Lead in Lipstick FDA Testing 2026: What FDA Found and Why Its 10 ppm Limit Is Still a Draft
Lead is not a lipstick ingredient. It is an impurity. FDA says lead occurs naturally in the environment and that its occurrence, as an impurity, in cosmetic products can’t be avoided. This piece covers what FDA’s lab testing found, what the 10 ppm number means and what it doesn’t, and how lead is regulated as a color additive impurity versus as an ingredient.
What FDA measured in lip products
The results are less alarming than the reputation. FDA says it has analyzed hundreds of lipsticks and other cosmetic lip products, lip glosses among them. It found lead levels from below the detection limit to about 7 ppm. The agency also published the method it developed for measuring lead in lipstick.
FDA puts it more broadly: most cosmetics sold in the U.S. generally already contain less than 10 ppm of lead. It also says a small number contained higher amounts, and that some cosmetics from other countries contain lead at higher levels.
FDA has also tested beyond lip products. In hundreds of externally applied cosmetics, such as eye shadows, blushes, shampoos and body lotions, it found lead from below the detection limit to 14 ppm. FDA says over 99% of the cosmetic lip products and externally applied cosmetics on the U.S. market contain lead at levels below 10 ppm. FDA explains the need for these surveys directly: cosmetic companies do not have to share their safety data or file their product formulations with FDA. Buying products off the market and testing them is how the agency learns what is actually being sold.
Ingredient or impurity: where the binding limits are
For most cosmetic ingredients there is no approval step. The Federal Food, Drug, and Cosmetic Act does not require FDA approval before most cosmetics or their ingredients go on sale. The only exception is for the color additives.
Color additives do have binding rules. Each approved color has a listing regulation that sets impurity limits. For lead, that limit is typically 10 to 20 parts per million. Some colors must come from FDA-certified batches, and certification includes testing each batch for lead. Colors are used in very small amounts, so FDA says these lead levels are unlikely to pose a health risk.
The guidance for lip products explicitly does not apply to hair dyes that contain lead acetate as an ingredient.
| Date | Event | Impact |
|---|---|---|
| Dec. 2016 | FDA issues draft guidance | 10 ppm lead recommended for lip products |
| Oct. 29, 2018 | Final rule on lead acetate | Removed from scalp hair-coloring rules |
| Apr. 1, 2019 | Final rule stayed | Objections and hearing request received |
| Oct. 28, 2021 | CDC reference value set at 3.5 µg/dL | Lower bar for flagging children’s lead |
| Jan. 6, 2022 | Lead acetate no longer allowed | Hair dye ingredient use ends |
The 10 ppm figure is a draft recommendation
FDA’s own pages describe it as a draft. In December 2016, FDA issued draft guidance to industry on lead as an impurity. The guidance covers lipsticks, lip glosses and lip liners. It also covers externally applied products such as eye shadows, blushes, shampoos and body lotions (fda.gov), plus compact powders (fda.gov). The docket number is FDA-2014-D-2275.
The wording on FDA’s pages varies. The agency’s cosmetics testing page says FDA has published draft guidance for industry recommending a 10 ppm maximum. The core “Lead in Cosmetics” page says only that FDA has issued guidance to industry limiting lead to that level, without calling it a draft. FDA asked commenters to respond within 60 days of its publication so the agency could consider their input before the draft guidance becomes final.
This matters for enforcement. A guidance document sets a recommendation, not a legal limit. FDA’s enforcement power comes from the adulteration standard: a cosmetic is adulterated if an ingredient or impurity may make the product harmful when it is used as intended. Before acting, though, FDA says it needs reliable scientific information proving that the product is adulterated. FDA can also act against an unsafe product even if it doesn’t contain an ingredient or impurity that is prohibited or restricted.
How FDA’s safety reasoning compares with CDC’s
FDA’s case for 10 ppm rests on exposure. Lead from lipstick gets into the body mainly by swallowing, for example when someone licks their lips. So FDA estimated exposure the same way it does for lead in food. It concluded that exposure from 10 ppm in lip products is very small and cannot be measured in routine blood testing. Skin absorption from products like eye shadow or lotion is even lower. FDA’s supporting document says detecting the increase requires state of the art analytical technology.
CDC and ATSDR approach lead from a different angle. ATSDR’s clinical guidance quotes the American Academy of Pediatrics: “There is no identified threshold or safe level of lead in blood”. It cites sufficient evidence for adverse health effects in children and adults at blood lead levels below 5 µg/dL. As of October 28, 2021, CDC uses a blood lead reference value of 3.5 micrograms per deciliter to flag children with higher-than-usual levels.
The two positions don’t contradict each other, but they answer different questions. FDA’s claim is that this source adds too little lead to measure. ATSDR’s claim is that no amount of lead in blood is proven safe, and that it is important to control or eliminate all sources of lead in children’s environments. A reader can accept FDA’s numbers and still see why reducing an avoidable source is reasonable.
Where things stand in 2026
FDA’s lip-product testing found lead levels up to about 7 ppm. That is below the agency’s own recommended maximum. The binding limits apply to color additives. FDA has issued draft guidance to industry recommending that cosmetic lip products and externally applied cosmetics not contain more than 10 ppm lead as an impurity.
Analysis: the main weak spot is imported products, not mainstream U.S. lipstick. FDA itself says that issue makes a recommended maximum all the more important as more products are imported. These sources don’t say whether FDA will finalize the guidance.
Sources
- fda.gov – “Lead in Cosmetics”
- fda.gov – “Limiting Lead in Lipstick and Other Cosmetics | FDA” (2022)
- fda.gov – “FDA’s Testing of Cosmetics for Arsenic, Cadmium, Chromium, Cobalt, Lead, Mercury, and Nickel Content | FDA” (2022)
- archive.cdc.gov – “Lead (Pb) Toxicity: What Are Possible Health Effects from Lead Exposure? | Environmental Medicine | ATSDR” (2023)
- fda.gov – “Supporting Document for Recommended Maximum Lead Level in Cosmetic Lip Products and Externally Applied Cosmetics | FDA” (2022)