News
10/29/1990
111 Ingredients
111 Ingredients
P90-50 Food and Drug Administration
FOR IMMEDIATE RELEASE Bonnie Aikman - (301) 443-3285
The Food and Drug Administration today proposed to ban 111 ingredients
in nonprescription diet drug products. The agency said the ingredients had
not been proven effective and that one of them, guar gum, presents a safety
hazard.
FDA also proposed a warning for any nonprescription drug containing guar
gum-like water-soluble gums.
Separately, on May 16, the agency proposed banning more than 225
ingredients in other nonprescription drug categories. Together, the bans
would speed up the agency's review of all ingredients in some 300,000
nonprescription drug products, including diet products.
FDA said the ban on weight control ingredients would not include
phenylpropanolamine (PPA) and benzocaine because the agency is reviewing
safety and effectiveness studies on these substances. Most major diet
products sold today include PPA as an appetite suppressant.
FDA said it had already given manufacturers numerous opportunities to
prove the ingredients were effective and, except for PPA and benzocaine, had
received no significant information.
A panel of non-federal medical experts earlier found none of the 111
ingredients effective and asked for more studies but none were submitted.
Page 2, P90-50
The ingredients include alcohol, corn syrup, dextrose, guar gum, kelp,
pineapple enzymes, rice polishings, saccharin, salt, sodium bicarbonate,
Vitamin C and wheat germ. Many products once containing these ingredients
have been reformulated or are no longer marketed.
The proposal, which will be published in tomorrow's Federal Register,
includes a discussion of a safety hazard associated with guar gum. On July
27, FDA told the distributor of Cal Ban 3000 diet tablets and capsules,
which contain guar gum, to stop distributing them because the agency had
received 17 reports of esophageal obstruction resulting from their use.
FDA later asked other companies distributing similar diet products to
take the same action. (The action does not affect small amounts of guar gum
that are approved in cheese, salad dressings, ice creams and other foods
where they pose no health hazard.)
Today's other proposal, calling for a warning on nonprescription drugs
containing water soluble gums, is also a result of reports of esophageal
obstruction following ingestion of diet and laxative products containing
these ingredients. It is also being published in today's Federal Register.
Products with such substances as active ingredients--guar gum, karaya
gum, psyllium, etc.--would have to bear labels warning users to take them
with adequate fluid and to avoid them altogether if they have ever
experienced difficulty in swallowing. The warning would read:
TAKE (OR MIX) THIS PRODUCT WITH AT LEAST 8 OUNCES (A FULL GLASS)
OF WATER OR OTHER FLUID. TAKING THIS PRODUCT WITHOUT ADEQUATE FLUID MAY
CAUSE IT TO SWELL AND BLOCK YOUR THROAT OR ESOPHAGUS AND MAY CAUSE
CHOKING. DO NOT TAKE THIS PRODUCT IF YOU HAVE EVER HAD DIFFICULTY IN
SWALLOWING OR HAVE ANY THROAT PROBLEMS. IF YOU EXPERIENCE CHEST PAIN,
VOMITING, OR DIFFICULTY IN SWALLOWING OR BREATHING AFTER TAKING THIS
PRODUCT, SEEK IMMEDIATE MEDICAL ATTENTION.
Page 3, P90-50
Diet drugs with water soluble ingredients would no longer be marketed
upon the effective date of today's other proposal banning the 111
ingredients. A number of bulk laxatives such as Fiberall, Metamucil and
Serutan, as well as a few antidiarrheal products such as Equalactin and
Mitrolan, would be affected by the warning proposal. However, they could
continue to be marketed.
There is a 60-day comment period for both proposals. Manufacturers are
being asked to voluntarily comply as soon as possible. The ban on diet
product ingredients would not be required by regulation until six months
after the final rule becomes effective. The warning notice would be
required on the publication date of that final rule.
Comments on both proposals should be sent to the FDA Dockets Management
Branch (HFA-305), Food and Drug Administration, Rm. 4-62, 5600 Fishers Lane,
Rockville, Md. 20857.
_____________
A list of the ingredients proposed for banning is attached.
INGREDIENTS COVERED BY THIS NOTICE
INGREDIENTS CLASSIFIED AS CATEGORY II -- Not generally recognized as safe
and effective: Alcohol, Alfalfa, Anise oil, Arginine, Ascorbic acid,
Bearberry, Biotin, Bone marrow-red, Buchu, Buchu-potassium extract,
Caffeine, Caffeine citrate, Calcium, Calcium carbonate, Calcium caseinate,
Calcium lactate, Calcium pantothenate, Cholecalciferol, Choline, Citric
acid, Cnicus benedictus, Copper, Copper gluconate, Corn oil, Corn syrup,
Corn silk-potassium extract, Cupric sulfate.
Also, Cyanocobalamin (vitamin B12), Cystine, Dextrose, Docusate sodium,
Ergocalciferol, Ferric ammonium citrate, Ferric pyrophoshate, Ferrous
fumarate, Ferrous gluconate, Ferrous sulfate (iron), Flax seed, Folic acid,
Fructose, Histidine, Hydrastis canadensis, Inositol, Iodine, Isoleucine,
Juniper-potassium extract, Lactose, Lecithin, Leucine, Liver concentrate,
Lysine, Lysine hydrochloride, Magnesium, Magnesium oxide, Malt, Maltodextrin.
Also, Manganese citrate, Mannitol, Methionine, Mono- and di-glycerides,
Niacinamide, Organic vegetables, Pancreatin, Pantothenic acid, Papain,
Papaya enzymes, Pepsin, Phenacetin, Phenylalanine, Phosphorus, Phytolacca,
Pineapple enzymes, Potassium citrate, Pyridoxine hydrochloride (vitamin B6),
Riboflavin, Rice polishings, Saccharin, Sea minerals, Sesame seed, Sodium,
Sodium caseinate, Sodium chloride (salt), Soybean protein, Soy meal, Sucrose.
Also, Thiamine hydrochloride (vitamin B1), Thiamine mononitrate (vitamin B1
mononitrate), Threonine, Tricalcium phosphate, Tryptophan, Tyrosine, Uva
ursi-potassium extract, Valine, Vegetable, Vitamin A, Vitamin A acetate,
Vitamin A palmitate, Vitamin E, Wheat germ, Yeast.
INGREDIENTS CLASSIFIED AS CATEGORY III -- Insufficient data; More studies
needed: Alginic acid, Carboxymethylcellulose sodium, Carrageenan, Chondrus,
Guar gum, Karaya gum, Kelp, Methylcellulose, Plantago seed, Sodium
bicarbonate, Xanthan gum.