
- Notification and repair, replacement, and refund
- Records and reports
California Proposition 65
California Proposition 65 prohibits the use of excessive toxic chemicals in consumer products without using the appropriate warnings, in the state of California. The proposition covers most consumer products, including sex toys.
Substance restrictions
California Proposition 65 regulates chemicals that are naturally existing or intentionally added to the products and that can cause health problems to humans. Below are examples of materials that might be found in sex toys, and that might contain substances that are restricted by California Proposition 65:
- Silicone, which might contain phthalates
- Plastic, which might contain phthalates
- Metal, which might contain lead, cadmium, or chromium
Warning requirements
California Proposition 65 requires importers or manufacturers to place warning labels on the products if they contain an excessive amount of restricted chemicals5. The label is to notify consumers that such products contain, or might contain, carcinogens or toxins to human reproductive systems.
California Proposition 65’s warning requirements include:
- Label format and content
- Warning symbol and text
- Warning statement
Lab Testing
Lab testing is necessary for verifying that a certain sex toy is safe and fully compliant. The testing protocol depends on the product type, but can cover the following:
- Battery safety testing
- Mechanical safety testing
- Chemicals and heavy metals testing
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