Lead is not good for animals or people. This mineral can cause a range of very serious health problems, from depression and memory loss to hypertension and multiple organ damage. That’s why we have been so puzzled by the FDA’s long-term lax attitude about the use of lead in hair dye.
The FDA and Lead in Progressive Hair Dyes:
We began bugging the FDA about lead acetate in so-called “progressive hair dyes” over 30 years ago. In 1990, we specifically asked the agency whether such products might pose a risk.
We wanted to know whether long-term exposure to lead in hair dye could be problematic. It just seemed to us that repeatedly smearing a lead-based cream on the hair might not be such a good idea.
The FDA basically told us not to worry. The message from the Food and Drug Administration was that the amount of lead people might absorb from their scalps was insignificant. If people used these products as instructed, and kept them away from irritated or abraded skin, there was no risk. In other words, go away and don’t bother us with such trivial concerns.
What Are Progressive Hair Dyes?
The key ingredient in progressive hair dyes has been lead acetate. This compound was used by the ancient Romans as a sweetener, hence its name “lead sugar” or “sugar of lead.” The Romans called it sapa and used it to sweeten wine.
It’s hard to say if the ancient Romans experienced ill effects from the lead in their wine. They were also exposed to this toxin from lead water pipes.
Pope Clement II died unexpectedly at the age of 42. His papacy was very short, from December 25, 1046, until his death in October, 1047. At that time, the cause of his death was a mystery.
In 1959, however, his body was tested. He died of an overdose of lead acetate. He, like the ancient Romans, apparently liked his sweetened wine, though it is possible he was poisoned.
Lead in Hair Dye:
How did lead acetate get in progressive hair dyes? The cosmetic industry has used lead acetate in some hair coloring products for many decades. It gradually darkens hair over several weeks.
Although women have long used a variety of “permanent hair dyes,” men largely relied upon over-the-counter products containing lead acetate. According to an article in the Journal of the American Pharmaceutical Association, Jan-Feb. 1997, the following products used to contain lead acetate:
- Grecian Formula
- Lady Grecian Formula
- RD Hair Coloring & Groomer, Crème Formula for Men
- Youthair Crème, Hair Dressing and Conditioner for Men and Women
Many progressive hair dye manufacturers, including the makers of Grecian Formula, have eliminated lead acetate from their formulations in the last few years. The FDA has not identified which products still contain this ingredient, however.
Readers Started Worrying About Lead in Hair Dyes:
In 1993, we received this question from Jack’s wife:
“I’m really worried about my husband’s health. For the last two years, he has been dying his hair to cover the gray. He says it’s essential to look youthful in his company, where he is a vice president. Jack is 42 and in great shape. Except for his gray hair, he could pass for a man in his mid-thirties.
“I’ve read that hair dye can increase the risk of cancer and I’ve tried to get Jack to quit, but it’s like talking to a brick wall. His father died of cancer and his uncle was recently diagnosed with colon cancer, so there is a family history.
“I don’t want Jack to jeopardize his health for the sake of his career. Am I worrying needlessly or is there a real danger?”
A. Back then, we cited epidemiologic research showing that men who dyed their hair frequently were more likely to develop multiple myeloma (American Journal of Public Health, Dec. 1992). We couldn’t imagine that any lead exposure would be healthy, but there was not yet a consensus on the danger.
In 1997, we received another question from a reader:
“My husband and I were shocked to read that the hair dye products designed for men contain lead. When we checked the label on the container, sure enough it said lead acetate.
“He has been using this stuff for many years. A youthful appearance is very important to him, but we never suspected that there might be a problem with his hair formula.
“The only health problem he has is high blood pressure. His doctor hasn’t been able to find a medicine that works. Could long-term lead exposure contribute to an increase in blood pressure?”
Questions About Lead In Hair Dye Remained:
By 2004, researchers had determined that chronic, low-level lead exposure could indeed raise blood pressure (Current Hypertension Reports, July 2004).
The FDA overlooked research showing that use of lead-containing hair dyes could result in high levels of lead on hands and household surfaces (combs, pillows, tap handles, hair dryers and telephones).
Skeptics described negative research about lead acetate as junk science. They downplayed any concern as “hair care scare.” The message was, don’t worry, be happy. No one was ever poisoned by lead-containing hair products!
Despite such reassurances, Canada banned lead acetate in 2008. But US regulators did not seem concerned.
We published this question in our syndicated newspaper column on November 16, 2009:
Q. I’ve been using a Grecian Formula for my graying hair for years. It has lead acetate in it. I checked the FDA website. They say they tested it and approved it. The lead has me a bit concerned. Any thoughts?
Our Answer:
A. The FDA does no testing of its own but did approve lead acetate as a “progressive” hair dye. That means it gradually darkens hair with repeated use.
The FDA concluded in 2002 that according to safety tests it received,
“No significant increase in blood levels of lead was seen in the trial subjects and the lead was not shown to be absorbed into the body through such use.”
Despite this reassurance, questions remain about the safety of lead-containing hair dyes. Canadian and European Union health authorities have banned lead from hair dyes and personal care products.
A study published in the Journal of the American Pharmaceutical Association (Jan/Feb, 1997) revealed that some lead residue is left on hands even after washing. Rubbing hands through hair may contaminate hands again.
The researchers noted that:
“Given the requirement to continually reapply these hair coloring agents, the user becomes a living purveyor of lead contamination.”
The FDA Takes Belated Action Against Lead in Hair Dye:
The FDA finally “banned” lead acetate in 2018.
Consumer Reports (Jan. 9, 2019) described the situation this way:
“‘We couldn’t believe it was the 21st century and lead acetate—a dangerous neurotoxin—was still allowed for use in hair dye,’ says William Wallace, senior policy analyst at Consumers Union, the advocacy division of Consumer Reports. ‘The decision by the FDA is the latest step toward getting lead out of products so it doesn’t harm consumers.’”
“The FDA cited the broad consensus that there is no safe level of lead exposure, and noted that the approval of lead acetate as a coloring agent in the first place was based on a 1980 study that included ‘deficiencies.’”
“‘We now know that the approved use of lead acetate in adult hair dyes no longer meets our safety standard,’ the FDA commissioner, Scott Gottlieb, said in a statement. ‘Lead exposure can have serious adverse effects on human health, including for children, who may be particularly vulnerable. Moreover, there are alternative color additives for hair-coloring products that consumers can use that do not contain lead as an ingredient.’”
Even then, though, the agency delayed enforcement because of objections by manufacturers.
Here was the FDA’s explanation for the delay:
“On April 1, 2019, the final rule was stayed because the agency received objections to its decision and a public hearing was requested within the allowable timeframe. The agency has reviewed the objections and has determined that they did not raise issues of material fact that justify a hearing.”
Over two years went by with no FDA action.
An Update on Getting the Lead in Hair Dye OUT At Last!
On October 7, 2021 the FDA announced a “final” rule repealing the use of lead acetate as a safe ingredient in hair dyes.
“The U.S. Food and Drug Administration (FDA) has amended the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp because new data, demonstrating that there is no longer a reasonable certainty of no harm from the use of this color additive, became available since lead acetate was permanently listed.”
This rule requiring the elimination of lead in hair dye finally goes into effect on January 6, 2022, but manufacturers will have up to a year to get their noncompliant products off shelves.
Here is how the FDA describes this additional delay:
“We intend to exercise enforcement discretion for 12 months following the effective date to provide industry with the opportunity to deplete their current stock and reformulate their hair dye products containing lead acetate.”
It took over 30 years for consumer advocates to get the FDA to recognize the danger of topical lead in hair dye. It will take a few more months for this rule to go into effect and longer still to verify that all products are lead-free. By the way, Grecian Formula no longer contains lead acetate. Instead, it has: Water, Isopropyl Alcohol, Triethanolamine, Bismuth Citrate, Sodium Thiosulfate, Fragrance, Panthenol.
What Do You Think?
Has the FDA surprised you with its snail’s pace? We have been asking the agency to do something about lead acetate for more than three decades. Needless to say, our patience ran out long ago.
The FDA is like an impenetrable fortress. When in doubt, the organization circles the wagons, pretends there is nothing to worry about, and waits for the dust to settle. In the case of lead, the dust never quite settled.
For a very long time we have been asking the FDA to be a more proactive organization when it comes to patient safety. That includes the way it approves of generic drugs, the way it oversees prescription drug commercials on television and the way it balances benefits against risks. Just read our article about the drug Aduhelm for Alzheimer’s disease to begin to understand our frustration.
We are starting a campaign to “End Deceptive Drug Commercials on TV.” It will doubtless be a long and challenging struggle. There is lot of money at stake. But we have demonstrated our willingness to fight the good fight over the last five decades. We hope you will join us.
One way you can help is by sharing articles like this with family and friends. It’s easy; just scroll to the top of the article and send it out via email, Twitter and/or Facebook. We bet people will be surprised to learn that lead acetate dates back to ancient Rome and sweetened wine. You may also want to encourage friends to subscribe to our newsletter.
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