Todd Harrison01.01.08
Watch What You Say
The following criteria can help guide companies when marketing their dietary supplements.
By Todd Harrison
Partner
Venable
Washington, D.C.
Criterion 1: A claim may not suggest that the product has an effect on a specific disease or class of disease.
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 alleviate the occasional blue feeling everyone experiences from time to time.
• 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
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 so 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 (FDA has questioned whether this claim is permissible.
• Helps maintain proper joint function.
• Helps maintain healthy blood sugar levels.[1] <#_ftn1>
• 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 or can cause significant harm if left untreated.
Examples of impermissible claims under this criterion include:
• 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 under this criterion include:
• Provides optimal nutritional support during menopause.
• Alleviates mood swings and hot flashes associated with menopause.
• Alleviates the pain associated with exercise.
• Alleviates symptoms associated with PMS.
• Alleviates occasional constipation.
• Alleviates occasional gas.
• Promotes sexual vigor and performance.
Criterion 4: A claim may not be disguised as a product name.
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.
For example, 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 carnitine 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.
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, 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 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.
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.
For example, 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. The preamble to the final rules indicate that use of the heart symbol on product label and labeling is an impermissible heart disease prevention claim.
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 particularly therapy.
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.
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:
• Use as part of a healthy diet to help maintain normal blood sugar levels.
• Helps alleviate nausea associated with chemotherapy.
Criterion 11: FDA adds a final “catchall” criterion that simply prohibits the use of a claim that “otherwise” suggests a disease or disease condition.
It appears that FDA has decided to use this last criterion to find a number of otherwise permissible claim to be impermissible. Indeed, in a host of recent courtesy letters, the agency seems to be back-tracking considerably from its initial interpretation of the rules, leaving many companies confused regarding the permissible scope of structure/function claims.