The U.S. cosmetics industry, the largest in the world, is expected to reach $62 billion in revenues in 2016. Yet, despite the fact that its products are regularly applied to, and absorbed by, the body’s largest organ (the skin) and even ingested in small amounts, the cosmetics industry is largely self-regulating.
There are over 57,000 different chemicals used in cosmetics. According to one research report, on average, women use 12 personal care products every day, exposing themselves to 168 chemical ingredients. Men use about half that, but still expose themselves to 85 unique chemicals a day. Many of these may be perfectly safe, we just don’t know which ones because most have not been tested for safety.
Increasing concerns about everything from contact dermatitis to carcinogens led Senators Dianne Feinstein (D-California) and Susan Collins (R-Maine) to introduce the Personal Care Products Safety Act, giving the FDA greater regulatory oversight of the cosmetics industry. The Senate Committee on Health, Education, Labor & Pensions held a hearing, “Exploring Current Practices in Cosmetic Development & Safety” last Thursday. A similar bill has been introduced in the House of Representatives. At least one other House bill was introduced in 2013 attempting to strengthen FDA regulatory authority over cosmetics, but it went nowhere.
Cosmetics are regulated under the Food, Drug and Cosmetics Act in pretty much the same manner as when the Act was originally passed in 1938. A “cosmetic” is defined by its intended use:
articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.
This covers a wide range of consumer products: skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, shampoos, permanent waves, hair colors, and deodorants, but, interestingly, not soap. If a product makes therapeutic claims, it can also be classified as a drug. So, from a regulatory standpoint, your dandruff shampoo isn’t soap, but it is both a cosmetic and a drug. It is not, however, a “cosmeceutical,” a fictional category made up by the cosmetics industry.
The FDA’s light-handed regulation of cosmetics bears a striking resemblance to its minimal regulation of dietary supplements, although you can’t blame the FDA for either. The fault lies with Congress and only Congress can remedy the situation.
- There is no required premarket testing for safety or efficacy. The FDA relies on the industry to assure that its products are safe and effective.
- The FDA can act to remove a product from the market only if it is “adulterated” or “misbranded.” “Adulteration” generally refers to the product’s containing poisons are other deleterious substances and it’s being produced under unsanitary conditions. “Misbranded” covers violations involving improperly labeled or deceptively packaged products.
- Ingredients must be listed and only a handful of ingredients are prohibited.
- No warnings or directions for use are required unless failure to include them would render the product improperly labeled, except in a few circumstances where specific warnings are required on some products. In fact, the warning requirements for cosmetics are more stringent than those for dietary supplements.
- The FDA does inspect cosmetic manufacturing facilities, but companies are not required to register with the FDA. (Dietary supplement companies are now required to register, although the response has been poor.)
- Companies making therapeutic claims for cosmetics without going through the OTC or prescription drug approval process can be prosecuted by the FDA. (One cannot help but note that the majority of companies receiving FDA Warning Letters for making illegal drug claims are promoting “natural” products.)
Personal Care Products Safety Act improvements
According to Sen. Feinstein’s summary, the Personal Care Products Safety Act would strengthen regulation of the cosmetics industry in several ways:
- Provide the FDA the authority to order recalls of certain personal care products that threaten consumer safety.
- Provide the FDA the authority to require labeling of products that include ingredients not appropriate for children and those that should be professionally administered. Complete label information, including ingredients and product warnings, would also be required to be posted online since approximately 40 percent of personal care products are purchased over the Internet.
- Require companies to provide contact information on their products for consumers and report serious adverse events to the FDA within 15 days, including death, hospitalization and disfigurement. Health effects that could have resulted in hospitalization without early intervention would also be required to be reported.
- Require manufacturers to register annually with the FDA and provide the agency with information on the ingredients used in their personal care products.
- Direct the FDA to issue regulations on Good Manufacturing Practices for personal care products.
The Act would also require the FDA to evaluate a minimum of five ingredients per year to determine their safety and appropriate use. According to Sen. Feinstein,
the review process set forth in the bill would provide companies with clear guidance about whether ingredients should continue to be used and if so, what the concentration levels should be and whether consumer warnings are needed. For example, a chemical may be deemed inappropriate for use in children’s products, or appropriate for professional application only.
The first set of chemicals for review includes:
- Diazolidinyl urea, an antimicrobial preservative used in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotion.
- Lead acetate, used as a color additive in hair dyes.
- Methylene glycol/formaldehyde, used in hair treatments.
- Propyl paraben, used as a preservative in a wide range of products including shampoo, conditioner and lotion.
- Quaternium-15, used as a preservative in a wide range of products including shampoo, shaving cream, skin creams and cleansers.
To fund these new oversight activities, the bill would authorize the FDA to collect user-fees from personal care products manufacturers, like it does for medications and medical devices.
Methylene glycol/formaldehyde, which can irritate the eyes, skin and respiratory tract and is a potential carcinogen, is a good illustration of the how the FDA’s lack of sufficient regulatory authority over cosmetics ingredients can lead to harm. In 2013, Cosmetic Industry Review, which is funded by the cosmetic industry but claims scientific independence, published a paper finding that methylene glycol/formaldehyde “in the present practice of use and concentration” in hair smoothing/straightening products is unsafe. The FDA did issue a warning letter to the marketers of “Brazilian Blowout Acai Professional Smoothing Solution,” stating that, despite its claim of being “formaldehyde-free,”
based on FDA sample analysis, Brazilian Blowout contains methylene glycol, the liquid form of formaldehyde, which, under the conditions of use prescribed in the labeling, releases formaldehyde when hair treated with the product is heated with a blow dryer and then with a hot flat iron. Methylene glycol is a deleterious substance, which at the levels present in this product, may harm users under the conditions of use prescribed in the labeling thereof. FDA analysis of approximately 50 mg samples of Brazilian Blowout confirmed the presence of methylene glycol, the liquid form of formaldehyde, at levels ranging from 8.7 to 10.4%.
Yet, because the FD&C Act does not give the FDA mandatory recall authority, the FDA could not move to recall the product. The FDA could, but has not, banned the use of methylene glycol/formaldehyde in cosmetics. Fortunately, OSHA and state agencies have stepped in to fill the regulatory gap.
Industry and consumer support
The Act has support from both the cosmetics industry and consumer and medical groups like the Environmental Working Group, March of Dimes, the American Cancer Society, and the Endocrine Society. However, the Consumer Federation of America and a group of which I was previously unaware, the Campaign for Safe Cosmetics, are not fully on board.
The Campaign for Safe Cosmetics thinks the regulations are too weak and doesn’t like the fact that the Act will pre-empt state regulation. While the Campaign has the worthy goal of informing consumers about dangerous chemicals in cosmetics and increasing cosmetic consumer protection, and may well be correct that this bill is not all it could be, the Campaign turns a blind eye to pseudoscientific claims by its own industry supporters and appears to fall for the appeal to nature fallacy, all of which makes one suspicious about exactly where it is coming from in its opposition. For example, here’s a pitch from a company recommended by the Campaign, Golden Path Alchemy, “formulated by licensed acupuncturists and herbalists” for its “Sacred Space Alchymst:”
White Sage, a profound and sacred medicinal plant native to the American West, cleanses and purifies mind, body and spirit. Pink Salt helps remove toxins and boost circulation. Pink salt contains more than 84 minerals and trace elements. It ionizes the air to nourish, clear and calm any space. Cedar promotes emotional balance, heightened spiritual awareness and meditation.
Or this, from Healing Scents Natural Products:
Essential Oil and Herbal Blends for almost any problem you may have in your life . . . Our most popular is our Cold/Flu/Sinus Oil – don’t get sick; use essential oils to stay healthy when everyone else is ill.
And this, from Creating Harmony, LLC, describing its “flower remedy mists:”
Everything on this planet has its own energy field surrounding it. Flower Essences and Gem Elixirs are the result of the interplay of a mineral or flower and sun/moonlight and water. The energy of the sunlight transfers the energetic imprint of this pattern into the water which has the capacity to hold the integrity of the energetic pattern. . . When you use a mist, you breathe into your body and aura the plant and gem vibrations that match the healing you are seeking allowing you to practice a different vibration.
I also note, with dismay, that the Campaign lists the endorsement of the appalling anti-vaccination organization, Holistic Moms Network. It is all well and good to advocate for safer cosmetics, but credibility is undermined when an organization is simply substituting one form of bad science for another. Why the Breast Cancer Fund, which apparently started the Campaign, would tolerate these associations is beyond me.
According to STAT, the Senate is set to adjourn later this week, so it is unlikely the bill will move forward this year. It will probably be reintroduced in January. At a mandate of only five chemicals a year, it will take long past our lifetimes to get to all of them. On the other hand, at least the FDA will know what companies are out there (assuming industry compliance) and will have the power to recall dangerous cosmetics. It’s far from perfect, but it’s better than the current system and, with industry and bipartisan support, has a chance of passing. Sadly, in today’s political climate, perhaps that’s the best we can hope for.