Inflammation is common—You just can’t talk about itInflammation is common—You just can’t talk about it
While labeling of food and dietary supplement products is challenging, expert guidance and input can allow presentations of the substantiated benefits to occur. Structurally or functionally, the matters of addressing inflammation are not the exclusive realm of drugs.
July 13, 2020
Numerous scientists support the notion that inflammation is a necessary everyday occurrence for the human species in order to activate certain processes. Simultaneously, we all know inflammation is not a good thing and chronic inflammation leads to specific physiologic challenges. Therein lies the debate of how to discuss the matter of inflammation.
Two things must be taken into consideration in the inflammation debate.
First is subject matter. While discussion of topics around inflammation generally is a matter of free speech, regulatory agencies contend that the context presented by such discussions creates a non-regulatory class of claims called “implied structure/function claims.” While there is a regulatory standard for implied nutrient content claims, no such standard exists in the regulations regarding structure/function claims.
The second issue is whether the discussion directly involves inflammation or the body’s response to inflammation. This is a different matter that brings with it restrictions. As science continues and additional information about the effects of certain nutrients on inflammation is known, the opportunities may expand from current limits.
Considering inflammation, FDA initially allowed related structure/function claims without challenge. This changed a few years back when FDA determined that discussion of the anti-inflammatory process is, with very few exceptions, a lead-in or part of an unacceptable claim. Part of the reasoning was that the anti-inflammatory process is not always active, unlike the immune system, and occurs only as the result of disease, damage or dysfunction. So, triggering, enhancing or affecting this process is a drug-like effect. Since the process occurs only as the result of the disallowed classes of insult, the claims are severely restricted.
The argument may be made that staying within the allowances for such claims is sufficient since the consumer should be able to extrapolate that enhancing or supporting the anti-inflammatory process occurs regardless of the source of the inflammation. To concede one of the underlying arguments, sometimes inflammation is the result of a dysfunction or disease process that may not be amenable to self-diagnosis. A question arises about whether enhancing the anti-inflammatory response is a bad thing in some cases, i.e. in all instances not associated with strenuous exercise. Added to this is the matter of how the “context” established is bounded from a regulatory perspective. The undefined “implied” border for the non-regulatory class of claims renders discussion of the topic itself as nearly eliminated.
The body’s anti-inflammatory response, as a function, is specifically limited by FDA to conditions associated with overall good health. This boundary is appropriate in many applications, unless you ignore sections of science. Inflammation and the anti-inflammatory response are not so differentiated. Discussion of the anti-inflammatory response is nearly always considered a drug claim, for the reasons noted earlier. So, while limiting the discussion specifically due to cause ignores basic science. This discussion, the one regarding the function of the anti-inflammatory response, becomes nearly off-limits. The marketing focus nearly mandates the use of the terms “inflammation” and “anti-inflammatory” in promotion of these products. Their effects and the substantiation of these effects can be debated but, even if it exists, the substantiation still cannot result in the crafting of an acceptable claim beyond the restrictions in place.
The solution to this in the short term is to carefully review, with expert advice, any claim remotely touching on the topic of inflammation. Questions to ask include whether the science backs the desired claim. If that is in order, the claims desired need to be carefully presented. Inclusive of the desire to use words that at least include the word “inflammation” or “anti-inflammatory,” discussion of the function using such language presents immediate regulatory risk. The approach then is to discuss whether the claim involves the function, the matter of inflammation generally, or something else. That something else is where opportunity exists.
Consider that the careful crafting of a discussion regarding inflammation is allowed. Consider next that the law allows for presentation of the “documented mechanism of action” of a nutrient as structure/function claims and the opportunity to discuss how your nutrient works in support of or to enhance the body’s anti-inflammatory response. This has been a recurring theme in presentations from this corner of the world, but it remains a truth. Rather than discuss the function of the anti-inflammatory response, why not discuss the structure? In a note of irony, the structure in control of this response is described in the same medical dictionary used by FDA to define specific terms in applying claims restrictions where we find “the cholinergic anti-inflammatory metabolic pathway.” This structure is not something transient as the response itself is described. It remains as a series of physiologic structures that may be nourished by supplemental intake.
Thus, while the discussion of inflammation in the labeling of food and dietary supplement products is challenging, expert guidance and input can allow presentations of the substantiated benefits to occur. Structurally or functionally, the matters of addressing inflammation are not the exclusive realm of drugs.
As chief operating officer, Jim Lassiter oversees all consulting operations at REJIMUS, formerly 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.
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