Todd Harrison11.01.10
In the past, I have written several columns regarding the fine line between a permissible structure/function claim and an impermissible disease claim. And still, the rules promulgated by FDA on this issue continue to perplex many industry members. Further, many of the distinctions between a permissible claim and an impermissible claim are not even logical. For instance, why is the claim “helps maintain cholesterol levels that are already in the normal range” permissible, and “helps maintain normal cholesterol levels” not permissible? To many, there is no difference between the two.
But FDA’s position on what is considered permissible and impermissible is not the final say. Reasonable minds can disagree over whether a claim is permissible and FDA has been unwilling to go any further than issuing a “warning letter” on a borderline claim. Regardless, the past year has witnessed an increase in the issuance of warning letters from the agency. Moreover, the FTC has apparently decided that it has the ability to police the Federal Food, Drug, and Cosmetic Act (the Act) under the guise of deceptive advertising. This claim to jurisdiction by the FTC is highly questionable.
That said, FTC was able to convince Iovate to sign consent orders that, in short, stated that if a claim is a “disease” or “drug” claim and there is not an FDA-approved health claim, FDA-permitted qualified health claim, or OTC monograph established for the ingredient, the company agreed that it would not make such a claim unless the product was approved by FDA. Accordingly, I thought it was timely to revisit the issue of what constitutes a permissible structure/function claim versus an impermissible disease claim.
Structure/Function Claims
Structure/function claims are those claims that relate the effect of a nutrient, dietary ingredient, dietary supplement or a food to the body’s structure or function.
FDA’s position is that structure/function claims for conventional foods must be based on the food’s nutritive value.
• Acceptable: “calcium supports bone health”
• Unacceptable: “caffeine provides energy”
Structure/function claims may make claims about nutrient deficiency diseases (e.g., vitamin C and scurvy), as well as claims regarding the effect of the supplement on general well-being.
Structure/function claims CANNOT, however, suggest that the product is useful in the diagnosis, cure, treatment, prevention or mitigation of a disease or health-related condition.
Standard #1 (21 CFR 101.93(g)(2)(i))
A claim may not suggest the product has an effect on a specific disease or class of disease. Examples of impermissible claims are:
• Reduces the pain and stiffness associated with arthritis
• Helps alleviate the blues associated with emotion despair (i.e., despair=depression)
Examples of permissible claims include:
• Helps maintain health and flexibility
• Helps alleviate the occasional blue feeling everyone experiences from time to time
Standard #2 (21 CFR 101.93(g)(2)(ii))
A claim may not refer to a characteristic or symptom of a disease or class of disease. Examples of impermissible claims are:
• Lowers serum cholesterol levels
• Lowers blood pressure
• Relieves painful joints
• Lowers blood sugar levels
Examples of permissible claims include:
• Helps maintain LDL cholesterol levels already in the normal range
• Helps maintain proper joint function
• Helps maintain blood sugar levels that are already in the normal range
• Helps alleviate minor aches and pains associated with daily life
Standard #3 (21 CFR 101.93 (Gg(2)(iii))
References to signs and/or symptoms of natural states are permissible as long as they are not uncommon or can cause significant harm if left untreated. Examples of impermissible claims are:
• Helps control proper inflammatory response in the prostate
• Helps alleviate BPH
• Helps alleviate endometriosis
• Helps alleviate chronic constipation
• Helps alleviate male potency problems (implied impotency claim)
Examples of permissible claims include:
• Provides optimal nutritional support during menopause
• Alleviates mood swings and hot flashes associated with menopause
• Alleviates the pain associated with exercise
• Alleviates occasional constipation
• Alleviates occasional gas
• Promotes sexual vigor and performance
Standard #4 (21 CFR 102.93(g)(2)(iv)(A))
A claim may not be disguised as a product name. Examples of impermissible product names are:
• Arthritis Formula
• Cho-less-terol
• Arthex
• Migraine Relief
Examples of permissible product names include:
• Mood Health
• Joint Flex
• Heart Health
Standard #5 (21 C.F.R. §101.93(g)(2) (iv)(B))
A claim may not refer to a supplement’s formulation if the statement suggests that the product is/was an FDA-regulated drug. Examples of an impermissible claim is:
• “This product contains L-carnitine—formerly only available as a prescription drug”
Standard #6 (21 CFR 101.93(g)(2)(iv)(C))
A citation 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. To ensure compliance with this criterion, the article:
• Should not be characterized in the copy;
• Should appear at the end of the promotional materials as part of a bibliography of other articles;
• Should be balanced; and
• Should not appear upon the product’s label
Additionally, a bibliography, which contains more than insignificant amounts of articles that refer to a particular disease would be considered suspect by FDA and should be avoided.
Standard #7 (CFR 101.93(g)(2)(iv)(D) & (viii)
The use of the terms disease, diseases, antiviral, antibacterial, antiseptic, antibiotic, analgesic, diuretic, antidepressant, vaccine, 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. Examples of impermissible claims are:
• 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
• A good diet including targeted nutrients and exercise promote overall good health and well-being and disease prevention
Standard #8 (21 CFR 101.93(g)(2)(iv)(E))
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. An example of an impermissible picture:
• A picture of a hand with joints highlighted in red
Standard #9 (21 CFR 101.93(g)(2)(v) & (vi))
A claim may not suggest that a supplement or its ingredients belong to a particular class of drugs or is a substitute for a particular therapy. Examples of impermissible claims are:
• Herbal antidepressant
• Helps maintain joint health without the use of NSAID’s
Standard #10 (21 CFR 101.93(g)(2)(vii) & (ix))
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. Examples of impermissible claims are:
• 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
Standard #11 (21 CFR 101.93(g)(2)(x))
FDA adds a final catch-all criterion that simply prohibits the use of a claim that “otherwise” suggests a disease or disease condition.
Additional Requirements for Dietary Supplements
FDA must be notified within 30 days of a structure/function claim first appearing on the label and labeling of a dietary supplement.
The following disclaimer must appear in connection with the structure/function claim:
“This claim has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease.”
Arguments exist that notification and disclaimer only be required when the structure/function claim could be construed as an implied health claim. However, FDA rejects this interpretation.
Exceptions for Disease Treatment Claims
For dietary supplements, certain publications that promote their use for the treatment of disease are exempt from labeling. In addition, medical foods may contain claims for the treatment of disease.
Exceptions for Dietary Supplements Labeling & Publications
Although the label and labeling of dietary supplements may not suggest disease claims, certain items have been exempted from the definition of labeling and may discuss the prevention or treatment of disease. The “Reading Room Exception” allows companies to use publications that:
• Are balanced, truthful and not misleading
• Do not promote a specific brand
• Are not attached (by physical attachment or reference) to the dietary supplement’s label or labeling
“Publications Held for Sale”
• This permits a company to publish and sell its own publications as part of its business of selling dietary supplements.
• Writers or publishers of publications must be independent of the company that sells the dietary supplements.
• Publication must be a bona fide business (i.e., publication is priced at fair market value)
