For manufacturers and suppliers of cosmetics and personal care products, navigating the convoluted state regulations is a critical concern for manufacturers and suppliers alike. With many states enacting bans or restrictions on various ingredients, the regulatory landscape has evolved into a complex patchwork that requires careful attention and strategic planning.
From banning formaldehyde-releasing agents to limiting per- and polyfluoroalkyl substances (PFAS), each state’s approach presents unique challenges and considerations. We interviewed Surya Kundu, an associate at Steptoe LLP, to discuss current state legislative activity surrounding the regulation of cosmetics and personal care products, examining the importance of key legislation and its impact on industry players across the country. I asked for some insight.
CDU: Can you provide an overview of the current major state legislative activity regarding the regulation of cosmetics and personal care products?
Surya Kundu (SK): At least 20 states have banned or restricted cosmetic ingredients. Significant differences in these laws have created a patchwork of laws that brands and manufacturers have to deal with, including what substances are covered.for example,Color additives; metals such as cadmium, lead, and mercury. Phthalates; Parabens; Per- and polyfluoroalkyl substances (PFAS); Formaldehyde; and more).
Also, the variations overlap with each other. Significant differences often exist, even between laws that address the same substance/category of substances. One common variation is a ban on children’s products and a ban on all cosmetic products.
For example, Minnesota bans the use of formaldehyde in children’s personal care products (including children’s cosmetics), but does not have a similar ban in adult cosmetics, while states like California and Maryland Other states, such as the State of California, have broader formaldehyde regulations for cosmetic products for all ages. Each state may also set different tolerance levels for restricted materials. There are also significant differences in how states define the scope of their prohibitions.
For example, several states have passed or proposed laws to limit PFAS substances intentionally added to cosmetics. Maryland law applies to 13 specific PFAS compounds and their salts that are intentionally added. California had previously banned the same 13 PFA compounds and their salts (if intentionally added), but passed AB 2771 in September 2022, expanding the ban to all classes of PFAS, and Colorado It became the second state to impose such broad restrictions after the state. Intentionally adding her PFA to cosmetics.
In particular, many state laws that restrict/prohibit cosmetic ingredients apply only to intentional additions, but there are important differences in the definition of that term. This already complex situation is likely to become even more complicated as more states propose and potentially pass additional legislation.
Although this focuses on laws that restrict/restrict ingredients, it is also important to pay attention to ingredient disclosure/reporting laws. California’s Prop 65 is one of the most notable examples, requiring consumer products to carry warnings about possible exposure to substances considered carcinogenic or reproductive. Toxins by California. The state maintains an extensive (and ever-growing) list of these compounds. and Provides for a private right of action that allows consumers to sue based on their claims of existence.
CDU: What are the implications of MoCRA’s pre-emption clause?
S.K.: MoCRA’s preemption provisions are notable for both their content and substance. I don’t Take the lead.
Broadly speaking, state or local governments are responsible for registration and product listing, recall, adverse event record keeping and reporting, demonstration of safety, and good manufacturing practices (note: pursuant to MoCRA, FDA is developing regulations and , the statutory deadlines are December 29, 2024 and December 29, 2025 for the proposed and final rules, respectively, but it is undetermined whether it will move forward (return).
States are not precluded from limiting or outright banning ingredients or amounts of ingredients or enforcing ingredient reporting requirements that were in effect at the time MoCRA was enacted. In practice, this means that states can still pass and enforce their own rules about what goes into cosmetics, including all new prohibitions and restrictions that have been passed or proposed.
CDU: Which states currently have bans on formaldehyde-releasing substances, PFAS, preservatives, and animal testing, and how are those bans enforced?
S.K.: At least 11 states (including California and New York) have some kind of restriction on the sale/sales of cosmetics that involve animal testing, but it is important to note when the law takes effect, the types of exemptions that apply, and existing There are important differences between products. – The last possible date on which the animal experiment was performed. Most laws impose fines and are intended to be enforced by state enforcement officers (AGs, DAs, etc.).
At least five states have some form of restriction on formaldehyde substances. These include a ban on children’s personal care products in Minnesota, a restriction on formaldehyde and formaldehyde-releasing agents in OR, a broad ban in Washington, and restrictions on certain substances in this class in CA and MD.
“Preservative” is a broad and vague category. This can include many different compounds and varies depending on the type of product and how the compound is used.
PFAS – At least seven states have banned/restricted PFA compounds intentionally added to cosmetics. The scope of the restrictions (specific PFAS compounds and classes as a whole), the definition of “intentionally added,” the date the ban will go into effect, and more. These laws have not yet been implemented, with the earliest legislation expected to go into effect in January 2025 (California, Colorado, Maryland, Minnesota, and Washington), so it remains to be seen how each state It is undecided whether to take this approach.
We also note that cosmetic ingredients in general are popular targets for private litigation and are often filed as class actions based on general national consumer protection, false advertising, and/or deceptive trade practices litigation. That is important.
CDU: Enacted laws like Cali AB 2762 and Washington HB 1047 set precedents that other states can follow suit with their own regulatory actions or influence proposed legislation like New York S4265. Is not it?
S.K.: It really varies. Some states explicitly reference and reference other existing regulations in other jurisdictions when proposing and passing cosmetic ingredient laws.
For example, MD’s HB 643 ban on cosmetic ingredients targeted the same substances as California’s previously enacted AB 2762. However, other states have taken different approaches, including CO when passing broad PFAS bans across compound classes.
Note that in September 2023, California also expanded its ban on PFAS in cosmetics to all classes with the passage of AB 2771. Other states have proposed cosmetic ingredient laws, and many have passed them. Therefore, despite some overlap and similarities, it is suggested that: , in the absence of uniform federal standards, the patchwork quilt will remain intact.
CDU: How should national manufacturers and suppliers of cosmetics and personal care products address individual state regulatory requirements to ensure compliance?
S.K.: That’s definitely a big practical challenge. Staying informed is an important first step. Track existing and proposed legislation in all markets where your product is sold or will be introduced (note changes such as additional restrictions on children’s products). A lawyer can help you with this.
It’s also important to have a strong internal team that understands your products and raw materials, establishes clear communication throughout your supply chain, and is ready to take action. Be proactive about substantiation, including tracking throughout the supply chain and obtaining testing/certification/other documentation as required. Next, you need to make choices that make sense for your business. In some cases, it may make sense to comply with the most restrictive standards.
In other cases, it may be more practical to restrict the sale of a product or develop alternative formulations. Finally, given the dynamic nature of this field, consider participating in industry associations and legislative processes. Your attorney can help you identify opportunities and take steps, such as submitting comments or other types of participation, as appropriate.
