HA S3

Claims for joint health—Structure first

Joint health marketing claims should focus on the structural benefits substantiated by studies with healthy populations, and these legal messages should be reflected in the overall labelling of the product.

“I figured my body always would be able to repair itself. I think all of us believe that – until you begin to age and get hit with deteriorating joints.”

— Lee Majors, American actor

It all began shortly after the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). The nutritional world was discovering the potential for products that contained glucosamine and chondroitin. This “revelation” was popularized in publications and opened the doors to what became the joint health market.

The science behind a great number of compounds in support of joint health, including glucosamine and chondroitin, is strong. A notable body of evidence supports several compounds regarding benefits to joint health from the perspective of lubrication to the potential regeneration of tissues. These benefits are a direct result of their role in replenishment of vital substances associated with joint health. There is a clear line to be drawn, however, when it comes to the benefits of these products and the claims made about them.

Going back to the beginnings, the popular books of the time when joint health suddenly became so important directly and correctly noted that there are forms of arthritis associated with the deterioration of the joint tissues apart from degenerative processes from disease. These remain in the general category of arthritis, since it is the inflammation (the “-itis” part of the word) that is the manifestation of the condition. The condition may be a lack of lubrication in the joints, or it may be wearing down the connective tissues and cushioning membranes that make up the joints.

To make effective, legitimate claims regarding joint health, it is necessary to separate the symptoms from the structures. The symptoms include inflammation and swelling. Treatment of these symptoms is the presentation of drug claims. Prevention of these conditions is also considered a drug claim. The benefits of joint health products may only be presented in terms of their effects with focus on the structures. The functionality benefits may also be presented, but the landscape for those claims is limited. Consider that a claim regarding the increase in lubricating fluid in joints would be an acceptable claim. The benefits of this lubrication may result in increased flexibility or mobility, which is a function. The boundaries begin to appear at this juncture. The discussion of the ability to improve flexibility may only apply to otherwise healthy individuals.

FDA considers the entirety of the context of the labeling item when considering claims made for products. The wording of everything else on the label must not significantly contribute context beyond the parameters allowed by FDA. Discussion of improvements in flexibility or range of motion, whether in combination with exercise or not, may be made provided the substantiation is sufficient. The population studied in the necessary substantiation must not be a group of arthritis sufferers. The substantiation for the claim must include demonstration of benefit across a broader range of individuals.

The discussion of joint inflammation is limited, but may find support in science. FDA allows inflammation claims as the result of “strenuous exercise.” Studies involving athletes can point the way to substantiation of such effects. Then, the matter of context returns concerning additional statements that may be made in the labeling.

Providing the focus on the structures affected and describing the functional benefits of these structural supports results in acceptable claims that require appropriate substantiation. The whole of the product presentation must align with acceptable messages allowed in this important market segment.

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.

Hide comments

Comments

  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Publish