Knowing the safety of your cosmetic ingredients is critical to your compliance program and can help you avoid FDA enforcement as well as potential litigation. Our ingredient review will compare your ingredients against FDA-recognized database for cosmetic ingredients, colors, and fragrances. We will also compare your ingredients against the California Safe Cosmetics Program, which identifies ingredients that must be recorded with California as well as ingredients that may create product liability under California’s notorious Proposition 65.

Cosmetic product manufacturers are responsible to substantiate the safety of all their cosmetic ingredients, as well as the finished product. FDA considers safety substantiated when experts in the relevant field would conclude that the product is safe for its intended use. This conclusion should be based on toxicological data, chemical composition, and other pertinent information.

FDA recognizes the findings of certain expert cosmetic ingredient databases as substantiation of the safety of cosmetic and fragrance ingredients. This enables cosmetic companies to rely on these FDA-recognized databases to determine the safety of their ingredients.

California Prop 65 and California Safe Cosmetics Companies that sell cosmetics into California must check their ingredients against the state list of reportable ingredients. If your product contains a reportable ingredient, then you must report the product to the State of California.

More importantly, many of the reportable ingredients are also Prop 65 ingredients. Any product sold in the State of California that exposes consumers to ingredients that cause cancer, or reproductive (as listed under Prop 65) harm must label their products with warnings disclosing the unsafe ingredient and the kind of harm(s) it represents to the consumer. What makes Prop 65 dangerous to your company is the fact that California allows private parties and the State to sue companies that fail to include a required warning. This leads to frequent litigation, often for quite large settlements. And this liability can attach even for companies that did not intend for their products to end up in California. This is why it is important to have your ingredients reviewed prior to going to market.