{"id":8366,"date":"2019-01-04T09:53:49","date_gmt":"2019-01-04T14:53:49","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=8366"},"modified":"2019-01-04T09:53:49","modified_gmt":"2019-01-04T14:53:49","slug":"lead-in-hair-dye-company-safe","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2019\/01\/04\/lead-in-hair-dye-company-safe\/","title":{"rendered":"Lead in hair dye \u2013 one company considers it safe"},"content":{"rendered":"

Tom Neltner, J.D.<\/em><\/strong><\/a>,\u00a0<\/em>Chemicals Policy Director <\/strong><\/p>\n

In October 2018, the Food and Drug Administration (FDA) banned<\/a> the use of lead acetate in hair dyes in response to a March 2017 color additive petition<\/a> from EDF and other health advocates. In December, we learned that Combe, Inc<\/a>., the maker of the lead-acetate based hair dye Grecian Formula, objected to FDA\u2019s decision, requested a formal evidentiary public hearing to review the decision, and claimed the use is safe. The objection puts the FDA\u2019s 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<\/a> has been identified.<\/p>\n

Combe\u2019s action was somewhat surprising because the company told CBS News<\/a> that it removed lead acetate from its Grecian Formula \u201cquite a long time ago,\u201d but was unable to provide an exact date. Presumably, someone in the know updated the product\u2019s Wikipedia page<\/a>, which says Grecian Formula does not contain lead acetate as of July 2018, although an earlier version<\/a> of the page said April 2018.<\/p>\n

Whatever the date it was reformulated, why would Combe block FDA\u2019s decision when it has long sold a lead-free brand \u2013 Just For Men<\/a> \u2013 and had already reportedly removed lead from Grecian Formula? From a market standpoint, objecting to FDA\u2019s decision benefits Youthair<\/a>, Combe\u2019s main competitor, which continues to sell a leaded-version of progressive hair dye.<\/p>\n

<\/p>\n

Combe\u2019s position is odder still since its corporate website does not list Grecian Formula as one of its men\u2019s hair care brands<\/a> \u2013 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\u2019s heritage page<\/a>. When I go to www.grecian-formula.com, I am redirected to Combe\u2019s corporate website.[1]<\/a> Despite the company\u2019s 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\u2019s presence with a simple test. It appears that the company is selling out its inventory as it walks away from the brand.<\/p>\n

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<\/a>. If the company allows FDA\u2019s ban to stand unchallenged, they are particularly vulnerable to legal challenges.<\/p>\n

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<\/a> and make a recommendation to the Commissioner.[2]<\/a> The law<\/a> directs FDA to act \u201cas soon as practicable after such request for a public hearing.\u201d In the interests of protecting people from the irreversible harm of lead, we think \u00a0the agency should move quickly.<\/p>\n

When the agency acts, EDF, as one of the petitioners that prompted the decision, anticipates participating in the hearing<\/a>. We plan to exercise our right to cross-examine Combe\u2019s witnesses and demand the company responds to written questions \u2013 interrogatories \u2013 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.<\/p>\n

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<\/a> that, contrary to FDA\u2019s analysis, there is \u201cconvincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive\u201d \u2013 the definition of safe<\/a> 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\u2019s resolve and stretch the agency\u2019s 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\u2019s decision to get the lead out of hair dyes.<\/p>\n

[1]<\/a> However, only the main page is redirected to Combe.\u00a0 People can still find the Grecian Formula website on search engines. The website no longer has any mention of lead acetate.<\/p>\n

[2]<\/a> FDA could also reverse its decision but that would draw objections from EDF and other health advocates.<\/p>\n

<\/div>","protected":false},"excerpt":{"rendered":"

Tom Neltner, J.D.,\u00a0Chemicals Policy Director 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, …<\/p>\n","protected":false},"author":69548,"featured_media":8367,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[69,114106,39263],"tags":[107224,107223,107222],"coauthors":[114044],"class_list":["post-8366","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-fda","category-lead","category-public-health","tag-grecian-formula","tag-hair-dye","tag-lead-acetate"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8366","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/users\/69548"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/comments?post=8366"}],"version-history":[{"count":0,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8366\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/8367"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=8366"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=8366"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=8366"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=8366"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}