FTC Targets Omega-3 Claims, And More

by Ricardo Carvajal, Wes Siegner and Susan Matthees

In mid-February, FTC issued a release stating the agency, sent letters to 11 companies that promote various omega-3 fatty acid supplements, telling them they should review their product packaging and labeling to make sure they do not violate federal law by making baseless claims about how the supplements benefit childrens brain and vision function and development. The companies were given two weeks to respond. As an example of the level of substantiation FTC would find acceptable, the letters point to well-conducted, clinical cause-and-effect studies demonstrating the use of the combination of omega-3 fatty acids provided in Product X, in the same dosage as provided by one serving of that product, improves or promotes brain function, cognitive function, attention span, intelligence, memory, learning ability and visual acuity in normal children ages 2 years and older.

FTC indicated it has challenged some claims that appear tenuous, but also claims that are standard and widely accepted claims for omega-3 fatty acids, specifically docosahexaenoic acid (DHA), such as claims that these ingredients support brain and eye health or support normal brain and vision development. Research into the differences between breast milk and infant formula and the higher scores of breast-fed infants on visual and developmental tests are largely responsible for recent changes in the formulation of most infant formula products to supplement with DHA and other fatty acids. It would appear companies challenged for making such standard claims would have a relatively easy task of responding to the FTC letter with evidence from peer-reviewed studies and/or qualified independent experts, assuming their products have sufficient levels of these ingredients. Some companies and industry associations are in the process of responding to the FTC challenge; the likely result will be standard claims will continue, whereas more adventurous and possibly misleading claims will not.

Regardless, this latest action is consistent with remarks delivered by an FTC staff attorney at the Food and Drug Law Institutes recent conference on hot topics in food and dietary supplement law. In her remarks, the staff attorney indicated FTC intends to closely scrutinize claims relating to omega-3s, probiotics, fiber, antioxidants and products marketed for use by children. The products targeted in FTCs latest action span two of these categories, suggesting they may have been at especially high risk. Notably, FTCs release encourages the filing of consumer complaints against companies that may be deceptively advertising dietary supplements for children.

The authors are all with Hyman, Phelps & McNamara P.C., a law firm with primary practice focused on FDA and FTC regulatory and enforcement matters. Wes Siegner is a director at the firm, Ricardo Carvajal is of counsel and Susan Matthees is an associate with the company. This INSIDER contribution is based on a blogpost from the FDA Law Blog .