What Testing Does the FDA Require for FDA Cleared Fertility Lubricants?

Did you know that the FDA considers sex lubricants to be medical devices? In fact, the US FDA even has a special category of medical devices, known as the PEB category, for lubricants designed to be used by couples when they are trying to get pregnant. The lubricants in this special PEB category are tested extensively prior to FDA clearance to ensure that they are safe for sperm, eggs and embryos. And, once these products are on the market, manufacturers of these FDA-cleared fertility-friendly lubricants are required to confirm that each batch of product does not harm sperm or egg function.

• FDA cleared fertility lubricants are specifically tested to ensure that the lubricant:
• is pH neutral (pH 7) and isosmotic/isotonic (e.g. 300 mOsmo/kg) with fertile cervical mucus and semen to prevent shock and damage to sperm and eggs.
• won’t interfere with human sperm motility, survival, or integrity.
• is the correct viscosity to allow sperm to swim into and through the lubricant.
• won’t interfere with embryo development.
• is safe to use for in vitro fertilization and other fertility interventions.
• is screened, both at time of production and throughout the shelf life of the lubricant, for endotoxins, which are toxins produced by bacteria that can harm sperm and egg function even at relatively low levels

When you are trying to conceive, the only sure way to know that your lubricant won’t harm sperm is to choose an FDA-cleared fertility lubricant. We all know that reading labels and marketing information is confusing, so use this guide to avoid common mistakes when selecting a fertility-friendly lubricant:

1) Avoid lubricants with very low pH levels (~pH 3), very high osmolality (>3,000 mOsm/kg), and/or the products that contain small penetrating chemicals (for example, glycerol)
2) Avoid confusing a lubricant labelled as non-spermicidal with an FDA-cleared fertility lubricant
3) Avoid lubricants that are labelled as organic or natural but are not FDA-cleared as fertility lubricants, as only the FDA-cleared lubricants are required to undergo testing that shows the product won’t harm sperm or eggs
4) Avoid using household oils, as household oils often contain toxic peroxides and inflammatory chemicals that develop over time due to exposure to light, room temperature, and the purity of the oil.

Bottom line, identifying that a lubricant is FDA cleared for fertility (PEB category) is a sure way to know if that lubricant is safe to use when you are trying to conceive.