Forum delves into state of inflammation claims enforcement and research backing for those claims

The forum, titled Inflammation: Trends and Opportunities​​​, featured four speakers:  Anne Skulas-Ray, PhD of Penn State University, Cheryl Kos, ND, in the regulatory group of practitioner channel specialist Metagenics, Corey Hilmas, MD, PhD, vice president of scientific and regulatory affairs for the Natural Products Association and Justin Prochnow, a shareholder in the law firm Greenberg Traurig.

Defining the problem​

A key point in dealing with inflammation is first defining the problem. It’s less easy than it sounds.

“Inflammation is a different condition in ever person in whom it occurs. It can depend on body adiposity, genetic variation or genetic variation,”​ Kos said. “The right amount of inflammation is exactly enough to address the immune challenges that exist in a body at the right the body at any given time and bring them to the right resolution.”​

“Inflammation has a function but it is important for that inflammation to turn off after it has served that function before it turns into chronic inflammation,”​ Skulas-Ray said.

Measuring the response​

Tracking the effect natural compounds on inflammation is often a case of measuring levels of c-reactive protein in the body in response to various challenges. It’s a highly useful too because it captures such a comprehensive view of the inflammatory response, Skulas-Ray said.

“CRP is a really useful marker because it has the broadest application,”​ she said. “CRP has been adopted by the American Heart Association as their marker for cardiovascular disease risk based on inflammation. It’s good to use that market as opposed to some of the cytokines because they can change acutely, even from just one night of bad sleep.  Even a minor condition like gingivitis can send cytokine levels up. Or is someone has a cold, their cytokine levels can be up, and that doesn’t reflect overall inflammation.”​

Eliciting a healthy response from regulators​

Measuring these effects is one thing.  Using that information to craft a message that won’t raise a red flag with regulators is something else. Marketers of inflammation products have a couple of avenues for staying within regulatory boundaries when crafting claims.  Hilmas, who spent some time at FDA before coming to NPA this year,  said a distinction must be made between nutrient content claims and structure/function type claims.  In the case of nutrient content claims, the agency recognizes vitamins A,C and E and the mineral selenium as having antioxidant activity, so the standard rules would apply as to how much of the material is in the product and word, “good,” “excellent,” etc. corresponds to that level.  Technically then, only these ingredients could be used to form the basis of an antioxidant inclusion claim. But Hilmas said during his time at the agency, if a company had an ingredient that had a demonstrated ORAC level, claims along the lines of “with antioxidants” or “includes antioxidants” were allowed to skate through.

Claiming to manage chronic inflammation is another kettle of fish, he said.

“On going after nutrient content claims the agency has historically been a little gun shy. But the agency has a very robust program on disease claims and have developed a solid body of case law around the enforcement of disease claims,” ​Hilmas said.

“During my time at the agency, a claim of ‘supports a healthy inflammation response’ was always considered a disease claim. In the agency’s view, this is always an immune response to something, and some of the ‘to somethings’ can really be serious things, like auto immune disorders,” ​Hilmas said.

Inconsistency creeps in​

But Hilmas noted that FDA’s claims enforcement operation has grown from one attorney to 11, and thus some inconsistency in the agency’s viewpoint has crept in over the past few years. In any case, of the potential disease claims the agency looks at, inflammation occupies the bottom rung.  

Prochnow said the in the current situation, claiming to support a healthy inflammation response seems to be a de facto​ safe claim.

“There is no specific law that says one way or the other what a permissible claim on inflammation is. While inflammation is of one the most frequently mentioned items in warnings letters, it is almost always when companies are mentioning inflammation in conjunction with specific diseases.  It is a very rare instance when FDA takes action on a claim with just the word ‘inflammation’ alone. There is one warning letter in the entire database of warning letters where FDA takes issue with the claim “health inflammation response,” and that warning letter included a lot of other specific disease claims,”​ Prochnow said.

To listen to the entire forum, which includes more on claims and enforcement and includes a detailed discussion of ingredients and the research behind them, click here​.