Cosmetic companies currently selling color cosmetics in Washington state will likely conduct a cost-benefit analysis to determine whether it is worth continuing to sell there given the trace lead limit imposed by the Toxic-Free Cosmetics Act, says an industry consultant.
Many independent or small brands will decide it makes more sense to pull their products.
“It’s not that big of a cosmetic market for indie or smaller brands,” noted Karen Yarussi, president of Clayton, NC-based Global Regulatory Associates, Inc. “They’d rather put a block in their system and just never sell there.”
Speaking in a 20 October interview, Yarussi – who has more than 25 years of experience managing regulatory affairs for major cosmetic brands including Avon, Burt’s Bees and StriVectin – said some independent and smaller companies may altogether ignore the regulation’s 1ppm ceiling on lead, which goes into effect 1 January 2025.
She suggested there is a frustration over the state’s decision to brush aside the US Food and Drug Administration’s proposed limit issued in a draft guidance to industry in 2016 after concluding up to 10ppm in cosmetic lip products and externally applied cosmetics would not pose a health risk. ([A#RS108980])
“Let’s say that I test the first batch before it goes out for commercialization and I check the spec sheet” and everything is under the 1ppm threshold, she said. “But now 10 batches in it exceeds the [lead] limit.”
Industry “feels like there’s a federal colorant regulation and there should have been preemption,” she said.
Lead is not intentionally added to cosmetic products but occurs naturally and is sometimes present in raw materials used by the industry, including those that impart color. In a 2010 study, FDA found that more than 99% of cosmetic products it tested had lead levels below 10ppm, with an average of 1.11ppm, above Washington’s limit.
In addition to addressing lead, the TFCA also bans the manufacture, sale or distribution of cosmetic products containing eight other chemicals or chemical classes, including formaldehyde, per- and polyfluoroalkyl substances (PFAS), ortho-phthalates, triclosan and methylene glycol, beginning in 2025. The bill sets a 1 January 2026 deadline for in-state retailers to sell existing stock. ([A#RS153696])
Yarussi is largely unconcerned with the ban of other chemicals targeted in the TFCA as “industry has been moving away from these for years.”
Industry Fearful of ‘Outing’ Products
While the Washington State Department of Ecology (DOE) has said it is open to data from industry arguing for a higher lead threshold, Yarussi said companies do not want to “out” their products by demonstrating that the 1ppm limit is not achievable.
During the 11 September session of the Independent Beauty Association’s fall 2024 Cosmetics Convergence Symposium, a DOE representative said the department has received a lot of questions and concerns about the 1ppm threshold. While it is authorized to use enforcement discretion with respect to the limit or raise it via rulemaking, the department is not inclined to do so unless it receives convincing data from industry.
Another major issue for companies is the cost and unreliability in testing products, which in some cases are derived from plants and often have trace levels of heavy metal from mineral-rich soil, said Yarussi. At 10 ppm, there was a buffer for some inconsistency in sampling.
“We are the only country in the world that has to have every single batch of [certain] colors pre-approved by FDA,” Yarussi said. Under the Federal Food Drug & Cosmetic Act, all color additives used in cosmetics must be approved by the FDA and a number of color additives must be batch-certified by FDA if they are marketed in the US.
Natural-based and mineral-based colorants are exempt from batch certification, but other colorants, largely synthetics such as Red 7, Blue 1 and Green 8, are required to be batch-tested and certified by FDA, which also inspects the establishments of manufacturers of batch-certified colorants to examine records of use and take samples for analysis.
Manufacturers of cosmetics typically conduct safety assessments and toxicological studies of their products and the costs stack up quickly. Manufacturers testing their products for heavy metals typically test a composite of five shades at once, which costs on average about $700 a test, a more affordable approach than testing each shade of product individually. A launch of 20 shades of lipstick in four composites would cost around $2,800.
“Let’s say that composite comes back at 8ppm,” Yarussi said. “I have to go back and test each shade individually. That cost goes up to $14,000.”
The DOE doesn’t have a sense of the cost of testing, she said. “They bought the equipment, it’s free for them to test, but they don’t understand for brands to test every batch of every shade, it’s expensive. They just don’t have any idea of the impact of what they’re asking brands to do from a cost perspective,” she said. “Washington is not that big a market compared to California, Texas, Florida and New York that people are willing to spend $8,000 to $10,000 every time they ship product into Washington and have to test to fully comply.”
Another common problem could be fluctuating trace levels of lead. “Let’s say that I test the first batch before it goes out for commercialization and I check the spec sheet” and everything is under the 1ppm threshold, she said. “But now 10 batches in it exceeds the limit.”
Those challenges in testing “haven’t been figured out” by the DOE, Yarussi said.
The impact of the law will be to “cut people off. They’ll put a block in their system and just not ship to Washington or they may just “go risky” and sell anyway, said Yarussi. “Or they will pass along the cost to consumers which will raise the price of products which will impact the very consumer that Washington is trying to protect.”
‘They Know Not What They Speak’
Yarussi is troubled by the data on which the DOE based its decision to limit lead at 1ppm.
“They know not what they speak. They don’t have data. They admitted it. They even asked if anybody had data on colorants because they had no data on colorants.”
In a January 2023 report to state legislators, the DOE presented phase one of a two-phase study testing the amount of targeted chemicals of concern in personal care and beauty products, prioritizing chemicals that “disproportionately impact people with higher rates of exposure” particularly black women, Native Americans and immigrants.
In the phase one report, the DOE noted that it conducted an assessment in collaboration with the Department of Health and researched how different communities use cosmetics. The work involves speaking with individuals from social justice organizations who studied differences in cosmetic usage.
Input also came from “LatinX, Black and multiracial Washington residents about what cosmetics products they used and what concerns they had about chemicals in cosmetics” and evaluating “where people buy cosmetics and what they prioritize.” That data was used to guide product testing.
As part of phase one, the DOE purchased 50 low-cost cosmetic products including makeup, hair straighteners, facial cleansers and intimate hygiene products from Walmart, Target, Fred Meyers and Dollar Tree. In testing foundations and lipsticks for contamination by heavy metals, the DOE detected lead at 5.55ppm in a dark-tint power foundation, lead at levels between 1ppm and 2ppm in a pressed powder foundation and in a lipstick.
The DOE noted that authoritative bodies, including the World Health Organization and the United States Centers for Disease Control and Prevention, have stated there is no safe level of lead exposure, particularly during childhood.
The department referenced separate product testing of the targeted chemicals conducted by non-governmental organizations, government organizations and academic research labs, the report noted. “When considered alongside reported uses of chemicals in cosmetics, these studies can fill in information gaps that exist when companies fail to report or are unaware of chemicals in products,” the department said. The report also cites regulations targeting cosmetic chemicals in other states.
Based on its own study and the other research, the DOE concluded: “The widespread presence of hazardous chemicals in a variety of cosmetic products means it is possible for people to be exposed to many of them through their daily personal care routine. People of color in Washington may have more exposure to these or other harmful substances. For many people of color, the negative impact of harmful cosmetics is compounded by other environmental and social factors.”
Yarussi is critical of the DOE’s focus on matters of diversity, equity and inclusion and not sound science.
“They make leaps of assumptions, like only Black women are injured by cosmetics. Sorry, this doesn’t work that way,” Yarussi said. “A woman of any ethnic group can buy a specific shade of an eyeshadow, and theoretically all women would be exposed to the exact same level of lead. Manufacturers do not create different formulas for different ethnic groups, they create one magenta eyeshadow for everyone. They are implying that a brand which may sell in Ulta and Target make two different formulas based on where they believe a target group shops and one is safe while the other is unsafe.”
Further, she noted the DOE stated in its report, “Some beauty standards are based on harmful stereotypes. Compared to White women, Black women have reported higher use of vaginal douches (up to four times higher than White women), which may be due to historical discrimination against Black women for perceived body odors (Branch et al., 2015; Ferranti, 2011).”
Yarussi questions the hypotheses. “They had to really stretch to draw these assumptions and the data is old,” she said.
Finally, Yarussi suggested the “alternatives” the DOE points industry to for safer ingredients within its report, including the US Environmental Protection Agency’s Safer Products program, are not legitimate options.
“They have three green chemistry links, one of which is the EPA. Well, EPA doesn’t know anything about cosmetics or how to formulate them, right?” she said. The other two links are for environmental groups, she said. “DOE suggests brands follow retailer clean lists like Sephora and Credo for alternatives, but both allow mineral-based colorants which contain lead,” she said.
DOE’s Response To Criticism
Commenting on the criticisms of its lead limit in a 25 October email, a DOE spokesperson said, “To protect human health and the environment, our goal is to reduce lead in cosmetic products to the lowest level possible. The 1ppm lead restriction is compatible with detection limits for analytical test methods.
“Product testing data from both Ecology and the US FDA demonstrate that the 1ppm lead limit is feasible in most products. We recognize that there is variability and complexity in product formulation and invite industry to share specific products where achieving 1 ppm lead is infeasible.”
Addressing concerns companies will “out” products in providing data on lead limits, the DOE acknowledged it has not received any data to date but does try to reassure stakeholders. “Organizations can request we protect their data using our statutory provisions for handling confidential business information, which prevents ‘outing’ of products,” the spokesperson said.
The DOE challenges the likelihood that independent and smaller companies will pull their products from the state, arguing the FDA as well as separate research including feasibility studies of Germany’s lead regulation and the DOE’s own 2023 report have found “the majority” of cosmetic products on the market today already meet the 1ppm lead limit. For companies found not to meet the limit, the department has said it is not planning to bring the hammer down as a first response when a company is found in violation of the TFCA but is willing to work alongside companies to help them reach compliance. ([A#RS155131])
Commenting on alternatives, the DOE said it is assessing alternatives to enable companies to comply with the new regulation and invites stakeholders with helpful information to contact the department “as soon as possible.”
