A Careful Eye on Health Claims

Originally Published NO April 2010

As the omega-3 craze is ramping up, so is federal oversight. This February, the Federal Trade Commission (FTC) proved active by sending warning letters to 11 marketers of children's omega-3 supplements, a market sector that FTC considers to be growing with very strong health claims.

"We saw very strong health-benefit claims being made about everything from increasing intelligence and cognitive function to [enhancing] educational achievements and visual acuity," said FTC staff attorney Devin Domond about the products involved, which were all marketed for children above the age of two. "There is a special concern that we generally have about children's products, and higher claims require higher standards of evidence."

Some months prior to the incident with these companies, Northwest Natural Products (NNP), a company based out of Vancouver, WA, went through a similar process. The company removed a lengthy list of brain-health claims, as well as images, from the labels for its L'il Critters brand Omega-3 Gummy Fish when the company was issued an access letter from FTC in August of last year.

Phrases like "Brain Booster" and "Smart Gummies For Smart Kids," and an image of a fish wearing a graduation cap, were some examples of discarded features.

The access letter issued to NNP would have directly preceded a nonpublic investigation of health claims, but NNP removed all of the product's cognitive claims last fall in an effort commended by FTC as "swift and voluntary." The company has since continued business, with no admission of any wrongdoing, or any accusation from FTC.

Now, hold on. It's not as if omega-3 products can't qualify for health claims. They can. In fact, since 2000, omega-3s have had a FDA-backed qualified health claim for coronary heart disease. The claim reads: "Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids."

Gaining government-backed health claims is a possibility, but submitted studies must meet stringent requirements. The ingredient tested in a study, the dosage level, and the population are just some of the key factors considered for any submitted study.

In all of the aforementioned omega-3 legal cases, a key reason for FTC's concern with submitted science was population; specifically, the age groups involved in studies. Because the products are intended for use in children above two years old (and in at least one case, children up to 16 years of age), scientific substantiation for these products should involve population groups that correspond with all of the ages of the target customers. It cannot be assumed, for instance, that results of omega-3 studies on adult and infant populations will necessarily carry over to other populations, such as teens.

FTC's decision to just send the 11 companies warning letters provided some measure of relief. Each company was given the opportunity to substantiate claims or simply change labels. All companies have since fully complied with FTC to ensure that product claims are truthful and not misleading.