The FTC sent letters to the companies last month for making “baseless” claims linking consumption omega-3 with “children’s brain and vision function and development”. The FTC statement can be found here.
Other claims related to intelligence, cognitive function, learning ability, focus, mood, memory, attention, concentration, visual acuity, and eye health.
But Andrew Shao, PhD, senior vice president of scientific and regulatory affairs, CRN, called on the FTC to clarify the criteria by which it found the claims in breach.
“For example, is it the specific wording of the claims, in other words would the use of ‘support brain function’ be acceptable to the agency, rather than using a claim that states ‘boosting or promoting’ brain function?” Shao asked
“Or is FTC saying the science on omega-3s in general is not strong enough to make any claims related to brain function in children?”
Or, Shao wondered, is the central issue the lack of product-specific trials, and therefore, “borrowing from the literature on an ingredient may not be acceptable?”
“The second and the third reasons are potentially troubling, but we’d like to give FTC the benefit of the doubt, for now,” Shao said, noting extrapolation to omega-3 claim-making being conducted by large food companies was not possible until further details came to light.
He added: “We’ll certainly be vigilant about this to make sure that FTC is not isolating supplements or specific supplement companies without solid reasons, but for now, we need to gather more information. Regulatory actions are complicated, and it would be unfortunate if consumers didn’t read beyond the headlines because omega-3s have many important health benefits for both adults and children.”
The FTC’s Devin Domond, from its Division of Advertising Practices, clarified that the FTC was not ruling out omega-3 children’s brain health claims altogether, but that they needed to be backed by product and population-specific trials to meet its standards of “competent and reliable science”.
Domond said some of the companies had altered their marketing already, others were working with the FTC to resolve the issues, and some were considering removing the products from shelves. She said the agency had a preference for human, clinical trials.
Shao’s counterpart at the Natural Products Association (NPA), Dan Fabricant, PhD, said the letters reinforced the need to back up claims with good science that often amounted to randomized clinical trials.
“Companies need to make sure they have the data and that the claims relate to that data,” he said.
In the warning letters sent on January 26, the FTC gave the companies two weeks to respond and explain the steps they have taken, or intend to take, to ensure they are complying with the law. The agency said it may take law enforcement action if companies make health-related claims for products without scientific proof.
To see a sample letter, click here.