More FDA regulations of cosmetics will not make them safer


As a dermatologist, I know countless people with sensitive skin. I see it every day. Some patients come to me with mild skin irritations and others with very debilitating symptoms. For patients with sensitive skin or with a low tolerance to allergens I tell them all to keep their skincare simple.

However, many patients come into my office perplexed by cosmetic products that over promise and make unfounded claims. Sorting through rows of overcrowded moisturizer shelves is overwhelming, and too many people have a hard time finding gentle skincare products that work for them. Every new trend, like the all-natural revolution, adds to the confusion.

{mosads}Many dermatologists struggle with advising patients who want to do something more for their skin but struggle to make sense of marketing claims such as “fragrance-free” and “hypoallergenic” which don’t always mean what consumers think they mean. 


Many of my colleagues are calling for Congress to address the hyperbolic claims of these cosmetics. In a recent NPR article, referencing a recent JAMA Dermatology article, some of my colleagues expressed frustration about misleading labeling that makes evaluating the safety and efficacy of cosmetic moisturizers harder. They expressed general support for Congress and the FDA to act. However, more rules will not make cosmetic labelling less confusing.

Efficacy standards should be reserved for drugs that make treatment claims, not cosmetic products. The Food Drug and Cosmetic Act, in addition to multiple regulations, prevents cosmetic manufacturers from making treatment claims. For that reason, cosmetic moisturizers do not actually claim to do much of anything. Terms like “dermatologist approved,” “organic,” “natural” and others do not suggest that a product can do anything.

Safety, on the other hand, needs to be proven and, currently, safety standards for cosmetic products are high. Products go through multiple tests, including patch testing, to satisfy legal and industry standards of practice.

The Personal Care Products Council already has developed a comprehensive vetting process for ingredients used in cosmetic products. The Personal Care Products Council, North American Contact Dermatitis Group, and the American Contact Dermatitis Society already provide information and guidance for people with hypersensitive skin.

The Contact Dermatitis Society keeps track of chemicals in personal care products and other items that can cause rashes for people with sensitive skin. Sometimes a rash could be due to an allergy (like you might see with poison ivy) and at other times it could be due to irritation (like you might see with bleach). American Contact Dermatitis Society names allergens of the year and has lists of top chemicals that cause allergy.

Anyone can be allergic to anything. So yes, labeling a product hypoallergenic can be misleading. However, it’s hard to see how a regulatory definition of the term “hypoallergenic” would solve this problem. The FDA could adopt a standard that “hypoallergenic” products do not contain any of the top 50 allergens identified by the American Contact Dermatitis Society. However, the list will likely change from year to year, making it difficult for manufacturers to keep up.

However, even with these standards there can be no guarantee that someone will not become allergic to or irritated by an approved ingredient in the product. Common allergens are not comprehensive.

Many allergies are uncovered on a case by case basis. It’s the reason patients consult with physicians to determine their allergies and then work with them to understand how to avoid contact. The same way people with food allergies learn to interpret food labels, people with contact allergies need to learn to interpret cosmetic labels and avoid certain ingredients.

Similar issues confront the term “fragrance free.” What many people don’t realize is that “fragrance-free” isn’t fragrance-free. A truly fragrance-free product would probably smell “medicinal,” “industrial,” or, simply put, bad. Which, by the way, is still a fragrance. So, products that advertise themselves as “fragrance-free” mostly utilize what we call masking fragrances. These are neutral, inoffensive scents that mask off-putting smells.

Masking fragrances are necessary to balance the natural odors of standard ingredients in personal care products. This concept is not generally known to consumers, but it’s essential to making a pleasant product. It’s like how a spoonful of sugar helps the medicine go down. Insisting that fragrance-free products contain no masking fragrances isn’t entirely practical.

However, fragrances that are added as a scent should be labelled “scented.” A product that is scent neutral should be labeled unscented even if masking fragrances are present. Many products already use better terms such as “scented” and “unscented” to describe their products.

The cosmetic industry already has standards that help consumers understand what they are buying. These standards were made to help people evaluate a product’s risks prior to purchasing it. I do not think that additional rules through the FDA or Congress will add any benefit to consumers. To the extent that additional standards are necessary, the guidance of professional associations such as the Personal Care Products Council would be more beneficial.

Janet H. Prystowsky MD, Ph.D is a dermatologist from New York City. She has conducted NIH laboratory based skin research and has participated in numerous clinical research trials. She is currently an Associate Clinical Professor at Mount Sinai in New York City. She volunteers by teaching at their Cosmetic Dermatology Resident Clinic.

Tags Cosmetics FDA

The Hill has removed its comment section, as there are many other forums for readers to participate in the conversation. We invite you to join the discussion on Facebook and Twitter.

More Healthcare News

See All
See all Hill.TV See all Video

Most Popular

Load more


See all Video