DSHEA Tutorial: Disease Definition Exceptions


Summary: the FDA has set aside a few conditions that, while considered temporarily inconvenient, are not considered a disease. The complete list is found lower on this page.

Are there any exceptions to these disease claim issues?

Of course, it works like this. If you are claiming to help with something that may be no big deal or in fact could be a big deal, the tie goes to the runner, which in this case is us!

What am I trying to say with my schoolyard baseball analogy? If there is a problem that can arise and pass away without doing any permanent harm, that’s really not a disease, but an inconvenience. So if a problem could be a real issue OR just an inconvenience, the FDA says that we can claim to treat it! Let’s take heartburn for instance. Heartburn can be due to eating too much or a bleeding ulcer. Because it is ambiguous, it is a claim that is allowed, however the FDA wants to see some qualifying verbiage such as “Bao He Wan for occasional heartburn” or something along those lines. Here’s what the FDA rules state:

Although “relief of heartburn” and “relief of acid indigestion” without further qualification are not appropriate structure/function claims, the agency has concluded that “occasional heartburn” and “occasional acid indigestion” can also be considered nonspecific symptoms, arising as they do in overindulgence and other sporadic situations. These claims could be appropriate structure/function claims. In contrast, “recurrent” or “persistent” heartburn and acid indigestion can be hallmarks of significant illness, and are therefore disease claims.

“Improves absentmindedness” or “eliminates frustration” are a couple of other examples of ambiguous (and hence treatable) symptoms. In particular, the FDA states:

“improves absentmindedness” as implying treatment of
Alzheimer’s disease because absentmindedness is not as serious as the
type of memory loss characteristically suffered by Alzheimer’s
patients; absentmindedness is, in fact, suffered predominantly by
people who do not have Alzheimer’s disease or any other disease. Stress
and frustration, while associated with some anxiety disorders, are not
the characteristic symptoms of those disorders; in addition, these
symptoms are equally associated with many other non-disease states.

There are certain issues that, while looking like a disease in print, are actually transitory non-serious complaints associated with normal physiological stages of life. We can treat symptoms associated with such conditions as

adolescence, the menstrual cycle, pregnancy,
menopause, and aging.

However, serious conditions that can cause significant or permanent harm if not effectively treated are not allowed for structure/function claims.

For example, pregnancy is associated with common and mild abnormalities such as morning sickness and leg edema that cause no permanent harm if left untreated, as well as with such serious conditions as hyperemesis gravidarum, toxemia of pregnancy, and acute psychosis of pregnancy, which can be life-threatening if not effectively treated.

Here’s a partial list of those conditions for which an herbal supplement can be allowed to (claim to) treat:

(1) Morning sickness associated with pregnancy;

(2) leg edema associated with pregnancy;

(3) mild mood changes, cramps, and edema associated with the menstrual cycle;

(4) hot flashes;

(5) wrinkles;

(6) other signs of aging on the skin, e.g., liver spots, spider veins;

(7) presbyopia (inability to change focus from near to far and vice versa) associated with aging;

(8) mild memory problems associated with aging;

(9) hair loss associated with aging; and

(10) non-cystic acne.

The following are examples of conditions that would remain disease claims:

(1) Toxemia of pregnancy;

(2) hyperemesis gravidarum;

(3) acute psychosis of pregnancy;

(4) osteoporosis;

(5) Alzheimer’s disease, and other senile dementias;

(6) glaucoma;

(7) arteriosclerotic diseases of coronary, cerebral or peripheral blood vessels;

(8) cystic acne; and

(9) severe depression associated with the menstrual cycle.

Next: This supplement labeling course has not been evaluated by the FDA.

Last modified: August 19, 2009  Tags: ,  В·  Posted in: Claims