The US FDA has put on hold its final rule that would ban the use of lead acetate as a coloring additive in hair dyes, following objections from the manufacturer of Grecian formula, Combe, International.
The proposed ban of lead acetate, which followed the agency’s consideration of an April 2017 petition filed by the Environmental Defense Fund and other NGOs, was published in the Federal Register in October 2018. In it, the FDA said new data indicates there is “no longer a reasonable certainty of no harm” from the use of lead acetate in products used to gradually darken gray hair.
The FDA’s plan to amend the color additive regulations were scheduled to take effect on December 3, 2018, with a one-year period of enforcement discretion to allow the hair dye industry to reformulate during the interim time.
But within the 30-day period for filing objections, personal care products company Combe International requested a formal evidentiary public hearing on the US FDA’s final rule, effectively placing the rulemaking action on hold.
The FDA had intended to publish a Federal Register notice in late 2018 staying the rule, pending resolution of the objections. That action, however, has been delayed due to the partial shutdown of the federal government.
Combe International – the manufacturer of Just for Men and Grecian Formula – said in its objections submitted on November 30, that the FDA had failed to show there is no longer a reasonable certainty of no harm for the use of lead acetate in progressive hair dyes.
Among the company’s concerns was the FDA’s use of what the company discribed as “unvalidated and novel computer analysis.” The company complained that this did not appear in the NGO petition, nor was it made available during the public comment period.
Combe also claimed that the FDA had “erroneously discarded a landmark clinical study” which it had partially relied on in its original 1980 approval of the color additive in its hair dye.
“The science supports the continued safety of lead acetate in hair dye,” Combe concluded.
Petitioner Vehemently Disagrees
In a blog post, the EDF’s chemicals policy director, Tom Neltner, said it was “unbelievable that a company is standing up for the use of the heavy metal in their product.”
Combe notes that it has reformulated its products to no longer include lead acetate. Nelter questioned whether a desire to reduce exposure to litigation motivated the objections.
“FDA acknowledged that the study on which the original safety decision was made in 1980 had five serious deficiencies, Mr. Neltner said. “If the company allows FDA’s ban to stand unchallenged, they are particularly vulnerable to legal challenges.”
Anthony Santini, senior vice president and general counsel for Combe, confirmed that the company no longer manufactures or distributes hair coloring products containing lead acetate.
But he said that the original formula of Grecian Formula was “safely used by loyal consumers for over five decades,” and that the FDA has “significantly misconstrued the evidence concerning lead acetate and erred in its conclusions regarding the color additive petition.”
“Combe trusts that through its objections and a formal evidentiary hearing, the record will be corrected regarding the long-time safe use of lead acetate in progressive hair dye products,” Mr. Santini added.
Neltner said his organization plans to participate in the hearing and cross-examine the company’s witnesses. “EDF and others are ready to defend FDA’s decision to get the lead out of hair dyes,” he concluded.
Grecian Formula was one of the first products to face a Proposition 65 enforcement action by the California Attorney General in the 1980s. Combe, Inc, entered into a settlement with the Office of the Attorney General requiring reformulation to eliminate the lead contained in its hair dye products.