Making immune health claims on a product label seems like dancing on the edge of the DSHEA volcano. After all, isn’t the immune system all about “preventing” illness?
“Companies have found themselves in trouble when mentioning the ability of a product to treat, prevent or shorten the duration of a particular illness, like the cold or the flu,” Wasserman, an attorney with Washington, D.C.-based law firm Manatt, Phelps & Phillips, told NutraIngredients-USA.
While some mistakes might seem obvious in hindsight, there have been instances where companies have crossed the line in their eagerness to come to market.
“There was a rash of (illegal) H1N1 illness claims back in the day,” Wasserman said.
Jason Sapsin, a Denver-based attorney with law firm Polsinelli Shughart, agreed that haste makes waste when contemplating claims.
“I think the problem with the structure function claims for the immune system is similar for structure function claims for weight loss in that these are particularly attractive and fast growing parts of the market. Folks are rushing to stay on that curve and they may be tempted to release products and make statements about products that haven’t been fully vetted, as opposed to a careful, thoughtful approach that the science would dictate,” he said.
Science serves as sticking point
So sticking to a straight “supports healthy immune response” or something similar is the basic game plan, both Wasserman and Sapsin say. The problem arises when companies go about figuring out scientifically how their product works. It’s hard to prove a negative; how do you know how many people would have gotten sick when not using your product? Big sample sizes could help here, by smoothing out the inevitable outliers that arise as a result of the natural variability of immune response among humans, but big studies are often too expensive to undertake for most dietary supplement manufacturers. One common tack is to study populations that are healthy, but subjected to stress. Groups like firefighters, or medical students, or athletes in various endurance events, where you would expect a certain amount of respiratory infections. Your experimental group fends infections off better than your control, and bingo, you’ve got your evidence. But wait, didn’t you just “prevent” a disease?
In this case, Wasserman says, a careful wording of the study title can be helpful. For example, “X compound supports healthy immune response in firefighters” would play better on a company’s website than “X compound prevents respiratory infections in a population under stress.” Even if the study in the first example might include some disease endpoints within the body of the document, you could probably still link to it on a website if you didn’t ballyhoo the results, Wasserman said.
Kitchen sink products
Another issue with claims associated with immune health products centers on the fact that so many of these formulations take a kitchen sink approach. If a product has a host of immune support ingredients, it can be all too easy to imply an additive or synergistic effect for such a formulation without having product-specific science to back it up, Sapsin said.
In two examples of products from well-known manufacturers, one says, “The vitamins, minerals, and amino acids present in X product work together with our herbal blend to support healthy immune function during seasonal changes and year-round.” Another product that includes three branded immune health ingredients along with vitamin D3, zinc and copper discusses the immune health benefits of these ingredients in isolation but makes no statement about their performance in combination. According to Sapsin’s recommendations, the latter would probably be safer than the former.