The United States Food and Drug Administration has published a final rule banning the use of lead acetate as a colour additive in hair dye. The additive, used in products to gradually darken grey hair, was permanently listed as safe for use in hair colouring cosmetics back in 1980. However, the FDA says that following an NGO petition in April 2017, data has become available that means “there is no longer a reasonable certainty of no harm” from its use. Tom Neltner, chemicals policy director at the Environmental Defence Fund (EDF), welcomed the FDA’s decision as an “important step to protecting people from a continued source of exposure to lead that is a more significant route than the agency originally thought over three decades ago”.
In its Federal Register notice, the FDA says it “agrees with the petitioners that there is no evidence available at this time to determine a safe level of exposure to lead or lead compounds intentionally used as a colour additive in hair dyes”. The conclusion, the agency says, is based on:
- a recognition of the current consensus that there is no safe exposure level for lead;
- deficiencies identified from a re-evaluation of its 1980 skin absorption study, which may have resulted in an underestimate of exposure to lead from its use in hair dye; and
- the fact that blood lead levels in the US have dropped significantly since 1980, meaning it can no longer conclude that exposure to lead from lead acetate-containing hair dye has no discernible effect on the steady-state blood lead level.
The FDA says it will “exercise enforcement discretion” for 12 months from the effective date of the final rule to allow industry time to reformulate its products. The agency says the transition period takes into account the fact that bismuth citrate is already being used as an alternative for lead acetate in hair dye products marketed in the US and elsewhere. To help consumers wanting to avoid these products during the transition period, lead acetate will be listed as an ingredient and a warning label will say: “For external use only. Keep this product out of children’s reach.”
More than a dozen NGOs and public health advocates signed a 2017 petition that resulted in the FDA consulting on the use of lead acetate in hair dyes. The signatories called for the prohibition on the grounds that such use results in “dangerous lead exposure”. They argued that the 1980 listing of lead acetate had allowed levels of lead in hair dye that greatly exceeded those previously set by the Consumer Product Safety Commission (CPSC) for use in household paint. And as well as direct contact with the scalp, the petition cited a study demonstrating lead contamination elsewhere for example on surfaces touched after using the dye such as on blow-dryers, combs and taps. The Federal Register notice allows for a 30-day period from the date of publication for filing objections. After this the rule will become effective, unless there are objections, in which case the FDA will be given time to respond.
Further information is available at:
- Federal Register notice
- FDA statement
- EDF statement
~sChemical Watch, 31 October 2018