Making cosmetic claims - C&EN Global Enterprise (ACS Publications)

facebook · twitter · Email Alerts ... Last month, the Federal Trade Commission, which regulates advertising claims in the U.S., came down hard on five...
3 downloads 0 Views 4MB Size
Cover story

In brief 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.

28

C&EN | CEN.ACS.ORG | MAY 9, 2016

Making cosmetic claims How scientists and the tools they wield can distinguish compelling, justifiable cosmetic claims from empty promises MARC S. REISCH, C&EN NEW YORK CITY

L

ast 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.

FTC also goes after cosmetic claims that aren’t quite highlighting a unique ingredient or desirable benefit. so flagrant. In March, the agency mailed out 10,620 reTo develop the ingredients and then back up the fund checks totaling more than $416,000 to consumers claims, armies of scientists work in the background for who bought two skin creams marketed by L’Occitane. raw material suppliers and cosmetic companies. Some FTC contends L’Occitane had no science to back up the of the claims that marketers develop can get pretty claim that the creams—Almond Beautiful Shape and aggressive. But cosmetic scientists say they try to walk Almond Shaping Delight—had “body the line between helping their compaslimming” capabilities. nies make alluring claims and doing Other times there’s science behind good science. cosmetic claims, just not enough of it. Reflecting on the 2014 charge against In June 2014, FTC charged that L’Oréal L’Oréal, a commentary on FTC’s deceptively advertised its Lancôme website by spokeswoman Leslie Fair Génifique products as “clinically provsuggested that deceptive use of scien” to “boost genes’ activity and stimuence was widespread in the cosmetic late the production of youth proteins” industry. that would cause “visibly younger skin “Flip through a magazine, and it’s in just 7 days.” L’Oréal “overstated the —David Steinberg, apparent that test tubes are overtaking science,” the agency concluded. consultant, personal care powder puffs in how some cosmetics Cosmetics and personal care prodindustry are marketed. When companies tout the ucts are profitable goods promoted scientific research behind their advertiswith attention-grabbing claims. Every day, new ing or say their products have been ‘clinically proven,’ and improved lotions and shampoos land on store those claims—like any other objective representashelves looking for an edge. Marketers often find it by tion—need appropriate support,” Fair wrote.

CREDIT: SHUTTERSTOCK

“So many advertising claims are ridiculous.”

MAY 9, 2016 | CEN.ACS.ORG | C&EN

29

A technician in BASF’s Tarrytown Consumer Testing Center uses a cutometer to measure skin elasticity.

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 Some cosmetic scientists themselves are with cosmetics that imply they are drugs says. Challenges can come from governskeptical of claims they often come across. with an unapproved healing effect. ment agencies, individuals, competitors, “So many advertising claims are ridicuJim Schwartz, a research fellow who foclass-action lawsuits, and nongovernmental lous,” says personal care industry consulcuses on the Head and Shoulders antidanorganizations. For instance, the National tant David Steinberg. He once joked with a druff shampoo line at consumer products Advertising Division of the Council of Better marketer about a skin product that claimed giant Procter & Gamble, says many of the Business Bureaus, a U.S. trade group, invesit “makes you look 20 years younger.” Stein- arguments that might develop when a prod- tigates complaints that companies make berg said he applied it to a seven-year-old uct is on the market can be avoided by getagainst one another for misleading and inacand afterward couldn’t find the child. ting scientists involved early in the claims curate claims. Those that don’t comply with FTC, the U.S. Food & Drug Administradevelopment process. its decisions are referred to FTC. tion, and European authorities keep an eye “The idea for a marketing claim can origTo back claims, scientists at personal on cosmetic claims. They allow some pretty inate either from marketing or research and care product makers need lab tools that aloutrageous ones to stand, often because development staff,” Schwartz explains. Sur- low them to “objectify the data,” Schwartz they consider them mere puffery that a rea- veys of what consumers are looking for in a points out. They will use tools that, for sonable person would not take seriously. product also provide inspiration, he says. instance, capture skin images under conBoth European and U.S. authorities are Some claims, “no matter how much trolled lighting to help characterize and more concerned about believable but unconsumers may like them,” are just not assess wrinkle depth, he says. substantiated claims, although Scientific instruments are U.S. officials are regarded as at the heart of the personal more aggressive. The U.S. Although differences exist, both EU and U.S. authorities require care laboratory operations at separates cosmetics into two claims substantiation. BASF, a German chemical giant categories: ones that are meant that is also a major personal only to enhance appearance care ingredient supplier. At its EUROPEAN UNION U.S. and ones that contain ingrenewly opened consumer testing Enforcement The European Commission The Food & Drug Administration dients such as sunscreens and center in Tarrytown, N.Y., BASF sets cosmetic standards and the Federal Trade Commission antidandruff additives and are is set up to develop claims for which are enforced by member both have jurisdiction over considered to be drugs. new ingredients it develops. It country regulatory authorities. cosmetic claims. Individual state In Europe, both categories also formulates products with have regulatory authority too. are considered cosmetics, and its ingredients to test them on Registration Cosmetic products must be Cosmetic products and formulators have more promoconsumers, and as a service it registered and proof of claims ingredients do not need FDA tional leeway. The European auwill also test its customers’ formust be filed before they go registration, but they can be thorities don’t quarrel publicly mulations to verify claims. on the market. registered voluntarily. Claims are with firms over their claims, For clinical studies, the test not filed with the agency. although they do require that center draws on a panelist pool Truthfulness Claims must be truthful. That Companies must have competent firms register products and of more than 1,000 people from is, if said to contain honey, it and reliable evidence to keep records to substantiate nearby communities. For a must contain honey. substantiate any ingredientclaims. modest payment, panelists subrelated claims. In the U.S., registration is mit to studies of whether bioacEvidence Claims should be supported To support performance claims not a requirement, but when tive ingredients can reduce the by verifiable evidence. companies need both clinically challenged, firms are expected appearance of wrinkles, skin Experimental studies should and statistically significant data. to be able to back claims. In relighteners can even out skin be reliable and reproducible. cent years, U.S. authorities have tone, and emollients can moisbeen increasingly concerned turize skin. Sources: European Commission, U.S. FDA, U.S. FTC

30

C&EN | CEN.ACS.ORG | MAY 9, 2016

CREDIT: ED CODY/BASF

Cosmetic science

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 mois-

turizing 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.”

Powerful

Stirring

Intuitive touch panel Sealed Housing

IP 54 classified

Max Power min noise level

RS232 or USB interface Maintains Speed w/ variable viscosity

(224) 265-9600 [email protected] HeidolphNA.com

MAY 9, 2016 | CEN.ACS.ORG | C&EN

31

32

C&EN | CEN.ACS.ORG | MAY 9, 2016

More online

CREDIT: GERMAIN PUCCETTI/ASHLAND

Proving a claim, either for A forearm is shown under certain effect. But one of Ashland’s own ingrediUV-A light before and their formula is realents or as a service to a customafter treatment with five ly a mixture of many er, can be a complex operation. different SPF 50 sunscreen ingredients, and it is “We have to design an experformulations. Patches in the hard to know if any iment that is appropriate. If a far right image show water one element truly methodology doesn’t exist, we resistance of sunscreens after makes a difference develop one,” Zhang says. In exposure to salt water. unless a study is well some cases, that might involve designed. “Concreating an instrument in-house. sumer preference claims, for example, don’t For example, an Ashland employee mean much without a placebo control,” he designed an instrument to measure the says. deposition of a conditioning polymer on “We have to do good science,” says Abel hair. The instrument takes advantage of the Pereira, research and technology director fact that hair has a negative charge and con- at the Edison, N.J., research labs of ingreditioning polymers have a positive charge. dient maker Croda. Though Pereira and his “With this instrument, we can measure the colleagues work to satisfy their employer’s presence of a film on the hair and the efficustomers, it is sometimes up to them to ciency of its deposition,” Zhang says. explain the value of a well-designed, placeAshland uses other tools to monitor bo-controlled study. active ingredients used in skin care formulaResearch and technology manager Fartions. Salicylic acid-based acne face washes ahdia Edouard recalls having to explain to a can contain no more than 2% of the ingredicustomer that she could not just test a hair ent, according to FDA rules, so it’s important treatment formulation with a new ingreto make sure more of the active ingredient dient against untreated hair. To accurately gets deposited on the skin than washes show whether the hair down the drain. Using a spectrofluoromeproduct was effective, ter to measure the emission spectrum of a she had to test it with treatment on the skin, “we can determine and without the new the optimal formulation of active, polymer, ingredient. thickeners, and pH,” says research scientist Croda’s expanded Mark Davies. Edison labs employ Not all cosmetic claims come with scien- about 20 people tific underpinnings. Claims that begin with working on personal phrases such as “90% of consumers felt” care and home- and or “most agreed that” may have their place health-care-related as marketing tools, says Randall Wickett, ingredients. The ina claims support consultant and professor stallation includes a emeritus of pharmaceutics and cosmetic synthesis lab where science at the University of Cincinnati. But chemists research they are not based on science. novel ingredients And not all claims backed with scientific with a focus on natudata are reliable, Wickett says. Some prodral and biobased raw uct makers may call out an ingredient for a 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 Multiple as well as pharmaceuimages of the tical, medical device, author taken with and dietary supplea Visia imaging ment companies. system made by In a former Singer Canfield. Light, sewing machine plant, filters, and software more than 100 techreveal pores, nicians work in labs sebum, brown equipped with instruspots, UV damage, ments including chroand other signs of matographs, mass wear and tear. See spectrometers, and more at cenm.ag/ spectroradiometers, cameras. 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.” ◾

5 WAYS TO TRANSFORM YOUR LABORATORY Information is your lab’s greatest asset. Put it to work with a powerful LIMS that guarantees data integrity, drives innovation and growth for lab excellence.

STARLIMS solution provides the flexibility and configuration you need to take on the challenges of today and seize the opportunities of tomorrow. abbottinformatics.com

USA Tel: +1 954 964 8663

GERMANY

UNITED KINGDOM Tel: +49 2302 915 244 Tel: +44 161 711 0340

FRANCE

NETHERLANDS

+33 1 61 37 02 00

Tel: +31 72 511 8100

SPAIN

AUSTRALIA Tel: +61 3 9670 0678

ASIA PACIFIC

LATIN AMERICA

Tel: +852 2793 0699

Tel: +1 954 964 8663

CANADA Tel: +1 888 455 5467

Tel: +34 91 663 67 64

4000 Hollywood Blvd, Suite 333 South, Hollywood, FL 33021-6755 USA [email protected]

®

LEAD THE HERD

American Chemical Society

The Leading Without Authority course from the ACS Leadership Development System® provides you with the skills to become an effective leader and get ahead of the pack. Get started at www.acs.org/LeadTheHerd

Brought to you by the ACS Career Navigator™ www.acs.org/CareerNavigator ©2015 American Chemical Society. CN1531

MAY 9, 2016 | CEN.ACS.ORG | C&EN

33

ACS NEWS COMMENT

How are ACS membership dues increases determined, and why are they necessary? ach spring, the Society Committee on Budget & Finance (B&F) reviews a proposed membership dues increase for the following calendar year. Between 2015 and 2016, dues increased $4.00, from $158 to $162. In 2017, dues will increase $4.00 again, to $166. These increases may seem arbitrary, but they are actually tied to inflation and determined using a formula specified in the ACS Bylaws. Bylaw XIII, Section 3 (www.acs.org/ bulletin5), set the base dues for 1986 at $69 and specifies that dues for each succeeding year will be calculated using the increase in the Consumer Price Index for Urban Wage & Clerical Workers (CPI-W) for services over the two years prior to the year in which the dues increase is considered. So for 1987, the dues increase was calculated by multiplying $69 by the change in the CPI-W for services between December 1984 and December 1985. The CPI-W reflects the average change in prices paid for services by households in which more than half of annual income comes from wage or clerical occupations. The Consumer Price Index is calculated by the Department of Labor as a proxy

for inflation and is a standard metric for adjusting prices. Between 2014 and 2015, the CPI-W increased 2.44%, and 2.44% of $162 is $3.95. Bylaw XIII specifies that dues increases should be rounded to the nearest dollar; this is how the $4.00 increase for 2017 was determined. B&F may propose that council accept the calculated increase, reject it, or increase dues by a lesser amount. Council votes on B&F’s proposal at the spring ACS national meeting. The CPI-W for services increased from 106.3 in December 1984 to 288.663 in December 2015—an average annual increase of 3.3% over 31 years. The corresponding dues increase was 2.8%—below the rate of inflation. That’s because B&F or council have decided not to increase dues four times since 1986 (1989–90, 1994–95, 1996–97, and 2000–01), and between 1992 and 1993, an increase less than the calculated amount was approved. This has kept ACS dues below average ACS membership dues are lower than some among our sister scientific socicomparable scientific societies. eties. If dues had increased comREPORTED mensurately with inflation, 2017 MEMBERS dues would have been about 2016 AT YEAR $189, slightly above the average. ASSOCIATION DUES END 2015 Bylaw XIII also specifies how American Association for Clinical Chemistry $227 8,000 most dues revenue is spent. Association for Psychological Science 216 26,000 Dues must be used to cover Royal Society of Chemistry 205 50,000 printing and distribution costs American Institute of Chemical Engineers 199 50,000 associated with the editorial portion of Chemical & EngineerInstitute of Electrical & Electronics 199 430,000 Engineers ing News (42% of dues revenue, $6.3 million, in 2015) and to American Physiological Society 185 10,500 fund local sections and diviAmerican Nuclear Society 170 11,000 sions (20% of dues, $3.15 milAmerican Association for the 165 120,000 lion, in 2015). Dues also support Advancement of Science member services, which sends American Chemical Society 162 157,000 us reminders to pay dues, inAmerican Physical Society 149 51,500 curs processing fees from credit Society of Plastics Engineers 144 18,000 card payments, and maintains American Society for Biochemistry & 140 12,000 and updates member records Molecular Biology ($3.8 million in 2015). And beAmerican Ceramic Society 120 9,500 cause ACS values education, all Source: Association websites revenue from student member

E

By the numbers

34

C&EN | CEN.ACS.ORG | MAY 9, 2016

dues ($400,000 in 2015) is allocated to student programs. Dues also offset information technology costs ($1.26 million in 2015). The remaining balance goes to support society programs. What happens when dues don’t increase? C&EN, member services, and IT still must be funded, so any increase in their costs is offset by a corresponding decrease in the contribution to society programs. But society programs are not predominantly supported by dues revenue; they are supported by contributions from ACS’s major business units, Chemical Abstracts Service (CAS) and ACS Publications, and by income from the society’s investments. CAS, Publications, and investments provided nearly $45 million in 2015 to support society programs, including the offices of Public Affairs, Education, and Membership & Scientific Advancement. By comparison, ACS’s total dues revenue is about $16 million. When dues don’t increase, the major impacts fall on local sections, divisions, and student programs—ACS’s grassroots units. The costs of these units’ activities also increase with inflation. When dues remain flat, our local section, division, and student volunteers have to get by with, effectively, less. A 2.44% dues increase translates directly into a 2.44% increase in the contribution to local sections and divisions, so when dues increase by $4.00 in 2017, about $77,000 more will go to local sections and divisions to help fund a host of activities in communities all over the nation, including National Chemistry Week and local government-affairs activities. Please consider this when your dues reminder arrives for 2017; from my perspective as a former local section chair, that $4.00 is a pretty good investment.

Views expressed on this page are those of the author and not necessarily those of ACS.

CREDIT: LOS ALAMOS NATIONAL LABORATORY

KRISTIN OMBERG, CHAIR, SOCIETY COMMITTEE ON BUDGET & FINANCE