On July 26, 2016, FDA issued an updated warning on beauty products, warning consumers to avoid certain “skin creams, beauty and antiseptic soaps, and lotions,” particularly those boasting “anti-aging” or “skin lightening” benefits, as potentially containing mercury. While the dangers of mercury exposure are well-known, mercury’s ubiquity in certain beauty products is not. Products that claim to “remove age spots, freckles, blemishes, and wrinkles,” including products targeting teenagers enduring acne, may contain mercury. Checking the label can help—look out for words like “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or of course, “mercury”, but it’s not fool-proof. As FDA points out, many of these beauty products are often made abroad and can be sold illegally in the U.S., without any labels. FDA continually monitors products like these, but is unable to catch all of them, especially due to their dubious channels of trade. For those that FDA does catch, FDA sets up an import alert to prevent future influxes of such products. Check here for all Consumer Updates from FDA. Thus, retailers should do their due diligence to know what the chemical content is of the products they sell beyond the labels.
In its warning, FDA again mentioned one of its growing complaints levied against cosmetics – that the product may actually be an unapproved new drug under the law.
There are important differences in the laws and regulations governing cosmetics and drugs — cosmetic products generally do not require FDA approval before they go on the market, whereas drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process, or conform to a monograph for that drug’s category. Whether a product is considered to be a cosmetic or a drug is determined by the product’s intended use.
FDA has increased its regulatory scrutiny in this area, and is finding an increased number of both (1) marketing a cosmetic with a drug claim, and (2) marketing a drug as if it were a cosmetic, without adhering to requirements for drugs. Because the regulatory scheme for cosmetics and drugs is so different and under increased scrutiny, manufacturers must be mindful of the claims being made on their products and ensure they match the intended use.