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Structure/function claims: follow the rules; It is important to start the new year off right by reviewing permissible and impermissible structure/function claims.

Developing structure/function claims is never an easy task. The lines between a permissible and impermissible claim can often be difficult to discern, even for the most experienced copywriters, regulatory affairs personnel and attorneys. FDA has promulgated a set of rules to help guide companies in drafting permissible claims. While far from perfect, the rules do provide a useful start in determining whether a particular claim is permissible. We provide a summary of those rules below; the rules can also be reviewed by consulting 21 C.F.R [section] 101.93.

1. A claim may not suggest that the product has an effect on a specific disease or class of diseases.

Examples of impermissible claims under this criterion are:

* Reduces the pain and stiffness associated with arthritis.

* Helps alleviate the pain associated with migraine headaches.

Examples of permissible claims under this criterion are:

* Helps build and strengthen joint cartilage.

* Helps maintain a healthy heart.

2. A claim may not refer to a characteristic, sign or symptom of a disease or class of diseases.

Examples of impermissible claims under this criterion are:

* Helps alleviate cloudy vision.

* Relieves painful joints. (Widely ignored by the industry.)

* Helps lower cholesterol levels. (Widely ignored by the industry.)

FDA considers these claims impermissible because they are associated with specific disease conditions or risk of disease (i.e., cataracts, arthritis, and heart disease). However, while FDA has sent warning letters over cholesterol claims, it has not gone further if the offending claim has not stopped. Indeed, a reasonable argument exists that a "helps lower cholesterol" claim without any other indication that the claim is a "reduced the risk of heart disease" claim is a permissible structure/function claim. Of course, this assumes that the product does not contain a nutrient or dietary ingredient that is the subject of an FDA-permitted health claim.

Examples of claims that are permissible under this criterion are:

* Helps maintain LDL cholesterol levels that are already in normal range.

* Helps maintain proper joint function.

* Helps alleviate minor aches and pains associated with daily life.

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.

Examples of impermissible claims under this criterion are:

* Helps reduce inflammation by blocking the COX-2 enzyme.

* Helps alleviate BPH (benign prostatic hyperplasia).

* Helps with erectile dysfunction.

Examples of permissible claims under this criterion are:

* Alleviates symptoms associated with PMS.

* Promotes sexual vigor and performance.

* Helps alleviate occasional hot flashes associated with menopause.

4. A claim may not be disguised as a product name, according to 21 C.F.R. [section] 101.93(g)(2)(iv)(A).

Examples of impermissible product names are:

* Cho-less-terol

* Arthex

* Diab-eet-ees

There are many companies that believe if a product name is trademarked it is not subject to FDA's rules or FTC's requirement that a claim be substantiated. It is clear from both an FDA and FTC perspective if a product name communicates a particular meaning (alleviates migraines) it is subject to the same rules as any other product claim. Accordingly, do not use a disease condition in the product name under the false assumption that neither the FDA nor the FTC can take issue with the brand name.

Examples of permissible product names are:

* Mood Health

* Joint Flex

* Heart Health

5. A claim may not refer to a supplement's formulation if the statement suggests that the product is/was an FDA-regulated drug.

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, however, 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.

7. 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.

Examples of impermissible claims are:

* Stimulates the body's antiviral capacity.

* A natural analgesic without the side effects associated with NSAIDs.

Examples of permissible claims are:

* Helps maintain proper immune function.

* Helps reduce stress and tension.

* Helps alleviate occasional constipation.

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.

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 (i.e., joints and pain).

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, according to 21 C.F.R. [section] 101.93(g)(2)(v) and (vi).

Examples of impermissible claims are:

* Herbal antidepressant.

* Helps maintain joint health without the use of NSAIDs.

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, according to 21 C.F.R. [section] 101.93(g)(2)(vii) and (ix).

Examples of impermissible claims are:

* Helps maintain blood sugar levels in insulin dependent people.

* Helps stimulate the immune system when undergoing chemotherapy.

FDA also has a catch-all rule to allow it to complain about any claim it does not believe is a permissible structure/function claim.


As one can see, the rules are hardly perfect. One good rule of thumb to use when drafting claims is to keep it simple and avoid a negative spin to the claim. In other words, write the claim in a manner that assumes the product is helping support a normal structure/function of the body rather than trying to correct an abnormal condition. By doing so, one will usually be able to avoid crafting an impermissible claim that could subject the product to regulatory scrutiny.

Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004; 202-344-4724; E-mail:
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Title Annotation:CAPITOL COMMENTS; Food and Drug Administration
Author:Harrison, Todd
Publication:Nutraceuticals World
Geographic Code:1USA
Date:Jan 1, 2007
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