This bill adds a new "Supply Chain Transparency" subchapter to the Federal Food, Drug, and Cosmetic Act. It requires suppliers to give brand owners safety and composition information about cosmetics and ingredients within 90 days of a request. Required information includes functions and uses, human health and environmental hazards, chemical identifiers (CAS numbers), safety data sheets, manufacturing flow charts, composition statements, fragrance allergen statements, full ingredient lists for formulations, and certificates of analysis. The bill directs the Food and Drug Administration (the Secretary) to create and keep a list of "nonfunctional constituents" that are known or reasonably expected to be present in cosmetics and that are harmful to human health or the environment. The definition of harmful refers to specific categories (for example, reproductive toxicants, endocrine disruptors, carcinogens) and several named lists used by other agencies and the European Union.
The bill requires the FDA to publish a proposed initial list and take public comment, convene an advisory committee (with equal representation from industry, nonprofit, scientific, and medical/public health communities), and finalize the list within specified deadlines. The FDA must also issue guidance on testing methods and detection limits. Suppliers must test for any nonfunctional constituent added to the FDA list within one year and provide brand owners a certificate of analysis with measured levels, test methods, detection limits, and heavy metal testing results before selling the ingredient or cosmetic. The FDA may request supply chain information when it has reason to believe a cosmetic is adulterated or misbranded; entities in the supply chain must keep and provide records to the FDA on request. Violations of key supply chain and testing provisions can lead to civil penalties of up to $10,000 per day. The bill also clarifies that certain state requirements about ingredient limits, reporting, or greater transparency are not preempted.
No publicly available information on estimated costs or budgetary effects is included in the bill text or metadata. The bill does require FDA actions (creating a list, convening an advisory committee, developing guidance, and a petition process) and imposes testing and recordkeeping requirements on suppliers and manufacturers, which could require resources, but the bill text does not include cost estimates.
No publicly available information.
No publicly available information.