POM Sues FTC over New Substantiation Standard for Food and Dietary Supplement Claims

Sep 24, 2010   

POM Wonderful LLC (“POM”) filed a Complaint against the Federal Trade Commission (“FTC”) on September 13, 2010. POM alleges that the FTC has adopted a “new standard” for substantiation that it is applying against food and dietary supplement companies. The “new standard” is reflected in two recently published consent orders against Nestle USA and Iovate Health Sciences, Inc., in which the FTC prohibits future claims by the companies unless the claims are supported by two well-controlled human clinical studies. The “new standard,” if POM is correct, marks a drastic change in FTC policy regarding substantial of claims.

According to the Complaint, FTC specifically referred POM to the Nestle and Iovate Consent Orders and asserted that the requirements contained in those consent orders constituted the “new standard” that FTC was applying with legal force and effect. POM alleges that the FTC is no longer interpreting present standards or rules by adopting the “new standard” for substantiation, but instead, the FTC has engaged in formal rulemaking without adhering to the process of notice and comment as required by the Administrative Procedures Act.

Furthermore, POM also alleges that the FTC is requiring advertisers to obtain prior Food and Drug Administration (FDA) approval before making certain disease claims about food, beverages, and dietary supplements. Disease claims are health related claims in which a product represents that it treats, mitigates, or prevents disease. According to POM, the FTC is requiring prior FDA approval for disease claims regardless of whether or not the claims are true or supported by competent, reliable scientific evidence. In addition, the FTC is requiring advertisers to conduct two well-controlled clinical studies for non-disease claims. If POMs allegations accurately reflect current FTC policy, these requirements may constitute a violation of the advertisers First Amendment rights and go beyond the authority of the FTC.

For more information on FTC regulations and substantiation requirements, please contact us at contact@fidjlaw.com.