On October 30, 2018, the US Food and Drug Administration (FDA) announced a final rule that prohibits the use of lead acetate as a color additive in hair dye. The basis of the rule, according to the FDA, is a petition submitted in April 2017 presenting recently available information that lead acetate in hair dye may cause harm to the user. In 1980, the FDA had approved the use of the chemical for hair coloring and set a maximum concentration level at 0.6%, but did not establish limits for how often the product can be used and what quantities are considered acceptable.
The FDA’s change in position was triggered by petitions from various NGOs and citizen groups who claim that the use of lead acetate in hair dye results in exposure to lead at dangerous levels. The 2017 petition was signed by more than one dozen groups. They maintain that the 1980 approval of lead generated lead levels in hair dye that surpassed levels previously determined to be safe by the Consumer Product Safety Commission for lead in household paint products.
The FDA’s decision is based on several factors. First, it cannot establish a safe level of exposure to lead or lead compounds used for hair dye based on current evidence. In addition, the agency reviewed its 1980’s skin absorption study and found that it did not accurately assess the exposure to lead for users of hair dye. Lastly, the FDA acknowledged that it can no longer determine that lead exposure linked to hair dye with lead acetate does not significantly alter the level of lead in the blood.
The agency will “exercise enforcement discretion” for one year after the effective date of the final rule in order to provide affected members of the industry to reformulate their hair dye products. In the United States, bismuth citrate is currently used instead of lead acetate in hair dye products. During the period designated for reformulation, users may be notified that lead acetate is an ingredient in hair dye through a warning label that states that children should refrain from contact with the product.
Grimaldi Law Offices has been advising clients for over 20 years on chemical and product law. For knowledgeable advice and in-depth analysis on your Prop 65 and other chemical regulatory compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].