Our Passion Natural Water-Based Lubricant formula was designed and manufactured in our facilities in the U.S. while strictly following all FDA guidelines to create a gentle body, toy, and condom-safe lubricant you and your partners can enjoy. This long-lasting lubricant has been 510(k) (K152628) cleared and accepted by the FDA. We continue to ensure our Passion Natural Water-Based Lubricant's quality is of the highest standard by continuously testing that our formula contains nothing but premium ingredients.