FDA Releases Final Rule, Relaxes Scope Of Structure/Function Supplement Claims
Defines ‘disease,’ creates cholesterol challenges.
By Todd Harrison
In an action considered by some as a victory for the supplement industry, FDA issued its long awaited final rules governing the permissible scope of structure/function claims for dietary supplements. In certain respects, the industry did achieve a limited victory when FDA opted for a limited definition of “disease” in the final rules1 instead of the broad definition set forth in its proposed rules, which would have had the effect of severely curtailing the scope of permissible claims. This decision will enable supplement companies to make claims that refer to abnormal bodily conditions in product claims, as long as the conditions mentioned are not closely related to a particular disease or health-related condition.
Indeed, FDA has, to a certain extent, opened the door for supplement companies to make properly qualified structure/function claims that were previously reserved for drugs. For instance, FDA previously considered references to “constipation,” “upset stomach” or “acid indigestion” to be impermissible “drug” claims because they described abnormal bodily states. Under the final rules, these claims are now permitted as long as the claims are appropriately qualified, e.g., “for the occasional relief of constipation.” The key phrase here is “occasional relief”; FDA properly decided that these type of claims should be permitted because they are not necessarily related to a particular disease or health-related condition.
FDA further surprised the drug and supplement industry by blessing “minor pain relief” claims for supplements as long as the claims in their entirety do not imply a disease treatment claim. For example, FDA would consider it impermissible to use a minor pain relief claim in connection with the claim “helps promote healthy joints and flexibility” because, in FDA’s opinion, mentioning pain relief in connection with healthy joints is an implied arthritis treatment claim. However, the relief of minor joint pain is not necessarily an indication of arthritis. Rather, it is more akin to pain associated with overexercising—a claim that FDA indicated is permissible under the final rules. Indeed, using FDA’s rationale for exercise-induced muscle pain, there is no reason to distinguish between a muscle pain relief claim and a properly qualified joint pain relief claim, e.g., “helps alleviate occasional joint pain associated with aging (or daily life),” since neither claim infers the existence of a particular disease. Of course, companies choosing to test the limits of this concession may find themselves on the receiving end of a “courtesy” or “warning” letter from FDA objecting to the use of pain relief claims in this manner.
The final rules also permit claims regarding signs or symptoms of otherwise normal natural states that are considered normal for that state. This means that properly worded claims regarding the “relief of hot flashes,” “relief of the signs and symptoms of PMS” and “reduction in age-related sexual vigor and performance” are now permissible.
1The final rules define “disease” as follows: a “disease” is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition. (21 C.F.R. § 101.93(g)(1).
However, signs and symptoms that are an indication of a serious disease or health-related condition, e.g., benign prostate hyperplasia (BPH), are still considered impermissible disease claims.
Unlike the proposed rules, the final rules also permit references to scientific articles that refer to diseases in their title if the promotional materials taken as a whole do not indicate that the supplement would be useful in the cure, treatment or prevention of a disease. For instance, promotional copy that contains a bibliography of references may be permissible as long as —
(1) undue attention or prominence is not drawn to a particular article that contains a disease reference;
(2) the article regards bona fide research; and
(3) the article is balanced.
However, FDA indicated in the preamble to the final rules that citing articles with disease references in their title on product labels or immediate packaging is not permitted.
FDA will also permit references to the term “disease” if the claim also discusses the benefit of proper diet and exercise on overall health and disease prevention, e.g., “good dietary practices and exercise can contribute to disease prevention and better health.” FDA permits this claim because it does not refer to a specific disease and it is generally accepted that a healthy diet and exercise is necessary to maintain overall good health. Consistent with this position, there is no reason this claim could not be modified to include a reference to a particular supplement, e.g., “good dietary practices that include targeted nutrients and exercise can contribute to disease prevention and better health.” However, references to specific diseases or health-related conditions are still impermissible under the final rules.
Now For The Bad News
While, at first blush, the final rules seem to be quite generous in the breadth of permissible claims now permitted, the final rules are not without limitations. Indeed, FDA continues to take the position that references to signs and symptoms that are associated with a particular disease may not be made. In particular, FDA still considers “cholesterol reduction” claims to be impermissible because elevated cholesterol levels are associated with an increase risk of coronary heart disease. FDA, however, would permit claims regarding “maintaining normal cholesterol levels” because cholesterol is necessary for specific bodily functions and is only associated with CHD if it is elevated. However, there is one caveat to “maintaining normal cholesterol” claims. FDA believes that the claim “helps maintain healthy cholesterol levels” is misleading because consumers may believe the reference is to HDL cholesterol levels, rather than LDL or overall cholesterol levels. Thus, FDA believes that cholesterol claims should be limited to “helps maintain cholesterol levels that are already within the normal range.” While this distinction appears to be somewhat meritless, there is some regulatory risk involved if a cholesterol claim is made in this manner.
Similarly, FDA would not permit the use of the “heart symbol” on product labels because consumers associate the symbol with the prevention of cardiovascular disease. This position is tenuous, especially considering that FDA agrees that the claim “helps maintain a healthy heart” is a permissible structure/function claim. Moreover, the use of the product term “heart” as part of the product’s name is permissible, as long as any additional claims would not indicate that the product is useful in the treatment or prevention of heart disease. Thus, FDA’s distinction appears to be less supportable in this regard. Indeed, it is difficult to believe that FDA will be willing to take action against a product because it carries the heart symbol on its packaging, but it could well do that.
Other examples of signs and symptoms that FDA would consider impermissible include “nervous tension headaches,” “anti-inflammatory” or “inflammation,” “alcohol intoxication,” “prevent bone fragility in post-menopausal women” and “improves joint mobility and reduces joint inflammation and pain.” The final rules also continue to prohibit the use of drug names, e.g., “herbal Prozac,” and class of drugs, e.g., “herbal anti-depressant” to be part of the product name or explain the products uses.
FDA also indicated in its final rules that it will be issuing a guidance document that provides specific examples of claims that it believes are permissible and impermissible. At the time of this writing, that document had not been issued.