Skincare Claims FDA

Mar 22, 2021

How to Make Claims with Personal Care Products

The personal care industry is full of products that make various claims. With so many products on the shelves, cosmetic companies often make claims about what their products can do to stand out from the competition. However, these cosmetic and drug product benefits need to be backed by science or data. It is the personal care product company’s responsibility to ensure their claims are truthful and have the evidence to support them.

Common Label Claims

The number and variety of claims that a personal care company can make for their products are plentiful. Correct claims on the label are important because they help to guide the consumer as to what a product can do. Claims are considered to be not only what is written on the label but include all texts, images, and symbols that are used by brands to describe the product. Some common label claims are:

  • Alcohol-Free
  • Aromatherapy
  • Cosmeceutical
  • Cruelty-Free
  • Hypoallergenic
  • Organic
  • Anti-aging
  • Heals sunburn

These claims fall under the cosmetic and drug categories. Whether a cosmetic or drug product, these claims, and any others, must be backed with supporting evidence otherwise the Food and Drug Administration (FDA) will flag them. If a benefit is listed on the label or any other material that the company produces, it must be true.

Are Claims for Cosmetics and Drugs Different?

Personal care companies might be wondering if the claims for cosmetics and drugs have different regulations. The FDA cosmetic definition and the FDA drug definition can help guide companies on how to categorize their products. The FDA does not require approval for the labeling of cosmetic products but does have more regulations regarding products that are in the drug category. Under the FDA drug definition, if a product prevents or treats disease or affects the function of the body, it must be categorized as a drug.

Both cosmetics and drugs must have truthful claims on their labels, and in their marketing and advertising. The FDA monitors what labels personal care product manufacturers are using and will take action against those that violate the laws. As a first step, the FDA will issue a warning letter to those companies that have made unapproved drug claims or falsely represented a product.

How to Make a Claim Backed by Science

One way to back label claims is by testing. Many personal care companies are now relying on technology and tools to evaluate their products. Today’s measurement tools are effective and reliable so that they properly substantiate any benefits that a product is claiming. It is important that these claims are able to be verified by third parties and consumers as well.

In the United States, pre-approval is not necessary for cosmetic products.  However, when asked for proof, personal care companies should be able to back their claims. Recently, the U.S. has targeted cosmetics that imply they are drugs as many companies are using language that could be deemed as deceiving.

How to Make a Consumer-Related Claim

Not all claims have to science-related as some relate more to the experience other consumers have had with the products. Using these claims as a marketing strategy appeals to consumers.  For example, phrases like “85% of consumers felt” or “most agreed that” are often used by companies in their marketing efforts. Consumer preference claims not backed by science are able to be used by cosmetic companies. However, if questioned by the FTC or FDA, they must be able to be supported with actual data.

Examples of False Claims

There are plenty of examples of how federal agencies have discovered false claims. In 2016, for example, the FTC (Federal Trade Commission) discovered that five small cosmetics companies were in violation that the claims that their skincare, sunscreens, and shampoos were ‘all natural’. In reality, each company used synthetic ingredients such as polyethylene and dimethicone in their products.

The violation is not always so apparent, though. In June 2014 the FTC charged L’Oreal with deceptively advertising Lancôme Génifique products with language such as ‘clinically proven to boost genes’ activity and stimulate the production of youth proteins. The cosmetics company claimed this would happen in just 7 days. The agency found that L’Oreal overstated what the product could actually do. If the personal care company was going to claim ‘clinically proven’ it needed more appropriate support by science. These examples prove that cosmetic companies should use best practices when creating their claims.

Making Sure Claims are Backed Appropriately

Although a claim on a cosmetic product might not need to be substantiated by the FDA, backing up the claim with evidence (whether science or peer-based) is the right choice. It lends validity to the brand and consumers are able to make informed choices based on the claims.  There are four main ways to back claims are:

  • Using scientific data from publications
  • Experimental studies (in vitro, ex vivo)
  • Clinical studies (on volunteers)
  • Gather evidence through consumer questionnaires

The methods that are used by the company should be reliable and able to be reproduced. The FDA ensures that label claims are compliant legally (especially for products that fall under the FDA drug definition), are truthful, have evidential support, and are clear for consumers to make an informed decision.

Jim Schwartz, a researcher at Procter & Gamble says that in order to correctly make claims about a personal care product, scientists should be involved from the start in the claim development process.  He states that “The idea for a marketing claim can originate either from marketing or research and development staff.”  Some claims, no matter how much they might appeal to consumers, just cannot be supported by science so they cannot be made. When P&G proves a claim, the effort involves a team of biologists, chemists, developers and statisticians.

Personal care companies must make sure that the claims that they make for all cosmetics and drugs are valid. If not, the company can lose credibility with customers and may be in violation of the FDA’s regulations.

Contact Us For More Information

If you're a vendor, please fill out this form. Any vendors who don't fill this won't be considered