Laws and Legislation Your Skincare Brand Should Know About in 2024
Personal Care Products Safety Act (PCPSA):
The Personal Care Products Safety Act (PCPSA) is legislation that was originally introduced in the United States Senate in 2015. It amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to strengthen the Food and Drug Administration's (FDA) oversight of cosmetics. The bill was originally introduced in the Senate in April 2015 and provisions from the bill were signed into law with bi-partisan support as part of the fiscal year 2023 government funding bill.
Key provisions of the PCPSA:
FDA recall authority: The FDA will now have the authority to recall products with a high likelihood of causing serious harm when a company refuses to voluntarily cease distribution and recall the product.
Good manufacturing practices: The FDA will issue regulations to outline good manufacturing practices for personal care products.
New requirements for cosmetic companies: Companies are required to register with the FDA, disclose ingredients involved in production, and attest that they have safety records for their products.
Adverse health reporting: Companies are required to report serious adverse health events associated with their products.
Small business flexibility: The FDA will provide technical assistance and additional flexibility for small companies to comply with the law.
Increased Safety
The PCPSA gives the FDA more authority to regulate personal care products. The FDA would be able to review the safety of ingredients used in personal care products and prohibit the use of ingredients that are found to be unsafe. The FDA would also be able to investigate potential problems with products and take action to protect consumers. For example, the FDA could recall a product that is found to be causing serious adverse events.
Greater Transparency
The PCPSA requires companies to register with the FDA and to report adverse events, which would make the personal care industry more transparent. Consumers would be able to access information about the ingredients in personal care products and about serious adverse events that have been associated with these products. This information allows consumers to make more informed choices about the products they use.
Empowered Consumers
The PCPSA gives consumers more information about the products they are using, which would allow them to make more informed choices. Consumers would be able to choose products that do not contain ingredients that they are concerned about and avoid products that have been associated with serious adverse events. The PCPSA would also give consumers more confidence in the safety of the personal care products they use.
Heading to a future free of PFAS
Per- and polyfluoroalkyl substances (PFAS) have received a lot of attention. Commonly known as “forever chemicals,” PFAS are now found in the air and soil, as well as local drinking water supplies, around the globe. These chemicals can accumulate in the tissues of plants, animals, and humans. PFAS take a very long time to break down in nature and may be linked to harmful health effects in humans and animals.
The U.S. Food and Drug Administration (FDA) is currently working with manufacturers to phase out the use of PFAS in food packaging. As part of the Personal Care Products Safety Act, The FDA is required to assess the use and risks of PFAS in cosmetics products and publish the results no later than January 2026.
Many industries have already stepped in to discontinue the use of PFAS as well as many states looking to curtail their use through food, cleaning products, and cosmetic packaging. Currently, 12 states have bans on PFAS used in food packaging and four have restrictions on PFAS use in personal care products.
You can track state-level legislation on PFAS and other substances at Safer States.
California Leads the Way
Proposition 65 (Prop 65), originally enacted in 1986, requires businesses to provide warnings about exposure to chemicals that are known to the state to cause cancer or reproductive harm. It is also known as the Safe Drinking Water and Toxic Enforcement Act of 1986. The law is designed to protect the state's drinking water sources from contamination with chemicals known to cause cancer, birth defects, or other reproductive harm. It also requires businesses to provide warnings to Californians about significant exposures to these chemicals.
As the most-populated state in the nation, California not only serves as one of the largest skincare markets but also as a bellwether for regulation. Skincare brands that sell their products in California should be aware of the Proposition 65 requirements and take steps to comply with the law.
The Office of Environmental Health Hazard Assessment (OEHHA) is responsible for implementing Proposition 65. OEHHA maintains a list of chemicals that are known to cause cancer, birth defects, or other reproductive harm. This list is updated regularly as new scientific information becomes available. Since the inception of the list, over 900 chemicals have been added.
Effective November 17, 2023, the Office of Environmental Health Hazard Assessment (OEHHA) is adding coal-tar pitch, fluoro-edenite fibrous amphibole, and silicon carbide whiskers to the list of chemicals known to the State of California. A complete list of the current Proposition 65 list is available online at the OEHHA website.
Not only does Proposition 65 affect brands and businesses, but a new law, known as Assembly Bill 496, expands on the state’s 2020 Toxic-Free Cosmetics Act. The original act banned 24 chemicals in skincare and personal care products. The original law takes effect in 2025, the new legislation won’t be enforced until January 1, 2027, providing companies time to reformulate their products if necessary. The banned ingredients, including vinyl acetate and specific colors, are found in numerous cosmetic items. You can learn more about California Assembly Bill 496 here.
The State of California offers access to its California Safe Cosmetic Program Product Database (CSCP) where the public can search “all products sold in California containing fragrance or flavor ingredients on designated lists cited in the California Health and Safety Code Section 111792.6.” You can access the CSCP database here.
And of course, Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
“The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.” This legislation will significantly impact businesses and brands in personal care and cosmetics. Many manufacturers and agencies like the Independent Beauty Association and the Personal Care Products Council have been helping craft policy and monitor ongoing developments as these laws go into effect.
The latest development in this legislation is the FDA will delay enforcement of facility registration for six months to ensure that facilities have sufficient time to comply.
From the FDA website:
MoCRA provided new authorities to FDA including:
Facility Registration: Cosmetic product manufacturers and processors must register their facilities with the FDA, update content within 60 days of any changes, and renew their registration every two years.
Product Listing: A responsible person must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.
The FDA offers guidance for facilities and brands to learn about these new regulations and how best to comply.
As a premier contract manufacturer for many skincare and personal care brands, from large household names to emerging independent businesses, Federal Package is committed to producing high-quality products that meet compliance standards throughout the market. Our experts are monitoring changes in the regulatory environment and are working to ensure that all the products we produce meet the highest standards.