By Scott Faber, Senior Vice President of Government Affairs
Chemicals and contaminants linked to cancer can be found in food, water, and many other everyday products. However, no category of consumer products is subject to less government oversight than cosmetics and other personal care products. Although many of the chemicals and contaminants in cosmetics and personal care products likely pose little risk, exposure to some has been linked to serious health problems, including cancer.
Since 2009, 595 cosmetics manufacturers have reported using 88 chemicals, in more than 73,000 products, that have been linked to cancer, birth defects, or reproductive harm.[1] Many of these chemicals should be banned from cosmetics, as proposed in California Assembly Bill 2762, the Toxic-Free Cosmetics Act. Among the toxic chemicals that should be banned are:
The Toxic Twelve Chemicals and Contaminants:
- Formaldehyde, a known carcinogen.
- Paraformaldehyde, a type of formaldehyde.
- Methylene glycol, a type of formaldehyde.
- Quaternium 15, which releases formaldehyde.
- Mercury, which can damage the kidneys and nervous system.
- Dibutyl and diethylhexyl phthalates, which disrupt hormones and damage the reproductive system.
- Isobutyl and isopropyl parabens, which disrupt hormones and harm the reproductive system.
- The long-chain per- and polyfluoroalkyl substances known as PFAS, which have been linked to cancer.
- M- and o-phenylenediamine, used in hair dyes, which irritate and sensitize the skin, damage DNA, and can cause cancer.
All of these toxic chemicals have been banned by the European Union and many other nations, and many have been slated for removal from the store brands of major U.S. retailers, including Target, Rite Aid, Walgreens, and CVS Health.[3] For example, as of the end of 2019, CVS Health prohibits the use of formaldehyde, many chemicals that release formaldehyde, many parabens, dibutyl phthalate, and diethylhexyl phthalate. Some of these are already banned from products sold in Whole Foods.[4]
Some of the chemicals included in A.B. 2762 do not have to be disclosed on the package because they are components of fragrance and are exempt from federal labeling requirements. In particular, two phthalates included in A.B. 2762 – dibutyl phthalate and diethylhexyl phthalate – may be included in combinations of chemicals disclosed on the label as fragrance but do not have to be disclosed as individual chemicals.
Dibutyl phthalate is an endocrine disruptor and a developmental toxicant that harms male reproductive system development. It can cause early puberty in boys and other changes in the reproductive system. Diethylhexyl phthalate harms the reproductive system and can affect the developing fetus. It has also been classified by the International Agency for Research on Cancer as possibly carcinogenic.
Many of these chemicals are rarely used in personal care products and will be easy to replace. For example, in Skin Deep®, EWG’s database of cosmetics and other personal care products, EWG found isobutylparaben and isopropylparaben in just 96 and 12 products, respectively, offered for sale since January 2017. A 2018 analysis by EWG found fewer than 200 products contained one of 13 PFAS chemicals.
The cosmetics industry has grown dramatically since 1938, when Congress last enacted cosmetics legislation, the Food, Drug, and Cosmetic Act. At that time, the cosmetics industry reported approximately $1 billion in sales. In 2016, it reported more than $169 billion in sales. Nevertheless, only two pages of the 829-page act governs cosmetics, and those provisions provide the Food and Drug Administration no financial resources and sharply limit its authority to regulate chemicals and contaminants that pose chronic risks.
Although Congress has since given the FDA the power to ensure that food additives, color additives, and pesticides pose “no harm” from repeat exposures, Congress has not given the agency the same authority to regulate the chronic risks posed by chemicals and contaminants in cosmetics. Instead, the FDA largely relies on the personal care products industry to regulate itself as a way to address the risks its products pose.
Consumers use a wide variety of cosmetics and personal care products. Few consumer products contribute as many chemical exposures as cosmetics and other personal care products. Each day, American women use an average of 12 personal care products that contain 168 different chemicals. Men use an average of six personal care products that contain 85 different chemicals. Many of these products are applied directly to the skin, the body’s largest organ, where ingredients can be absorbed directly into the bloodstream.
Consumer use of cosmetics continues to grow dramatically. Since 2010, the U.S. cosmetics market has grown an average of 4.1 percent annually, and internet sales have expanded to account for 8.4 percent of the total market share. Cosmetic imports are also on the rise. In fiscal year 2016, 2.9 million lines of cosmetics were imported into the U.S. from 181 different countries. Lines of cosmetic imports doubled over the past decade, with a substantial increase after FY 2011. Cosmetic imports from China increased by 79 percent between FY 2011 and FY 2016.
Although most chemicals in cosmetics pose little or no risk, some have been linked to serious health problems, including cancer, reproductive and neurological harm, and developmental delays. Some chemicals used in personal care products pose risks at very low doses and can interfere with the hormone system. Research shows that “endocrine disrupting” chemicals such as parabens and phthalates may pose the greatest risk during prenatal and early postnatal development when organ and neural systems form. Exposure to these chemicals has been linked to endocrine diseases and some types of cancer.
Many cosmetics have also been linked to acute risks, including burns and infections. Formaldehyde-based hair-straightening procedures, referred to as “keratin treatments,” have been linked to hair loss, rashes, blisters, nosebleeds, bleeding gums, and loss of taste and smell. Other cosmetics have caused hair loss. The FDA continues to find cosmetics contaminated with bacteria or containing banned color chemicals.
Under the current law, the FDA has little authority to review chemicals in cosmetics and other personal care products. Personal care products companies do not have to register with the FDA, provide the FDA with ingredient statements, adopt Good Manufacturing Practices, report adverse events to the FDA, or provide the FDA with access to safety records. The FDA does not have the power to suspend registration or order recalls when products pose a risk of serious adverse health consequences or death. By contrast, manufacturers of food, drugs, and medical devices must register with the FDA, maintain and give the FDA access to records, and report adverse events. If food, drugs, or devices are unsafe, the FDA can suspend production and product licenses.
Of more than 10,000 chemicals used to formulate cosmetics, just 11 have ever been banned or restricted by the federal Food and Drug Administration. By contrast, the FDA, the Environmental Protection Agency, and the Consumer Product Safety Commission have broad authority to ensure the safety of chemicals in other consumer products.
The U.S. has also fallen far behind our international trading partners in the regulation of cosmetics. More than 40 nations have taken steps to ban or restrict, in combination, more than 1,400 chemicals or contaminants in cosmetics and personal care products, including chemicals linked to cancer, reproductive harm, and neurological harm. All of the chemicals identified in A.B. 2762 have already been banned by the EU, including isopropylparaben and isobutylparaben, dibutyl phthalate and diethylhexyl phthalate, mercury, formaldehyde, and many PFAS. Other nations have restricted the presence of chemicals such as formaldehyde and perfluorooctanoic acid (PFOA).
The cosmetics industry has long fought meaningful oversight. Since the early 1950s, it has defeated efforts by Congress to modernize cosmetics law. Since 2015, some cosmetics companies have supported giving the FDA the authority and resources to review and regulate chemicals and contaminants of concern in cosmetics, and have supported requiring manufacturers to register, provide ingredient statements, adopt GMPs, and report adverse events.
Some companies have also supported giving the FDA the power to suspend production of dangerous products and order mandatory recalls. However, other companies have not supported FDA review and oversight.
Consumers overwhelmingly support federal oversight of cosmetic chemicals. Two-thirds of consumers believe chemicals in cosmetics are already reviewed by the FDA, according to polling conducted in 2016. Three-fourths of consumers – regardless of age, race, or party affiliation – support stricter oversight of chemicals in cosmetics, and nearly nine in 10 consider stricter rules very important.
In addition, nine in 10 consumers believe cosmetic companies should have to notify the FDA if their products harm consumers, support giving the FDA mandatory recall authority, and support rules ensuring cosmetics are produced in clean environments.
FAQs
Q: Are all the chemicals identified in A.B. 2762 banned by other countries?
A: Yes, all of the chemicals identified in A.B. 2762 have already been banned by the European Union, and many other nations have also restricted or banned them due to their links to cancer, reproductive harm, and neurological harm.
Q: What authority does the FDA currently have to regulate chemicals in cosmetics?
A: The FDA has limited authority to regulate chemicals in cosmetics compared to its authority over food additives, color additives, and pesticides. The FDA relies on the personal care products industry to regulate itself, which has led to gaps in oversight and limited protection for consumers.
Q: Do consumers support stricter oversight of cosmetic chemicals?
A: Yes, according to polling conducted in 2016, three-fourths of consumers support stricter oversight of chemicals in cosmetics, regardless of age, race, or party affiliation. Consumers believe that cosmetic companies should be required to notify the FDA if their products harm consumers and support giving the FDA mandatory recall authority.
Conclusion
Cosmetics and other personal care products play a significant role in our daily lives but can also pose risks to our health. The presence of toxic chemicals and contaminants in these products highlights the need for stricter oversight and regulation. By banning the Toxic Twelve chemicals and contaminants, we can better protect consumers from potential health risks associated with cosmetics.