Natural Products Insider

JUL-AUG 2018

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18 INSIDER July/August 2018 The inevitability of time presents all living things with challenges. Current demographics show a marvelous number of aging consumers are seeking assistance in working against the inevitability of time. The result is an expanding market for products in the anti-aging category. Marketers targeting these consumers—the aging population— want to discuss their products' benefi ts. The good news is aging is not a disease; the inevitability of physiologic change over time (getting older) is not a disease. Unless you are FDA. The types of products that populate the anti-aging category attempt to address the declining physiologic states that naturally occur as a consequence of aging. These natural declines include "mild conditions commonly associated with particular stages of life," which FDA has allowed as acceptable targets for structure/function (S/F) claims (Federal Register 65, No. 4; January 6, 2000; pp1019-20). Thus, the fi rst boundary involves the determination of what constitutes a "mild condition." This interpretive clause allows for restriction of claims depending on whether the effect as described is against a "mild" condition; if the condition is not mild, it is disease. The frequency with which these natural conditions occur is not suffi cient to preclude the condition being considered a disease. Only natural changes as the result of aging that are not likely to result in serious or irreversible damage if left untreated medically may be discussed. This two-step criteria model is very real and must be used in the determination of whether the claim is acceptable, or if it is to be considered a disease claim. A second challenge is in the nature of the S/F claim being made. Yes, the desired claims are all S/F claims, but the operative verb (to get grammatical about it) makes a tremendous difference in acceptability. A frequent, desired presentation claims a product "restores" something that might be lost as a natural consequence of aging. Claims may also suggest a "reduction" in some physiologic parameters associated with aging. The challenge in these claims lies in the other edge of the S/F claims sword: substantiation. Substantiation for all such claims must exist. When claims are made regarding some of these natural process issues, they are often presented in a circumspect fashion. As an example, discussion of a better night's sleep relating to a prostate health supplement is a means of describing a benefi t not specifi cally descriptive of the effects of the product or its constituents. These claims typically avoid the "restore" or "reduce" active verb, but discuss the benefi ts in indirect terms. The substantiation requirement is not removed and the data in that substantiation might even lead to the stronger active verb. When presenting information regarding an improvement in short-term memory performance, again with the appropriate substantiation, a more direct approach is allowable. Careful evaluation of all substantiation is critical, regardless of the claim being made. Overall, the maintenance of the human body as it ages is precisely an area of discussion S/F claims were designed to describe. The natural decline that occurs as we age may be slowed by the consumption of additional nutrients of benefi t to many physiological systems. The challenge then is to craft messages that meet the target audience's wishes, but that also have the substantiation required. The product label has requirements for certain information, but the remaining space is fair game for marketing content. However, care and caution must be applied because both FDA and FTC consider the entire context of the labeling presentation. FDA may consider some of the other non-S/F claims as suffi cient context to render the S/F claims as disease claims and, therefore, disallowed. The term "implied disease claim" lacks a regulatory defi nition, but is increasingly applied in FDA's review of labels and labeling for products. Thus, even with the most appropriately worded claim backed by substantiation presented, it may all be rendered unacceptable owing to the implications in the balance of the copy surrounding it. Aging is not a disease in itself. That is a point where industry and FDA are in agreement. The divergence begins with the determinations of what is the result of the natural process of aging and what added criteria (as FDA has imposed) must also be considered. In the case of aging, natural states of decline include common conditions that may lead to serious health consequences if not medically treated. Where that line is drawn is not fully defi ned. In the interim, the target of the claim (natural decline) must be clear; the action of the claim (active verb) must be carefully selected; substantiation (suffi cient in content and volume) is mandatory; and the rest of the marketing presentation (other copy not specially claims) must be thoroughly evaluated from the standpoint of context. 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 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). Healthy Aging Claims: Time Is the Ultimate Regulator by Jim Lassiter Supplements: Healthy Aging Age is inevitable. Aging isn't.—Marv Levy The good news is aging is not a disease; the inevitability of physiologic change over time (getting older) is not a disease. Unless you are FDA.

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