Dermatologists Call for Regulation of Direct-to-Consumer Skin-Lightening Products

By Carolyn Crist

December 29, 2020

NEW YORK (Reuters Health) - Direct-to-consumer cosmetic products that lighten or bleach the skin pose a major public-health concern and should be regulated, a group of dermatologists says.

These products may contain toxic levels of ingredients and cause adverse effects, which are sometimes irreversible, they write in the Journal of the American Academy of Dermatology.

"Many people may be surprised to learn that companies that produce direct-to-consumer cosmetic products, which includes skin-lightening agents, do not have to demonstrate any degree of product safety," said senior author Dr. Harrison Nguyen of the Emory University School of Medicine in Atlanta, Georgia.

"Packaging labels are often misleading, which makes it challenging for the consumer to understand potential risks of using a cosmetic product," he told Reuters Health by email.

Dr. Nguyen and colleagues discuss the products and the need to implement some form of regulation. The popularity of skin-lightening cosmetics has grown in recent years, they note, and although dermatologists can prescribe specific products to treat hyperpigmentation disorders, many products are available to consumers without regulatory oversight or medical supervision.

A large number of these products contain toxic levels of mercury, which can damage the nervous system and kidneys, according to the authors.

Patients have reported numerous adverse effects, the team adds, including bluish-black skin pigmentation, inflammation, a change in skin elasticity, acne, sunburn, excessive hair growth and fragile skin. Some of the effects can't be reversed.

Unlike prescription and over-the-counter drugs, direct-to-consumer cosmetic products and ingredients aren't reviewed or approved before going to market. The U.S. Food and Drug Administration (FDA) has purview over medications, medical devices and food, but cosmetic companies aren't required to report adverse events from their products.

Even when a safety issue is found, the FDA doesn't have the authority to recall the product. Some states have attempted to address unregulated cosmetic ingredients, but their reach is often limited. Federal regulation of domestic and imported cosmetics could have a broader impact, the authors write.

"Federal regulation, such as expanding the FDA's authority, is needed in order to hold cosmetic companies to a basic standard of safety," Dr. Nguyen said.

Two pieces of legislation have introduced this idea - the Personal Care Products Safety Act, or Senate Bill 726, and the Cosmetic Safety Enhancement Act, or House Resolution 5279.

Both bills would require manufacturing facilities to be registered and follow adequate manufacturing practices, mandate companies to submit cosmetic-ingredient statements to the FDA and make them public for consumers, implement a system for tracking and reporting serious adverse events, and allow the FDA to assess ingredient safety and issue mandatory recalls. Both have been referred to Congressional committees but haven't advanced since early this year.

"Interestingly, many of the largest cosmetic manufacturers, including Johnson and Johnson, Estee Lauder, and Procter and Gamble, have supported establishing minimum safety standards for the industry and have backed changes in federal regulation," Dr. Nguyen said.

Beyond federal regulation, dermatologists should speak with their patients about the potential harms of using direct-to-consumer skin-lightening products, the authors write, particularly among Sub-Saharan African, Hispanic and East Asian communities where the products have been most popular.

In addition, dermatologists should discuss skin-lightening product types and frequency with their patients who have hyperpigmentation but also report hypopigmentation or contact dermatitis.

"In a city like Montreal, many of the products advertised for their skin-lightening properties are sold in small stores and have been imported from abroad," said Dr. Marc Amyot of the University of Montreal. Dr. Amyot, who wasn't involved with the new paper, has researched ingredients in skin-lightening products in West Africa and Canada.

In previous studies, he and his scolleagues found that the majority of skin-lightening creams and soaps exceeded regulatory guidelines for at least one active ingredient. Labels often misstated the concentration of ingredients, particularly for mercury and hydroquinone, a skin-bleaching agent.

"Individuals regularly using these products can develop a series of skin disorders, but in more severe cases, there may be kidney and central nervous system disorders," he told Reuters Health by email. "It is important to better regulate these products and inform the users about the risks of using them."

SOURCE: https://bit.ly/2Ki2SJY Journal of the American Academy of Dermatology, online December 6, 2020.

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