Reviewed and Approved by Maged Sharaf, Ph.D., EAS Consulting Group Senior Director, Labeling, Cannabis, and Claims Consulting Services
1-Minute Summary
- Claims substantiation is required by law in the U.S.
- Failure to substantiate claims can lead to regulatory actions and fines.
- The FTC uses targeted requests for claims substantiation.
- Substantiation methods vary for objective and subjective claims.
How to Substantiate Label Claims for Cosmetic and Personal Care Products
Cosmetic and personal care brands often use label claims to help their products stand out in the highly competitive market. Claiming that your product “Helps Make Wrinkles & Fine Lines Less Visible” or provides “Visible Results in Only One Week”, for example, grabs the buyer’s attention.
However, it's not enough to simply make these claims; you must substantiate them before selling such products in the United States. Failure to do so can lead to serious consequences, including regulatory action, fines, and damage to your brand's reputation.
So, how do you substantiate a label claim? What regulations govern cosmetic and personal care claim substantiation?
To provide guidance, we consulted Maged Sharaf, Ph.D., EAS Consulting Group Senior Director, Labeling, Cannabis, and Claims Consulting Services. In this article, Dr. Sharaf answers common questions about cosmetic and personal care claims substantiation, providing insights for brands looking to ensure their advertising is both truthful and compliant.
Q. Why is Substantiating Product Claims So Crucial for Cosmetic and Personal Care Brands?
Dr. Sharaf: Substantiating product claims is required by law in the USA and may help companies avoid actions by the FTC, other regulatory bodies, or a competitor. It also establishes company confidence in its own brand and consumer’s trust in the brand.
Q. What are the Potential Consequences for a Brand that Fails to Substantiate its Claims?
Dr. Sharaf: It increases its liability to warning or legal actions by regulatory authorities and challenges from competitors and lawyers.
Q. What Specific U.S. Regulations Govern Cosmetic and Personal Care Claims Substantiation?
Dr. Sharaf: Primary laws applicable to cosmetics include:
- Federal Food, Drug, and Cosmetic Act (FD&C Act)
- Fair Packaging and Labeling Act (FPLA)
Additional Laws/Oversight:
- Consumer Product Safety Act (CPSA)
- Customs and Border Protection (CBP)
- Environmental Protection Agency (EPA)
- Federal Trade Commission (FTC)
- United States Department of Agriculture (USDA)
Q. What are the Differences Between “Objective” and “Subjective” Claims?
Dr. Sharaf: Objective claims are those related to product performance and function that the consumer experiences or expects. These are based on facts. Example, a deodorant is used to mask unwanted body odor.
Subjective claims are the perception about the attributes of a product by the consumer and are based on opinions. Example, the smell of a perfume.
Q. What Types of Evidence are Required to Substantiate Each Type of Claim?
Dr. Sharaf: The types of evidence depend on the claim(s) and its context. For objective claims, a well-conducted, blinded, clinical study is preferred. While for subjective claims, well-conducted, independent consumer surveys or consumer home use tests are used.
Q. How Does the U.S. FTC Determine Whether a Claim is Substantiated?
Dr. Sharaf: The U.S. FTC has substantiated claims checked using two primary methods. Initially, the FTC used industry-wide "rounds," which involved publicized inquiries targeting several firms within a specific industry or across different industries making similar claims. These inquiries involved identical or substantially similar demands for substantiation from multiple firms.
However, this method proved to be costly for both the recipients and the FTC. Consequently, the FTC has shifted its focus to a more cost-effective approach by sending specific requests for substantiation directly to individual companies under investigation. This targeted method is more efficient and reduces the overall burden on both the firms and the agency.
Q. Where Can Brands Get Help Developing and Reviewing Label Claims for Regulatory Compliance?
Dr. Sharaf: By relying on internal expertise or through help from outside resources, such as a consulting firm with expertise in claims substantiation for cosmetic, personal care, and other products. EAS Consulting Group can help substantiate your claims to ensure regulatory compliance. Reach out to us with questions and we’ll be glad to help.
