Most companies that market cosmetics intend to be conscientious compliant corporate citizens. Doing so is becoming increasingly difficult, as the number of compliance issues to track, understand and implement are rapidly increasing.
Log in to view the full article
Most companies that market cosmetics intend to be conscientious compliant corporate citizens. Doing so is becoming increasingly difficult, as the number of compliance issues to track, understand and implement are rapidly increasing.
This column briefly outlines a variety of current concerns for cosmetic companies marketing products in the U.S. – from PFAS and environmental claims, to packaging issues and more. It also provides suggested plans of action, including for companies to prepare for the upcoming changes mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).1
MoCRA and Adulterated Products
Under MoCRA,1 if the safety of a product is not adequately substantiated, the product is considered adulterated and is subject to recall. Complying with this mandate is therefore a top priority.
For larger cosmetic companies, this safety substantiation is likely already in place. The chief concern is for smaller companies that have historically relied on raw material supplier information. Safety substantiation cannot be based on these datasheets, but rather must be based on assessment of the final product placed on the U.S. market.
Additionally, if the product has not been manufactured under conditions that meet good manufacturing practice (GMP) requirements, it can be considered adulterated and is subject to recall. The last guidance from FDA was in 2013.2 Under MoCRA, FDA must issue a GMP proposed rulemaking by Dec. 29, 2024, with final rulemaking due Dec. 29, 2025
Action plan: To ensure compliance, companies must conduct or commission safety assessments of their products, keeping them up to date and reviewing them annually for formula or packaging changes. Until FDA issues the final rulemaking on GMP, it would be wise for companies to obtain verification that every manufacturing site they use is certified GMP according to ISO 22716 or another equivalent standard.
PFAS and Other Prohibited Ingredients
PFAS: Per- and polyfluoroalkyl substances (PFAS) or “forever chemicals” are a regulatory hot topic. There are many facets to the underlying issues, including persistence in the environment and related possible health concerns. As such, states are proactively adopting measures to address these issues.
Originally, PTFE, a high-molecular weight synthetic fluoropolymer of tetrafluoroethylene, was the most commonly used PFAS cosmetic ingredient because it provided a smooth, sleek finish; however, most cosmetic companies have moved away from it. There are a variety of ways fluorinated ingredients may unintentionally appear in products despite their omission from the original ingredient lineup, including coating on mineral or powdered raw materials.
While many people look for fluoro in the ingredient name, this does not cover all ingredients with at least one fully fluorinated carbon atom. Take, for example, polysilicone-10, polyurethane-26, polyacrylate-48, pentapeptide-35, HC Yellow 13 and dimethicone acrylate copolymer.
Twenty-one of the fifty U.S. states currently have pending or finalized legislation relating to PFAS in a variety of industry sectors; firefighting foam and food packaging are the largest. Eight of the fourteen states with enacted legislation have laws relating to personal care products (California [AB 2771], Colorado [HB 22-1345], Maryland [HB 643], Minnesota [HF 2310], Maine [LD 1503], Oregon [SB 546], Vermont [S 25] and Washington [HB 1047]); only one (Minnesota) has designated cleaning products as a category for restriction/prohibition of PFAS.
Other prohibited ingredients: States are also active in restricting or prohibiting several other ingredients, such as triclosan, formaldehyde, specific parabens and mercury, among others. While companies may not be using these specified ingredients, it is important to remain vigilant in watching state activity on ingredient prohibition. Additionally, California’s Proposition 65 is of note, as conscientious compliant corporate citizens will want to vet all raw materials to confirm the Prop 65 warning against cancer or reproductive harm is not required.
As most readers know, there are also chemicals that, while never intentionally added to formulas, can be expected in certain products. Lead is one example – it is ubiquitous in the environment and can be in your product from water, colorants or plant-based raw materials. Washington State is seeking to impose a 1 ppm limit.3 While the industry is advocating strongly for a more reasonable level, readers are advised to act now to lower lead limits wherever possible.
Similarly, New York’s 1,4-dioxane restriction requires the close monitoring of all formulas with ethoxylated ingredients.4 One category often glossed over that contains 1,4-dioxane is polysorbates. The storage of ethoxylated products will be critical to keeping the 1,4-dioxane content low as heat tends to cause an increase in levels.
Action plan: To ensure compliance with these restrictions, companies should monitor state as well as federal legislative activities. Industry associations can be a good source; there are also subscription services to track key words like cosmetic, PFAS, etc.
Companies also should vet all raw materials by asking each supplier to provide a PFAS statement indicating the raw material does not contain PFAS. A definition should also be included; this author suggests “one fully fluorinated carbon atom,” as it is the most common definition in state legislation.
These actions should be taken for all ingredients of concern.
Environmental Claims
Another hot button regulatory item concerns environmental claims. Greenwashing, defined as making environmental claims that are not true, are overstated or are overly broad, goes against the very principle of being a conscientious compliant corporate citizen. Many companies, in trying to promote their sustainability objectives, make broad claims such as compostable, biodegradable and recyclable, or use the popular recycling symbol to encourage recycling.
One problem with this is that not all materials are recyclable. In addition, unless the containers are thoroughly cleaned before disposal in the recycling bin, those containers cannot be recycled.
California is taking a hard stance on recycling claims, as outlined in SB 343, also known as California’s “Truth in Recycling” law, which mandates that the chasing arrow symbol cannot be used unless manufacturers, distributors and retailers substantiate their recycling claims with empirical evidence obtained by compliance with the state’s recycling parameters. Materials must be both: a) collected for recycling by jurisdiction programs covering at least 60% of the state’s population; and b) sorted into defined streams for recycling processing by large volume transfer/processing facilities serving at least 60% of recycling programs statewide.5
In addition to the term recyclable, there are various state definitions for compostable and biodegradable, so companies must be sure their claims meet these definitions to avoid noncompliance in any given jurisdiction.
Action plan: The best approach to avoiding inadvertent greenwashing is for companies to do their research. Know what is and is not recyclable, sustainably sourced, organic or natural, etc. Review every claim. State clearly, with specificity, any environmental claims based on rese arch of federal and state regulations and document why the claim is true and not misleading.
Regarding product disposal and recycling, as rules vary from state to state, this may prove a daunting task. It is advised that companies form a project plan that includes ongoing monitoring for new rules and regulations. Companies should not claim anything they cannot document/substantiate. Using third-party certifications whenever possible is an additional option.
Packaging Issues
In 2008, a very young child tragically died from ingesting baby oil that aspirated into its lungs.6 This brought about the childproof cap rule7 for low-viscosity liquid products containing hydrocarbons.
Bisphenol A (BPA) in baby bottles also started a tremendous chain reaction that got the attention of NGOs and legislators. This resulted in numerous packaging laws and regulations, including its designation as a reproductive toxin under California’s Prop 65 warning requirement. PFAS are implicated in these as various jurisdictions seek to reduce exposure to “forever chemicals.”
In addition, there are state laws now requiring minimum recycled content in packaging (take for example Washington’s SB 5022, which requires personal care product to have 15% recycled content by Jan. 1, 2025; 25% by Jan. 1, 2028; and 50% by Jan. 1, 2031). The industry knows all too well that the use of plastic is an issue.
Action plan: To avoid some of these packaging issues, companies are advised to follow the action plan for ingredient issues described above. Again, track state (and federal) legislation. Vet all packaging – ask for, and keep on file, compliance statements. Also, have a plan to regularly review this information on a recurring basis.
Product Claims and Misbranding
MoCRA has raised the bar on what constitutes a misbranded cosmetic by adding the requirement for companies to list contact information for consumers to report any adverse reactions; i.e., a domestic address or phone number, or electronic contact information that may include a website. This does not mean the label must include the words “to report an adverse reaction;” however, information on the label must be sufficient for users to report an adverse event easily via writing, calling or emailing.
Note that if the product label is false or misleading in any way, the product is considered misbranded. And if all the required labeling elements are not prominent and clearly legible (and indelible), the product is considered misbranded. This includes fragrance allergens that, under MoCRA, will soon be a required component of a product’s ingredient listing – although it is not yet known what this will entail. The author advises companies to plan for label transitioning once the U.S. Food and Drug Administration (FDA) opines on which fragrance allergens require labeling and at what levels.
MoCRA has additionally given the FDA the authority to implement product recalls, which can be based on misbranding. Some consumer protection laws can even give rise to class action lawsuits based on false or misleading claims. California is the best/worst example of this as class action suits are frequently filed under the Unfair Competition Law (Business and Professions Code § 17200), the False Advertising Act (Business and Professions Code § 17500) and the Consumer Legal Remedies Act (Civil Code §§ 1750-1784). As such, if using claims such as clean, natural, sustainable, net zero or the like, companies should add specifics to define what these terms mean. Seek to inform – ensure claims are not misleading by being non-specific.
Additional label components that make product claims but may be overlooked include: 1) the product name; 2) ingredient callouts (e.g., stating that a product contains aloe vera when the amount present is insufficient to be efficacious); 3) label images that give the appearance that a product contains ingredients it does not; 4) icon imagery (e.g., recycling, as described above); and 5) any general, non-specific phrases.
Action plan: Reviewing and substantiating every product claim is crucial to ensuring compliance. Every time the formula changes, even just a little bit, the product’s claims should be reviewed. Look at each claim and ask: Is it truthful? is it specific and substantiated by documentation on file? and is it misleading in any way?
Extended Producer Responsibility
Finally, four U.S. states have established or are in the process of establishing extended producer responsibility (EPR) regulations: California (SB 54), Colorado (HB 22-1355), Oregon (SB582B 2021) and Maine (38-A M.R.S. § 24). Others are likely to follow suit. Reporting requirements will begin in July 2025 for Oregon and Maine, and in April 2026 for California; the date is yet to be determined for Colorado. California has notably included in its EPR a requirement for 25% plastic reduction in the industry sector.
One producer responsibility organization (PRO) has been contracted with these states: the Circular Action Alliance (CAA). In order to comply with these EPR regulations, registration with the CAA is required. This organization will advise when fees are set by the states.
Action plan: To comply with EPR regulations, companies should put a plan in place for capturing sales data by jurisdiction that can be extrapolated to report plastic content/volume and other details.
Conclusion
This article provides just a sampling issues in the U.S. of which companies should be aware. Manufacturers are encouraged to stop, educate themselves and plan for the implementation of the described regulations to ensure they fulfill their intents as conscientious and compliant corporate citizens.
References
1. One Hundredth Seventeen Congress of the United States of America (2023). Consolidated Appropriations Act. U.S. Government. Available at https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf
2. U.S. Food and Drug Administration (2013, Jun). Draft guidance for industry: Cosmetic good manufacturing practices. FDA. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-cosmetic-good-manufacturing-practices
3. Bureau Veritas (2023, May). Washington State passes Toxic-free Cosmetics Act. Available at https://www.cps.bureauveritas.com/newsroom/washington-state-passes-toxic-free-cosmetics-act
4. New York State (2022). 1,4-Dioxane limits for household cleansing, personal care and cosmetic products. Available at https://dec.ny.gov/environmental-protection/help-for-businesses/household-personal-cosmetic-dioxane-limits
5. California Legislative Information (2021, Oct). SB-343 Environmental advertising: Recycling symbol: Recyclability: Products and packaging. Available at https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202120220SB343
6. Mikkelson, D. (2008, Oct. 23). Have infants died from aspirating baby oil? Snopes. Available at https://www.snopes.com/fact-check/baby-oil-danger/
7. Code of Federal Regulations (1972, Aug 7). Part 1700 – Poison prevention packaging. National Archives. Available at https://www.ecfr.gov/current/title-16/chapter-II/subchapter-E/part-1700
