Last month, the Federal Trade Commission, which regulates advertising claims in the U.S., came down hard on five small companies for falsely promoting skin care, shampoos, and sunscreens as “all natural.” Their sin? Each firm listed synthetic ingredients, including phenoxyethanol, dimethicone, and polyethylene, on their product labels.
Cosmetic bottles line retail store shelves festooned with an array of claims. Many promise to rejuvenate and tone the face or erase skin wrinkles. Others promise to repair dull hair and make it soft and shiny. But how many of those promises are empty and what role do scientists play in making claims that stick? Read on to get an inside look at the cosmetic chemistry labs set up to verify claims before they ever go on a bottle.
FTC also goes after cosmetic claims that aren’t quite so flagrant. In March, the agency mailed out 10,620 refund checks totaling more than $416,000 to consumers who bought two skin creams marketed by L’Occitane. FTC contends L’Occitane had no science to back up the claim that the creams—Almond Beautiful Shape and Almond Shaping Delight—had “body slimming” capabilities.
Other times there’s science behind cosmetic claims, just not enough of it. In June 2014, FTC charged that L’Oréal deceptively advertised its Lancôme Génifique products as “clinically proven” to “boost genes’ activity and stimulate the production of youth proteins” that would cause “visibly younger skin in just 7 days.” L’Oréal “overstated the science,” the agency concluded.
Cosmetics and personal care products are profitable goods promoted with attention-grabbing claims. Every day, new and improved lotions and shampoos land on store shelves looking for an edge. Marketers often find it by highlighting a unique ingredient or desirable benefit.
To develop the ingredients and then back up the claims, armies of scientists work in the background for raw material suppliers and cosmetic companies. Some of the claims that marketers develop can get pretty aggressive. But cosmetic scientists say they try to walk the line between helping their companies make alluring claims and doing good science.
Reflecting on the 2014 charge against L’Oréal, a commentary on FTC’s website by spokeswoman Leslie Fair suggested that deceptive use of science was widespread in the cosmetic industry.
“Flip through a magazine, and it’s apparent that test tubes are overtaking powder puffs in how some cosmetics are marketed. When companies tout the scientific research behind their advertising or say their products have been ‘clinically proven,’ those claims—like any other objective representation—need appropriate support,” Fair wrote.
Some cosmetic scientists themselves are skeptical of claims they often come across. “So many advertising claims are ridiculous,” says personal care industry consultant David Steinberg. He once joked with a marketer about a skin product that claimed it “makes you look 20 years younger.” Steinberg said he applied it to a seven-year-old and afterward couldn’t find the child.
FTC, the U.S. Food & Drug Administration, and European authorities keep an eye on cosmetic claims. They allow some pretty outrageous ones to stand, often because they consider them mere puffery that a reasonable person would not take seriously.
Both European and U.S. authorities are more concerned about believable but unsubstantiated claims, although U.S. officials are regarded as more aggressive. The U.S. separates cosmetics into two categories: ones that are meant only to enhance appearance and ones that contain ingredients such as sunscreens and antidandruff additives and are considered to be drugs.
|European Union||United States|
|Enforcement||The European Commission sets cosmetic standards which are enforced by member country regulatory authorities.||The Food & Drug Administration and the Federal Trade Commission both have jurisdiction over cosmetic claims. Individual states have regulatory authority too.|
|Registration||Cosmetic products must be registered and proof of claims must be filed before they go on the market.||Cosmetic products and ingredients do not need FDA registration, but they can be registered voluntarily. Claims are not filed with the agency.|
|Truthfulness||Claims must be truthful. i.e. if said to contain honey it must contain honey.||Companies must have competent and reliable evidence to substantiate any ingredient-related claims.|
|Evidence||Claims should be supported by verifiable evidence. Experimental studies should be reliable and reproducible.||To support performance claims companies need both clinically and statistically significant data.|
In Europe, both categories are considered cosmetics, and formulators have more promotional leeway. The European authorities don’t quarrel publicly with firms over their claims, although they do require that firms register products and keep records to substantiate claims.
In the U.S., registration is not a requirement, but when challenged, firms are expected to be able to back claims. In recent years, U.S. authorities have been increasingly concerned with cosmetics that imply they are drugs with an unapproved healing effect.
Jim Schwartz, a research fellow who focuses on the Head and Shoulders antidandruff shampoo line at consumer products giant Procter & Gamble, says many of the arguments that might develop when a product is on the market can be avoided by getting scientists involved early in the claims development process.
“The idea for a marketing claim can originate either from marketing or research and development staff,” Schwartz explains. Surveys of what consumers are looking for in a product also provide inspiration, he says.
Some claims, “no matter how much consumers may like them,” are just not scientifically supportable, Schwartz notes. Especially challenging are situations when marketing executives get excited by a proposed claim, but the R&D folks pull back and say, “We don’t know. Let’s think about it.”
But when P&G sets out to develop and prove a claim, the effort is a multidisciplinary undertaking involving chemists, biologists, methods developers, and statisticians, Schwartz says. The team approaches a claim as if it has received a completed puzzle “which we have to reverse engineer and then reassemble,” he says.
Claims substantiation is important because “we are occasionally challenged and rigorous data is very convincing,” Schwartz says. Challenges can come from government agencies, individuals, competitors, class-action lawsuits, and nongovernmental organizations. For instance, the National Advertising Division of the Council of Better Business Bureaus, a U.S. trade group, investigates complaints that companies make against one another for misleading and inaccurate claims. Those that don’t comply with its decisions are referred to FTC.
To back claims, scientists at personal care product makers need lab tools that allow them to “objectify the data,” Schwartz points out. They will use tools that, for instance, capture skin images under controlled lighting to help characterize and assess wrinkle depth, he says.
Scientific instruments are at the heart of the personal care laboratory operations at BASF, a German chemical giant that is also a major personal care ingredient supplier. At its newly opened consumer testing center in Tarrytown, N.Y., BASF is set up to develop claims for new ingredients it develops. It also formulates products with its ingredients to test them on consumers, and as a service it will also test its customers’ formulations to verify claims.
For clinical studies, the test center draws on a panelist pool of more than 1,000 people from nearby communities. For a modest payment, panelists submit to studies of whether bioactive ingredients can reduce the appearance of wrinkles, skin lighteners can even out skin tone, and emollients can moisturize skin.
The studies don’t just include clinical evaluations of efficacy; they frequently call on panelists to offer opinions on the products they use. After all, what good are claims if customers don’t like how a product feels or smells? The studies can take just a day or last several months in the case of a long-term study of a new formulation.
Instruments in BASF’s consumer testing lab include Canfield’s Visia multispectral imaging system, which examines subjects for wrinkles and skin pigment. Another, the AEVA-HE from the French instrument maker Eotech, maps forehead wrinkles, crow’s feet, eye bags, and pigment spots, says Wendy Chan, clinical research manager at the lab.
Other instruments include tools to measure skin elasticity. One, known as a cutometer, from the instrument maker Courage + Khazaka, creates a vacuum on a small patch of skin and measures how fast the skin regains its shape when the suction is released, Chan says. Another, a ballistometer, drops a ball on the skin and measures how the skin rebounds.
The testing center is also equipped with a hair salon. Professional cosmetologists test and evaluate hair products with newly developed ingredients.
The consumer testing center is attached to a four-story concrete and glass building that houses more conventional labs for BASF businesses including personal care. The site is a development center for ingredients intended for antiaging formulas and has access to chromatography and mass spectrometry tools, microscopes, and nuclear magnetic resonance equipment. These tools can be used to characterize active ingredients and formulations or help pinpoint how much of an ingredient is deposited on skin or hair.
Today’s crop of cosmetic ingredients aim to reduce the signs of aging, guard against the effects of pollution, and come from natural sources, according to BASF technical manager Manasi Chavan.
With such ambitious claims on the line, personal care companies increasingly are relying on sophisticated tools to help them objectively evaluate their products, says Gary Grove, vice president of Cyberderm, a skin instrument maker and distributor. Grove, who has run skin testing labs and developed testing techniques and tools for 40 years, says today’s measurement tools are pretty reliable.
“But the tools can mislead you because they are so easy to use,” Grove says. For example, scientists can measure water loss from skin with a conductance probe made by DermaLab, but in some cases the electrical properties of a film-forming moisturizing cream could prevent an accurate reading, he says.
In other cases, erratic pressure on the probes could result in misleading and inconsistent readings. “You need to know when instruments are applicable and when they are not,” Grove says. “And you need to know the proper way to use the tools.”
In addition, Grove notes, skin probes generally need to be recalibrated from time to time. Pharmaceutical industry customers, which might use the instruments to evaluate prescription skin care products, must keep certification records and are good about regular calibration, he says. “Cosmetic customers seem less interested in doing so,” he says.
But firms like the specialty chemical maker Ashland say they have every interest in keeping their equipment and testing procedures up to snuff. “It is expensive for our customers to launch, package, and advertise a new product. The claims need to be validated and meet consumer expectations. It’s a similar path for a new raw material. That’s why we as a raw material supplier make a big investment in research,” says Linda Foltis, R&D vice president for Ashland’s care specialties business.
Foltis, whose past experience includes R&D work at L’Oréal and Unilever, says “we’ve designed our R&D application efforts to be an extension of our customers’ R&D efforts.” Substantiation of benefits and claims is an important part of that work. “Our customers need to be able to reproduce our claims in their lab too,” she says.
Ashland’s research facility in Bridgewater, N.J., is a multistory structure at a former Sanofi pharmaceutical R&D site. It has labs and offices for nearly 300 people in the firm’s specialty ingredients business. Personal care ingredient experts at the facility focus on the development of polymers for hair, skin, and oral care.
Among the instruments the facility uses to put hair to the test is an atomic force microscope, or AFM. People who style their hair with blow dryers and curling irons can end up with dull, damaged hair. Staff scientist Guojin Zhang explains that she uses the AFM to scan the surface of heat-treated hair samples and document the cracks or micropore formations on hair cuticle surfaces.
She can then use the microscope to document the extent to which an Ashland conditioning polymer smooths the rough hair surface. Or, she says, “we can show how the polymer protects hair from heat damage.”
Zhang also records infrared spectra of hair samples both before and after treatment with a polymer. With this technique, she says, “we can see protein structure changes in hair after heating.”
Proving a claim, either for one of Ashland’s own ingredients or as a service to a customer, can be a complex operation. “We have to design an experiment that is appropriate. If a methodology doesn’t exist, we develop one,” Zhang says. In some cases, that might involve creating an instrument in-house.
For example, an Ashland employee designed an instrument to measure the deposition of a conditioning polymer on hair. The instrument takes advantage of the fact that hair has a negative charge and conditioning polymers have a positive charge. “With this instrument, we can measure the presence of a film on the hair and the efficiency of its deposition,” Zhang says.
Ashland uses other tools to monitor active ingredients used in skin care formulations. Salicylic acid-based acne face washes can contain no more than 2% of the ingredient, according to FDA rules, so it’s important to make sure more of the active ingredient gets deposited on the skin than washes down the drain. Using a spectrofluorometer to measure the emission spectrum of a treatment on the skin, “we can determine the optimal formulation of active, polymer, thickeners, and pH,” says research scientist Mark Davies.
Not all cosmetic claims come with scientific underpinnings. Claims that begin with phrases such as “90% of consumers felt” or “most agreed that” may have their place as marketing tools, says Randall Wickett, a claims support consultant and professor emeritus of pharmaceutics and cosmetic science at the University of Cincinnati. But they are not based on science.
And not all claims backed with scientific data are reliable, Wickett says. Some product makers may call out an ingredient for a certain effect. But their formula is really a mixture of many ingredients, and it is hard to know if any one element truly makes a difference unless a study is well designed. “Consumer preference claims, for example, don’t mean much without a placebo control,” he says.
“We have to do good science,” says Abel Pereira, research and technology director at the Edison, N.J., research labs of ingredient maker Croda. Though Pereira and his colleagues work to satisfy their employer’s customers, it is sometimes up to them to explain the value of a well-designed, placebo-controlled study.
Research and technology manager Farahdia Edouard recalls having to explain to a customer that she could not just test a hair treatment formulation with a new ingredient against untreated hair. To accurately show whether the hair product was effective, she had to test it with and without the new ingredient.
Croda’s expanded Edison labs employ about 20 people working on personal care and home- and health-care-related ingredients. The installation includes a synthesis lab where chemists research novel ingredients with a focus on natural and biobased raw materials.
After safety testing, many newly developed ingredients are moved on to the claims substantiation lab. According to Edouard, the instruments in that lab built up over a number of years and represent an investment of around $2 million. They are used largely to evaluate hair care products, she says.
Equipment in the lab includes a scanning electron microscope to visualize the effects of conditioner, polymers, and proteins on hair samples. The lab also measures hair strength with a Dia-Stron tensile tester, an instrument that is used to test the strength of textile fibers.
Other instruments are adapted from different industries. Edouard explains that Croda has a texture analyzer made by Texture Technologies and widely used for food testing. Croda adapted it to measure the softness of hair fibers treated with conditioning polymers.
The firm also developed what it calls a Flexabrasion tester. To substantiate hair claims, a thin wire abrades a weighted hair sample inside a humidity-controlled test chamber until it breaks. The tester is meant to mimic combing.
Many small personal care formulators lack the infrastructure for claims substantiation. They can take advantage of help from ingredient suppliers like Croda, or they can hire a third-party independent lab, such as Consumer Product Testing in Fairfield, N.J. Larger firms also will hire CPT to confirm their in-house research or conduct tests they are not equipped to do, says its president, Craig Weiss. The 40-year-old firm, started by Weiss’s father Melvin, a cosmetic chemist, began as a toxicology testing lab for consumer product firms and today does clinical safety tests and claims validation for cosmetic makers as well as pharmaceutical, medical device, and dietary supplement companies.
In a former Singer sewing machine plant, more than 100 technicians work in labs equipped with instruments including chromatographs, mass spectrometers, and spectroradiometers, the latter of which is used to calibrate lamps for sunscreen testing.
An “environmental” room in the facility tests the effectiveness of antiperspirants and helps substantiate dryness claims, Weiss says. Test subjects enter the room, set at 38° C and 40% relative humidity, for 15 minutes, after which technicians measure their sweat levels.
A salon with four cosmeticians on staff tests shampoos, conditioners, and hair sprays to assess attributes such as curl retention and the effects of shampoos on hair color. The facility even includes three hot tubs to help test sunscreens for water resistance.
Clinical studies for clients generally start with 30 people but can go as high as 120, Weiss says. “It depends on what the sponsor needs to help substantiate a claim,” he says.
Some smaller testing labs specialize. Cantor Research Laboratories, for instance, focuses on antiaging claims.
Shyla Cantor, who runs the 15-person lab in Blauvelt, N.Y., says that for a good skin moisturization/wrinkle reduction study, “I’d like all formulators to test with at least 30 panelists, but small firms can’t always afford to test that many subjects. So they usually test with 20, which also gives statistically significant data,” she says.
Regardless of the number of participants, testing conditions have to be closely monitored. In dry weather, moisturizers can appear to be more effective than they would in warm, humid weather conditions. “I have a humidity-controlled room so I can get reproducible results,” Cantor says.
Panelists also have to be closely followed, she says. If they take home a product for a multiweek study, “you have to weigh it before they go home and after they come back,” to gauge whether they are using the products as they’ve been told.
People generally respect scientists for the discipline they bring to their work. Marketers know it and therefore love to paste scientific sounding claims on high-priced cosmetics. Although scientists acknowledge that it is the marketing folks who control claims research budgets, it is still their job to make sure claims are legitimate.
And ethics aside, scientists know they and their employers will have trouble if they don’t make their claims with care. P&G’s Schwartz, for example, says his company works hard to develop claims that are accurate and unassailable under scrutiny by regulators, competitors, or class-action suit lawyers.
And scrutinize they will. When developing claims, he says, “we take every step to ensure they can withstand any challenges.”
These ghoulish self-portraits show how scientists
use photographic evidence to stake cosmetic claims
During a tour of cosmetic ingredient maker Ashland’s Bridgewater, N.J. personal care products testing lab last month, I suddenly found myself the subject of a skin care study. It was all in good fun and no cosmetic preparations were ruined in the experiment.
But what the opportunity did afford was an up close and personal view of the Visia complexion analysis instrument by tool maker Canfield. Of all the instruments to verify cosmetics claims I’d seen on lab visits this one seemed the most delightful and frightful.
Where others involved skin probes to plot skin moisture or graph skin elasticity on a computer screen, the Visia took colorful and positively ghoulish pictures full of mystery—and scientific meaning. So when Germain Puccetti, an Ashland skin care research specialist, offered to take and analyze a few pictures of me, I agreed.
The actual photo session was mercifully brief. I placed my chin on a sculpted plastic platform and my forehead against a stabilizing bar. Instructed to close my eyes and remain expressionless, Puccetti triggered four flashes: three taken with a normal daylight flash of which one was taken with parallel polarized light and one with cross polarized light, and a fourth taken with only ultraviolet-A light.
The images, Puccetti explained, allow scientists to evaluate skin with and without the application of cosmetic preparations. Electronic filters and software highlight such things as pores, wrinkles, and brown spots before and after cosmetic cover-ups.
This image shows the pores and oil on the surface of my skin. Puccetti said that people don’t want to look oily and such an image can verify whether a makeup intended to “mattify” effectively absorbs the skin’s sebum and covers up fine lines and skin imperfections.
This ghastly ultraviolet-A image of my face reveals my enviable tan.
When the same ultraviolet-A image is processed through Canfield’s proprietary filter program, it brings out my UV damage spots. Puccetti told me the spots are a sign of cumulative UV damage possibly during a childhood spent outdoors without sunscreen. Sunscreens, he said, would protect against excess formation of such spots over the years.
This image highlights my brown spots and freckles. Freckles tend to appear naturally, but in some eastern cultures, their appearance is unwelcome, Puccetti said. A series of such images over time can show whether one skin lightener or another is effective in reducing the appearance of those spots.
My personal favorite. This image highlights microvascular veins just below the skin’s surface. My lips appear red, which is a good thing, and only a few fine veins show up around the nostrils. But for those whose vein networks are more prominent or those who may have acne, a series of such photos could confirm the successful application of makeup containing a green “beauty pigment” to camouflage the undesirable evidence of inflammation, Puccetti told me.
Before tools such as the Visia became available, every cosmetic firm had its own method for calibrating images of study subjects before and after cosmetic use, Puccetti explained. The beauty of these admittedly unglamorous images, he pointed out, is that they offer a standardized visualization protocol to substantiate a variety of claims.