Who is responsible for substantiating the safety of cosmetics?
Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients. The law also does not require cosmetic companies to share their safety information with FDA (1).
Most consumers assume that the FDA regulates skincare products the same way it does drugs...It does not. The FDA must approve all drugs before they go to the marketplace. This involves short- and long-term testing on animals, then people, to make sure the drug is not toxic and has no long-term side-effects. The FDA assumes responsibility for drug safety. So, to develop, test and sell a drug is a long, drawn-out, prohibitively expensive process, but concocting and peddling cosmetics is fast, cheap and lucrative, as there are no hard guidelines, real science, or critical FDA review, because the FDA only minimally monitors and reactively regulates cosmetics, "Companies and individuals who market cosmetics have a legal responsibility to ensure that their products and ingredients are safe for the intended use." That's it... But...
Skincare products can be both cosmetics and drugs. For example, a serum with SPF protection has to comply with the FDA requirements for both cosmetics and drugs, but, more often than you would assume and believe, cosmetics contain chemicals that act as drugs, but are not approved and circumvent any regulation by the FDA.
For instance, a cosmetics company that violates the FDA laws merely is sent a warning letter and asked only to fix the violations. So, most companies do not change the ingredients in the product, just the words used to describe and market the product. For example, an ingredient in Peter Thomas Roth MegaRich™ Intensive AntiAging Cellular Eye Crème was described as, "Tetrapeptide and Oligopeptide - Peptides that work synergistically to help promote collagen production while helping to stimulate fibroblast cells in the skin," which is fairly accurate. But, according to the FD&C Act, this makes the product a drug because it is intended to change your body structure and function. After receiving a warning letter from the FDA, the description was replaced by, "Tetrapeptide & Oligopeptide - peptides that work synergistically to help improve the look of skin firmness while helping to reduce the appearance of wrinkles." Same ingredients, same product; less precise language raising hopes and revealing intent.
The product has the same effect on your skin cells and health. Except, now you are led and expected to believe that these same ingredients somehow are benign and not intended to change your body structure and function.
Skincare products like these are not benign; these so-called cosmetics are specifically intended to alter your body structure and function...