A 2007 broadcast of the UK science television show Horizon prompted panic buying on the high street. Stocks of Boots Protect & Perfect serum, an anti-ageing beauty product featured on the show, quickly ran out. Horizon showed Manchester University professor of dermatology Chris Griffiths’ findings that, unlike many other products, Protect & Perfect actually worked on skin to counter sun damage at levels previously seen only in prescription products.
It’s no secret that anti-ageing products are big business. Market research by Global Industry Analysts indicates that the world anti-ageing product market is set to reach $115.5bn by 2010. Robust growth is fuelled by demand for novel active ingredients with documented functionality, along with cosmetic companies targeting younger consumers before the signs of ageing set in.
Marketing claims for many products are backed by increasingly solid research. Regulators are slowly beginning to consider what the beauty industry has been arguing for some time: that some cosmetics have a measurable physiological effect. But if so, should anti-ageing creams be tested and licensed like medicines?
Formulation fix
The Boots Company’s skincare scientific adviser,
global product development, Stewart Long says
that Boots is not likely to seek regulatory approval
for Protect & Perfect (also sold in the US as Restore
& Renew). ‘But it’s not to say that we wouldn’t do
so in the future with a different product.’
To license a product you need a defined active ingredient. For instance acne treatments incorporate salicylic acid at a defined level and grade. However, this requirement can hinder progress, Long says. US Food and Drug Administration (FDA) sunscreen regulation is a case in point. ‘Because the FDA treats sunscreens as drugs and the registration process is very slow, some excellent sunscreens are not available in the US that have been used in Europe for many years,’ says Long. ‘This is very restrictive, and is why European sun protection products are ahead of the US sun protection products in terms of UVB and UVA performance.’
Product licensing freezes the formulation. The cosmetics industry is renowned for constant innovation and product tweaks, both to improve products and to keep consumers interested. Significant cost is involved in registration, clinical trials and making a product to medicinal standards. Boots considered this path because of its strong background in pharmacy. However, ‘it would be more difficult for some of the pure cosmetics and beauty companies,’ Long suggests.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) borderline section considers those products that are harder to distinguish from medicines, including certain cosmetics or food supplements. Products can be classified as medicinal products either because they make claims to treat or prevent adverse conditions, or because they contain agents capable of physiological effects through immunological, pharmacological or metabolic action. ‘Wrinkles are not regarded as an adverse medical condition,’ commented an MHRA spokesperson, adding that although anti-ageing claims themselves won’t bring a product within MHRA’s remit, even without medical claims certain ingredients might.
Historically, cosmetics have fallen foul of the borderline due to claims. ‘However, advances in product technology and science increase the potential for more to be regarded as medicinal “by function” in the future,’ according to MHRA.
It is not just the wording of claims that counts: ‘Legal test cases have established that it is the message conveyed by product presentation and the perception of the consumer which are most germane,’ states MHRA. ‘Therefore there is little scope, if any, for finding alternative ways of making unacceptable claims.’
The cosmetics industry is co-regulatory: manufacturers must ensure compliance with the legislation, overseen and checked by competent authorities. In the UK, these include Trading Standards, acting for the Department for Business and Regulatory Reform, covering legislative compliance, and Clearcast and the Advertising Standards Agency covering advertising claims. The Cosmetics Directive requires cosmetic products to be safe, of good quality and effective, according to Christopher Flower, director general of the UK Cosmetic, Toiletry & Perfumery Association (CTPA). ‘The laws governing efficacy are enhanced by general legislation covering advertising claims for any product,’ he adds.
Greater authority involvement in certain areas would be welcomed – at least by Boots, which also retails cosmetics. ‘There are some deeply suspicious products on the market,’ Long says. However, heavy-handed regulation can impact innovation to the detriment of consumers.
US sunscreen classification requires stricter production processes and quality control than would be required for a cosmetic. Because the sun is responsible for 80-90% of skin ageing, a product with a high sun protection factor (SPF) can make anti-ageing claims on this basis alone. An SPF of 50 could reduce sun exposure by as much as 97%, says Long. Although the sunscreen may legitimise a product’s anti-ageing claims, the FDA is only interested in the sun filter.
Major companies like Boots, L’Oreal or Procter & Gamble are able to bear the additional cost of launching beauty products containing sunscreen in the US. However this does not compare with an entire anti-ageing formulation registered as a drug.
Registering benefits?
Would cosmetic companies and consumers gain
from anti-ageing products undergoing drug-like
registration? One upside is greater protection for
the formulation compared with a patent alone.
However, a registered product’s active ingredient must be defined and precisely controlled. Like many competing products, Protect & Perfect is based on a combination of natural ingredients. ‘We know that an extract of white lupin is active,’ Long explains, ‘but controlling active levels in the crop is difficult, and therefore how many parts per million you need to have in the product to meet licensing requirements.’
Skin is complicated, and product manufacturers believe it benefits from a combination of ingredients. ‘We don’t believe there’s a single wonder ingredient out there – skin just doesn’t work like that,’ Long says. Certain peptides with known structures used in skin creams have greater potential to be pinned down, but registering these would require every product containing them to be reclassification as a drug.
With the formulation on hold, a competitor can create a more interesting and effective combination of ingredients within six months. ‘I think the consumer will jump ship,’ says Long.
There are no standard tests for cosmetic claims, with the exception of sunscreens. ‘For almost anything else, whether it’s wrinkle reduction, fading age spots or elasticity, you can approach it with whatever method you want, as long as you can justify it,’ says Long. Boots is among companies that publish results in scientific journals. ‘It is a challenge to the industry to be more transparent,’ says Long. ‘There is some terrific science out there, but also some smoke and mirrors.’
Properly controlled experiments are vital, along with reasonable sample sizes. Skin is very sensitive to the environment, so reputable companies make trial subjects wait in a room with controlled temperature and humidity before testing products.
According to Flower, companies may now use sophisticated instruments with computer logic and optical recognition systems to detect the average depth and length of lines and wrinkles before and after using a product. ‘This allows robust measurements to be made and these data can augment the subjective assessment of skin condition,’ says Flower. Previously, the surface of the skin was copied using a material similar to dental rubber applied to the skin and then removed. Skin scientists would take surface profile measurements from the relief of ridges on the model. This technique yields measurements at distinct points, rather than integrated data from a larger skin area available today. Other data come from expert ‘wrinkle assessors’ as well as consumers participating in trials.
‘We know that cosmetics are changing the skin,’ says Long. ‘There’s a slow realisation that cosmetics can have a physiological action – so you should be able to say “reduces the depth of wrinkles” not “reduces the appearance of wrinkles” but we’re not there yet.’ Today this would still be considered a drug claim for a cosmetic product.
The skin has a physiological response to environmental factors: even playing the violin can cause calluses on the fingers. Moisturisers cause measurable changes in genes in the skin.
‘The fact that we can measure that doesn’t make a moisturiser a drug in my opinion. It just means we have a level of knowledge now which has superseded the definition as was,’ says Long.
P&G Beauty, which includes brands such as Olay, has carried out genomics work to explore how skin and hair-related genes function and respond to ageing and environmental stress at the molecular level. ‘Using sophisticated tools, we can now map the gene expression profile of young vs. aged skin to identify differences at the most fundamental levels,’ explains senior scientist Sîan Morris. ‘This helps us identify which ingredients can shift the molecular fingerprint of aged skin toward the molecular fingerprint of younger skin.’ P&G Beauty’s genomics team is working toward incorporating digital gene expression profiling to provide even more biological insights with greater speed, higher accuracy and reduced costs. ‘It will allow P&G scientists to sequence an extensive number of genes at once and provides more information about genes than is currently available,’ says Morris.
Despite the hype, many products require regular application over an extended period for results to appear. These remain only while the product is used regularly. Behind big brands, fine chemical manufacturers are among the winners in the anti-wrinkle game. According to Freedonia, increased demand for novel active ingredients with documented functionality means cosmeceutical formulators have shifted considerable R&D, including concept development, testing and formulation, onto chemical suppliers. Eastman Chemical is one company continuing to formulate anti-ageing ingredients based on rice bran to add to its portfolio. ‘In today’s highly competitive marketplace, personal care brand owners are turning to powerful natural ingredients to distinguish their brands and deliver visible benefits to their customers,’ according to James McCaulley, Eastman’s global market development manager, personal care. These ingredients give brands the opportunity to substantiate their claims and keep consumers happy too.
Helen Carmichael is a freelance science writer based in Vancouver, British Columbia, Canada.
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