"Age is inevitable. Aging isn’t." — Marv Levy

The inevitability of time presents all living things with challenges as the time passes beyond achieving maturity. Current demographics show a marvelous number of the time-affected consumers seeking assistance in working against the inevitability of time. The result is an expanding market for products in the “anti-aging” category. Products targeting this category of consumer—the aging population—wish to discuss their benefits. 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 are acceptable targets for structure/function claims (Federal Register 65, No. 4; January 6, 2000; pp1019-20). Thus, the first boundary involves the determination of what is 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 sufficient 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 structure/function claim being made. Yes, the desired claims are all structure/function 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 structure/function claims sword: substantiation. Substantiation for all such claims must exist. The requirements for such substantiation are rigorous and warrant careful evaluation for claims to “restore” or “reduce” with regard to any structure or function.

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 benefit not specifically descriptive of the effects of the product or its constituents. These claims typically avoid the “restore” or “reduce” active verb, but discuss the benefits 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 that structure/function claims were designed to describe. The natural decline that occurs as we age may be slowed by the consumption of additional nutrients of benefit 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. This does not move the regulatory line that exists concerning drug claims, but it does outline the boundaries for these claims.

In addition, space available on any piece of labeling (whether it is a product package or marketing collateral of another sort) is precious real estate. The product label has requirements for certain information, which consumes space, but the remainder is fair game for the marketing of the product. 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-structure/function claims as sufficient context to render the structure/function claims as disease claims and, therefore, disallowed. The term “implied disease claim” lacks a regulatory definition, 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 defined. 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 (sufficient 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. Aging gracefully is challenging and telling people how to accomplish this graceful goal remains equally challenging.

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.