Does silicone used in sex toys in the US require FDA certification?
In the US, whether silicone used in sex toys requires FDA certification depends on the specific use scenario and contact method of the product. The core criteria are FDA regulatory requirements for "materials in contact with the human body":
1. Circumstances requiring compliance with relevant FDA standards
If the silicone portion of a sex toy comes into direct contact with human mucous membranes (such as the vagina or rectum), or comes into contact with the skin for extended periods (over 30 days), it must comply with FDA safety standards for "medical-grade/human-contact materials." Specifically, these standards include:
Material safety: Silicone must be FDA certified as "food contact grade" (FDA 21 CFR Part 177) or "medical grade" (such as FDA Class I/II medical device standards), demonstrating:
Non-toxic, non-irritating, and non-sensitizing;
Does not release harmful chemicals (such as heavy metals, plasticizers, residual monomers, etc.);
Strong chemical stability, ensuring it does not decompose after contact with human secretions or lubricants.
Manufacturing Compliance: The manufacturing process must comply with FDA's Good Manufacturing Practice (GMP) regulations to ensure material purity and consistency.
