An important criterion for distinguishing between a supplement and a drug are

the claimed benefits from its intended use. A critical but confusing distinction

is that between a permissible "structure/function" claim and an impermissible

"health" claim. This is also an essential component of the labeling requirement

for dietary supplements. A direct claim that a product cures, mitigates, treats,

or prevents a disease will subject it to regulation as a drug. However, the

DSHEA provides certain "safe harbor" claims of nutritional support for the

use of dietary supplements.4 These permissible claims include a benefit related

to a classical nutritional deficiency disease which also discloses the prevalence

of such disease in the United States, or a claim that general well-being can be

derived from the consumption of the dietary ingredient. In addition, a claim of

a role of the nutrient or dietary supplement in affecting the "structure or

function" in humans, or a description which characterizes the documented

mechanism by which the ingredient acts to maintain structure or function, is

also permissible. Under the original FDC Act, a product that is "intended to

affect the structure or any function of the body" was ordinarily subject to

regulation as a drug. However, this limitation has not traditionally been applied

to foods and now also does not apply to dietary supplements within the scope

of the DSHEA. The distinction is, however, subtle. For foods, claims such as

calcium helps build strong bones or protein helps build strong muscles have

been tolerated by the FDA as acceptable. The FDA has provided an

illustration of the delicate contrast between these claims in explaining

statements associated with the use of cranberry juice cocktail or supplements.

A claim that a cranberry product helps to "maintain urinary tract health" is

likely to be a permissible claim (so long as it is truthful and not misleading),

while a claim that the same product "prevents the recurrence of urinary tract

infections" is impermissible. The stated reason is that the former is not a

health claim because no specific disease is mentioned either explicitly or

implicitly.

In 1998, the FDA proposed a new rule to help clarify the distinction between a

permissible structure/function claim and an impermissible disease claim.5 It

began by defining a disease as:

"...any deviation from, impairment of, or interruption of the normal

a disease."

Significantly, the characteristic laboratory or clinical measurements of a

disease include elevated cholesterol, uric acid, blood sugar, and other lab

determinations, while the characteristic signs would include elevated blood

pressure and other physical signs. The FDA proposed ten criteria to use in

identifying disease claims which would be impermissible for a dietary

supplement. The pharmacist should be aware of the subtle distinctions

between permissible and impermissible claims made by supplement

manufacturers and labels as an aid in interpreting their meaning. These criteria

are:

1. A claimed effect on a specific disease or class of diseases. An

impermissible claim would be that a product protects against the development

of cancer or reduces the pain and stiffness associated with arthritis. However,

a claim that a product promotes relaxation or helps maintain cardiovascular

function and a healthy circulatory system would be permissible.

2. A claimed effect on a sign or symptom which would be recognizable to a

health care professional or consumer as characteristic of a specific disease.

For example, a claim that a product reduces joint pain, lowers elevated

cholesterol, or improves urine flow in men over 50 would be recognized as a

laboratory or clinical characteristic of certain disease states and would be

impermissible. On the other hand, a claim that a product inhibits platelet

aggregation or reduces stress and frustration does not refer to a specific

disease and is permissible. Less clear cut are claims that a product would

help maintain a normal function such as a healthy cholesterol level or

regularity. The FDA has requested comments on these types of claims.

3. A claimed effect on a consequence of a natural state that may be

associated with characteristic abnormalities. A claim that a product helps

toxemia of pregnancy, premenstrual syndrome, or decreased sexual function

would be recognizable as constituting an abnormality, while a claim that a

product is for men over 50 or meets the nutritional needs of pregnancy would

be permissible.

4. Claimed effects on a disease through a product name, publication, or

illustration. A product called "Heptacure" or "Carpaltum" implying an effect on

a liver problem or carpal tunnel syndrome would not be permissible, but a

product called "Cardiohealth" would be allowable. A picture, symbol, or other

illustration which suggests an effect on a disease also would not be

permissible. Some examples cited by the FDA include a reference to

prescription use, pictures of organs, or an electrocardiogram tracing.

5. A claim that a product belongs to a class of drugs. Identifying a product as

a antibiotic, analgesic, diuretic or other accepted drug class would not be

acceptable, while calling a product an "energizer," "rejuvenator" or "revitalizer"

would be allowed.

6. An implied claim that a product is a substitute for a therapeutic product,

such as calling a product "Herbal Prozac," would also not be permissible.

7. A claim that a product augments or is an adjunct to a therapy or drug

would be a disease claim.

8. A claim that a product has a role in the body’s response to disease. A

claim that a product affects the body’s ability to kill a pathogen or supports

the body’s ability to treat infection would not be permissible, while a claim

that a product supports the immune system would be acceptable.

9. A claimed effect on adverse events associated with disease therapy. A

claim that a product reduces the nausea associated with chemotherapy or

helps avoid diarrhea associated with antibiotic therapy would be an

impermissible disease claim, but a claim that the product helps maintain

healthy intestinal flora would be permissible.

10. Finally, the FDA reserved a "catch all" category for claims that otherwise

suggest an effect on a disease. As noted above, a manufacturer making a

permissible claim must notify FDA within 30 days of making such a claim.

Labeling

Another important aspect of the DSHEA is the labeling requirement for

dietary supplements. One part of the labeling regulation addresses the use of

various claims about the supplement’s health benefits.2 This is similar to the

distinction between permissible and impermissible claims described above. A

label which expressly or implicitly promoted a health claim would be

unacceptable. Under the DSHEA, supplement manufacturers are allowed to

use three types of claims when appropriate: nutrient-content claims, nutrition

support claims, and disease claims. A nutrient-content claim describes the

level of a nutrient in a supplement. For example, a supplement could be labeled

as "high in calcium" or "an excellent source of Vitamin C" if sufficient

quantities of the claimed nutrient may be found in the product. Nutrition

support claims may describe a link between a nutrient and a deficiency state

that would result from a lack of the nutrient in the diet. When this type of

claim is used, the label must state the prevalence of the nutrient deficiency in

the United States. For example, a vitamin C product could state that vitamin C

prevents scurvy. The nutrient support claims also include structure/function

claims (see above) which refer to the nutrient’s effect on the overall structure

or function of the body. For example, a label may say that calcium builds

strong bones or that antioxidants maintain cell integrity. A disease claim shows

a link between a particular substance and a health-related condition. These are

authorized by the FDA based upon a review of scientific evidence or may be

based upon an authoritative statement from certain scientific bodies such as

the National Academy of Sciences. Some acceptable disease claims include:

the link between calcium and osteoporosis; the link between folic acid and a

decreased risk of neural tube defects in pregnancy; and the link between

psyllium seed husks along with a low cholesterol and fat diet and coronary

artery disease. In all of these instances, there must be adequate

(therapeutically relevant) amounts of the nutrient in the product to justify the

claim and the claim must be made in compliance with the FDA resolution.

It should be remembered that a manufacturer can use a structure/function

claim without prior FDA authorization. The claim must be based upon the

manufacturer’s review and interpretation of the scientific literature and must

be supportable by the manufacturer, but the manufacturer is not obligated to

provide the FDA with the documentation prior to marketing. When a

structure/function claim is used by the manufacturer, the label must be

accompanied by a disclaimer that states:

"This statement has not been evaluated by the Food and Drug Administration.

This product is not intended to diagnose, treat, cure or prevent any disease."

The second sentence, it may be recalled, defines a drug. If a product promotes

itself as diagnosing, treating, curing, or preventing a disease (see guidance

above), the FDA may advise the manufacturer to revise or delete the claim.

The use of the disclaimer, however, cuts both ways. While the disclaimer

permits the manufacturer to make certain statements about the product, there

is also no independent source which can be used by the consumer as a

guardian of the product’s effectiveness. This is unlike the situation for drugs

which receive FDA approval. The pharmacist who investigates and

understands these claims can help to fill this void for the consumer.

More complete labeling of supplements will be required in 1999. Among the

revised requirements for inclusion on the labels of supplements are: a

supplement facts panel listing the name, quantity, serving size, and total weight

of each ingredient; a list of other ingredients (e.g., excipients) in descending

order of predominance; the net quantity (e.g., number of capsules); directions

for use; the identity of any plant part from which a botanical ingredient is

derived; the name and place of business of the manufacturer, packer, or

distributor; and the term dietary supplement. If it the product claims to

conform to an official compendium (e.g., USP), it must meet those

specifications.

A more controversial aspect of labeling is the use of publications and other

supporting documents which could circumvent the ban on health claims. The

DSHEA exempts publications used in connection with a sale even though the

publication may contain information of a therapeutic nature. The exemption

applies so long as the publication does not accompany the product and is not

part of an integrated plan to promote the product. Supporting publications

include articles, book chapters, and official abstracts of peer-reviewed

scientific publications which appear in the article and are prepared by the

author or editor. In order to qualify as an exemption, the publication:

(a) must not be false or misleading;

(b) cannot promote a particular manufacturer or brand;

(c) must present a balanced scientific view of the available

information;

(d) must be reprinted in its entirety; and

(e) the display of the material in a retail store must be physically

separated from the dietary supplements and may not contain

appended stickers.