The lawsuit was filed on August 11 by one Jeffrey Johnson under the aegis of the San Ramon, CA law firm Fazio Michiletti LLP which specializes in bringing class actions. The suit, filed in the Northern District of the State of California, where many such suits are filed, alleges that Schiff and parent company Reckitt Benckiser have misled consumers about how effective its MegaRed krill oil omega 3 product is in reducing the risk of cardiovascular disease.
The claim hinges on the precise wording that Schiff chose to use on its packages. Any dietary supplement must, as a matter of law, avoid claiming to prevent, cure or treat a disease, whatever scientific evidence a company may feel it has to support the efficacy of its products. An exception to this rule is the the qualified cardiovascular health claim the Food and Drug Administration has approved for omega-3s.
Many marketers of omega-3 products have chosen not to use the approved health claim wording, believing that it is too vague to be of much use in connecting consumers with the benefits of their products. Most, therefore, chose to rely on a structure/function claim. Nordic Naturals, on its EPA Elite product, uses the claim “(to) Support normal triglyceride levels and heart health.” Similarly, Barleans, on the package of its Wild & Whole Alaskan Salmon Oil product says “Supports heart health, cognitive function, visual acuity and positive mood.” All such claims as a matter of course have (or ought to have) asterisks that refer to standard the DSHEA disclaimer.
Schiff, according to the lawsuit, chose to use its own version of the approved qualified health claim. On its packages, Schiff said the product “may reduce the risk of coronary heart disease.” The suit alleges this overstates the purported effectiveness of the product and leaves out the critical qualifying information in the approved health claim wording. The full wording of the approved claim is: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”
The suit also takes Schiff to task over its reliance on the purported greater bioefficiency of krill oil’s phospholipid structure as a way to deliver omega-3s into the body. For years, the marketing message has been “only one small pill” was needed to get the benefits of omega-3s via this delivery vehicle, versus the multiple, larger pills called for by its direct competitor, fish oil. The suit makes the case that this is a de facto claim of efficacy at a given dose, something it says FDA has specifically prohibited. “Specifically, the FDA considers ‘any label or labeling suggesting a level of omega-3 fatty acids to be useful in achieving a reduction in the risk of coronary heart disease for the general healthy population to be false and misleading,’ ” the lawsuit reads.
Opening the door
“It seems like FDA approved those qualified health claims in 2003 or 2004. They looked at the science available at the time. It seems as if the plaintiff is attacking the level of support for the claim,” Bethany Kennedy, an attorney in the firm Emord & Associates told NutraIngredients-USA, who is not involved in the lawsuit in any way.
“As it is worded, the Schiff language is a disease reduction claim. Schiff could claim that there has been more research done since the claim was approved. I’m guessing that’s how they’ll try to respond,” she said.
But straying from the approved language does open the door a crack, a crack into which an enterprising law firm can stick a foot.
“If you are going to use the qualified health claim you have to use the exact language,” said Steven Shapiro, with the firm Ullman, Shapiro & Ullman, who is also not involved in the case.
Neither Schiff nor the filing law firm was immediately available to comment further.