“The right raw materials can . . . double or triple the protective power of the immune system.”

—Dr. Joel Fuhrman

While this is a great claim, its substantiation can be challenged. The flu season causes the public to become aware of their immune heath through repeated reminders to obtain the latest vaccination. This heighted awareness also affects the natural products industry. Sales spike in the immune health category. Regardless of the level of awareness, the immune system can use all the help it can get owing to the continual assault it undergoes from day-to-day living.

Making claims regarding the immune system involves challenges that stem from the science behind the claims. The demonstration of an increase in immunity is difficult to prove unless research starts with a diseased population. The scientific proof that a product may prevent a disease renders a claim, a drug claim or, at the very least, a health claim (which is nothing more than a drug claim that may be made for foods and may only describe prevention). The fact that immune system support claims are allowed at all is surprising. As FDA has continually narrowed the field of allowable claims, the matter of immune system health is an area that has been relatively untouched. The claims presented that have resulted in regulatory action reflect the negative side of the industry, but capture headlines. While products demonstrate support for the immune system, claims must be careful not to overstep into the realm of treating a disease.

Another challenge regarding these claims is that FDA has stated it will apply FTC’s standard of “competent and reliable evidence” evaluated based on “the totality of scientific evidence” for consideration of structure/function claims substantiation. If that wording sounds familiar, it should. It is the standard applied when evaluating health claims. FDA further specifically noted in previous draft guidances that claims regarding the immune system must be based on studies with clear, measurable and reproducible endpoints. These criteria are not inconsequential.

Additive to this challenge is the assurance that the materials studied are the same as those found in the product making the claim. Extrapolation of data concerning one form (or species) of an ingredient is not always applicable. Careful evaluation of data offered as substantiation for the claims made is mandatory.

Making claims regarding the immune system may never achieve the level of claim shown in the quote that opened this article. Interpretation of the regulations and what constitutes a “disease claim,” and consideration of context would likely prevent that. While there is no current definition of an “implied disease claim,” as described in regulations for nutrient content claims, a de facto effort is underway to apply this more nebulous standard in regulatory action. The support of the immune system intends to address the body’s ability to stay well, which implies disease prevention. While room remains for claims concerning the effects of a product on the human immune system, substantiation must be established. Each of these components is essential to safe claims.

As chief operating officer, Jim Lassiter oversees all consulting operations at Ingredient Identity. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards.