US Food Labels: Structure/Function Claims vs. Disease Claims

Structure/function claims are one of the common claims found on US food labels. They describe how a nutrient or dietary ingredient supports or maintains normal structure or function in the human body. These claims must not mention or imply any disease. A disease claim involves stating that a product can diagnose, cure, mitigate, treat, or prevent a disease. According to 21 CFR 101.93(g), 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.

Food labels are prohibited from making explicit or implicit disease claims unless these claims have undergone the pre-market review by the US Food and Drug Administration (FDA) and have been authorized as “health claims” (click here for more on health claims). Apart from this, disease claims are only permitted for drugs.

These two types of claims can sometimes be easily confused. To help clarify the distinction, the FDA has established ten criteria to help manufacturers, packers, and distributors differentiate between the two and ensure more accurate use of structure/function claims.

Criterion 1: Claims an effect on a disease or class of diseases

• A statement is a disease claim if it mentions a specific disease or class of diseases. For example, a claim that a product is “protective against the development of cancer” or “reduces the pain and stiffness associated with arthritis” would be a disease claim;
• A statement is also a disease claim if it implies that it has an effect on a specific disease or class of diseases by using descriptions of the disease state. Examples of implied disease claims are “relieves crushing chest pain (angina),” “improves joint mobility and reduces inflammation (rheumatoid arthritis),” or “relief of bronchospasm (asthma).”

Criterion 2: Claims an effect on characteristic signs or symptoms of disease using scientific or lay terminology

• Some claims imply disease treatment or prevention because they are so intimately tied to a disease. For example, “inhibits platelet aggregation” or “reduces cholesterol” are such characteristic signs or symptoms associated with stroke and cardiovascular disease and interventions to treat those diseases that any claim about them would be an implied disease claim;
• Other signs or symptoms are associated with a wide range of disease and non-disease states and do not necessarily imply an effect on a specific disease. For example, although “improves absentmindedness” might imply treatment of Alzheimer’s disease and “relieves stress and frustration” might imply treatment of anxiety disorders, both of these signs also are characteristic of non-disease states. So, if there is no context linking them to a disease, they would be appropriate structure/function claims.

Criterion 3: Claims an effect on a condition associated with a natural state or process

• Some natural states or processes such as aging, menopause, and the menstrual cycle are not themselves diseases, but can be associated with abnormal conditions that are diseases. Two criteria determine if such a condition will be considered a disease: (1) if the condition is uncommon (if it occurs in fewer than one-half of those experiencing that stage or process); or (2) if the condition can cause significant or permanent harm;
• Examples of acceptable structure/function claims are “mild memory loss associated with aging,” “noncystic acne,” or “mild mood changes, cramps, and edema associated with the menstrual cycle”; and
• Examples of disease claims are “Alzheimer’s disease or senile dementias in the elderly,” “cystic acne,” or “severe depression associated with the menstrual cycle.”

Criterion 4: It is an implied disease claim because of the product name, formulation, use of pictures, or other factors

• Claims that are the name of the product: Two principles form the basis for the distinction between product names that are structure/function claims and those that are disease claims. To be a structure/ function claim: (1) the name should not contain the name, or a recognizable portion of the name, of a disease; and (2) the name should not use terms such as “cure,” “treat,” “correct,” “prevent,” or other terms that suggest treatment or prevention of a disease. Additionally, context is very important here. For example, “Soothing Sleep” could be considered a claim to treat insomnia, a disease, unless other context in the labeling makes clear that the claim relates to a non-disease condition, such as occasional sleeplessness;
• Claims about product formulation: If the ingredient has been regulated by the FDA primarily as a drug (either over-the-counter or prescription) and is well known to consumers for its use or claimed use in preventing or treating a disease, you have made an implied disease claim when you list it in the ingredient list or make a claim that a product contains that ingredient. For example, aspirin, digoxin, and laetrile; and
• Use of pictures, vignettes, symbols, or other means: In general, any picture or vignette or other symbol can be used if it doesn’t imply a disease. For example, pictures of healthy organs would constitute an appropriate structure/function claim while a picture of an abnormal tissue or organ would be an implied disease claim. The heart symbol and the EKG tracings are also generally considered implied disease claims.

Criterion 5: Claims that a product belongs to a class of products that is intended to diagnose, mitigate, treat, cure, or prevent a disease

• Certain product class names are so strongly associated with treating and preventing diseases that claiming membership in the product class constitutes a disease claim. Examples of such product classes are analgesics, antibiotics, antidepressants, antimicrobials, antiseptics, antivirals, or vaccines;
• However, some product classes may be associated both with diseases and with structure/function effects. In such cases, if it is clear from the context of the claim that the dietary supplement is represented as a member of the product class intended to affect structure/function and not disease, then the claim will not be a disease claim. That is, claiming to be a laxative, an anti-inflammatory, or a diuretic will not be a disease claim if there is context that makes clear that the intended effect of the product is on structure/function and not disease. For example, an appropriate product claim would be “diuretic that relieves temporary water-weight gain.”

Criterion 6: Claims to be a substitute for a product that is a therapy for a disease

• A claim that a product is a substitute for a drug or other therapy for disease, or has fewer side effects than a therapy for disease, is an implied disease claim;
• However, if a dietary supplement claims to be a substitute for a drug that is not intended to treat or prevent disease (i.e., a drug intended to affect the structure or function of the body), the claim comparing the drug and the dietary supplement would not be a disease claim.

Criterion 7: Claims to augment a therapy or drug intended to diagnose, mitigate, treat, cure, or prevent a disease

• A claim that a dietary supplement will augment a particular therapy or drug action that is intended to diagnose, mitigate, treat, cure, or prevent disease is a disease claim. In general, mentioning the name of a specific therapy, drug, or drug action will associate the claim with the intended use of the therapy, drug, or drug action and be a disease claim.

Criterion 8: Has a role in the body’s response to a disease or to a vector of disease

• A claim that a dietary supplement fights disease or enhances disease-fighting functions of the body is a disease claim. Under this criterion, context and specificity are important. Claims such as “supports the body’s ability to resist infection” and “supports the body’s antiviral capabilities” are disease claims because the context of the claim is limited to the disease prevention and treatment capabilities;
• A claim that a product “supports the immune system” is not specific enough to imply prevention of disease because the immune system has both structure/function and disease-fighting roles. A general claim of this type doesn’t specifically focus the intended use of the product on the disease aspect of the system’s function.

Criterion 9: Claims to treat, prevent, or mitigate adverse events associated with a therapy for a disease

• A claim that a product will affect adverse events associated with a therapy for disease is a disease claim if the adverse event is itself a disease. For example, “to maintain the intestinal flora in people on antibiotics” is a disease claim because the claim implies that the product will prevent pathogenic bacterial overgrowth (a disease condition) associated with antibiotic use; and
• If the adverse event is not a disease, then this type of claim is acceptable. For example, a claim that a product is useful because it counterbalances the effect of a drug in depleting a nutrient or interfering with the metabolism of a nutrient would be an acceptable structure/function claim.

Criterion 10: Otherwise suggests an effect on a disease or diseases

• This provision of the regulation is intended to allow for implied disease claims that may not fit into the other nine criteria. This provision recognizes that a claim may be a disease claim based on its wording or on the context in which the claim appears on the product’s label or labeling, even if not covered by the other nine criteria.

The manufacturer must submit a notification to the FDA no later than 30 days after marketing the dietary supplement with the claim, accompanied by a “disclaimer”. However, the FDA does not require conventional food manufacturers to notify the FDA about their structure/function claims, and disclaimers are not required for claims on conventional foods.

Proper use of structure/function claims allows you to compliantly and effectively promote the benefits of your product. Click here to learn more about our US FDA dietary supplement structure/function claim notification service.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.