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Make Your Claims Bulletproof: Let Science Serve as Your Vest

April 28, 2016 | Contact Author | By: Robert Ross-Fichtner, MSc, and Claire Robichaud, Focal Point Research Inc., Mississauga, Ontario, Canada
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Keywords: claim | substantiation | regulation | labeling | packaging | testing | efficacy | evidence

Abstract: Manufacturers are easy and frequent targets of litigation for claims they make on their products. You can avoid unwanted attention from regulatory organizations by ensuring your claims are substantiated by science.

Scientists spend years mastering the tools of their trade, whether they’re biology, chemistry or physics; or laboratory techniques and instrumentation. During our years of study and practice, only rarely does the subject of honesty enter into our discussions.

We may think that honesty belongs in the social sciences like philosophy and sociology. After all, we are trained to expect that our science will be beyond reproach and carried out to the highest ethical standards. But from time to time, we see reports of questionable practices, driven by the need for publicity and, of course, the need to sell products and services. The subject of claims substantiation takes us squarely into the subject of honesty.

Claims substantiation is defined as the process of proving and documenting that the claims you plan to make are true. Some of the earliest documented issues related to claims and honesty include a 1917 decision of the United States District Court for Rhode Island. In that case, the court fined Clark Stanley the outrageous sum of $20 for ”misbranding” its Clark Stanley Snake Oil Liniment. Stanley and many of his like-minded travelling salesmen were selling cheap, synthetic versions of “snake oil,” which in traditional Chinese medicine is a useful treatment for a variety of ailments.

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Scientists spend years mastering the tools of their trade, whether they’re biology, chemistry or physics; or laboratory techniques and instrumentation. During our years of study and practice, only rarely does the subject of honesty enter into our discussions.

We may think that honesty belongs in the social sciences like philosophy and sociology. After all, we are trained to expect that our science will be beyond reproach and carried out to the highest ethical standards. But from time to time, we see reports of questionable practices, driven by the need for publicity and, of course, the need to sell products and services. The subject of claims substantiation takes us squarely into the subject of honesty.

Claims substantiation is defined as the process of proving and documenting that the claims you plan to make are true.1 Some of the earliest documented issues related to claims and honesty include a 1917 decision of the United States District Court for Rhode Island. In that case, the court fined Clark Stanley the outrageous sum of $20 for ”misbranding” its Clark Stanley Snake Oil Liniment.2 Stanley and many of his like-minded travelling salesmen were selling cheap, synthetic versions of “snake oil,” which in traditional Chinese medicine is a useful treatment for a variety of ailments.

What is a Claim?

Cosmetic claims are words, sentences, paragraphs, logos, graphics or simply implications that describe the proposed use of a cosmetic, its benefits and its attributes. We’ve all seen these claims as they can be found on almost everything we use, from product labels and package inserts, to product catalogs, advertisements, company websites and social media. It is important for companies to be honest and consistent about what they are explicitly or implicitly stating on their products.3

It is critical for marketers to understand that even if individual phrases or graphics are accurate, because if they convey the wrong “total net impression,” their claims can be found to be misleading. Claims can be as benign as, “improves the look of skin,” to more challenging claims such as, “20% improvement in 30 days.”

The most aggressive claims are usually comparative claims, such as “20% better than the leading competitor.”4 As a rule, any numerical claim is going to require the highest standard of proof, and any comparative claim is going to require a strong stomach and the company’s legal advisers.

In our experience, the cosmetics and beauty industry works hard to ensure claims made about products and services are true. In its simplest form, products from these industries make people look and feel better. What could be wrong with that?

Despite this, the industry is not immune to challenges about honesty and integrity. One U.S. study concluded that four out of five beauty claims cannot be substantiated.5 While the methodology to develop these conclusions was far from clear-cut, regulatory bodies are always interested to ensure that cosmetics manufacturers accurately portray the benefits of their products and services.

There are, of course, many types of claims that make regulatory oversight complicated. Cosmetic claims can relate to the physio-chemical characteristics of the cosmetic, chemical analysis, product performance and customer preference. This being said, not all claims require substantiation, such as emotive claims that say nothing about the product but simply refer to the consumer on an emotional basis.6

All claims relating to product features, functions or benefits require claim substantiation. Claims must be based on competent and reliable scientific evidence, which may include tests, analysis, research, consumer studies, or evidence based on the expertise of professionals in the relevant area. These forms of support must be conducted and evaluated in an objective manner, by persons qualified to do so.7

At times, marketers have been diligent to provide accurate claims on packaging components while forgetting that the leaflet inserted into the package or the company’s website contained vastly different claims. These kinds of omissions often pique the interest of regulators and cause grief for marketers.

Regulatory Oversight

When substantiating claims, it is extremely important to complete the proper testing and respect jurisdictional differences. While processes differ in various jurisdictions, Canada and the United States have very similar regulatory bodies. Health Canada and the U.S. Food and Drug Administration (FDA) are the respective health agencies interested in the safety of products provided to consumers. They are also keenly interested in the packaging and claims made about products, particularly if they could move a product from one regulatory classification to another. A cosmetic claiming to “reverse aging by synthesizing collagen” is likely going to catch the attention of these agencies.

In the world of advertising, Advertising Standards Canada (ASC) and the National Advertising Division (NAD) of the Better Business Bureau provide faster and simpler solutions to advertising claims challenges than the courts.8 These industry-supervised, self-regulatory mechanisms have proved to be extremely useful in settling disputes.

Finally, Canada’s Competition Bureau and the U.S. Federal Trade Commission (FTC) are law enforcement agencies that challenge products and companies they feel are grossly misleading consumers with their advertising or labelling.9 Many newcomers to the industry do not have sufficient appreciation for these two regulators, who have the power to impose serious fines and even imprisonment under the various statutes which they operate. Anyone who has been on the receiving end of a complaint by these agencies is likely to never forget it.

According to the FTC, its mission is to “prevent business practices that are anticompetitive or deceptive or unfair to consumers; to enhance informed consumer choice and public understanding of the competitive process; and to accomplish this without unduly burdening legitimate business activity.”10 Therefore, it regulates advertising claims and expects advertisers to have, “competent and reliable scientific evidence”10 in support of their claims.

The FTC enforces advertising standards under the Federal Trade Commission Act, which mandates that advertisements be fair and non-deceptive, and that those advertisers back up their claims.11 Additionally, the FTC developed the Statement of Policy Regarding Comparative Advertising, which means to compare a product to another company’s product in an advertisement. This document states that comparative advertising is appropriate where the comparisons are clearly identified, truthful and non-deceptive.12

Under the Federal Trade Commission Act:13

  • Advertising must be truthful and non-deceptive
  • Advertisers must have evidence to back up their claims
  • Advertisements cannot be unfair

When determining if an ad is deceptive, the FTC first looks at the ad from the point of view of the “reasonable consumer.” Rather than focusing on specific words, it looks at the context of the advertisement to determine what it could mean to consumers. It also looks at what the ad implicitly says; meaning the failure to include information that leaves consumers with a misimpression about a product’s performance.

In other jurisdictions, it’s essential to also have the proper testing completed. In Europe, guidelines for the appropriate usage of instrumental techniques and the accurate measurement of skin function or properties have been published by expert groups such as the European Group for Efficacy Measurement of Cosmetics and Other Topical Products (EEMCO).14 It is important that any claimed effect of a cosmetic on the skin should find appropriate techniques for clear demonstration.

The sixth amendment of the European Directive on Cosmetic Products requires manufacturers to have a readily available dossier with the proof of the claims made on their products. Commission Regulation (EU) No 655/2013, was published July 10, 2013, along with associated guidelines for proper use of the regulations.15 These documents lay down the common criteria for the justification of claims used in relation to cosmetic products.

The common criteria they discuss are things such as legal compliance, truthfulness, evidential support, honesty, fairness, informed decision making along with detailed information of the best practices to apply to experimental studies.16 The commission authorizes the filing of a complaint when it has a reason to believe that the law has been or is currently being violated.

And the regulatory agencies don’t stop at cosmetics; they provide guidance and regulations for various other areas, including dietary supplements, technology and even food. In the past 10 years, the FTC has filed more than 120 cases challenging the health claims made on dietary supplements alone. In one case, the FTC was able to collect up to $3.2 million from marketers of a supplement product.17 This is an extreme but very instructive case as to the kinds of penalties possible for misleading product claims.

We asked Craig Weiss, President of Consumer Product Testing Company, what were some of the most common mistakes made in developing advertising claims support, based on his many years of developing support for companies worldwide. According to Weiss, it’s critical to:

  • Test products per the written usage directions
  • Don’t print labels prior to getting the results. Begin lab processes early
  • Make sure studies are conducted in a controlled environmental room
  • Audit the laboratory. You have the right to see the data being produced

Lastly, don’t assume that a claim made by a competitor will work for your brand. If a competitor makes a very compelling claim, get to the lab or to the consumer and test your product rigorously.

As scientists, we have a duty to keep our companies safe by ensuring the claims made about products are true. If you even have a shadow of doubt about a claim, consult with colleagues you trust, and review it with your legal advisors. There is no room for snake oil salesmen in today’s market, only ample incentive to avoid the pain and suffering that today’s regulators can inflict.

References

  1. Marsh, K. (n.d.). 8 Things you Need to Know About Claim Substantiation. Retrieved from Marketing Flexibility: http://marketingflexibility.com/can-you-substantiate-that-claim/
  2. Rhode Island. (n.d.). In Wikipedia. Retrieved March 23, 2016, from https://en.wikipedia.org/wiki/Rhode_Island
  3. Health Canada. (2006). Labelling of Cosmetics. Ottawa, Ontario, Canada: Health Canada. Retrieved from http://www.hc-sc.gc.ca/cps-spc/alt_formats/hecs-sesc/pdf/pubs/indust/cosmetics-cosmetiques/labelling-etiquetage-eng.pdf
  4. Health Canada, Advertising Standards Canada. (2006). Guidelines for Cosmetic Advertising and Labelling Claims. Ottawa: Health Canada. Retrieved from http://publications.gc.ca/collections/collection_2014/sc-hc/H128-1-06-453-eng.pdf
  5. Knapton, S. (2015, July 28). Four in five beauty claims cannot be substantiated. Retrieved from The Telegraph: http://www.telegraph.co.uk/news/science/science-news/11768
    390/Four-in-five-beauty-claims-cannot-be-substantiated.html
  6. Wiechers, Johann W. (n.d.). Four Basic Rules of Cosmetic Claim Substantiation [Powerpoint Slides]. Retrieved from http://www.scientificspectator.com/documents/personal%20care%20spectator/Wiechers-The%20Basic%20Rules%20of%20Cosmetic%20Claim%20Substantiation.pdf
  7. Jackson, Michelle C. (2012, March 9). Claiming to be the Best: Understanding How to Substnatiate Your Claims [Powerpoint Slides]. Retrieved from https://www.venable.com/files/Event/3acb39e9-0914-445b-a85e-171f5425f205/Presentation/EventAttachment/4646a584-0a48-42b5-b1aa-382bb4fcc804/Expo_West_2012_presentation.pdf
  8. Advertising Standards Canada. (2014, May). Guidelines for the Nonprescription and Cosmetic Industry Regarding Non-Therapeutic Advertising and Labelling Claims. Retrieved from http://www.adstandards.com/en/clearance/cosmetics/Guidelines-for-the-Nonprescription-and-Cosmetic-Industry.pdf
  9. Competition Bureau. (2015, March 11). Enquiries and Complaints. Retrieved from Competition Bureau: http://www.competitionbureau.gc.ca/eic/site/cb-bc.nsf/eng/h_00019.html
  10. Federal Trade Commission. (n.d.). About the FTC. Retrieved from Federal Trade Commission: Protecting America’s Consumers: https://www.ftc.gov/about-ftc
  11. Advertising Substantiation and Standards for Conducting Research for Advertising Claims. (2015, April 15). Retrieved from Marketing Research Association: http://www.marketingresearch.org/issues-policies/best-practice/advertising-substantiation-and-standards-conducting-research
  12. Federal Trade Commission. (1979, August 13). Statement of Policy Regarding Comparative Advertising. Retrieved from Federal Trade Commission: https://www.ftc.gov/public-statements/1979/08/statement-policy-regarding-comparative-advertising
  13. Federal Trade Commission. (2001, April). Advertising FAQ’s: A Guide for Small Business. Retrieved from Federal Trade Commission: https://www.ftc.gov/tips-advice/business-center/guidance/advertising-faqs-guide-small-business
  14. Barel, A. O., Paye, M., & Maibach, H. I. (2009). Handbook of Cosmetic Science and Technology: Third Edition. New York: Informa Healthcare USA, Inc.
  15. European Commission. (2013, July 10). Commission Regulation (EU) No 655/2013. Official Journal of the European Union, 31-34. Retrieved from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:190:0031:0034:en:PDF
  16. European Commission. (2013, July). Guidelines to Commission Regulation (EU) No 655/2013. 1-12. Retrieved from file:///C:/Users/clairer/Downloads/guide_reg_claims_en.pdf
  17. Federal Trade Commission. (2016, February 25). District Court Ruling Allows FTC to Attempt to Clalect up to $3.2 Million [Press Release].Retrieved from https://www.ftc.gov/news-events/press-releases/2016/02/district-court-ruling-allows-ftc-attempt-collect-32-million