Natural Products Insider

MAY-JUN 2018

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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30 INSIDER May/June 2018 Shortly after the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), as the nutritional world was discovering the potential for products that contained glucosamine and chondroitin, the "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 backs the use of several compounds to help lubricate and regenerate joint tissues by replenishing vital substances found in joints. There is a clear line to be drawn, however, when it comes to the benefi ts of these products and the claims made about them. 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 infl ammation (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 infl ammation and swelling. Treatment of these symptoms is the presentation of drug claims. Prevention of these conditions is also considered a drug claim. The benefi ts of joint health products may only be presented in terms of their effects with focus on the structures. The functionality benefi ts may also be presented, but the landscape for those claims is limited. Consider that a claim regarding the increase in lubricating fl uid in joints would be an acceptable claim. The benefi ts of this lubrication may result in increased fl exibility or mobility, which is a function. The boundaries begin to appear at this juncture. The discussion of the ability to improve fl exibility 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 signifi cantly contribute context beyond the parameters allowed by FDA. Discussion of improvements in fl exibility or range of motion, whether in combination with exercise or not, may be made—provided the substantiation is suffi cient. The population studied in the necessary substantiation must not be a group of arthritis sufferers. The substantiation for the claim must include demonstration of benefi t across a broader range of individuals. The discussion of joint infl ammation is limited, but may fi nd support in science. FDA allows infl ammation 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 benefi ts 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 offi cer, Jim Lassiter oversees all consulting operations at Ingredient Identity (ingredientidentity.com). He has more than four decades of experience in quality control (QC), and government and regulatory affairs. Sports Nutrition: Joint Health Claims for Joint Health—Structure First by Jim Lassiter "I fi gured 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

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