What are Washington state and FDA lead limits for cosmetics/toothpaste and how do they compare to public‑health guidance?
Executive summary
Washington state’s new statutory approach to lead in cosmetics and some toothpastes sets an action level near 1,000 parts per billion (ppb, 1 ppm), far stricter than the U.S. Food and Drug Administration’s (FDA) recommended maximum for cosmetics of 10 parts per million (ppm) and the much higher FDA thresholds applied to toothpastes in practice (up to 10,000–20,000 ppb reported for some categories) [1] [2] [3]. Public‑health authorities, including the CDC and WHO, stress that there is no known safe level of lead exposure, and toxicologists and pediatricians argue lower limits (or elimination) are preferable to protect children and pregnant people [4] [5].
1. What Washington state requires and why it is stricter
Washington’s Toxic‑Free Cosmetics Act and related policy materials reflect a push to sharply reduce lead in products sold in the state by targeting concentrations around 1,000 ppb (1 ppm) for certain cosmetics and rinse‑off products, and the state has issued interim policies and compliance pathways to help manufacturers meet those statutory concentrations [6] [7] [8]. The Washington legislative and Ecology documents note technical feasibility of lower concentrations (example targets cited as low as 2 ppm for general cosmetics in guidance) while also acknowledging transitional policies for industry [7] [6]. Reporting and state notices cite the 1,000 ppb action‑level as a recent legal benchmark that led to several tested toothpastes exceeding the new standard [5] [1].
2. The FDA’s position and numerical thresholds
The FDA’s current draft guidance for industry recommends a maximum of 10 ppm (10,000 ppb) for lead as an impurity in cosmetic lip products and externally applied cosmetics and explains that this level was judged not to pose a health risk based on the agency’s exposure assessment [2] [9]. For toothpastes specifically, academic and media sources summarize that FDA regulatory practice has tolerated higher numerical thresholds—reports cite up to 10,000 ppb for fluoride‑free toothpastes and 20,000 ppb for fluoride toothpastes under current federal frameworks—while noting most tested products fall well below those upper bounds [10] [1]. The FDA also treats fluoride‑containing toothpastes as over‑the‑counter drugs (subject to drug regulation) while non‑fluoride toothpastes are classified as cosmetics, a distinction that affects which numerical limits and oversight apply [5] [11].
3. How these numerical limits compare to public‑health guidance
Public‑health guidance from agencies and experts emphasizes that “there is no known safe level of lead,” and therefore even small amounts in consumer products are a concern for neurodevelopment in children and reproductive harm in adults [4]. Toxicology assessments translate product concentrations into potential daily intakes and compare them to health‑based guidance values; some recent risk assessments used a health‑guidance value designed to protect children and pregnant women that is several times lower than FDA’s informal intake reference levels, implying that products with lead at 1,000 ppb could be more consistent with protective public‑health thresholds than FDA’s higher cosmetic guidance [8] [9]. In short, Washington’s 1 ppm approach aligns more closely with precautionary public‑health principles than the FDA’s 10 ppm cosmetic recommendation or the higher toothpaste thresholds referenced in investigations [4] [2] [1].
4. Industry, regulatory tradeoffs and competing rationales
The FDA frames the 10 ppm recommendation as achievable with current manufacturing practices and not posing a public‑health risk based on its exposure models, aiming for harmonization with international norms [9] [12]. Washington’s stricter limit, by contrast, is driven by a precautionary public‑health posture and advocacy reports showing detectable lead in many products, prompting legislators to prioritize lower allowable concentrations even while offering interim compliance relief to manufacturers [6] [5]. Critics of stricter limits argue feasibility and supply‑chain implications; proponents stress the irreversible harms of early‑life lead exposure and point to international jurisdictions that set far lower cosmetic and toothpaste maxima [10] [4].
5. Bottom line and limits of available reporting
Numerically: Washington ≈1,000 ppb (1 ppm) action level for certain cosmetics/toothpaste types, FDA guidance recommends up to 10 ppm for cosmetics and has historically allowed substantially higher limits cited for toothpastes (10,000–20,000 ppb) depending on classification; public‑health bodies assert no safe level of lead and favor much tighter protections, particularly for children and pregnant people [6] [2] [1] [4]. Reporting and regulatory documents do not fully reconcile every numerical discrepancy (for example, product‑type distinctions and transitional rules), and available sources note that exposure assessments and legal classifications drive much of the difference in policy outcomes [11] [9].