Omega-3 group: FDA remains focused on claims

The Global Organization for EPA and DHA Omega-3s (GOED) reminded its members that FDA continues to focus on improper marketing claims, including those made for omega-3 supplements.

“While GOED does not actively monitor the FDA warning letters database, we have noticed what seems to be an excessive number—five in less than a year—of warning letters sent to companies marketing omega-3 supplement products,” Harry Rice, vice president of regulatory and scientific affairs, wrote in an Oct. 25 email to his members. “For this reason, we want to take the opportunity to remind members that our industry is not invisible to the FDA and to be careful about the claims it makes.”

The email linked to FDA letters to 1st Phorm LLC, Fresh Nutrition Inc., NeuroHydrate LLC, iThrive.health and Bodyhealth.com LLC. The letters were issued between December 2020 and July 2021.

Rice cited examples of claims that caught FDA’s attention, including:

•             “Combat cardiovascular disease and heart attacks”

•             “Lower blood pressure”

•             “Migraine prevention”

•             “Reduced symptoms of depression”

•             “Resolution of inflammation…in the context of severe COVID-19”

Rice did not speak with the firms that received an FDA warning letter, and none of them are GOED members, he said in an interview.

None of the companies that received a warning letter immediately responded to requests for comment for this story.

When GOED members ask him about the kinds of claims that can be made, Rice reflected, he reminds them they cannot “talk about curing, mitigating, treating or preventing disease. It’s really about maintaining a certain status.”

In the interview, he also stressed the importance of supporting claims with scientific evidence, and he said firms should keep a file of journal articles and other evidence—in the event regulators have questions about their substantiation.

Justin Prochnow, an attorney in Denver who counsels supplement firms on their labeling and marketing practices, said there was nothing especially striking about FDA’s warning letters.

For instance, the letter to iThrive.health mentioned, among other things, a blog, “How To Boost Your Immune System Naturally Against COVID-19?”

“Guess what? You’re going to get a letter every time when you put up stuff about covid,” Prochnow, a partner with Greenberg Traurig LLP, said in an interview.

The lawyer didn’t believe five letters over the course of several months signals the agency is focused on omega-3 products. In addition to the letters being spread over several months, they were focused on various supplement products—not just those in the omega-3 category. FDA also highlighted other alleged violations of the law. For instance, in the letter to 1st Phorm, FDA contended its supplements containing hordenine—a new dietary ingredient (NDI)—were “adulterated.”

Prochnow contrasted the letters with a strategy adopted by FDA in which it has sent groups of letters simultaneously focused on specific claims, such as those treating depression, infertility and hangovers.

Rice’s email to GOED members was sent about three years after his organization published an industry advisory on making dietary supplement claims in the U.S. The Nov. 15, 2018, advisory highlighted the FDA regulation on structure/function claims.

“GOED is issuing this industry advisory to remind members and the dietary supplement industry that it is NOT permissible to promote dietary supplement products by citing journal articles reporting on studies in diseased populations, as this connection may cause your product to be considered a drug,” GOED cautioned.

Of the out-of-bound claims Rice identifies, they are typically related to “cancer," he said. However, he described the claims within the omega-3 industry as fairly “tempered.”