In October 2018, the Food and Drug Administration (FDA) banned the use of lead acetate in hair dyes in response to a March 2017 color additive petition from EDF and other health advocates. In December, we learned that Combe, Inc., the maker of the lead-acetate based hair dye Grecian Formula, objected to FDA’s decision, requested a formal evidentiary public hearing to review the decision, and claimed the use is safe. The objection puts the FDA’s decision on hold awaiting a process that may take years to resolve. Apparently, the company thinks it is safe for men to slather skin-soluble lead on their head every couple of days and to risk exposing their families to a heavy metal for which no safe level of exposure has been identified.
Combe’s action was somewhat surprising because the company told CBS News that it removed lead acetate from its Grecian Formula “quite a long time ago,” but was unable to provide an exact date. Presumably, someone in the know updated the product’s Wikipedia page, which says Grecian Formula does not contain lead acetate as of July 2018, although an earlier version of the page said April 2018.
Whatever the date it was reformulated, why would Combe block FDA’s decision when it has long sold a lead-free brand – Just For Men – and had already reportedly removed lead from Grecian Formula? From a market standpoint, objecting to FDA’s decision benefits Youthair, Combe’s main competitor, which continues to sell a leaded-version of progressive hair dye.
Combe’s position is odder still since its corporate website does not list Grecian Formula as one of its men’s hair care brands – only Just For Men is identified. I reviewed all of the webpages on the site and found no mention of Grecian Formula, even on the company’s heritage page. When I go to www.grecian-formula.com, I am redirected to Combe’s corporate website. Despite the company’s apparent claims of removing lead from Grecian Formula, I bought a bottle at a Walgreens in the Midwest on December 20 that lists lead acetate as ingredient. I confirmed the chemical’s presence with a simple test. It appears that the company is selling out its inventory as it walks away from the brand.
I suspect that Combe is either trying to reduce risk of potential lawsuits by users and their families exposed to lead or possibly to protect its market in developing countries that typically require FDA approval. FDA acknowledged that the study on which the original safety decision was made in 1980 had five serious deficiencies. If the company allows FDA’s ban to stand unchallenged, they are particularly vulnerable to legal challenges.
Whatever the reason, Combe has leveraged a provision of the law that gives FDA little choice but to put its decision on hold and move forward by appointing a hearing officer to convene a formal evidentiary public hearing and make a recommendation to the Commissioner. The law directs FDA to act “as soon as practicable after such request for a public hearing.” In the interests of protecting people from the irreversible harm of lead, we think the agency should move quickly.
When the agency acts, EDF, as one of the petitioners that prompted the decision, anticipates participating in the hearing. We plan to exercise our right to cross-examine Combe’s witnesses and demand the company responds to written questions – interrogatories – in advance of the hearing. For instance, we would ask Combe to provide any information it has received since 1980 indicating that customers or their families had concerns about lead exposure from the product. The information would include whether Combe adequately investigated the claims and properly reported them to FDA.
Ultimately, FDA will make the decision whether the lead acetate as a color additive in hair dye is safe. Combe will have the burden of proving that, contrary to FDA’s analysis, there is “convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive” – the definition of safe for color additives. Since Combe claims to have reformulated its Grecian Formula to have no added lead-acetate and appears to be walking away from the brand, the company must see its potential legal liability and financial strain as so significant that it has chosen to test FDA’s resolve and stretch the agency’s already limited resources. With what we now know about the risks of lead exposure, it seems unbelievable that a company is standing up for the use of the heavy metal in their product. Despite this setback, EDF and others are ready to defend FDA’s decision to get the lead out of hair dyes.