FDA will permit dietary supplement makers to make structure/function claims for "common, mild symptoms associated with normal life stages or processes." Examples of allowable claims include hot flashes associated with menopause and mild mood changes, cramps and edema related to the menstrual cycle.

The agency's final rule on structure/function claims, published in the Jan. 6 Federal Register, clarifies the types of label statements industry may use when conveying the effect of a dietary supplement on the structure and function of the body. The reg modifies several provisions of the proposed rule, issued in April 1998 (¹ [A#05060180000]).

FDA's proposed rule stated that, while natural states such as aging, menopause, pregnancy and the menstrual cycle are not themselves diseases, they can be associated with abnormal conditions that are diseases. Since its publication, FDA has issued a number of "courtesy" letters to companies asserting menopause symptom and PMS structure/function claims were, in fact, disease claims.

The bulk of the comments on the proposed rule strongly opposed classifying common conditions associated with natural states as diseases. In the final rule, FDA concludes "it is not appropriate, under [the Dietary Supplement Health & Education Act], to treat certain common, nonserious conditions associated with natural states as diseases."

"There are a wide variety of conditions representing impaired function of an organ or system that are associated with particular states of life or normal physiologic processes," which can vary from "common, relatively mild abnormalities" to "serious conditions that can cause significant or permanent harm if not effectively treated," FDA says.

"Whether all of these conditions represent diseases is, in part, a matter of definition and, in part, depends on the consequences of the conditions if not effectively treated, and on how commonly they occur, i.e., whether they may be considered 'normal,'" FDA adds.

Other conditions for which structure/function claims could be made include: morning sickness and leg edema associated with pregnancy; wrinkles, other skin problems such as liver spots and spider veins, presbyopia, or the inability to change focus from near to far and back, and hair loss, all associated with aging; and noncystic acne.

Examples of conditions that FDA continues to classify as disease claims are: toxemia of pregnancy; hyperemesis gravidarum; acute psychosis of pregnancy; osteoporosis; Alzheimer's disease and other senile dementias; glaucoma; arteriosclerotic diseases of coronary, cerebral or peripheral blood vessels; cystic acne; and severe depression associated with the menstrual cycle, the final rule notes.

In response to queries regarding the claims "Supports a normal, healthy attitude during PMS" and "Supportive for menopausal women," FDA concludes they are appropriate structure/function claims. The former "is acceptable because PMS is generally a common, mild condition associated with a normal physiologic process," and the latter "is acceptable because it is a general statement that does not refer to symptoms of any conditions at all," FDA notes.

"Claims about diminishing the normal symptomatology of premenstrual syndrome or menopause would also be acceptable structure/function claims, if they did not suggest, for example, prevention or treatment or osteoporosis, or another disease associated with these states," the final rule explains.

FDA did not include benign prostatic hypertrophy on either list because the agency does not believe it should be considered a consequence of aging. "Even if BPH were considered a direct consequence of aging, however, claims to treat or prevent it would still be treated as disease claims because failure to obtain effective treatment can cause significant or permanent harm," the agency says.

One comment had inquired about the claim "Helps to maintain normal urine flow in men over 50 years old." FDA responds it is an "implied disease claim because...the average or 'normal' state in men over 50 years old is diminishing urine flow, in most cases due to BPH, so that the apparent 'maintenance' really represents a claim of improvement (treatment)."

Another major change from the proposed rule is FDA's consent for labeling to include titles of publications referring to diseases. "The use in labeling of a publication title that refers to a disease will be considered a disease claim only if, in context, it implies that the product may be used to diagnose, treat, mitigate, cure or prevent disease," the final rules states.

Hot Flashes, PMS Structure/Function Claims Allowed Under Final Rule

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