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STRUCTURE/FUNCTION CLAIMS OVERVIEW

Daniel Gastelu 

The FDA published final regulations defining the types of structure or function claims permitted on dietary supplement labels in February 2000. 

The exact language of the regulation is provided below. 

During the rule making, the FDA considered many issues as to what makes a suitable structure or function claim, or a disease claim.  Along with the final regulation, there was over 50 pages of text reviewing historical and decision-making issues. 

While this information is not part of the final regulation, there were many examples of what the FDA considers structure or function claims, and disease claims.  Accordingly, this overview contains excerpts of these claims, which appeared in the larger FDA document. This overview should be read to appreciate the nuances involved, the methods and madness involved behind the FDA’s logic of deciding what constitutes a valid structure or function claim, and what constitutes a disease claim.  Pay special attention to what the FDA considers claims that can be considered “implied disease claim”.

To assist you in identifying the FDA’s examples of structure and function claims are bolded, underlined, and italicized, for example;

…  hot flashes, common symptoms associated with the menstrual cycle, ordinary morning sickness associated with pregnancy, mild memory problems associated with aging, hair loss associated with aging, and noncystic acne will not be treated as diseases under this provision. 

“Aphrodisiacs” monograph, “arouses or increases sexual desire and improves sexual performance” is an acceptable structure/function claim

FDA does not agree that “appetite suppressant” should be considered a disease claim.

“Helps promote urinary tract health,” “helps maintain cardiovascular function and a healthy circulatory system,” “helps maintain intestinal flora,” and “promotes relaxation.”

and disease claims are only in bold;

FDA provided as examples of such disease claims:

“Improves urine flow in men over 50 years old,” “lowers cholesterol,” “reduces joint pain,” and “relieves headache.”

Uncommon or serious conditions like senile dementia, toxemia of pregnancy, severe depression associated with the menstrual cycle, and cystic acne will continue to be treated as diseases under the final rule.

Anyone interested in the entire document which appeared in the Federal Register can request a copy by sending an email to Daniel Gastelu at dan@supplementfacts.com, or if you are in need of food, dietary supplement and drug regulatory consulting, manufacturing, product development, claims substantiation, and GMP compliance services, and all related writing and education services.

Highlights of the Final Rule on Permitted Structure/function Statements

Like the proposed rule, the final rule contains criteria to determine when a labeling statement made about a dietary supplement constitutes a structure/function claim for which no prior FDA review is required and when it constitutes a disease-related claim that requires either authorization of a health claim or review under the drug provisions of Federal Food, Drug, and Cosmetic Act (the act). FDA has, however, made several important changes in the final rule in response to comments.

First, the agency has deleted the proposed definition of “disease.” Rather than creating a new definition of disease, FDA will use the preexisting definition of “disease or health-related condition” in Sec. 101.14(a)(5) (21 CFR 101.14(a)(5)) (formerly Sec. 101.14(a)(6)), which was issued as part of the implementation of the health claims provisions of the Nutrition Labeling and Education Act (NLEA). This change has been made in response to the large number of comments that objected to the proposed definition and urged that FDA retain the NLEA definition.

Second, FDA has revised the criterion that applies to conditions associated with such natural states or processes as menopause, aging, adolescence, and pregnancy. The proposed rule stated that menopause, aging, and pregnancy are not themselves diseases but that certain conditions associated with them are diseases if they are recognizable to consumers or health professionals as abnormal. Many comments objected to classifying as diseases such common conditions as hot flashes, premenstrual syndrome (PMS), and decreased sexual function associated with aging. In response to these comments, FDA has revised proposed Sec. 101.93(g)(2)(iii). Common conditions associated with natural states or processes that do not cause significant or permanent harm will not be treated as diseases under the final rule. For example, hot flashes, common symptoms associated with the menstrual cycle, ordinary morning sickness associated with pregnancy, mild memory problems associated with aging, hair loss associated with aging, and noncystic acne will not be treated as diseases under this provision.  Uncommon or serious conditions like senile dementia, toxemia of pregnancy, severe depression associated with the menstrual cycle, and cystic acne will continue to be treated as diseases under the final rule.

Third, FDA has revised the criterion that relates to the use in labeling of the titles of publications that refer to diseases. In response to comments objecting that, as proposed, this criterion would hamper manufacturers from providing consumers with information substantiating their claims, FDA has revised this criterion. Under the revised criterion, 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. Highlighting, bolding, using large type size, or prominent placement of a citation that refers to a disease use in the title could suggest that the product has an effect on disease. Placing a citation to a scientific reference that refers to a disease in the title on the immediate product label or packaging will be considered a disease claim for that product. The agency will also consider whether the cited article provides legitimate support for the express structure/function statement made for that dietary supplement. Enhancing the bibliography with citations to scientific references that refer to a disease in the title and that have no reasonable relation to the statement made will be considered a disease claim. Similarly, the agency will consider whether citations are to bona fide research.

Although FDA believes that dietary supplements have potential benefits for consumers, dietary supplements labeled with unproven disease claims, i.e., those that have not met the requirements for health claim authorization or new drug approval, can pose serious risks. Such claims may encourage consumers to self-treat for a serious disease without benefit of a medical diagnosis or treatment. They may also cause consumers to substitute potentially ineffective products for proven ones, foregoing or delaying effective treatment for serious and  life-threatening illnesses. Reliance on disease prevention claims may encourage consumers to feel sufficiently protected from developing serious diseases (e.g., cancer or human immuno deficiency virus (HIV) infection) that they delay or forego regular screening, and forfeit the  opportunity for early medical treatment that may be critical to survival. Finally, use of dietary supplements to treat disease may increase the risk of adverse reactions due to the interaction of the dietary supplement with other compounds a consumer is taking for that disease or for other conditions, e.g., prescription medications.

The agency also declines to adopt a “truthful and non-misleading” standard instead of the final rule. Section 403(a)(1) of the act already subjects all food claims, including structure/function claims on dietary supplements, to the “truthful and non-misleading” standard, so promulgating the same standard through regulations is unnecessary. In addition, section 403®(6)(B) of the act already requires dietary supplement manufacturers to have substantiation that their statements are truthful and non-misleading. Finally a fundamental problem with this approach is that a “truthful and non-misleading” standard, unlike the final rule, would not provide any criteria for differentiating between structure/function claims and disease claims.

The Regulation

Sec. 101.93   Certain types of statements for dietary supplements.

 (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.

(g) Disease claims.

(1) For purposes of 21 U.S.C. 343®(6), 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.

(2) 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®(6) if it meets one or more of the criteria listed below. These criteria are not intended to classify as disease claims statements that refer to the ability of a product to maintain healthy structure or function, unless the statement implies disease prevention or treatment. In determining whether a statement is a disease claim under these criteria, FDA will consider the context in which the claim is presented. A statement claims to diagnose, mitigate, treat, cure, or prevent disease if it claims, explicitly or implicitly, that the product:

(i)Has an effect on a specific disease or class of diseases;

(ii) Has an effect on the characteristic signs or symptoms of a

specific disease or class of diseases, using scientific or lay terminology;

(iii) Has an effect on an abnormal condition associated with a natural state or process, if the abnormal condition is uncommon or can cause significant or permanent harm;

(iv) Has an effect on a disease or diseases through one or more of the following factors:

(A) The name of the product;

(B) A statement about the formulation of the product, including a

claim that the product contains an ingredient (other than an ingredient that is an article included in the definition of “dietary supplement” under 21 U.S.C. 321(ff)(3)) that has been regulated by FDA as a drug and is well known to consumers for its use or claimed use in preventing or treating a disease;

(C) Citation of a publication or reference, if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease, e.g., through placement on the immediate product label or packaging, inappropriate prominence, or lack of relationship to the product’s express claims;

(D) Use of the term “disease” or “diseased,” except in general

statements about disease prevention that do not refer explicitly or

implicitly to a specific disease or class of diseases or to a specific

product or ingredient; or

(E) Use of pictures, vignettes, symbols, or other means;

(v) Belongs to a class of products that is intended to diagnose,

mitigate, treat, cure, or prevent a disease;

(vi) Is a substitute for a product that is a therapy for a disease;

(vii) Augments a particular therapy or drug action that is intended to diagnose, mitigate, treat, cure, or prevent a disease or class of diseases;

(viii) Has a role in the body’s response to a disease or to a vector of disease;

(ix) Treats, prevents, or mitigates adverse events associated with

a therapy for a disease, if the adverse events constitute diseases; or

(x) Otherwise suggests an effect on a disease or diseases.

Examples of

Structure/function claims

and

Disease Claims

Examples of Structure/function claims, and Disease Claims.

Note that the final rule classifies many more claims as structure/function claims than the proposed rule would have.

FDA included the following examples of such disease claims: “Protective against the development of cancer,” “reduces the pain and stiffness associated with arthritis,” “decreases the effects of alcohol intoxication,” or “alleviates constipation.”

FDA included the following examples of claims that do not refer explicitly or implicitly to an effect on a specific disease state: “Helps promote urinary tract health,” “helps maintain cardiovascular function and a healthy circulatory system,” “helps maintain intestinal flora,” and “promotes relaxation.”

FDA proposed to treat both express and implied disease claims as disease claims that could not be made for dietary supplements without prior review either as health claims or as drug claims. Implied disease claims do not mention the name of a specific disease, but refer to identifiable characteristics of a disease from which the disease itself may be inferred. There are many possible ways to imply treatment or prevention of disease, from listing the characteristic signs and symptoms of the disease to providing images of people suffering from the disease. Nine of the 10 criteria proposed by FDA for identifying disease claims could be considered methods of implying disease treatment or prevention.

In the July 8, 1999, Federal Register notice announcing a public meeting and reopening the comment period, FDA sought additional comment on the applicability of the rule to implied disease claims. The discussion in the notice offered three examples of possible implied disease claims:

1)   “shrinks tumors of the lung” or “prevents development of malignant tumors” (“treats cancer” would be the corresponding express claim);

(2)  “prevention of seizures” (“treatment of epilepsy” would be the corresponding express claim);

(3) “relief of sneezing, runny nose, and itchy watery eyes caused by exposure to pollen or other allergens” “treatment of hayfever” would be the corresponding express claim).

FDA continues to believe that structure/function claims should not imply disease treatment or prevention.

The following examples of implied disease claims demonstrate that it is not difficult to convey prevention or treatment of a specific disease or class of diseases without actually mentioning the name of the disease, which are given in parentheses: “Relieves crushing chest pain” (angina or heart attack), “prevents bone fragility in post-menopausal women” (osteoporosis), “improves joint mobility and reduces joint inflammation and pain” (rheumatoid arthritis), “heals stomach or duodenal lesions and bleeding” (ulcers), “anticonvulsant” (epilepsy), “relief of bronchospasm” (asthma), “prevents wasting in persons with weakened immune systems” (AIDS) (acquired immune deficiency syndrome), “prevents irregular heartbeat” (arrhythmias), “controls blood sugar in persons with insufficient insulin” (diabetes), “prevents the spread of neoplastic cells” (prevention of cancer metastases); “antibiotic” (infections), “herbal Prozac” (depression).

terms “antibacterial,” “antimicrobial,” “antiseptic,” or “kills germs” constitute implied drug claims that cause products carrying them to be drugs); 58 FR 47611, 47612 (September 9, 1993) (labeling indicating that “hormones” are present in a product constitutes implied drug claim); 58 FR 28194, 28204 (May 12, 1993) (products carrying term “sunscreen” are drugs because “sunscreen” implies disease prevention, even if not expressly promoted for prevention of skin cancer)).

FDA has considered the comments on constipation and agrees that certain constipation claims should not be treated as disease claims.  Constipation has a variety of causes, many of them unrelated to disease. For example, constipation can be caused by changes in diet and schedule, and by travel. Constipation can also, however, be a symptom of such serious diseases as bowel obstruction and irritable bowel syndrome. FDA is aware that there may be differences of opinion about whether occasional constipation, alone, constitutes a disease, but believes that treating it as a disease would not be consistent with the intent of DSHEA. “For relief of occasional constipation” would therefore not be considered a disease claim under the rule. The labeling of a product that claimed to treat occasional constipation should make clear, however, that the product is not intended to be used to treat chronic constipation, which may be a symptom of a serious disease.

FDA provided as examples of such disease claims:

“Improves urine flow in men over 50 years old,” “lowers cholesterol,” “reduces joint pain,” and “relieves headache.” [note that with special statements some of these types of claims can actually be considered structure function claims.]

Stating that claims of an effect on symptoms that are not recognizable as characteristic of a specific disease or diseases would not constitute disease claims, FDA provided the following examples of acceptable structure/function claims: “Reduces stress and frustration,” “inhibits platelet aggregation,” and “improves absentmindedness.”

The agency also stated that if the context did not suggest treatment or prevention of a disease, a claim that a substance helps maintain normal function would not ordinarily be a disease claim.  Examples included: “Helps maintain a healthy cholesterol level,” or “helps maintain regularity.”

FDA noted that the members of the Commission were divided on this issue, but that the final report concluded that “statements that mention a body system, organ, or function affected by the supplement using terms such as ‘stimulate,’ ‘maintain,’ ‘support,’ ‘regulate,’ or ‘promote’ can be appropriate when the statements do not suggest disease prevention or treatment or use for a serious health condition that is beyond the ability of the consumer to evaluate” (the report, p. 38). Recognizing that claims relating to maintaining healthy cholesterol levels raise particularly difficult issues, FDA sought specific comment on these claims.

FDA also believes that “joint pain” is characteristic of arthritis. According to the Merck Manual, joint tenderness is the most sensitive physical sign of rheumatoid arthritis (Ref. 6). The claim “helps support cartilage and joint function,” on the other hand, would be a permissible structure/ function claim, because it relates to maintaining normal function rather than treating joint pain.

FDA agrees in part and disagrees in part with this comment. The agency agrees that references in dietary supplement labeling to physiologic markers or symptoms of a disease that are quantifiably linked to that disease in an official government health agency summary statement or consensus report would be appropriately treated as implied disease claims. Indeed, in the cases described, elevated blood pressure (hypertension) and elevated cholesterol (hypercholesterolemia) are diseases themselves, with subsequent events (heart attack, stroke) the late consequences of those diseases. Although FDA agrees that fever and elevated white cell counts are almost always evidence of a disease, FDA does not agree that the second criterion appropriately describes the remaining circumstances in which references to signs or symptoms should be treated as disease claims. The appropriate test is whether:

1)   The condition to be treated or prevented is a disease and

2)    the signs and symptoms referred to in the labeling, in context, are characteristic of a disease and thus permit the inference that the product is intended to treat or prevent the disease. The second criterion offered by the comment does not provide information on either of these elements.

Nonetheless, dietary supplement labeling that refers to the characteristic signs or symptoms of a specific disease or class of diseases will still be considered to have made an implied disease claim.

Labeling that claims a product “prevents bone fragility in post-menopausal women,” clearly implies that the product prevents osteoporosis. Similarly, labeling that claims a product “prevents shortness of breath, an enlarged heart, inability to exercise, generalized weakness, and edema” has made a congestive heart failure claim.

FDA does not agree that health maintenance claims must always be treated as implied disease claims. Section 403®(6)(A) of the act demonstrates that Congress intended to treat as structure/function claims some claims concerning maintenance of normal structure or function, because it expressly permits statements that “characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.”

FDA also believes that many claims concerning the maintenance of “normal” or “healthy” structure or function do not imply disease prevention in the context of dietary supplement labeling, unless other statements or pictures in the labeling imply prevention of a specific disease or class of diseases.

There may be cases, however, in which a statement of health maintenance can be understood only as a claim of prevention of a specific disease, in which case it will be considered a disease claim. Thus, any reference to “maintaining a tumor-free state” would be a disease claim.

Similarly, a claim to “maintain normal bone density in post-menopausal women” is a disease claim because post-menopausal women characteristically develop osteoporosis, a disease whose principal sign is decreased bone mass.

Statements should not be made that products “restore” normal or “correct” abnormal function when the abnormality implies the presence of disease. An example might be a claim to “restore” normal blood pressure when the abnormality implies hypertension.  (Report at pp. 38 and 39.)

FDA agrees that if a health maintenance claim implies disease treatment or prevention, it would not be acceptable. (In FDA’s view, a claim promoting “use for a serious health condition that is beyond the ability of the consumer to evaluate” is simply one form of implied disease claim.) FDA believes that many health maintenance claims are acceptable. In some cases, a health maintenance claim could use terms that are so closely identified with a specific disease or that so clearly refer to a particular at-risk population that FDA would consider the claim to be an implied disease prevention claim, e.g., “maintains healthy lungs in smokers” would imply prevention of tobacco-related lung cancer and chronic lung disease. “Maintains healthy lung function,” alone, however, would be an acceptable structure/function claim.

FDA continues to believe that “lowers cholesterol,” however qualified, is an implied disease claim. As many comments argued, lowering cholesterol is inextricably linked in the public mind with treating elevated cholesterol and preventing heart disease. The agency also believes that “promotes cholesterol clearance” is an implied disease claim because it is directed at lowering cholesterol rather than maintaining levels already determined to be within a normal range.  FDA will review all cholesterol claims to determine whether the labeling as a whole implies that the product is intended to lower elevated cholesterol levels. In such cases, FDA would consider the labeling to create an implied disease claim.

Although DSHEA requires that manufacturers who make structure/function claims have substantiation, manufacturers are not currently required to submit that substantiation to FDA for premarket review, nor does FDA have the resources to inspect and review the quality of the substantiation in most cases. For this reason, FDA does not believe that permitting “lowers cholesterol” claims on dietary supplements without prior review serves the public health.

The proposed rule stated that natural states such as aging, menopause and the menstrual cycle, are not themselves diseases, but can be associated with abnormal conditions that are diseases. FDA proposed in Sec. 101.93(g)(2)(iii) to treat as a disease claim a statement that a product had an effect on a condition associated with a natural state if the condition presented “a characteristic set of signs or symptoms recognizable to health care professionals or consumers” as an “abnormality.” FDA provided as examples of such abnormal conditions the following:  premenstrual syndrome; hot flashes; and presbyopia, decreased sexual function, and Alzheimer’s disease associated with aging.

For example, the menstrual cycle is commonly associated with mild mood changes, edema, and cramping that do not cause significant or permanent harm if left untreated, but also, more rarely, with serious cyclical depression that can result in significant harm if not effectively treated. Aging is almost invariably associated with characteristic skin and scalp changes, such as wrinkles and hair loss, which do not need medical attention. It is also, however, associated with serious diseases that will result in significant, often irreversible damage, many of which can be effectively treated. These diseases include osteoporosis, glaucoma, and arteriosclerotic diseases of coronary, cerebral, and peripheral vessels. Adolescence is commonly associated with mild acne, which does not cause significant or permanent harm if not treated, and, rarely, with cystic acne, which can produce severe physical and psychological scars if not effectively treated.

The following are examples of conditions about which structure/ function claims could be made under Sec. 101.93(g)(2)(iii):

mild mood changes, cramps, and edema associated with the menstrual cycle;

hot flashes;

 wrinkles;

other signs of aging on the skin, e.g., liver spots, spider veins;

 presbyopia (inability to change focus from near to far and vice versa) associated with aging;

mild memory problems associated with aging;

hair loss associated with aging; and

noncystic acne.

The following are examples of conditions that would remain disease claims:

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.

FDA has not included benign prostatic hypertrophy (BPH) on either of these lists, because the agency does not believe that BPH should be considered a consequence of aging. Like many other diseases, e.g., diabetes, prostate cancer, and heart disease, the incidence of BPH is much higher among older men. This does not mean that BPH or prostate cancer is caused by the aging process. 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.

FDA agrees that “supports a normal, healthy attitude during PMS” and “supportive for menopausal women” are appropriate structure/ function claims.

“Supports a normal, healthy attitude during PMS” is acceptable because PMS is generally a common, mild condition associated with a normal physiologic process.

“Supportive for menopausal women” is acceptable because it is a general statement that does not refer to symptoms of any conditions at all.

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 of osteoporosis, or another disease associated with these states.

“Helps to maintain normal urine flow in men over 50 years old,” however, is an implied disease claim because, as many comments pointed out, 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).

Under proposed Sec. 101.93(g)(2)(iv), FDA stated that a statement would be considered a disease claim if it claimed explicitly or implicitly to have an effect on disease through one or more of the following factors:

1)   The name of the product (e.g., “Carpaltum” (carpal tunnel syndrome), “Raynaudin” (Raynaud’s phenomenon), “Hepatacure” (liver problems)). Names that did not imply an effect on a disease, such as “Cardiohealth” and “Heart Tabs,” would not constitute disease claims;

2)    statements about the formulation of the product, including a claim that the product contained an ingredient that has been regulated by FDA predominantly as a drug and is well known to consumers for its use in preventing or treating a disease (e.g., aspirin, digoxin, or laetrile);

3)   citation of a publication or other reference, if the citation refers to a disease use. For example, labeling for a vitamin E product that included a citation to an article entitled “Serial Coronary Angiographic Evidence That Antioxidant Vitamin Intake Reduces Progression of Coronary Artery Atherosclerosis,” would create a disease claim under this criterion;

(4)   use of the term “disease” or “diseased;” or

(5)   otherwise suggesting an effect on disease by use of pictures, vignettes, symbols, or other means (e.g., electrocardiogram tracings, pictures of organs that suggest prevention or treatment of a disease state, or the prescription symbol (Rx)). The proposed rule stated that a picture of a body would not constitute a disease claim under this criterion.

Some product class names are so strongly associated with use to treat or prevent a specific disease or class of diseases that claiming membership in the product class implies disease treatment or prevention. Under proposed Sec. 101.93(g)(2)(v), a statement would have been considered a disease claim if it claimed that the product belonged in a class of products recognizable to health care professionals or consumers as intended for use to diagnose, mitigate, treat, cure, or prevent a disease. The preamble provided the following examples of class names that would imply disease treatment or prevention: Claims that the product was an “antibiotic,” a “laxative,” an “analgesic,” an “antiviral,” a “diuretic,” an “antimicrobial,” an “antiseptic,” an “antidepressant,” or a “vaccine.” These examples were not intended to constitute an exclusive list of product class names that convey disease claims. Under the proposed rule, claiming that a product was in a class that is not recognizable to health care professionals or consumers as intended for use to diagnose, mitigate, treat, cure or prevent disease would not have constituted a disease claim under this criterion.

The preamble provided as examples of acceptable structure/function claims: Claims that the product was an “energizer,” a “rejuvenative,” a “revitalizer,” or an “adaptogen.”

In light of the agency’s decision that claims for relief of “occasional constipation” should not be considered disease claims, the term “laxative” will not be considered a disease claim under the final rule, as long as the remainder of the labeling makes clear that the product is not intended to treat chronic constipation.

FDA does not agree that “appetite suppressant” should be considered a disease claim. As discussed elsewhere in this document, although obesity is a disease, overweight is not. An appetite suppressant may be intended for ordinary weight loss, rather than as a treatment for obesity. Therefore, “appetite suppressant” would only be considered a disease claim in a context where it implies use for obesity.

FDA agrees that “tonic” is not a disease claim. “Tonic” is commonly understood as a general term for anything that refreshes, and, by itself, would not be considered to constitute a disease claim.

FDA agrees that dietary supplements may carry statements that characterize “the documented mechanism of action by which a nutrient or dietary ingredient acts to maintain * * * structure or function,” but only to the extent that such a statement does “not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases” (section 403®(6) of the act). In the examples provided in the comment, FDA is unaware of evidence establishing that the claims actually describe “documented” mechanisms by which the products “maintain” a calm stomach. Nevertheless, assuming that these statements met the other requirements of section 403®(6)(A) of the act, FDA would not consider the term “antispasmodic” to constitute a disease claim because the agency does not believe that it is closely associated with treatment or prevention of gastrointestinal disease. 

The term “anti-inflammatory” is, however, strongly associated with treatment of certain serious gastrointestinal diseases, and would constitute a disease claim.

FDA agrees with these comments that obesity is a disease, and that obesity claims are not acceptable structure/function claims. Being overweight, i.e., being more than one’s ideal weight but less than obese, however, is not a disease. FDA believes that it is commonly understood that “weight loss plans” relate to a broad range of overweight statuses. Therefore, weight loss plans are not so narrowly associated with disease treatment that a reference to use as part of a weight loss plan should be considered a disease claim.

Finally, FDA does not agree that, under United States v. Ten Cartons, More or Less, of an Article * * * Ener-B Vitamin B-12, 72 F.3d 285 (2d Cir. 1995), dietary supplements making weight loss claims must necessarily be regulated as drugs. The court in Ener-B held that a dietary supplement that makes a structure/function claim may nevertheless be regulated as a drug, under certain circumstances. In that case, the court found that FDA could regulate a product as a drug, based on its method of intake (nasal administration). Nothing in that case suggests that FDA must regulate dietary supplements making weight loss claims as drugs.

FDA agrees that some minor pain relief claims may be appropriate structure/ function claims for dietary supplements. A claim that a product is intended to treat minor pain, without reference of any other conditions, symptoms, or parts of the body that would imply disease treatment or prevention, would be an appropriate structure/function claims, because minor pain, by itself, can be caused by a variety of conditions, not all of them disease-related.

FDA does not agree, however that general well-being or health maintenance claims would encompass such pain claims. Pain is not a normal state, nor are there “normal pain levels.” The claim is thus clearly one of pain treatment or prevention. FDA also does not agree that section 403®(6) of the act authorizes a product whose name promises freedom from or relief of pain (“pain-free” or “pain product”) and whose labeling includes claims related to maintenance or support of joints. While the latter claims alone are appropriate structure/function statements, in conjunction with a name that includes the term “pain,” the product is clearly making a claim related to treatment or prevention of joint pain. As explained elsewhere in this document, joint pain is a characteristic symptom of arthritis, and joint pain claims are therefore disease claims. Acceptable structure/ function claims could be made, however, for pain associated with nondisease states, e.g., muscle pain following exercise.

FDA agrees that “boosts stamina, helps increase muscle size, and helps enhance muscle tone” are acceptable structure/function claims, because they do not refer to any disease. However, the agency notes that a claim to increase muscle size implies an effect that may subject the product regulation as an anabolic steroid under the Controlled Substances Act (see 21 U.S.C. 802(41)).

“Deters bacteria from adhering to the wall of the bladder and urinary tract” is not an acceptable structure/function claim because it implies prevention of bacterial infections of the bladder and urinary tract.

The claims “dietary support during the cold and flu season” and “promotes general well-being during the cold and flu season” are disease claims because they imply that the product will prevent colds and flu or will mitigate the symptoms of those diseases.

FDA agrees that certain smoking alternative claims may be acceptable structure/function claims, if they do not imply treatment of nicotine addiction, relief of nicotine withdrawal symptoms, or prevention or mitigation of tobacco-related illnesses. “Smoking alternative,” “temporarily reduces your desire to smoke” and “mimics the oral sensations of cigarette smoke” may be acceptable (for products that otherwise meet the definition of a dietary supplement), if the context does not imply treatment of nicotine addiction, e.g., by suggesting that the product can be used in smoking cessation, or prevention or mitigation of tobacco-related diseases. For example, such claims would not be disease claims if the context made clear that they were for short-term use in situations where smoke is prohibited or socially unacceptable.

“To be used as a dietary adjunct in conjunction with your smoking cessation plan,” however, is a disease claim because it is a claim that the product aids in smoking cessation, thereby implying that the product is useful in treating nicotine addiction.

As noted earlier, a claim that the product is useful in counterbalancing the effects of a drug in depleting a nutrient or interfering with the metabolism of a nutrient would be acceptable as a structure/function statement.

FDA agrees that some of the claims on the comment’s list of OTC drug claims may be acceptable structure/function claims, but believes that others on the list are disease claims. Of the claims listed in the comment from the “Antacids” monograph, “relief of sour stomach” and “upset stomach” are acceptable structure/function claims, because they refer to a nonspecific group of conditions that have a variety of causes, many of which are not disease-related. Thus, they are not characteristic of a specific disease or class of diseases. Although “relief of heartburn” and “relief of acid indigestion” without further qualification are not appropriate structure/function claims, the agency has concluded that “occasional heartburn” and “occasional acid indigestion” can also be considered nonspecific symptoms, arising as they do in overindulgence and other sporadic situations. These claims could be appropriate structure/function claims.

In contrast, “recurrent” or “persistent” heartburn and acid indigestion can be hallmarks of significant illness, and are therefore disease claims.

All of the claims listed in the comment from the “Antiflatulents” (antigas) monograph are acceptable structure/ function claims, because the symptoms in the claims are not sufficiently characteristic of specific diseases: “Alleviates the symptoms referred to as gas,” “alleviates bloating,” “alleviates pressure,” “alleviates fullness,” and “alleviates stuffed feeling.”

The claim listed in the comment from the “Antiemetics” monograph, “for the prevention and treatment of the nausea, vomiting, or dizziness associated with motion,” is also a permitted structure/ function claim.

Of the claims listed in the comment from the “Nighttime” sleep-aids monograph, “for the relief of occasional sleeplessness” is an acceptable structure/function claim, because occasional sleeplessness is not a characteristic symptom of a disease.

“Helps you fall asleep if you have difficulty falling asleep,” and “helps to reduce difficulty falling asleep” are disease claims because, unless the context makes clear that the product is only for occasional sleeplessness, they imply treatment of insomnia, a disease.

The claim listed in the comment from the “Stimulants” (alertness aids) monograph, “helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness,” is an acceptable structure/ function claim because occasional fatigue and drowsiness are not characteristic symptoms of a specific disease or class of diseases. FDA notes, however, that chronic fatigue or daytime drowsiness can be symptoms of chronic fatigue syndrome and narcolepsy, respectively.  Products labeled “to help restore mental alertness or wakefulness when experiencing fatigue or drowsiness” should not imply treatment of either of these diseases.

Of the claims listed in the comment from the “Daytime” sedatives monograph, almost all are acceptable structure/function claims.  “Occasional simple nervous tension,” “nervousness due to common every day overwork and fatigue,” “a relaxed feeling,” “calming down and relaxing,” “gently soothe away the tension,” “calmative,” “resolving that irritability that ruins your day,” “helps you relax,” “restlessness,” “nervous irritability,” and “when you’re under occasional stress, helps you work relaxed” are all acceptable structure/function claims, because all suggest occasional rather than long-term or chronic mood changes. Although occasional or acute symptoms can be characteristic of diseases in other settings, none of the occasional symptoms referred to here is characteristic of a specific disease. “Nervous tension headache” is a disease claim because tension headache meets the definition of a disease.

Of the claims listed in the comment from the “Aphrodisiacs” monograph, “arouses or increases sexual desire and improves sexual performance” is an acceptable structure/function claim because it does not imply treatment of a disease. “Helps restore sexual vigor, potency, and performance,” “improves performance, staying power, and sexual potency,” and “builds virility and sexual potency” are disease claims because they use the term “potency,” which implies treatment of impotence, a disease. If, however, these claims made clear that they were intended solely for decreased sexual function associated with aging, they could be acceptable structure/function claims.

The claim from the “Products for relief of symptoms of benign prostatic hypertrophy” monograph (“To relieve the symptoms of benign prostatic hypertrophy, e.g., urinary urgency and frequency, excessive urinating at night, and delayed urination”) is a disease claim, because benign prostatic hypertrophy meets the definition of a disease.

The claim listed in the comment from the “Anticholinergics” monograph is a disease claim. “Relieve excessive secretions of the nose and eyes” refers to the characteristic signs or symptoms of hay fever.

Of the claims listed in the comment from the “Products for certain uses” monograph, “digestive aid,” “stool softener,” “weight control,” and “menstrual” are, by themselves, acceptable structure/function claims if the labeling does not otherwise imply treatment or prevention of a disease.

None mentions a characteristic symptom of a disease. “Laxative” is a not a disease claim, if the labeling makes clear that the intended use is for treatment of occasional rather than chronic constipation.

“Nasal decongestant,” “expectorant,” and “bronchodilator” are disease claims. “Nasal decongestant” is a treatment for a characteristic symptom of colds, flu, and hay fever. “Expectorant” is a treatment for a characteristic symptom of colds, flu, and bronchitis. “Bronchodilator” is a treatment for bronchospasm, a characteristic symptom of asthma.

The claim from the “Products for the treatment and/or prevention of nocturnal leg muscle cramps” monograph (“treatment and/or prevention of nocturnal leg muscle cramps, i.e., a condition of localized pain in the lower extremities usually occurring in middle life and beyond with no regular pattern concerning time or severity”) is an appropriate structure function claim. Nocturnal leg cramps do not meet the definition of disease.

As is clear from this response, FDA agrees that inclusion of a claim in an OTC monograph does not preclude its use as a structure/ function claim. FDA notes, however, that in light of the statutory requirement that dietary supplements bear all information that is material in light of consequences that may result from use of the product or representations made about it, dietary supplements that contain or are labeled as containing ingredients covered by an OTC monograph and that are being sold for the claims covered by the monograph may be misbranded to the extent that they omit material information required under the monograph. For example, if the OTC monograph required a label statement that products containing a particular ingredient should not be used by persons taking a prescription monoamine oxidase inhibitor, a dietary supplement containing that ingredient would be misbranded if its label did not include such statement.

 AUGUST 25, 2005 UPDATE

Some structure/function claim issues continue to evolve. Since the publication of the rules, categories dealing with blood pressure, cholesterol, and blood sugar levels, for example, FDA has made specific comments about in warning letters. If a general claim is made for lowering or maintaining healthy blood pressure, cholesterol, and blood sugar levels, FDA has warned companies that these are drug claims.

In order to turn such claims in to structure/function claims, the statement must indicate that this applies to people who have normal blood pressure levels, cholesterol levels, blood sugar levels.

 Contact dan@supplementfacts.com for all your specialty regulatory consulting and writing needs in the food, dietary supplement, drug, health and fitness product industries.

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