Todd Harrison04.01.05
Over the years, I have written in great detail regarding claims. However, I am still struck by the wide variety of claims that are being made about dietary supplements and how many would likely run afoul of FDA's position on this issue. First and foremost, it is important to remember that FDA's regulations prohibit the use of disease claims. FDA's regulations define "disease" as: "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).
To help decipher what is meant by this definition, FDA went on to delineate criteria to help companies determine whether a particular claim was a permissible structure/function claim or an impermissible disease claim. FDA followed this regulation with a guidance document on the same issue. However, neither the regulation nor the guidance document provides much practical advice to companies. The following discussion is intended to provide companies with that guidance.
Criterion 1: A claim may not suggest that the product has an effect on a specific disease or class of disease. 21 C.F.R. 101.93(g)(2)(i).
Examples of impermissible claims under this criterion include:
"Reduces the pain and stiffness associated with arthritis"
"Helps alleviate the pain associated with migraine headaches"
"Helps alleviate the blues associated with emotional despair" (i.e., despair=depression)
Examples of claims that do not violate this criterion include:
"Helps build and strengthen joint cartilage"
"Helps maintain joint health and flexibility"
"Helps maintain a healthy heart"
Criterion 2: A claim may not refer to a characteristic sign or symptom of a disease or class of disease. C.F.R. 101.93(g)(2)(ii).
Examples of impermissible claims under this criterion include:
"Lowers serum cholesterol levels"
"Lowers blood pressure"
"Relieves painful joints"
"Lowers blood sugar levels"
FDA considers these claims impermissible because they are associated with specific disease conditions or risk of disease, i.e., risk of heart disease, hypertension, arthritis and diabetes, respectively.
Examples of claims that are permissible under this criterion include:
"Helps maintain healthy LDL cholesterol levels"
"Helps maintain proper joint function"
"Helps maintain healthy blood sugar levels"
"Helps alleviate minor aches and pains associated with daily life"
Criterion 3: References to signs and/or symptoms of natural states are permissible as long they are not uncommon and cannot cause significant harm if left untreated. 21 C.F.R. 101.93(g)(2)(iii).
Examples of impermissible claims under this criterion include:
"Helps reduce inflammation by blocking the COX-2 enzyme"
"Helps alleviate BPH"
"Helps alleviate joint pain"
Examples of permissible claims under this criterion include:
"Alleviates symptoms associated with PMS"
"Promotes sexual vigor and performance"
"Helps alleviate occasional hot flashes associated with menopause"
Criterion 4: A claim may not be disguised as a product name. 21 C.F.R. 101.93(g)(2)(iv)(A).
Examples of impermissible product names include:
Arthritis Formula
Cho-less-terol
Arthex
Migraine Relief
There is no restriction, however, on the use of a product name that merely mentions a part, organ, structure or function of the body.
Examples of permissible product names include:
Mood Health
Joint Flex
Heart Health
Criterion 5: A claim may not refer to a supplement's formulation if the statement suggests that the product is/was an FDA-regulated drug. 21 C.F.R. 101.93(g)(2)(iv)(B).
L-carnitine is an FDA-approved active drug for use in certain heart patients. L-carnitine is also a permissible dietary ingredient and may be used in dietary supplements as long as its FDA drug status is not referred to on the product label or in promotional materials. Thus, the label and labeling of a dietary supplement could not mention L-carnitine's use as an FDA approved drug (e.g., "This product contains L-carnitine-formerly only available as a prescription drug").
Criterion 6: Citations to an article that refers to a disease in its title is permissible if the labeling taken as a whole does not imply a disease prevention or treatment claim. 21 C.F.R. 101.93(g)(2)(iv)(C).
Reference to an article that refers to a disease is not permitted on the product's label or immediate packaging. To ensure compliance with this criterion, the article (1) should not be characterized in the copy; (2) should appear at the end of the promotional materials as part of a bibliography of other articles, and (3) the article should be balanced. Moreover, a bibliography that contains more than an insignificant amount of articles that refer to a particular disease would be considered suspect by FDA and should be avoided.
Criterion 7: The use of the terms disease, diseases, antiviral, antibacterial, antiseptic, antibiotic, diuretic, antidepressant, vaccine, analgesic, or any other word that would suggest that the product belonged to a class of products intended to cure, treat, or prevent disease is not permitted. 21 C.F.R. 101.93(g)(2)(iv)(D) and (viii).
Examples of impermissible claims include:
"Stimulates the body's antiviral capacity"
"Helps alleviate depression"
Examples of permissible claims include:
"Helps maintain proper immune function"
"Helps reduce stress and tension"
"Helps alleviate occasional constipation"
"Helps maintain regularity"
"A good diet including targeted nutrients and exercise promote overall good health and well being and disease prevention"
Criterion 8: The use of pictures, vignettes, symbols, or other means in a manner that would otherwise suggest the presence of a disease condition is not permitted. 21 C.F.R. 101.93(g)(2)(iv)(E).
A picture of a hand with the joints highlighted in red may be considered an implied "disease" claim because the red highlight could be interpreted as a sign of pain or arthritis. Alternatively, however, a picture of a hand-standing alone-would probably not be considered a "disease" claim because it does not reference a particular endpoint-joints and pain. However, FDA believes that the heart symbol is so tied to heart disease that it is unlikely that its use is permissible. However, it is difficult to understand how the use of the heart symbol is anymore linked to heart disease than the claim "helps maintain a healthy heart." Indeed, it is doubtful that FDA would draw a line in the sand on this issue, but it is always a possibility.
Criterion 9: A claim may not suggest that the supplement or its ingredients belong to a particular class of drugs or is a substitute for a particular therapy. 21 C.F.R. 101.93(g)(2)(v) and (vi).
Examples of impermissible claims include:
"Herbal antidepressant"
"Helps maintain joint health without the use of NSAIDs"
Criterion 10: A claim may not suggest that a product is useful as a companion to regular drug therapy, or that it prevents or treats adverse events associated with a disease if the adverse events are also disease conditions. 21 C.F.R. 101.93(g)(2)(vii) and (ix).
Examples of impermissible claims include:
"Helps maintain blood sugar levels in insulin dependent people."
"Helps stimulate the immune system when undergoing chemotherapy.
Examples of permissible claims include:
"Helps alleviate nausea associated with chemotherapy"
"Use as part of a healthy diet to help maintain healthy blood sugar levels"
Criterion 11: FDA adds a final "catchall" criterion that simply prohibits the use of claims that "otherwise" suggest a disease or disease condition.NW
To help decipher what is meant by this definition, FDA went on to delineate criteria to help companies determine whether a particular claim was a permissible structure/function claim or an impermissible disease claim. FDA followed this regulation with a guidance document on the same issue. However, neither the regulation nor the guidance document provides much practical advice to companies. The following discussion is intended to provide companies with that guidance.
Criterion 1: A claim may not suggest that the product has an effect on a specific disease or class of disease. 21 C.F.R. 101.93(g)(2)(i).
Examples of impermissible claims under this criterion include:
"Reduces the pain and stiffness associated with arthritis"
"Helps alleviate the pain associated with migraine headaches"
"Helps alleviate the blues associated with emotional despair" (i.e., despair=depression)
Examples of claims that do not violate this criterion include:
"Helps build and strengthen joint cartilage"
"Helps maintain joint health and flexibility"
"Helps maintain a healthy heart"
Criterion 2: A claim may not refer to a characteristic sign or symptom of a disease or class of disease. C.F.R. 101.93(g)(2)(ii).
Examples of impermissible claims under this criterion include:
"Lowers serum cholesterol levels"
"Lowers blood pressure"
"Relieves painful joints"
"Lowers blood sugar levels"
FDA considers these claims impermissible because they are associated with specific disease conditions or risk of disease, i.e., risk of heart disease, hypertension, arthritis and diabetes, respectively.
Examples of claims that are permissible under this criterion include:
"Helps maintain healthy LDL cholesterol levels"
"Helps maintain proper joint function"
"Helps maintain healthy blood sugar levels"
"Helps alleviate minor aches and pains associated with daily life"
Criterion 3: References to signs and/or symptoms of natural states are permissible as long they are not uncommon and cannot cause significant harm if left untreated. 21 C.F.R. 101.93(g)(2)(iii).
Examples of impermissible claims under this criterion include:
"Helps reduce inflammation by blocking the COX-2 enzyme"
"Helps alleviate BPH"
"Helps alleviate joint pain"
Examples of permissible claims under this criterion include:
"Alleviates symptoms associated with PMS"
"Promotes sexual vigor and performance"
"Helps alleviate occasional hot flashes associated with menopause"
Criterion 4: A claim may not be disguised as a product name. 21 C.F.R. 101.93(g)(2)(iv)(A).
Examples of impermissible product names include:
Arthritis Formula
Cho-less-terol
Arthex
Migraine Relief
There is no restriction, however, on the use of a product name that merely mentions a part, organ, structure or function of the body.
Examples of permissible product names include:
Mood Health
Joint Flex
Heart Health
Criterion 5: A claim may not refer to a supplement's formulation if the statement suggests that the product is/was an FDA-regulated drug. 21 C.F.R. 101.93(g)(2)(iv)(B).
L-carnitine is an FDA-approved active drug for use in certain heart patients. L-carnitine is also a permissible dietary ingredient and may be used in dietary supplements as long as its FDA drug status is not referred to on the product label or in promotional materials. Thus, the label and labeling of a dietary supplement could not mention L-carnitine's use as an FDA approved drug (e.g., "This product contains L-carnitine-formerly only available as a prescription drug").
Criterion 6: Citations to an article that refers to a disease in its title is permissible if the labeling taken as a whole does not imply a disease prevention or treatment claim. 21 C.F.R. 101.93(g)(2)(iv)(C).
Reference to an article that refers to a disease is not permitted on the product's label or immediate packaging. To ensure compliance with this criterion, the article (1) should not be characterized in the copy; (2) should appear at the end of the promotional materials as part of a bibliography of other articles, and (3) the article should be balanced. Moreover, a bibliography that contains more than an insignificant amount of articles that refer to a particular disease would be considered suspect by FDA and should be avoided.
Criterion 7: The use of the terms disease, diseases, antiviral, antibacterial, antiseptic, antibiotic, diuretic, antidepressant, vaccine, analgesic, or any other word that would suggest that the product belonged to a class of products intended to cure, treat, or prevent disease is not permitted. 21 C.F.R. 101.93(g)(2)(iv)(D) and (viii).
Examples of impermissible claims include:
"Stimulates the body's antiviral capacity"
"Helps alleviate depression"
Examples of permissible claims include:
"Helps maintain proper immune function"
"Helps reduce stress and tension"
"Helps alleviate occasional constipation"
"Helps maintain regularity"
"A good diet including targeted nutrients and exercise promote overall good health and well being and disease prevention"
Criterion 8: The use of pictures, vignettes, symbols, or other means in a manner that would otherwise suggest the presence of a disease condition is not permitted. 21 C.F.R. 101.93(g)(2)(iv)(E).
A picture of a hand with the joints highlighted in red may be considered an implied "disease" claim because the red highlight could be interpreted as a sign of pain or arthritis. Alternatively, however, a picture of a hand-standing alone-would probably not be considered a "disease" claim because it does not reference a particular endpoint-joints and pain. However, FDA believes that the heart symbol is so tied to heart disease that it is unlikely that its use is permissible. However, it is difficult to understand how the use of the heart symbol is anymore linked to heart disease than the claim "helps maintain a healthy heart." Indeed, it is doubtful that FDA would draw a line in the sand on this issue, but it is always a possibility.
Criterion 9: A claim may not suggest that the supplement or its ingredients belong to a particular class of drugs or is a substitute for a particular therapy. 21 C.F.R. 101.93(g)(2)(v) and (vi).
Examples of impermissible claims include:
"Herbal antidepressant"
"Helps maintain joint health without the use of NSAIDs"
Criterion 10: A claim may not suggest that a product is useful as a companion to regular drug therapy, or that it prevents or treats adverse events associated with a disease if the adverse events are also disease conditions. 21 C.F.R. 101.93(g)(2)(vii) and (ix).
Examples of impermissible claims include:
"Helps maintain blood sugar levels in insulin dependent people."
"Helps stimulate the immune system when undergoing chemotherapy.
Examples of permissible claims include:
"Helps alleviate nausea associated with chemotherapy"
"Use as part of a healthy diet to help maintain healthy blood sugar levels"
Criterion 11: FDA adds a final "catchall" criterion that simply prohibits the use of claims that "otherwise" suggest a disease or disease condition.NW