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Toxic Chemicals & Nanoparticles in Conventional CosmeticsThreaten Public Health

Particles of faith

Scientific advances offer the chance for health and beauty products to penetrate deeper into our bodies. But is it safe? By Sarah Boseley May 8, 2004

The Guardian (UK)

There is a man in New Orleans who is said to have an answer to the fading bloom and gradual ruin that tell the tale in all our faces of the years we have seen. His name is Don Owen, he is an ex-Vietnam fighter pilot as well as a scientist who runs three biotech companies, and his cheerleaders would have us believe that he may have found the key to lifelong youth and bottled it.

A genuine elixir of youth is something for which the immensely wealthy cosmetics industry would pay good money. But the big companies will hesitate to knock on the door of Owen's biotech enterprise with an open chequebook, even though their own research labs are looking in the same scientific direction.

As yet, this is not something to be sold in an expensively elegant package across an upmarket department store counter. Owen's potion, called Agera Rx, is not a fragrant, magic unguent that can be smoothed across the cheeks and turn back the years overnight. It could make your skin peel and look worse before you look better. It could take four months to see a difference.

At the moment, it is handed out only in skincare clinics in the UK by someone who is medically qualified. But this is the future - a biochemical compound with the ability to penetrate deeper into our protective layers of skin than any cosmetic product before. And its arrival - and likely imitation and refinement for the high street or shopping mall - raises important and urgent questions about what we are doing to our bodies and to our environment in the name of beauty.

Owen is using nanotechnology - the science of the microscopically minute. Most creams cannot get far through the barrier of skin that protects us from the outside environment. Very tiny particles can.

Nanotechnology is the next new thing in cosmetics and skincare. Owen may be ahead of the field, but he's not alone. Very small particles of titanium dioxide (although at 2,000 nanometers, they are 10 times larger than his) are already being used in sunscreens, because they disappear completely into the skin, providing an invisible protective layer.

L'Oréal, one of the biggest research players, is investigating the delivery of vitamin E into the skin through nanoparticles, while Estée Lauder's Clinique brand already has a serum that contains them.

Some toxicologists are alarmed by this trend. The skin is a barrier for a reason - to keep harmful substances out. If nanoparticles can penetrate, will they end up in the bloodstream and brain? Will they do damage? Will other less welcome substances piggy-back on those tiny particles? And what will happen if a number of different nanoparticles, from our hand cream, sunscreen and foundation, join in the swim together? Where Owen's research scientists might legitimately go, do we want the entire, profit-led, self-regulated cosmetics industry to follow? Ask the major cosmetics companies whether their nanoparticles will penetrate the skin to reach the bloodstream or circulate around the body, and they instantly say no. They insist that their chemical compounds will not go further than the first layer - the stratum corneum.

But Owen is not afraid to voice a different view. He has entered skincare from a medical background, where nanoparticles are already being successfully used to deliver drugs across the blood-brain barrier. He has doctorates in pharmacology and organic chemistry, and one of his biotech companies, Vital Assist, is devoted to preserving human organs for transplantation. It was there that they made the discovery that took them into the cosmetics field.

"We kept spilling our artificial blood on the skin and it went right through the skin before we could wash it off," says Owen. "We knew we had an interesting skincare delivery system. I ended up developing Agera to use that technology."

So where was the artificial blood going? Did it reach the veins to merge with the real thing? Of course it did, says Owen. "Twenty years ago, we did not have the technology to monitor blood parts per million. Now, we can monitor parts per billion. Frankly, everything goes everywhere. When you wash your hair or brush your teeth, you are putting agents into the bloodstream. So I think the issue is not whether it goes into the system, but does it go into the bloodstream in any significant amounts?"

There's no point trying to turn back the clock, he says. "We live in a chemical soup, quite frankly. I think we always have, whether you are smearing bear grease on your skin or one of our refined products."

He says there could be a problem if these tiny particles delivered large concentrations of a product, and he thinks that there needs to be better scientific scrutiny of the newer technologies. "Ninety-eight per cent of the cosmetic companies out there, because we have done away with animal testing, they don't do any testing," he says.

If nanotechnology is the delivery system, what Agera Rx delivers are growth peptides - synthetic versions of the body's protein messengers that instruct cells to regenerate. At the age of 20 or 30, you have loads of them. By 50-plus, they are in short supply. Another of Owen's companies, Therapeutic Peptides, manufactures the growth peptides and sells some of them, although not those he uses in Agera Rx, to cosmetic companies.

The technology of growth peptides is already five or six years old, says Owen. More recently, he has found a way to stimulate cells to produce their own growth factors. But there are two types (at least) of growth peptides - those that instruct cells to regenerate on a daily basis, and the much more lively sort involved in wound healing. You have to make sure you trigger the gentle daily repair variety.

Even so, Owen insists that there's no danger of over-stimulating cells into the manic pattern of unstoppable division that produces cancer. On the contrary, delivering high doses of vitamin C and peptides to the cells can actually prevent skin cancer, he says.

Is this cosmetics? No, says Owen - it is cosmeceuticals. It's a word that is increasingly used for the borderline that the industry is now toeing.

Cosmetic is a temporary improvement. Anything that changes the body permanently is pharmaceutical. But while cosmetics are largely self-regulated - companies do whatever product safety testing they consider necessary - a new pharmaceutical drug has to undergo years of very expensive clinical trials.

The American drug regulator, the Food and Drug Administration, has so far not intervened because the cosmetics industry has been careful not to make claims that might attract its attention. But, says Owen, the cosmetics companies are now walking on thin ice.

"As far as I'm personally concerned as director of a cosmeceuticals company, I'm watching all the retail advertisements in skincare and they are making drug claims."

It's a tricky situation. What women - and men - really want is the permanent disappearance of lines and wrinkles. But any amount of vitamins, oils and rehydration of the outer skin layers will not achieve that.

Much of what the cosmetics companies do now is provide feel-good creams that offer, at best, an improvement while they are being used. No wonder they are interested in going deeper, while at the same time they are keen to stay clear of anything - such as Agera Rx - that could possibly be described as a drug.

Estée Lauder is one of the biggest in the business. When Lauder herself died last month at the age of 97, her obituaries noted the company's $3bn annual turnover and a personal fortune of $400m. According to Dr Harvey Gedeon, head of Estée Lauder's research and development facilities in Long Island, New York, the company has been working on nanoparticles for some time, in collaboration with outside researchers, and already has several products that use nanoemulsions and nanoparticles.

The new technology is going down well in Japan, where several of Estée Lauder's lines already use them. One of the company's many famous brands is Clinique. Its Repair Wear intensive serum contains nanoparticles, says Gedeon. But there is nothing to worry about, he says, because the particles used are not so very small.

"We are dealing in cosmetics.You can have nanoparticles that would penetrate into the bloodstream. That is not what we are trying to do. We want them to remain in the serum corneum. Safety to us is the most important thing. Anything we use in our products must go to [our ] toxicologies board first. Even if it is a banana. If it is brought into this company, it must go to toxicology."

L'Oréal has a huge research complex in Paris underpinning its many brands, including Vichy, Helena Rubinstein, Cacharel and Maybelline. It files almost a patent a day, more than any other company in the field, and is also pursuing nanoparticles or, as they call them, nanosomes, to penetrate between the layers of skin delivering vitamin E.

The rush towards the use of nanoparticles in cosmetics is starting to cause concern outside the industry. Dr Charles Vyvyan Howard, head of research with the developmental toxico-pathology research group at Liverpool university, says the tiny particles have a toxicity that seems to be directly related to their size, which can cause inflammation. He also points out that studies have shown that fine particles of the size now being used in sunscreen have gone through the skin and ended up in the lymphatic system.

"If you apply them to the skin or ingest them, where do they go to?" he asks. "Do they go to the brain or the foetus? There is no regulation. As is usual with brand new technologies, it is way ahead of the regulators."

Procter &Gamble, another huge player, owning Olay, Camay, Max Factor and Cover Girl among others, has not moved into nanotechnology yet. But Raniero De Stasio, director of technical communications and a toxicologist who has worked in the fields of safety and regulation, does not rule it out.

There are no safety concerns yet, he says, but adds, "For the future, I would like to see more reassurance that these particles truly do not penetrate [further than the outer skin layers]. If they do, they become part of our body fluids."

The questions over nanoparticles might be less unsettling if there were not other disturbing issues around the safety of the cosmetics we all use every day.

Environmentalists have begun to question the use of certain chemicals in our shampoos, deodorants and perfumes that at best remain permanently in the body and at worst could do us harm. Some do not even have to be named on the label because of a loophole in the legislation designed to protect the commercial secrets of the manufacturers.

Despite this, the cosmetics industry is booming. We spent nearly £6bn on beauty products and toiletries in the UK last year. In 2002, Europe as a whole paid out €56.7bn, with the UK the third biggest spender after Germany and France. The US retail market in 2002 was worth nearly $39bn.

The trend in recent decades has been the creation of global cosmetics giants, as one small, personalised company after another has been swallowed up. But the identity of the individual brands has been carefully preserved and nourished, because each has a dedicated following and a niche.

So Helena Rubinstein, Biotherm, Cacharel, Lancôme, Giorgio Armani Parfums and Ralph Lauren Parfums, Maybelline, Shu Uemura, Kerastase and Vichy all belong to L 'Oréal, which calls itself "the world leader in cosmetics" and claims a presence in every country. Estée Lauder has Aramis, Clinique, Prescriptives, Origins and La Mer, as well as several brands launched by professional make-up artists such as Bobbi Brown, Stila and MAC. It owns Aveda, Jo Malone, the New York hair care company Bumble and bumble, and the Tommy Hilfiger, Donna Karan, Kate Spade and Michael Kors lines. It has six research centres around the world, in Canada, Belgium, Romania, Japan, Minnesota and Long Island, New York. The last is the biggest, although still smaller than the L'Oréal operation, with 400 people. They have two non-product development groups - one in basic biological science and the other in polymers (synthetics) - looking for new concepts that might suit any of the brands.

More unusual, says Dr Gedeon, Estée Lauder's head of R&D, is the New Venture group. "Their job is to look out of the box. They have no charter. They look for ideas, whether from Nasa or the food industry or the automobile industry. What does the car industry use in terms of paint or new technology to highlight the colours? They will go to the Caucasian mountains to ask why do people live for such a long time? What type of water and food do you have?"

The bright ideas and research breakthroughs go to the applied technology group, which look at the practicality of turning it into a product. Then Gedeon decides which brand or brands should take it on and adapt it to suit their line. Safety testing begins as soon as a new, potentially useful substance is identified, and before any of the development takes place, whether it is a chemical or a Chinese mushroom, says Gedeon. Then there are tests on the finished products, from scratch tests and patch tests to try-outs on volunteers. None of the testing is mandatory.

"In the US, we are not required to do anything," says Gedeon. Although legislation stipulates products must be safe, it is up to the manufacturers themselves to to determine what is safe. There is no independent regulatory body.

Then there are the expert panels - the mascara panel, the foundation panel and the moisturiser panel of specially trained and paid consumers who will wear a new product and report back.

"They come in the morning and put it on and evaluate it against certain criteria for wearability," says Gedeon.

The big prestige companies are adamant that their first concern is safety, and that their toxicology testing is second to none. But the complaint from environmental lobby groups such as Greenpeace, Friends of the Earth and the Women's Environmental Network (Wen) is that skin creams, shampoos, perfumes and other cosmetics and toiletries contain chemicals that the human body cannot flush out. They claim the chemicals bio-accumulate and there is evidence that some of them could be harmful.

Of greatest concern are the phthalates (pronounced thalates), which are found in plastic toys, vinyl floor tiles, glues and inks. In cosmetics, they are used as solvents. Two chemicals in the family, DEHP and DBP, have already been banned from use in cosmetics by the European Commission and are in the process of being phased out. Six have been banned from the sort of plastic toys that children tend to chew.

The problem with phthalates, say campaigners, is that they bio-accumulate and that they are hormone disrupters - a study on four commonly used phthalates found that they reduced the male hormone action in rats, disrupting the growth of the male sex organs; another study found that Puerto Rican girls with premature breast development had high phthalate levels in their blood.

The cosmetics companies say that the small amounts they use are completely harmless. But if you decide you want to avoid all phthalates, it's no good reading the shampoo or skin-cream label, because they don't have to be listed. Phthalates are used in the fragrance of cosmetics, and their presence is hidden by the catch-all term "parfum" in the label. The same goes for artificial musks, which give perfume its staying power.

According to Friends Of The Earth, they are "persistent and bio-accumulative and are widespread contaminants of the environment and the human body, for example being found in breast milk".

Mark Strutt, a Greenpeace toxics campaigner, says, "Our position is that any chemical that accumulates in the body, that the body cannot metabolise, we shouldn't be using. They are not performing an essential function. We shouldn't be taking the risk."

The cosmetics companies say the evidence of harm is thin, although they are twitchy over the issue, perhaps because Greenpeace and Wen have both run tests on branded products and display lists on their websites.

Raniero De Stasio, of Procter&Gamble, says its data does not come to the same conclusions as that of the lobbyists. The banned phthalates might be a problem if you swam in a pool of neat chemical, he says, but P&G might use two or three molecules in a nail varnish. The other phthalates, he says, "are completely safe. They are not classified anywhere in the world even at high concentrations."

De Stasio is similarly reassuring about musks. "We have extremely strong environmental studies and human safety studies that say that for both main types of musk, those products are very effective and very safe." Furthermore, without musks you cannot have a perfume that lasts, he says, and that is what the consumer wants.

But at Green People in West Sussex, neither phthalates or artificial musks are used. There is nothing artificial in its products and most ingredients are organic. Ian Taylor, who is in charge of the company's research and development, says, "People are becoming far more aware that there may be problems with their skincare products."

Green People was started by Charlotte Vohtz, whose two-year-old daughter Sandra suffered from eczema and skin allergies. She found that taking chemical-based products out of the home and replacing them with herbal products solved the problem.

Small, alternative companies such as Green People may be a growing market, but it's unlikely that the bulk of the population will suddenly shift from cosmetics as we know them to the chemical-free alternatives.

Cosmetics, says Don Owen, are 20% product and 80% marketing, and the marketing that goes into conventional cosmetics is phenomenal, backed by film star endorsement and cultural pressures since the early days of Hollywood. The truly natural will almost certainly remain a niche unless concern grows about what we are slapping on our skin and washing off into our rivers. But the move into genuinely scientific skincare and cosmetics should surely make us sit up. After all, even those in the business are sounding a quiet note of caution.

Dr Mervin Pattison of Woodford Medical, a chain of skincare clinics in the UK that uses Agera Rx, says, "We are moving into an area where skincare is actually doing something to the skin. This is a grey area where the cosmetics industry ends and the pharmaceutical industry takes over." He has full confidence in Owen, but not necessarily in his potential imitators.

There's no doubt not only that nanotechnology is here to stay, but that there will be a lot more cosmeceutical scientific innovation to come. In a field that is no longer quite as "cosmetic" or harmless as it used to be, we need some watchdogs, with teeth. Guardian Unlimited © Guardian Newspapers Limited 2004