57
did Congress, in its 1976 revision of the “device” definition, substitute the broader term
“article” for listing narrower product categories to be regulated as devices found in the
FD&C Act since 1938.7
The preceding background information was included in my earlier article and clearly
demonstrates the marked differences between devices and drugs. Both leeches and mag-
gots derive their effects through chemical action. Maggots secrete substances that kill
bacteria and stimulate the growth of healthy tissue. Leeches produce hirudin, a direct
thrombin inhibitor, and other enzymes.8 However, according to FDA, the primary mode
of maggots is chewing for leeches, it is the chewing of blood.9 Both of these were deemed
mechanical processes. (Predicate devices included scalpels and maggots that had been
sold before passage of the Medical Device Amendments.) Honey, as noted in the informa-
tion that follows, also produces an antiseptic compound. The late Senator Clark would, no
doubt, have objected to all three agency decisions.
Therapeutic Honey
Honey has been used for treating wounds since early antiquity. The Smith Papyrus of 1700
BC and the Ebers Papyrus of 1500 BC describe packing severe wounds and burns with a
combination of coagulated milk and honey kept in place with a muslin bandage.10 The early
Greek and later Roman civilizations mixed honey with grease or fat and applied the mixture
to wounds. Physicians used honey to soothe ailments of the eye and ear, to eliminate skin
infections, and to promote the healing of wounds or the site of surgeries such as circumci-
sion. Babylonians used honey to preserve corpses by preventing putrefaction.11 Accounts
of the use of honey as a wound dressing are not confined to ancient records. During World
War I, Russian soldiers used honey-based preparations to prevent wound infections, and
during World War II, the Chinese mixed an ointment out of honey and lard.12 A number of
reports have been published in the medical literature regarding the rediscovery of honey as
a therapeutic agent, no doubt as the result of its antibacterial activity.13
Properties
Several studies have demonstrated that some varieties of honey have a broad spectrum of
activity against a number of pathogenic bacteria and fungi. Some of the bacterial strains
tested were antibiotic-resistant. Antibacterial activity is greater than would be expected
from honey’s sugar content. (Honey is a complex product with low water activity, acid-
ity and high sugar content, but this does not contribute significantly to the antibacterial
activity.) The action of these honeys is linked to the production of hydrogen peroxide.
According to several authors, bees help preserve honey in the hive by adding an enzyme,
glucose oxidase, to the nectar gathered from flowers while it is being processed into
honey. When honey comes into contact with body moisture, the glucose oxidase slowly
releases hydrogen peroxide.14
The production of the peroxide could lead to the formation of free radicals such as
hydroxyl and superoxide. Honey also provides a substrate for glycolysis, which is the
major mechanism for energy production in macrophages, and thus allowing them to
function in damaged tissues with low oxygen supply. There are additional benefits to
leucocytes and monocytes that can affect the molecular mechanisms of wound healing
and tissue repair.15,16
Therapeutic vs Culinary Honey
Therapeutic honeys are distinctly different from the culinary honeys found in the super-
market. Therapeutic honeys must have a high osmotic activity and an acid pH (3.2 to 4.2)
produce a slow, low level of hydrogen peroxide and be derived from specific plant-
derived factors, such as Leptospermum scoparlum (Manuka).17
Maggots, Leeches and Now Honey—Putative Medical Devices?
did Congress, in its 1976 revision of the “device” definition, substitute the broader term
“article” for listing narrower product categories to be regulated as devices found in the
FD&C Act since 1938.7
The preceding background information was included in my earlier article and clearly
demonstrates the marked differences between devices and drugs. Both leeches and mag-
gots derive their effects through chemical action. Maggots secrete substances that kill
bacteria and stimulate the growth of healthy tissue. Leeches produce hirudin, a direct
thrombin inhibitor, and other enzymes.8 However, according to FDA, the primary mode
of maggots is chewing for leeches, it is the chewing of blood.9 Both of these were deemed
mechanical processes. (Predicate devices included scalpels and maggots that had been
sold before passage of the Medical Device Amendments.) Honey, as noted in the informa-
tion that follows, also produces an antiseptic compound. The late Senator Clark would, no
doubt, have objected to all three agency decisions.
Therapeutic Honey
Honey has been used for treating wounds since early antiquity. The Smith Papyrus of 1700
BC and the Ebers Papyrus of 1500 BC describe packing severe wounds and burns with a
combination of coagulated milk and honey kept in place with a muslin bandage.10 The early
Greek and later Roman civilizations mixed honey with grease or fat and applied the mixture
to wounds. Physicians used honey to soothe ailments of the eye and ear, to eliminate skin
infections, and to promote the healing of wounds or the site of surgeries such as circumci-
sion. Babylonians used honey to preserve corpses by preventing putrefaction.11 Accounts
of the use of honey as a wound dressing are not confined to ancient records. During World
War I, Russian soldiers used honey-based preparations to prevent wound infections, and
during World War II, the Chinese mixed an ointment out of honey and lard.12 A number of
reports have been published in the medical literature regarding the rediscovery of honey as
a therapeutic agent, no doubt as the result of its antibacterial activity.13
Properties
Several studies have demonstrated that some varieties of honey have a broad spectrum of
activity against a number of pathogenic bacteria and fungi. Some of the bacterial strains
tested were antibiotic-resistant. Antibacterial activity is greater than would be expected
from honey’s sugar content. (Honey is a complex product with low water activity, acid-
ity and high sugar content, but this does not contribute significantly to the antibacterial
activity.) The action of these honeys is linked to the production of hydrogen peroxide.
According to several authors, bees help preserve honey in the hive by adding an enzyme,
glucose oxidase, to the nectar gathered from flowers while it is being processed into
honey. When honey comes into contact with body moisture, the glucose oxidase slowly
releases hydrogen peroxide.14
The production of the peroxide could lead to the formation of free radicals such as
hydroxyl and superoxide. Honey also provides a substrate for glycolysis, which is the
major mechanism for energy production in macrophages, and thus allowing them to
function in damaged tissues with low oxygen supply. There are additional benefits to
leucocytes and monocytes that can affect the molecular mechanisms of wound healing
and tissue repair.15,16
Therapeutic vs Culinary Honey
Therapeutic honeys are distinctly different from the culinary honeys found in the super-
market. Therapeutic honeys must have a high osmotic activity and an acid pH (3.2 to 4.2)
produce a slow, low level of hydrogen peroxide and be derived from specific plant-
derived factors, such as Leptospermum scoparlum (Manuka).17
Maggots, Leeches and Now Honey—Putative Medical Devices?