NEW YORK, June 12, 2012 — -- The active chemical used in spray tans, dihydroxyacetone (DHA), has the potential to cause genetic alterations and DNA damage, according to a panel of medical experts who reviewed 10 of the most-current publicly available scientific studies on DHA for ABC News, including a federal report ABC News obtained through the Freedom of Information Act.
Six medical experts in areas ranging across the fields of dermatology, toxicology and pulmonary medicine said they "have concerns" after reviewing the literature and reports about DHA, the main chemical in the popular "spray-on" tan, which has conventionally been referred to as the "safe" alternative to tanning under ultraviolet lights.
None of the reviewed studies tested on actual human subjects, but some found DHA altered genes of multiple types of cells and organisms when tested in different labs by different scientists after the chemical was approved for use in the consumer market.
"I have concerns," said Dr. Rey Panettieri, a toxicologist and lung specialist at the University of Pennsylvania's Perelman School of Medicine. "The reason I'm concerned is the deposition of the tanning agents into the lungs could really facilitate or aid systemic absorption -- that is, getting into the bloodstream."
Panettieri, like all the experts ABC News consulted with, said more studies should be done. He emphasized the available scientific literature is limited. Still, he said, he has seen enough to say the warning signs of serious health concerns exist.
"These compounds in some cells could actually promote the development of cancers or malignancies," he said, "and if that's the case then we need to be wary of them."
The FDA originally approved DHA for "external" use back in 1977, when it was popular in tanning lotions. Those lotions, previously famous for turning skin orange, were never as popular as current products that produce better tans. In recent years, the use of DHA has exploded in the newer "spray" application of the product, which provides a more even tan for consumers.
The FDA told ABC News it never could have envisioned the chemical's use in spray tan back in the 1970s, and says "DHA should not be inhaled or ingested" today. It tells consumers on its website, "The use of DHA in 'tanning' booths as an all-over spray has not been approved by the FDA, since safety data to support this use has not been submitted to the agency for review and evaluation."
The agency advises consumers who spray tan they are "not protected from the unapproved use of this color additive" if they are inhaling the mist or allowing it to get inside their body. The agency recommends, "Consumers should request measures to protect their eyes and mucous membranes and prevent inhalation."
However, ABC News found some tanning salons offering consumers advice that directly conflicts with what the Food and Drug Administration has recommended.
In response to ABC News' findings, the tanning industry has announced it will launch a major national training initiative that will hit thousands of salons across the United States over the next few weeks, intended to inform both salons and customers who "spray tan" about the FDA recommendations.
Tanning Salons: Undercover Investigation
However, in an attempt to see if that message was reaching consumers, ABC News sent undercover cameras into a dozen randomly selected tanning salons in New York City ranging from a large corporate location to smaller mom-and-pop salons.
Every salon ABC News visited said spray tanning was completely "safe" with or without protective gear.
When asked, nine out of 12 salons did not have any eye covers in stock. Similarly, nine out of 12 salons did not have nose plugs in stock. Eleven out of 12 failed to have any protective gear for the mouth available.
However, even if salons had some of the gear in stock, every salon ABC News visited discouraged using it.
"You don't need it. You really don't need it," one salon employee said.
Another discouraged eye protection, saying it would impact the appearance of the tan.
"We wouldn't recommend for you to wear them because when you spray your face that part is going to be not tan," a salon employee said.
A different salon said, "We also have goggles but you don't need them."
Yet another salon wrongly told undercover ABC News producers that DHA is so safe, it is used to help treat diabetes and can be injected into the body.
The findings by ABC News were enough to convince the industry's top tanning salon trainer to launch the comprehensive national program to reinforce the FDA's safety recommendations.
"As a result of your investigation I will be developing a unit to emphasize training points on the usage of the protective measures by spray tanning clients," said Joe Levy in an email to ABC News.
Levy is the executive director of the International Smart Tan Network, the educational institute for the North American sun bed community.
"I am going to personally review protocol in facilities that are doing this effectively and, based on that assessment, immediately put training in place to improve compliance everywhere," he said.
Levy said his message will go out in several phases over the next few weeks and estimated that it should hit "nearly every salon in the United States."
Spray Tans: False Sense of Security Given Online
ABC News also discovered many tanning salons across the nation wrongly telling consumers on their websites that DHA is so safe that it is "food grade," and, "approved for ingestion by the FDA."
One potential source of the inaccurate information was one of the largest manufacturers of spray tan product in America, Norvell Skin Solutions, ABC News found.
The company runs what it calls "Norvell University," a detailed educational course designed for tanning salons and technicians who wish to offer spray tans to clients. ABC News found Norvell wrongly training salons online and in its course material by saying that "DHA is a food grade product approved for ingestion by the FDA. In fact, the largest user of DHA in the world is the health supplement industry."
The salons and Norvell may have been confusing two very different kinds of "DHA," each with the same abbreviated name. The type of DHA the FDA tells consumers not to inhale or ingest, also called dihydroxyacetone, is the chemical that turns your skin brown.
However, an omega 3 fatty acid called docosahexaenoic acid also shares the same abbreviation "DHA." That type of DHA can be found in salmon or milk. It is approved by the FDA to be eaten and is thought to help reduce the risk of coronary disease.
"We were absolutely in error," said Rick Norvell, president of Norvell Skin Solutions, after ABC News contacted him about the discrepancy.
Norvell subsequently removed the inaccurate claims from the company's course material and took it offline. He also issued a letter to all of the tanning salons and distributors who use the company's product nationwide. In that letter, Norvell referenced the ABC News report and said, "In our most recent review of the Norvell and Norvell University documents and websites we have removed the term 'food grade' in reference to our products."
The manufacturer also informed tanning salons it is now recommending full implementation of the FDA recommendations for consumers to use protective measures when spray tanning.
"As many of you may be aware, the FDA has suggested guidelines as to the recommended use and operation of our products within the sunless industry," Norvell wrote to his customer base. "We should also point out these guidelines apply to at home use products such as aerosols and bag-on-valve self-tanning sprays containing DHA. Our professional industry should not be singled out. ... Although not mandated, anything the FDA suggests, we at Norvell take seriously."
Norvell went on to specifically note:
"When spraying DHA the FDA recommends and Norvell concurs with utilizing the following guidelines:
Norvell told ABC News in an email, "This reminder was sent via Eblast, Twitter and Facebook to approximately 14[,000]-16,000 contacts."
Further, Norvell provided those contacts with a printable sign "for use at your front counter or within your sunless spray rooms," which informs consumers of the safety recommendations.
DHA: 'A Potential Health Hazard'?
The FDA recently released a report to ABC News, following a Freedom of Information Act request, in which agency scientists wrote, "New information regarding the genotoxicity and carcinogenicity of DHA has become available since the listing of DHA as a color additive."
In the report, dated 1999, agency scientists cited the "new information" discovered by non-FDA researchers who had tested DHA in laboratory settings and found it had the potential for what they called a "mutagenic" effect on genes. The various studies, conducted mostly by university researchers, tested DHA's effects on different types of cells and organisms, including bacteria, salmonella, ecoli and mice skin cells grown in a lab. None of the tests done at the time tested human cells or humans themselves. Still, the results were enough to prompt the agency in the 1990s to attempt to determine how much DHA might be seeping into the living areas of the body when applied to the skin to tan.
Prior to the FDA release this year of its 1999 report to ABC News, the tanning industry and even many in the field of dermatology thought DHA only interacted with proteins in the outer protective layers of human skin, also called the stratum corneum, where the skin cells are already dead and where DHA could pose no health risk.
However, in the report released to ABC News, FDA scientists concluded that DHA does not stop at the outer dead layers of skin.
They wrote: "The fate of DHA remaining in skin is an important issue, since high DHA skin levels were found."
They added that tests they performed revealed that much of the DHA applied to skin actually ended up in the living layers of skin.
They concluded: "This leaves about 11 percent of the applied DHA dose absorbed remaining in the [living] epidermis and dermis."
Four years after the report was issued, the FDA wrote a follow-up paper based on the same data, concluding that "probably" only 0.5 percent of each application of DHA becomes "systemically available," meaning distributed throughout the body after reaching the bloodstream.
The agency concluded that 0.5 percent of an applied dose of DHA was poor absorption, and no further testing was done to check for actual toxicological impacts on the human body. The thinking was that because only a little bit of DHA entered the bloodstream, the health risk would be very low.
However, any absorption into the living areas of the skin could be pose a potential risk, even if none of it made it into the bloodstream, said Dr. Darrell Rigel, an NYU professor of dermatology. The fact that some does potentially get into the bloodstream raised additional red flags for him that he said needed to be further explored.
Rigel was especially concerned for repeated users of the product and those in higher-risk groups such as pregnant women or young children.
Girls as young as 4 years old who compete in beauty pageants are known to be spray tanned by their moms, who believe the tan to be a completely safe way to give their children a darker glow.
Rigel believes the FDA paper, combined with other literature he reviewed, would surprise many of his colleagues in the medical field. He said the papers were enough to make him change what he will tell his patients about spray tanning.
"What you showed me certainly leads me to say I have to rethink what I'm doing and what I'm saying because there's ... a real potential problem there," he said. "I feel that I must give my patients the information that you've given to me, because I think it is valid."
Following receipt of the 1999 FDA report, ABC News located nine other studies performed mostly by non-government university researchers on DHA. ABC News asked Rigel and five other medical experts to review the papers and anything else they could find on their own, and to offer their analysis about potential health risks.
Before he read all of the papers, Rigel said, he would "tell my patients what every other dermatologist tells them: 'If you want to be tanned, [tanning with DHA] is effective, it's not being absorbed and there's no long-term problems.' After reading these papers, I'm not sure that's true anymore."
"A potential problem has been identified and for public safety, more studies should be done," added Rigel, a former president of the three largest dermatological groups in the nation: the American Academy of Dermatology, the American Dermatological Association, and the American Society for Dermatologic Surgery.
"The concern here is we never thought this was getting absorbed," he said. "We thought it's binding to the surface of the skin and that's where the stain is. So this is ... news that, in fact, it is penetrating beyond that."
ABC News also presented the panel of experts with information about some studies that found no carcinogenic or potential cancer-causing impacts of DHA, such as when it was tested on mice.
However, that same FDA report from the 1990s raised questions about whether some of those tests came up negative simply because the DHA never absorbed into the skin of the particular type of mice tested.
Dr. Lynn Goldman, the dean of the School of Public Health and Health Services at George Washington University, reviewed the same group of papers and said that DHA tested positive for mutating genes in far too many different types of studies to reject concerns about its health implications.
"The substance seems to have a potential for what they call creating mutations or changing DNA in living cells, which is a serious problem and needs to be further investigated, yet hasn't been," she said.
"What we're concerned about is not so much that reaction that creates the tanning, but reactions that may occur deeper down with living cells that might then change DNA, causing a mutation and what the possible impacts of that might be," she said. "I'd be very concerned for the potential of lung cancer."
Researchers should, however, not just be concerned about cancer, but other health effects such as birth defects, especially if a woman who was pregnant was spray tanning and allowing the mist to get inside her body, Goldman said.
One tanning salon employee ABC News visited undercover, the lead trainer for a large corporate chain of salons in New York, told undercover television producers that DHA is "super safe," and, "great for pregnant women," something Goldman disagreed with.
Goldman is a pediatrician appointed by President Clinton and approved by the Senate to serve in a top position at the EPA overseeing chemical safety. She has since left the position and gone back to university work. Her experience in both public health science and government gives her an unusual perspective which bridges both health and regulatory issues.
"I think a lot of people assume that because things are on the market that it means somebody has very carefully evaluated them and that they're safe," she said.
She was concerned about DHA mainly on two fronts -- firstly, because of the new information scientists have learned about DHA since it was approved for use in the 1970s. She believed the information was strong enough to warrant a full review of the product's safety that takes into account all potential health implications.
Secondly, she said, the explosion in DHA's use in spray tanning means many more people will be exposed to it in a manner that has never been subject to an FDA safety review.
"The use is expanding and it doesn't prompt a re-evaluation," she said, "and I think that's a serious problem."
Dr. Panettieri, the lung specialist, agreed.
He told ABC News he believes the dose from an individual spray tan or two is likely low enough to not have a demonstrable impact on someone's health. But he would definitely "have concerns" for those who regularly spray tan, week after week.
He was especially concerned for tanning salon workers who apply 15 to 20 spray tans a day without wearing protections, thinking the mist is "safe."
Panettieri noted that the lungs have an unusually large surface area and are built to absorb oxygen and distribute it throughout the body. They will do the same thing with chemicals like DHA that reach them, he said -- and unlike the skin, the lungs do not have a protective layer.
Panettieri's review of studies ABC News provided and his own review of published scientific papers showed that no long-term tests of DHA's effects on lungs have ever been performed.
Like Goldman, he was worried not only about cancer but also other health effects that can be caused from mutations in DNA.
"These compounds in some cells could actually promote the development of cancers or malignancies, and if that's the case then we need to be wary of them," he said. "And in this case, there are more than just [one] instance that this compound was associated with toxicity. So when you put all the evidence together, the concern exists."
Panettieri was mostly concerned about long-term exposures. He said problems might not immediately arise after shorter exposures, saying that even if large amounts of DHA were applied in a few applications to the lungs, it might not cause immediate problems.
"Frankly, right now, given the evidence I've seen, it's time to pursue this question in a more rigorous fashion and really answer: Is it safe or not?" he said.
The industry points to a ruling from 2010 by the European Commission that found DHA, as used in spray tan facilities, is safe for consumers. The European Commission provides guidance to the European Union on a variety of matters, including health.
Panettieri, Goldman and Rigel pointed to flaws and limitations they saw in the European review of DHA.
The European review took place after the cosmetics industry in Europe chose evidence for the European Commission to review, according to the commission. Because the cosmetics industry selected the evidence, nearly every report the commission's eventual opinion referenced came from studies that were never published, never peer-reviewed and, in the majority of cases, were performed by companies or industry groups linked to the manufacturing of DHA -- entities that had a financial incentive to see the chemical widely used.
Panettieri noted an additional flaw that he called "artful": The cosmetics industry, in asking the European Commission to review DHA, left out nearly all of the peer-reviewed studies published in publicly available scientific journals that identified DHA as a potential mutagen.
Goldman, through a spokeswoman, said the European report did not have all bad information but "did not contain information from peer-reviewed literature and is, therefore, not thorough."
Dr. Arthur Grollman, a toxicologist at Stony Brook University in New York, agreed, saying the European review was "flawed" and "incomplete."
Joe Levy of the International Smart Tan Network presented ABC News a critique of one of the more recently published studies that concerned experts. The study, published in the scientific journal "Mutation Research" in 2004, found that DHA as used in sunless tanners "damages DNA." Levy provided ABC News with a letter written by a Merck KAag scientist in late May 2012 criticizing the study.
Merck KAag is the largest manufacturer of DHA, Levy said.
In its critique of the 2004 study, a Merck KAag toxicologist cited results of two studies performed in Merck KAag's own laboratories that concluded DHA was safe for consumers. Those Merck KAag studies were never peer reviewed and are not available to scientists or the public for review. When ABC News asked for a copy, Merck KAag declined to provide them.
ABC News also asked the European Commission for a copy of the papers upon which it based its 2010 opinion. The commission responded that it generally doesn't release copies of such papers and that permission would have to be granted from the entity that asked for a review.
In America, the FDA said that no manufacturer has ever attempted to present similar evidence or go through an American safety review of DHA in spray tans.
The agency told ABC News in an email that it does not step in to stop what it calls on its website "the unapproved use" of DHA because, "FDA does not regulate the operation of commercial enterprises such as indoor or sunless tanning salons. This would be a function for OSHA or state/local public health regulators, much as for hair or nail salons. FDA has oversight responsibility for the safety of the cosmetic products and the devices [UVA light sources and beds] in the indoor tanning salons."
ABC News checked with local regulators in New York City and confirmed that no city agency regulates spray tan applications. The New York Department of Health, which regulates UV tanning, does not regulate spray tans.
Industry groups such as the International Smart Tan Network were unaware, when asked, if any state or local entity anywhere regulates spray tans.
Swift Response From a Major Tanning Salon Chain
Two of the 12 salons ABC News visited in its random undercover check belonged to the company Beach Bum Tanning, whose top trainer, Dante Fitzpatrick, said DHA was "super safe" and "great for pregnant women."
ABC News went back to Fitzpatrick and openly asked him if he believed DHA was safe to drink. He responded by taking a vial of the DHA fluid and drinking it.
Subsequently, the CEO of Beach Bum Tanning, James Oliver, contacted ABC News to say his company was taking swift and widespread steps to make sure consumers were educated about the FDA's recommendations and take all necessary safety precautions.
In response to this report, Oliver said he has now posted a sign in all of his stores informing customers of the FDA's recommendations. Beach Bum is also making a version of the sign available to hang on the walls in all sunless booth and airbrush rooms, recommending the use of protective gear while spray tanning.
A spokesman for a Washington, D.C.-based public relations firm told ABC News it also prepared an email that was to be sent out to Beach Bum's entire customer base saying the same.
In addition, Beach Bum has since posted the recommendations on its Facebook page, where it estimates 9,000 people may have seen it.
"We, at Beach Bum Tanning, are always striving to promote both customer and employee safety in the use of both UV and spray tanning equipment," Oliver wrote in a statement. "As products and research evolve, it sometimes becomes necessary to revise and update our policies and customer standards. Although we have always made eyewear, nose guards and lip balm available to every sunless booth and airbrush tanning customer, effective immediately we are taking the following steps to better inform our customers on the FDA guidelines:
"We have already started ...
"We know that our actions go above and beyond the FDA recommendations," Oliver wrote, "but we feel, in light of the unknown effects of the DHA mist, it is in everyone's best interest to take these proactive steps."
Oliver later told ABC News he is also purchasing new top-of-the-line industrial fans for his salons that will remove as much of the DHA from the air as soon as possible after application. He said that was intended to provide the safest possible experience for consumers who wish to continue to spray tan.
He said that would make using salons such as his safer than using at-home products that can be purchased over the counter and applied by consumers in a closed-in shower.
ABC News' Teri Whitcraft and Mollie Riegger, and former medical residents Murtaza Akhter and Rishi Sharma, contributed to this report.
Our panel of six experts included Dr. Arthur Grollman of Stony Brook University, Dr. Lynn Goldman of George Washington University, Dr. Rey Panettieri of the Univ. of Pennsylvania Perelman School of Medicine, dr. Fred Guengerich of Vanderbilt University, and Dr. Darrel Rigel of NYU.