| The signs of aging are not easy
for most people to accept. Maybe it's the eyes that go first.
Or maybe it's the hair as it dries, thins, and turns gray. Or
maybe it's those wrinkles at the corner of the mouth or across
the forehead.
While nothing short of laser surgery will reverse eyesight
troubles, personal care formulators have always been ready with
a host of color and coverup products to revive hair, even out
skin tones, and plump up dry skin.
But over the past decade, cosmetics--the stuff of hopes and
dreams--have gone well beyond the rouges, moisturizers, eyeliners,
and skin softeners of the past. A new class of age-defying and
skin complexion enhancers has emerged--including vitamins, fermentation
products, algae derivatives, and other extracts. The makers of
these ingredients say they have the studies to prove the ingredients
work. And the personal care companies that employ such ingredients
in their products would have consumers believe they are a veritable
fountain of youth.
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DEGUSSA PHOTO |
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Maybe they are and maybe they are not. Manufacturers of "cosmeceuticals"--cosmetics
with pharmaceutical-like active ingredients--walk a fine line
between beauty enhancements and drugs in what they sell. The Food
& Drug Administration doesn't recognize the category and
now seems ready to step in where cosmetic makers claim therapeutic
benefits.
Last June, FDA set the groundwork for joint oversight of cosmetics
that make drug claims by two FDA units that separately regulate
drugs and cosmetics. Then, early this year, the agency issued
a warning letter to cosmetics maker University
Medical Products charging the company with marketing unapproved
new drugs.
According to FDA, the firm's skin creams promised, among other
things, to reduce deep wrinkles by up to 70%; to strengthen collagen
and elastin fibers; to reduce cellulite by stimulating cells and
releasing stored fat; and to reduce weight through appetite suppression,
increased metabolism, and fat burning. Product ingredients include
retinol, green tea extract, and vitamin C.
FDA says that because the products were intended to "affect
the structure or function of the body," they are drugs. Whenever
a cosmetic maker claims a product cures, prevents, or mitigates
disease or otherwise affects the structure or function of the
human body, FDA considers that product a drug. The firm has since
changed the labeling of its creams.
But cosmetic makers have plenty of wiggle space. Under a concept
FDA recognizes as "puffery," it is legal to say the industry's
products enhance beauty and sex appeal. Image is what the industry
sells, and it is up to the consumer to believe it or not.
AND IMAGE
is what consumers buy. High-end U.S. department stores
sold $2 billion worth of skin preparations in 2003, up 6% compared
with three years earlier, according to the NPD
Group, a research firm that tracks retail sales.
Sales in the antiaging category increased 14% in 2003, more
than double the 5% growth rate in each of the prior two years,
NPD says. Products in the category include Estée
Lauder's Re-Nutriv Ultimate Lifting Cream, which costs $250
for a 1.7-oz jar, and Perfectionist Correcting Serum for Lines
and Wrinkles, at $52 for a 1-oz spray bottle.
 In
a break from the past, ingredient suppliers and formulators are
generating clinical data to show that the newest ingredients really
work, says Meyer R. Rosen, president of Interactive Consulting.
Cosmetic formulators are also closely comparing the composition
of younger and older skin, Rosen says. And they are extending
that research to discover and include in new formulas active ingredients
that increase the level of skin components that decrease in older
skin.
Many antiaging formulas typically contain sunscreens to minimize
the damaging effect of ultraviolet light on skin, Rosen points
out. Alyson Emanuel, cosmetic ingredients director for BASF,
agrees that "sunscreens do prevent photoaging of the skin," and
adds that effective antiaging formulas also contain retinol and
other active ingredients to reduce the appearance of lines along
with anti-irritants such as the vitamin panthenol.
 If
the skin is not protected by sunscreens, "reactive oxygen species
are generated by exposure to ultraviolet radiation and can cause
oxidative damage to DNA, collagen, elastin, and lipids within
the skin, leading to wrinkles," Emanuel explains. The use of antioxidants
prevents this from happening.
If a formulation is designed correctly, "you can slow skin
aging, but you can't reverse the aging process," says Shyam Gupta,
R&D director at Arizona
Natural Resources, a privately held contract formulator. However,
"the majority of the products on the market are mediocre. They
do not have sufficient quantities of active ingredients to provide
results," he says.
 It's
no wonder that consumers are often confused by the competing claims
formulators make, Gupta says. "It's a jungle out there now," he
says, and the marketing hype invites some form of regulation.
Legitimate formulators understand the limitations on the claims
they can make; they also understand that customers want something
that works, says Janet C. Kosiek, home and personal care ingredients
marketing manager in Degussa's
Goldschmidt subsidiary. "Formulators don't want FDA in their
business," and so, she asserts, "they are careful about the claims
they make."
Goldschmidt itself, for instance, is using DNA chips containing
genetic data to test the biological effects of specific compounds
on the human epidermis to help back up the claims it makes for
its ingredients. Studies employing the chips provide information
on how a compound will influence biological pathways and thus
suggest the physiological impact of a new compound on human skin.
Goldschmidt has tested phytosphingosine-SLC--a patented conjugate
of phytosphingosine and salicylic acid--using DNA chips. The testing
indicates that the conjugate increases skin ceramide content,
improves skin barrier function, and down-regulates genes involved
in inflammation.
Because it influences skin appearance but doesn't prevent physical
aging, phytosphingosine-SLC is a useful ingredient in age-defying
formulations, Kosiek says. "It minimizes the appearance of wrinkles.
They may be there, but you don't see them," she says.
Responsible companies often use consumer panels to test their
products before launching them in the market, Kosiek says. Something
that works in the lab is not guaranteed to work once it's formulated
for consumer use. And because there are many skin types, a formula
may work well with one skin type but not another. Only testing
with consumers will tell if a product really provides benefits,
she says.
Many ingredient suppliers closely watch academic research for
suggestions on new ingredients with consumer benefits. Vince Gruber,
director of research and marketing development for Arch
Chemical's personal care business, says a protein called cytoglobin,
in part discovered by Iowa State University biochemistry professor
Mark S. Hargrove and his group, "bears a striking resemblance
to the protein we have been investigating from soy and lotus root
nodules called leghemoglobin."
Gruber says these globin proteins may be useful for scavenging
free radicals such as nitric oxide, which some researchers think
is part of a biochemical cascade that is responsible for the redness
caused by sunburn. Such irritation can ultimately lead to the
formation of skin wrinkles. The lotus and soy root nodule derivatives
Arch recently launched may therefore be useful to slow photoaging
of skin, Gruber suggests.
It is important not to encroach on pharma's turf when introducing
a new cosmetic ingredient, says Ratan K. Chaudhuri, cosmetics
research and applications director for EMD
Chemicals, the U.S. affiliate of Germany's Merck. For instance,
EMD's Emblica may be best called a skin brightener or toner for
cosmetic purposes rather than a skin lightener.
EMD-commissioned lab tests on human volunteers showed that
Emblica, a standardized extract from the fruit of the Asian plant
Phyllanthus emblica, minimizes the appearance of freckles and
age spots and is also an effective antioxidant and matrix metalloprotease
inhibitor. EMD has completed studies to demonstrate that, as an
antioxidant, Emblica is a broad-spectrum quencher of free radicals
and an inhibitor of collagenase and stromelysin, Chaudhuri says.
Nutritional supplements and even foods are considered likely
skin care ingredients. Arizona Natural's Gupta considers such
ingredients "nutracosmetics" and says that, with the right skin
delivery systems, they can have "greater efficacy" than when they
are eaten and degraded through digestion.
FOR INSTANCE,
astaxanthin, a carotenoid often taken as a nutritional
supplement to help prevent macular degeneration, is an especially
useful antioxidant for ameliorating UV damage to skin, says Sid
Hulse, sales manager at U.S. Nutraceuticals.
The firm not only sells its Zanthin supercritical CO2
algae extract alone for cosmetic use, but it also sells the extract
in combination with a cranberry seed oil extract "naturally high
in mixed tocopherols and tocotrienols," making it a good skin
emollient.
"Many cosmetic companies are going beyond traditional ingredients
to nutrition and food for crossover products," says Jon Anderson,
vice president of new technologies at Actives
International. Probiotics, often used as nutritional supplements
to complement naturally occurring microbes in the gastrointestinal
tract, are the source of new extracts from Actives International.
In combination with small plant-derived compounds, they act as
biological response modifiers for the skin by boosting the immune
system and preventing the damaging effects of UV exposure, he
says.
At least one food ingredient maker has developed a significant
and separate cosmetic ingredient business. Swedish vegetable oil
processor Karlshamns
formed its Lipids for Care business in 2000 to focus on providing
customers with a specially developed family of shea oil from nuts
harvested in West Africa near the Sahara desert. According to
Jan Gunnerdal, president of the personal care business, shea oil
is widely used to make lipsticks.
While shea lipids help provide a physical "structure" for lipstick
and other cosmetics, they also have some "minor bioactivity" that
is often valuable to cosmetic makers, Gunnerdal says. These emollients
can protect against environmental degradation and act to screen
the sun's rays, he says. The firm's studies show the lipids also
have anti-inflammatory and "cell renewal" properties.
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SKIN SAVER The market is large and growing
for products to prevent and ameliorate effects of the elements
on skin.
PHOTODISC |
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A PROBLEM
for formulators of cosmetics that boast wrinkle-easing
properties or antioxidant effects is designing effective "delivery
systems" for the most beneficial ingredients, says Interactive
Consulting's Rosen. Ingredients have to remain stable in the bottle
and then must penetrate the skin under a variety of conditions.
Putting a delivery system together "that gets the ingredients into
the stratum corneum at the right time and the right rate" is the
subject of a book Rosen is readying for publication later this
year.
"Until now, aesthetics were more important than efficacy,"
says Johann Wiechers, principal scientist and skin care R&D
manager at ICI's Uniqema
unit. "Many companies have a number of standard formulations with
sensory properties to which the latest new ingredient is simply
added," he says. When a new active ingredient won't work in the
standard formulation, it's simply tossed aside. More important
is choosing an emollient system appropriate for the ingredient,
he says, to make sure the ingredient can penetrate the skin.
Some ingredients are difficult to preserve long enough to be
useful when a consumer opens and uses a formula that may have
been sitting on a shelf for a year. Sunscreen active ingredients
like avobenzone and octyl methoxycinnamate, vitamins like retinol
and vitamin E, and ß-carotene are not very stable in a bottle,
EMD's Chaudhuri points out.
EMD has recently developed and patented an antioxidant photostabilizer
for such unstable ingredients--diethylhexyl syringylidene malonate.
The company is just beginning to introduce the preservative to
customers under the more easily managed trade name Oxynex ST.
While EMD's preservative will allow the consumer to dispense
active ingredients, another ICI company, National
Starch & Chemical, is working on systems to ensure that
such ingredients don't wash down the drain. It is now developing
a process for depositing active ingredients on skin that depends
on some trigger, such as body pH, says James A. Mish, global marketing
director for personal care.
The system might use an existing cationic or anionic "chassis"
with which formulators are already familiar, Mish says. When,
for instance, a consumer applies a body wash gel, a "triggerable
event," such as the dilution of the gel, precipitates a polymer
complex containing active ingredients. The event allows the active
ingredients, such as a sunscreen or moisture agent, to be deposited
on the skin.
It's a technology that is not yet ready for prime time, Mish
says. However, within two years the firm hopes to fine-tune its
triggerable deposition technology so that it will allow the formulator
to control the degree and speed of penetration of the active ingredient
into the skin.
Scientists will continue to work on technologies that bottle
solutions for mature skin. At the same time, FDA will be keeping
an eye on the science-based proof that ingredients suppliers and
formulators say they are generating. In FDA's view, aging is a
natural process, not a disease. Cosmetics can promise sex appeal,
but they cannot be cures for what is, after all, inevitable. |
