Reintroduction of the Personal Care Safety Act

Ten years of au Naturale Activism in Washington, D.C.

For the last decade we at au Naturale have been a voice of activism in Washington D.C. pushing for safety regulation in the personal care product industry–an industry that has seen zero updates since 1938!

Thousands of potentially harmful chemicals have been introduced into the U.S. cosmetics market without health and environmental safety checks and balances.

Those of you that have followed our journey with Senators Dianne Feinstein (D-CA) and Susan Collins (R-MA) know that we have supported edits and efforts to pass The Personal Care Products Safety Act. This bill will once again be introduced the week of June 14th. We are both excited and eager to push this legislation forward in this Congress that has renewed energy for bringing safety to the personal care products industry for every single American. 

The changes incorporated in the renewed Personal Care Product Safety Act are outlined below. We will update our blog with the entire Bill when it is introduced in a couple weeks.

Thank you for supporting federal change that will immediately impact the lives of all Americans should it seek passage in this Congress. The Au Naturale community has kept us energized in our lobbying efforts since 2011. Let’s keep after our lawmakers to see this latest version of the Personal Care Product Safety Act passed this year! We also want to thank the staffers in Sen. Feinstein and Collins’ office for tirelessly working on this legislation; we commend your efforts and hope they are finally make into law!

With Gratitude,

Ashley Prange

Changes from last Congress:

• Instead of specifying the first 5 ingredients to review in the bill, the FDA will be able to choose which product.
• Ingredients are reviewed within the first year of enactment.
• The ingredient review section now clarifies that color additives in cosmetic products that are already subject to a safety review and approval by FDA are not subject to the ingredient review established by this bill.
• GAO will be required to issue a report on the FDA ingredient review process no later than 5 years after enactment of the bill.
• Consistent with report language passed in last year’s spending bill, the labeling section now directs FDA to work with industry and health experts to define the term “natural” when it is used on cosmetic labels.
• Annual registration fee setting timeline has been pushed back by 2 years.

New provisions:

• A new section has been added to require fragrance ingredients that commonly cause allergic reactions to be listed on product labels.
• A new section has been added to direct FDA to issue a ban on products that intentionally contain the harmful chemical PFAS (perfluoroalkyl or polyfluoroalkyl substance).
• A new section has been added to strengthen oversight over counterfeit cosmetic products by giving FDA the authority to initiate seizure of these products and seek civil penalties for violations.

Bill summary:

New FDA authorities and requirements:

• FDA may recall products likely to cause serious harm when the company refuses to voluntarily cease distribution and recall the product.
• FDA will issue regulations to outline good manufacturing practices for personal care products.
• FDA will conduct a safety review of cosmetic ingredients annually with the goal of determining whether the ingredient is safe in cosmetic products, safe under specific conditions of use, or not safe in products.

Requirements for personal care product companies:

• Companies must register with the FDA, disclose the ingredients they use, and attest that they have safety records for their products.
• Companies must report serious adverse events (such as infections that required medical treatment) to the FDA within 15 days after receiving this information and submit an annual electronic report summarizing all adverse health events (including less serious reactions, such as rashes).
• Specific labeling may be required for certain products that contain ingredients not appropriate for the entire population, including warnings that vulnerable populations, such as children or pregnant women, should limit or avoid using the product.
• Internet sales of cosmetics must offer the same information that is included on the product’s packaging and regularly made available through in-person sales.
• User fees are collected to support FDA’s cosmetic safety activities. Annual fees are structured to accommodate manufacturers of different sizes and generate a total of $20.6 million per year.

Small businesses:

• The FDA will provide technical assistance and additional flexibility for smaller companies to comply with law.
• Domestic businesses selling under $500,000 in cosmetics products (or under $1 million if producing cosmetics in a private residence) are exempt from registration.
• Domestic businesses between $500,000 (or between $1 million if producing cosmetics in a private residence) and $2 million in sales have a simplified registration process. If a business produces more complex products, such as tattoo ink or hair dye, it will also provide FDA with information about ingredient concentrations. This does not include common handmade products such as soap, lotion, and sugar scrub.
• Business size is determined based on the previous three-year average in order to give small businesses time to adjust as they grow.

Preemption:

• The FDA’s findings on the safety of personal care product ingredients will preempt state regulation of those ingredients (for use in personal care products) following the date of enactment of this legislation.
• State laws in effect prior to the date of enactment are grandfathered and can remain in effect.
• States cannot implement new regulatory requirements for registration of companies.
• Manufacturing practices, mandatory recalls, or adverse event reporting after the bill is passed into law.