Some of the biggest challenges are coming from class action lawsuits and consumer-enforced accountability around contaminants and substances deemed unsafe for consumers rather than from Federal Drug Administration requirements, Donald Frey, president of the Independent Beauty Association, told CosmeticsDesign.
One of the prominent issues for Frey is recent recalls of benzene-related products ensuing from analytical testing performed by Connecticut-based pharma and analytics company Valisure. In that case, Frey said recalls were not driven by FDA action, but by the “court of public opinion.”
“The levels detected were very low but there was a lot of press about it which has caused some companies to withdraw their products from the market until they can figure out what is causing it,” he said. “Benzene is obviously a safety concern, but these are cases where it was not knowingly or intentionally added.”
As well as having to recall their products, companies such as Johnson & Johnson, Beiersdorf and Bayer HealthCare have been hit with class action suits.
Click through to read about the prohibited substances IBA says mid to small beauty brands need to worry about.
One of IBA’s current priorities is making sure its member companies - small and medium-sized beauty product manufacturers and brands - do not expose themselves to the risk of class action litigation.
“There are bounty hunters out there who will specifically test products for Prop 65 ingredients and will put out class action suits against different manufacturers and suppliers in the hopes of getting a settlement,” Frey said.
Smaller companies may not have the resources to handle class action lawsuits, which is why Frey said IBA tried to make its members aware of the threat and how to protect their brands.
He said it is largely about having the appropriate records, which is something smaller companies often struggled with. This advice doesn’t just apply to testing for benzene but extends to any banned ingredients or contaminants that are deemed as presenting a risk to consumer safety.
Frey said another contaminant to watch for at the moment is 1,4-dioxane, which can form as a byproduct during the manufacturing of ethoxylated products such as surfactants and thickeners.
In January 2022, a new law passed in the state of New York banning all but trace amounts of 1,4-dioxane in cosmetics, personal care and cleaning products. Limits will go into effect as of the end of 2022.
The issue that beauty manufacturers and brands face, Frey said, is the possibility that 1,4-dioxane levels may increase over time after manufacturing.
“This is a new discovery and we don’t yet understand the mechanism that is causing this to happen but it could mean that although a product is compliant at the time of manufacturing, after sitting on the shelf the level of 1,4-dioxane may creep up so it is no longer compliant,” he said.
Frey also said because the threshold for 1,4-dioxane compliance is so low, individuals may pursue class action lawsuits similar to those involving benzene. It is not yet clear what the repercussions for violating the law will be.
PFAS are another group of substances that beauty manufacturers and brands need to have on their radars, Frey said.
PFAS 101
Recent research has suggested PFAS may have a number of serious health impacts including increased cholesterol, changed liver enzymes, decreased infant birth weight, decreased vaccine response in children, higher risk of high blood pressure or pre-eclampsia in pregnant women and increased risk of kidney and testicular cancer. Additionally, research estimates as many as 98% of American adults have PFAS in their bloodstream.
The No PFAS in Cosmetics Act, which seeks to ban the use of intentionally added PFAS in cosmetics, was introduced in the House of Representatives in June 2021. The bill has been assigned to the House Energy and Commerce Subcommittee on Health, but no hearing has been scheduled.
While PFAS are used in multiple industries, Frey said cosmetics are being singled out because they are sometimes added specifically to products like lipstick, mascara and eyeshadow to extend wear.
One of the issues with regulating PFAS is that they exist in everything at low levels. Sometimes they are added intentionally to products, but other times they enter the supply chain through water or the environment, Frey said.
“If these laws do get written, one of the issues for manufacturers will be how to deal with PFAS because to some extent it is outside their control,” Frey said. “There needs to be some sort of reality check.”
Even if the bill doesn’t make it into the statute books, plaintiffs and consumer groups are still intent on exposing the presence of PFAS in a variety of products. There are also several states passing laws to limit PFAS in consumer products, as previously reported by CosmeticsDesign.
Frey said the challenge for beauty manufacturers and brands is making sure they are not making marketing claims that can be undermined by the presence of certain chemicals.
“What companies need to avoid is making claims about their ingredients being ‘clean’ or ‘natural’ and then using PFAS materials which, although they don’t have to be declared on the label, are clearly not ‘clean’ or ‘natural’,” Frey said. “Even though they are added at very low levels, that raises the question of whether the company is being honest in their product description.”
Orveon-owned brand bareMinerals is a case in point. In December 2021, five plaintiffs filed a class action lawsuit against Shiseido Americas Corporation, which owned the brand at the time, on behalf of “all consumers who purchased bareMinerals products.”
The plaintiffs alleged that bareMinerals were falsely advertised as “clean,” “pure” and “free of harsh chemicals and unnecessary additives” because they contained PFAS, which the plaintiffs asserted were “not clean or natural.”
Even without PFAS in the equation, Frey said that claims such as ‘green’, ‘sustainable’, ‘clean’ and ‘natural’ can be a real “trigger point” for companies getting themselves into trouble if they are not descriptive enough or specific enough about what they mean.
“Shorthand claims are very impactful but the devil is in the detail when it comes to supporting these claims, so it is very important that companies have back-up and understand that they have to be very cautious about making claims,” Frey said. “If they are saying something is ‘natural’, what is their definition of ‘natural’, for example.”
While the Federal Trade Commission provides guidance on some claims, he said there is no set definition for many terms so it is important that manufacturers define them.
“There might not be any regulations but consumers will hold brands to account,” Frey said.
