FTC's widespread review of omega-3 fatty acid supplement claims reminds firms they must support claims with "competent and reliable scientific evidence," a standard stakeholders argue is unclear and at times impractical.

In January letters, FTC warned 11 unnamed marketers of children's omega-3 fatty acid supplements that if they could not adequately substantiate claims that their products can enhance the intelligence, mood and visual acuity of children older than 2 years, the commission might take enforcement action, according to a Feb. 16 release.

"Our big concern is we want companies to have competent and reliable scientific evidence to support products where they are making health claims and health benefit claims," Devin Domond, an FTC staff attorney, said in an interview.

She explained FTC wants to see "human clinical cause and effect studies ... of the age group that the product is intended for."

FTC seeks studies demonstrating the products and omega-3 fatty acids benefit brain and vision function in children older than 2, Domond said.

For years, industry stakeholders have complained that FTC and FDA's preference for randomized controlled trials to support supplement claims is not always feasible, and it inappropriately dismisses a significant body of useful science. They also complain that FTC has not clearly defined "competent and reliable scientific evidence" (¹ Also see "FDA Keeps Door Open To Help Observational Studies Work For Health Claims" - Pink Sheet, 19 January, 2009.).

Recognizing these concerns, in future orders FTC will outline the number and characteristics of clinical studies required to support specific claims, Christine Lee DeLorme, an FTC staff attorney, said Jan. 28 at a Food and Drug Law Institute conference in Washington.

DeLorme said the best studies test a finished product, not individual ingredients, and test relevant clinical endpoints, the same dose and delivery method, and a representative human population. The best studies offer statistically significant results and appear in peer-reviewed journals, she said.

Daniel Fabricant, VP of scientific and regulatory affairs at the Natural Products Association said, "Those are tough studies to come by and they are tough to make them stand up to the FTC's bar which is really more randomized clinical trial-based, whereas these types of development claims and studies are really better supported and served by observational studies."

But, he acknowledged, "We know the FTC standard and, knowing that, folks before they get out there with such claims need to mind their p's and q's."

The letters are not FTC's first on the subject.

DeLorme noted FTC's concern about omega-3s during the FDLI conference, and Domond explained that the commission began reviewing omega-3 claims after its investigation into Northwest Natural Products found questionable claims that L'il Critters Omega-3 Gummy Fish boosts, improves or promotes brain function, brain development, intelligence or academic achievement in children.

In response to FTC's request for substantiation, Northwest Natural dropped claims that "omega-3 promotes healthy brain function," among others, and removed from labeling and advertisements pictures of a report card with a prominent "A" grade and of a fish wearing a mortarboard graduation cap, according to a letter FTC sent the firm in October.

FTC did not take enforcement action against Vancouver, Wash.-based Northwest Natural in light of its cooperation, and held the firm up as an example in the latest round of letters.

Several other firms that received FTC letters followed Northwest Natural's lead and changed their claims, while others removed their products altogether, Domond said. FTC, which gave letter recipients until Feb. 8 to outline corrective actions, continues to work with some firms, she said.

More Warnings About Omega-3 Claims Likely

"FTC is really digging their heels in on this one," said Fabricant. "I would imagine ... there will be a whole lot more" FTC warnings.

Domond acknowledged other firms likely market products making similar claims, and FTC may send additional warning letters.

She said the latest round of letters focused on products in popular retail outlets and on firms with extensive marketing.

The timing of the investigation could be related to the significant media attention paid to benefits associated generally with omega-3s.

Food and drug law attorney Marc Ullman said the media's recent attention to omega-3s "would, in FTC's analysis, provide the background for companies to push the envelope and make claims that might go beyond what can be documented in order to take advantage of what they feel is a favorable market environment."

Fabricant agreed and cautioned firms that "if something appears in the newspaper, it doesn't necessarily mean you can use it in a claim."

He maintained that a single study, no matter how positive, is not going to meet FTC's "high bar" for scientific standard for a claim "unless it is an incredibly large study" across a broad population.

Claims Aimed At Children Are A High Priority

The fact the products targeted concerned parents also likely prompted FTC to expand its probe into the omega-3 claims, Ullman, with New York firm Ullman, Shapiro & Ullman, notes.

"FTC has made it clear that it intends to focus on claims for children's products across the board - not just in the supplement area," he said.

"We are generally concerned about children's products," Domond agreed, but she added that FTC is interested in all types of products that make health benefit claims.

FTC also is concerned about fiber products, antioxidants and products making immune system claims, DeLorme said during the FDLI conference. Another high-interest area for FTC is health claims and products related to obesity, Fabricant observed.

Ultimately, the recent letters' message extends beyond omega-3 supplements and children, said Ullman. "The message applies across the board: Be prepared to support your product claims."

- Elizabeth Crawford ( ² e.crawford@elsevier.com )

Omega-3 Probe Underscores FTC Standard For Claims Substantiation

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