Alternative Medicine Review 1999 (Feb); 4 (1): 5-9 ~ FULL TEXT
By A.F. Czap, Publisher
On March 23, 1999, dietary supplement companies will have
made the transition from an "anything goes" label to a federally
imposed label similar to the one now required for foods. Forever after,
dietary supplements shipped in interstate commerce must have the new "Supplement
Facts" label attached.
The following outline is a general guide to a purchaser
of dietary supplements regarding what information the new "Supplement
Facts" label must disclose. In addition, the existence of other pertinent
information, not required to be disclosed by the new label, is also outlined.
The FDA labeling regulation requires ingredients designated
as having a "Daily Reference Value" or a "Reference Daily
Intake" to be listed in a specific order, with the same nomenclature,
and with the percentage of Daily Reference Value delineated.
list their salt sources in a uniform format. Herbs and herbal extracts
must be listed with their common name and Latin name as delineated by the
American Herbal Products Association official listing "Herbs of Commerce,"
as well as the plant part which is used.
Under "Other Ingredients," just below the Supplement Facts box, you will find additives:
Binders (to bind tablets together);
Lubricants (to assist powder flow in manufacturing);
Coatings (to coat tablets and permit easier swallowing);
Colorings (cosmetic reasons); and
Fillers (used to fill space).
The following is a list of many such additives grouped
into general categories relative to their potential to cause allergic or
sensitivity reactions, impede absorption, or have an undesired physiological
(See Figure 3)
Universally tolerated, generally inert product additives:
Individual amino acids. Basic minerals Calcium, Magnesium, etc.,
as Oxides, Carbonates, Phosphates or Organic Acid complexes, e.g., Calcium
Citrate or Magnesium Aspartate, Ascorbate, Malate, etc., but not "Amino
Acid Chelates," which can contain partially digested protein instead
of pure amino acids. Also, Titanium Dioxide (the white color used in some
tablets and capsules), Silicon Dioxide (fumed Silica), Talc, and Silicates
Generally well-tolerated product additives: Cellulose
as filler, binder, or coating, generally labeled as: Cellulose, Hydroxypropyl
Methylcellulose, Ethyl Cellulose, Hydroxypropyl Cellulose, Microcrystalline
Cellulose, and Croscarmellose Sodium. Also, Crospovidones, Bentonite, and
Generally tolerated additives, with possibility of sensitive
patient reaction: Sodium Starch Glycolate, Starch, Mannitol, Sucrose, Acacia
and other gums. Preservatives such as Benzoates, Parabens, Sorbates and
Propionates. Antioxidants such as BHT and BHA. Coatings such as Pharmaceutical
Glaze and Zein (See Coatings in "NAME DECEPTION").
Additives utilized for economy or appearance, presenting
potential patient problems: Lactose, Corn Starch, Sucrose, all FD&C
dye lakes, all organic coloring agents.
Additives utilized in virtually all tablets and most capsules*
for lubrication which impede absorption and present the possibility of
patient sensitivity: Stearic acid, Magnesium Stearate, Calcium Stearate,
Ascorbyl Palmitate, Fractionated Vegetable Oil, Hydrogenated Vegetable
Oil, Castor Oil, etc. (See Lubricants in "NAME DECEPTION").
Lubricants enable manufacturing machines to run more efficiently but inhibit eventual dissolution of the nutrient. Each nutrient particle is coated with a layer
of Stearic, Palmitic or other fatty acid, which may prevent absorption
by a patient with a compromised digestive system. It also presents the
problem that delivery of the active ingredient may be considerably further
down the intestinal tract than the site originally intended. Potentially
this may result in a nutrient being delivered distal to its optimal absorption
site. Not only can this impede absorption, in some cases it might be harmful.
Consider this with a simple substance such as niacin, which in Time-Release
form can cause elevated liver enzymes. In tablet or capsule form, use of
Stearic or Palmitic Acid in manufacturing a niacin supplement effectively
results in a Time-Release dosage, which may cause the same liver problem
or inhibited absorption. * (In some cases, large tablets [slugs] are made,
and then ground up and put in capsules so more density and a higher dosage
weight can be achieved.)
Name Deception: In many cases, an ingredient carries a
negative connotation, so the manufacturer uses instead an euphemistically
Deceptive names for Coatings: Pharmaceutical Glaze, Confectioners Glaze or Natural Glaze are names for SHELLAC. Natural Vegetable Coating,
Natural Protein Coating, Vegetable Coating, and Maize Protein are names
for Zein which is CORN PROTEIN.
Deceptive names for Lubricants: Stearates are primarily
Stearic Acid, alone or complexed with another ingredient, such as magnesium.
The National Formulary monograph requires that Stearic Acid be composed
of at least 40-percent Palmitic Acid, which has the same properties as
refined Stearic Acid. A small amount of Ascorbyl Palmitate (palmitic acid)
is added to many products as a "Vitamin C source;" however, its
purpose in almost all cases is to act as a lubricant to aid in tabletting
or capsuling although it has the same negative properties as Stearic Acid
(reduced dissolution and inhibited absorption).
(see Figure 4 and Figure 5) Castor Oil as an ingredient
is usually Hydrogenated Castor Oil; it can exhibit the same properties
as Stearic Acid, as can other oils utilized in the manufacture of tablets
and most encapsulated products.
What's not disclosed:
INGREDIENTS NOT "ADDED"
BY THE MANUFACTURER Kudos to the FDA for requiring better and more consistent
labeling, although the mandated "Supplement Facts" panel is rather
cosmetically flawed. The problem remains, however, and will always remain,
that there are ingredients the purchaser of a dietary supplement may never
be aware of. These are the ingredients already in the raw material purchased
by the manufacturer.
As an example, two apparently identical labels are shown,
both of which include what appears to be similar ingredients. (see Figure 6)
Product A is made by a manufacturer with concern for quality
ingredients Product B is made in a very typical manner, with no excipients
listed; however, the raw material choices show the difference.
The comparison of Product A and Product B is not unique
to dietary supplements the same issue exists with regard to the labeling
of food products. The critical point, however, is that many of the ingredients
in raw materials are considered minor manufacturing additives that are
not required to be listed on the label. For the FDA to require otherwise
mandating the labeling of each and every "minor ingredient"
in a dietary supplement would create a labeling nightmare. For example,
if a manufacturer usually purchased an ingredient in a base of Dicalcium
Phosphate, and his supplier ran out, and the only similar ingredient available
was in a base of Calcium Carbonate, a label change would be necessary to
include this new "sub-ingredient." But such is not now the case.
The "Supplement Facts" label will bring more
information to consumers of dietary supplements, and will do so in a consistent
and easily recognizable format. However, disclosure of the "Supplement
Facts" is not disclosure of "All The Facts." Thus, disclosure
of many of the ingredients in dietary supplements Binders, Lubricants,
Coatings, Colorings, and Fillers will remain at the discretion of
the manufacturer, in whose interest disclosure may be uncertain.
U.S.P. 23/ NF 18 J Pharm Sci 1986 Jun:75 (6):534-45
Pharmaceutical Technology 1985 Apr:9(4):28-41
Remington's Pharmaceutical Sciences, 16th Edition.
The Merck Index, 12th Edition
Food Chemicals Codex, 4th Edition
Various manufacturers' literature, data and technical
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