Justin Prochnow, Greenberg Traurig
This is for informational purposes only and is not intended to be construed or used as general legal advice. Please contact the author if you have questions regarding the currency of this information; see end of document.
Structure/function statements describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans. They may also characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function. Additionally, structure/function statements may also describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the United States. The Food and Drug Administration (FDA) is the primary federal regulatory agency that has the responsibility of regulating such statements that appear on the labels or labeling of food products.
Conventional Foods vs. Dietary Supplements
Historically, structure/function statements have appeared on the labels of conventional foods, dietary supplements, and drugs. The passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory procedures for such statements for dietary supplement labels. While structure/function statements for conventional foods generally focus on nutritive effects, statements for dietary supplements may focus on nutritive as well as non-nutritive effects. For the most part, the FDA regulates structure/function statements in a similar manner for conventional foods as it does for dietary supplements. One big difference is that the FDA does not require conventional food manufacturers to provide notice of structure-function statements and does not require a disclaimer on the labeling of conventional food products like that which is required for dietary supplements.
Section 6 of DSHEA
Section 6 of DSHEA added section 403(r)(6) to the Federal Food, Drug, and Cosmetic Act (FFDCA). This section of the law states that a dietary supplement may bear certain statements on its label or in its labeling if the statement meets certain requirements. Section 6 of DSHEA mandates that the manufacturer is responsible for ensuring the accuracy and truthfulness of such statements and the statements must be truthful and not misleading. Section 6 also mandates that a certain disclaimer must accompany any structure/function statement. Finally, Section 6 provides that manufacturers of dietary supplements that make structure/function claims on labels or in labeling must submit a notification to the FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim.
Final Rule on Structure/Function Statements
On January 6, 2000, the FDA published a Final Rule titled “Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body” at 65 Federal Register 1000. The resulting Final Rule, 21 CFR 101.93, originates from Section 6 of DSHEA and section 403(r)(6) of the FFDCA and defines the types of structure/functions statements that may be used on labels and in the labeling of dietary supplements. The regulation also provides criteria to assist one in determining when a statement about a dietary supplement is a disease claim, that is, a claim to diagnose, cure, mitigate, treat or prevent disease. Disease claims may be made only for products that are approved drug products or for foods under separate legal provisions that apply to claims called “health claims.”
Requirements for Structure/Function Statements
21 CFR 101.93 sets forth the basic requirements for making structure/function statements. 21 CFR 101.93(a) addresses the procedure necessary for providing the 30-day notification to the FDA regarding structure/function statements. 21 CFR 101.93(b)-(e) sets forth the requirements for the disclaimer required to accompany any structure-function statement. That familiar disclaimer is the following:
“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Pursuant to 21 CFR 101.93(d), this disclaimer must either appear next to each structure/function statement or be linked to each statement by a symbol, such as an asterisk. If linked to each statement, the disclaimer must appear in a box, separate from any other information on the label or labeling. 21 CFR 101.93(e) further provides that the disclaimer should appear in boldface type in letters no smaller than 1/16 inch.
Definition of Structure/Function Statements
Section 101.93(f) simply restates part of the definition of the types of claims that may be made pursuant to Section 6 of DSHEA and section 403(r)(6) of the FFDCA. Section 101.93(f) reads:
(f) Permitted structure/function statements. Dietary supplement labels or labeling may, subject to the requirements in paragraphs (a) through (e) of this section, bear statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, provided that such statements are not disease claims under paragraph (g) of this section. If the label or labeling of a product marketed as a dietary supplement bears a disease claim as defined in paragraph (g) of this section, the product will be subject to regulation as a drug unless the claim is an authorized health claim for which the product qualifies.
Definition of Disease
Conversely, 21 CFR 101.93(g) addresses certain types of claims that are not allowed for dietary supplements, known as disease claims. A disease is defined in 21 CFR 101.93 as:
[d]amage 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.
Structure/Function Statements vs. Disease Claims
It is not always an easy determination to ascertain whether a statement is a proper structure/function statement or a disease claim. Look at the objective evidence in your labeling to assess whether a claim explicitly or implicitly is a disease claim. For example, a statement may not mention a disease, but may refer to identifiable characteristic signs or symptoms of a disease such that the intended use of the product to treat or prevent the disease may be inferred. First, the context of the statement, decided from information on the label and in other labeling, will determine if the statement is considered to be a disease claim. Second, dietary supplements may not bear disease claims, explicit or implied, unless the claim has undergone premarket review by the FDA and has been authorized or approved under the rules for health claims or drugs, as appropriate. 21 CFR 101.93 includes 10 criteria intended to help clarify the types of claims that may be made for dietary supplements without prior authorization or approval by the FDA. The 10 criteria are set forth in 21 CFR 101.93(g)(2)(i)-(x).
Section 101.93(g)(2) -- Disease Criteria
21 CFR 101.93(g)(2) provides that the FDA will find that a statement about a product claims to diagnose, mitigate, treat, cure or prevent disease (other than a classical nutrient deficiency disease) under 21 U.S.C. 343(r)(6) if it meets one or more of the criteria listed in 21 CFR 101.93(g)(2)(i)-(x). These criteria are not intended to classify statements that refer to the ability of a product to maintain healthy structure or function as disease claim, unless the statement implies disease prevention or treatment. In determining whether a statement is a disease claim under these criteria, the FDA will consider the context in which the claim is presented.
21 CFR 101.93(g)(2)(i): 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 also is 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)."
21 CFR 101.93(g)(2)(i): Claims an Effect on Characteristic Signs or Symptoms of Disease Using Scientific or Lay Terminology
A statement is a considered a disease claim if it explicitly or implicitly claims an effect on one or more signs or symptoms of a disease. The test of whether claimed effects are characteristic signs or symptoms depends on two questions: (1) Is the condition, to which the signs and symptoms refer, related to a disease; and (2) are the signs and symptoms referred to in the labeling characteristic of the disease and permit the inference that the product is intended to affect that disease.
A look to medical texts and other objective sources of information about disease can determine if a label statement implies treatment or prevention of a disease. 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.
There are many conditions that are "normal," but under certain circumstances are also disease claims. The rule states that such claims (for example, maintaining normal cholesterol levels) may be appropriate structure/function claims and would not imply a disease if the claim made absolutely clear that the claim is referring to structure/function claims that are already normal. This context would remove the inference to an effect on a structure/function that was abnormal (for example, "maintain cholesterol levels that are already in the normal range").
21 CFR 101.93(g)(2)(iii): Claims an Effect on a Condition Associated with a Natural State or Process
A statement is a considered a disease claim if it claims an effect on an abnormal condition associated with a natural state. 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. The conditions associated with these stages or processes can vary from common, relatively mild abnormalities, for which medical attention is not required, to serious conditions that can cause significant or permanent harm if not treated effectively. Two criteria determine if such a condition will be considered a disease: (1) if the condition is uncommon; or (2) if the condition can cause significant or permanent harm. For purposes of the rule, a condition is uncommon if it occurs in fewer than one-half of those experiencing that stage or process. A condition can cause significant or permanent harm if it must be treated effectively to prevent that harm and for which effective treatments are available.
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." Examples of disease claims are "Alzheimer's disease or senile dementias in the elderly," "cystic acne" or "severe depression associated with the menstrual cycle."
21 CFR 101.93(g)(2)(iv): 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 statements and those that are disease claims. To be a structure/ function statement: (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. Context is also very important here.
Names such as "CarpalHealth" or "CircuCure" are disease claims because they are implied disease claims for carpal tunnel syndrome and circulatory disorders, respectively. In some cases, whether a product name is a disease claim will depend on context. 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 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. Of course, an ingredient that is excluded from the definition of a dietary supplement under section 201(ff)(3) of the FD&C Act because it was approved as a drug before being marketed as a dietary supplement never can be used in a supplement.
Claims that Use Citations of Publication Titles
If the citation to a publication title implies treatment or prevention of a disease, it is a disease claim. Thus, if in the context of the labeling as a whole its presence implies treatment or prevention of disease (for example, by placement on the immediate product label or packaging, inappropriate prominence, or lack of relationship to the product's express claims), the citation is a disease claim.
If the citation is used in labeling, its context determines if it is a disease claim. A citation that is used in the bibliography section of labeling, is included in a balanced discussion of the scientific literature, is not excessively prominent relative to other citations, and provides legitimate support for a structure/function claim made for the product would not be a disease claim.
Claims that use the Term "Disease" or "Diseased"
A company may make general statements about health promotion and disease prevention as long as the statement doesn't imply that your product can diagnose, cure, mitigate, treat, or prevent a disease. In general, if the statement identifies a specific disease or directly references the product or its ingredients, it would imply that the product itself has the effect and would be a disease claim.
An example of an acceptable claim is "a good diet promotes good health and prevents the onset of disease" or "better dietary and exercise patterns can contribute to disease prevention and better health." An example of a disease claim is "Promotes good health and prevents the onset of disease" because the claim infers that the product itself will achieve the intended effect.
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. As with other types of implied claims, it is the context of the total claim that is important. Some symbols, like the heart symbol, are so widely recognized as symbols for disease treatment and prevention that their use is ordinarily an implied disease claim. Symbols such as EKG tracings are also implied disease claims because they are strongly associated with heart disease and the average consumer cannot distinguish a healthy tracing from an unhealthy one to provide context to remove the implied disease treatment or prevention claim. It would be an unusual circumstance in which the use of these two symbols would not be implied disease claims.
The use of the prescription drug symbol "Rx" or the use of the word "prescription" should not be interpreted automatically as a disease claim because not all prescription drugs are intended for disease conditions (some are for conditions that would not be considered to be diseases). However, the use of these terms on dietary supplements may deceive consumers into thinking they are purchasing a prescription drug without a prescription. Thus, the use of these two terms is misleading and will misbrand the product if, in the context of the labeling as a whole, the terms imply that the product is a prescription drug.
21 CFR 101.93(g)(2)(v): 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."
21 CFR 101.93(g)(2)(vi): 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. Such claims carry with them the clear implication that the dietary supplement is intended for the same disease treatment or prevention purpose as the therapeutic product. 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.
21 CFR 101.93(g)(2)(vii):: 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. A dietary supplement may state that it is useful in providing nutritional support, as long as that claim doesn't imply disease. 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.
21 CFR 101.93(g)(2)(viii): 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. However, 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.
21 CFR 101.93(g)(2)(ix): 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. 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.
21 CFR 101.93(g)(2)(x): 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.NS
Justin J. Prochnow is an Of Counsel lawyer in the Denver office of the international law firm of Greenberg Traurig LLP. His practice concentrates on legal issues affecting the food & beverage, dietary supplement and cosmetic industries. He can be reached at (303) 572-6562 or firstname.lastname@example.org.