News
11/07/1990
Clean-Up of Ineffective Ingredients in OTC Drug Products
Clean-Up of Ineffective Ingredients in OTC Drug Products
P90-52 Food and Drug Administration
FOR IMMEDIATE RELEASE Bonnie Aikman - (301) 443-3285
In a broad clean-up of ineffective ingredients in nonprescription drug
products, the Food and Drug Administration today banned 223 ingredients in
19 classes of products for problems ranging from acne to a need to stop
smoking.
FDA said no proof that the ingredients are effective for certain
conditions has been submitted during the agency's ongoing review, even
though manufacturers have had many opportunities.
Among the substances banned are juniper tar and pine tar in dandruff
products, various enzymes and dehydrated garlic in digestive-aid products,
aspirin in external medications and prune concentrate and powders in
stimulant laxatives. These ingredients were introduced into products before
1962, when a change in the law required manufacturers to submit
effectiveness data for FDA's approval before future drug products could be
marketed.
In 1972, FDA began a massive review of some 300,000 nonprescription
products then on the market. In earlier actions, FDA has banned ingredients
when their safety or effectiveness was in doubt and has required revised
labeling for many drugs.
In addition to the 223 ingredients banned today, FDA also proposed Oct.
29 to ban 111 drug ingredients in so-called diet products sold without
prescription. (See press release P90-50.)
Some manufacturers have already abandoned some of the ingredients
because in the early stages of FDA's nonprescription drug review advisory
panels of non-government medical experts had reported there was insufficient
evidence to judge their effectiveness.
Some major products would be affected by the ruling, published in
today's Federal Register. Anti-dandruff products such as Tegrin Lotion
could no longer include allantoin, and Packers shampoo and Packers Soap
could no longer include pine tar. The antidiarrheal product Donnagel could
no longer include atropine sulfate, hyoscyamine sulfate and scopolamine
hydrobromide.
Other ingredients affected by the ban include some used for allergies,
boils, cold symptoms, digestive problems, ingrown nails, constipation, oral
health problems, pain, psoriasis and other skin problems, nailbiting and
thumbsucking, seborrheic dermatitis, smoking and swimmer's ear.
Some of these same ingredients have been found effective for other
conditions. For example, aspirin is banned in today's action as an external
analgesic ingredient. However, when used in internal pain relief products,
it is considered effective.
Page 2, BAN, P90-52
Once the ban takes effect in six months, manufacturers wishing to
include any of these ingredients in nonprescription products will have to
provide FDA evidence that the ingredient is safe and effective for its
intended use and obtain the agency's approval.
In the agency's review of nonprescription drugs, officials review
advisory panel reports and subsequent public comments. FDA then publishes a
proposed rule with another comment period that includes an opportunity for a
public hearing. Ultimately, FDA issues a final regulation or monograph that
in effect becomes a "recipe" listing acceptable ingredients, doses,
formulations and labeling.
A list of the banned ingredients is attached.
Ingredients Covered by this Notice
NOTE: If only one form of the ingredient is covered, this form appears
in parentheses; i.e., "Camphor (Lozenge)."
(1) Topical Acne Drug Products: Alcloxa, Alkyl Isoquinolinium Bromide,
Aluminum Chlorohydrex, Aluminum Hydroxide, Benzocaine, Benzoic Acid, Boric
Acid, Calcium Polysulfide, Calcium Thiosulfate, Camphor,
Chlorhydroxyquinoline, Chloroxylenol, Coal Tar, Dibenzothiophene, Estrone,
Magnesium Aluminum Silicate, Magnesium Sulfate, Phenol, Phenolate Sodium,
Phenyl Salicylate, Pyrilamine Maleate, Resorcinol, Resorcinol Monoacetate,
Sodium Borate, Sodium Thiosulfate, Tetracaine Hydrochloride, Vitamin E, Zinc
Oxide, Zinc Stearate, Zinc Sulfide, Povidone Iodine, Salicylic Acid (Over 2
Up to 5 Percent), Thymol
(2) Anticaries Drug Products: Acidulated Sodium Phosphate, Sodium
Carbonate, Sodium Monofluorophosphate (6% Rinse), Sodium Phosphate, Hydrogen
Fluoride
(3) Antidiarrheal Drug Products: Glycine, Scopolamine Hydrobromide,
Aluminum Hydroxide, Atropine Sulfate, Calcium Carbonate,
Carboxymethylcellulose, Homatropine Methylbromide, Hyoscyamine Sulfate,
Lactobacillus Acidophilus, Lactobacillus Bulgaricus, Opium-Powdered, Opium
Tincture, Paregoric, Phenyl Salicylate, Zinc Phenolsulfonate
(4) Antiperspirant Drug Products: Aluminum Bromohydrate, Aluminum Chloride
(Alcoholic Solutions), Alum-Potassium, Aluminum Chloride (Aqueous Solution)
(Aerosol Only), Aluminum Sulfate, Aluminum Sulfate-Buffered (Aerosol only),
Sodium Aluminum Chlorohydroxy Lactate
(5) Boil Treatment Drug Products: Aminacrine Hydrochloride, Bismuth
Subnitrate, Calomel, Cholesterol, Ergot Fluidextract, Hexachlorophene,
Isobutamben, Lanolin, Menthol, Methyl Salicylate, Oxyquinoline Sulfate,
Petrolatum, Pine Tar, Rosin, Rosin Cerate, Sassafras Oil, Thymol, Zinc
Oxide, Camphor, Juniper Tar, Magnesium Sulfate, Phenol
(6) Cold Cough, Allergy, Bronchodilator and Antiasthmatic Drugs Products:
A) Antihistamine Drug Products - Methapyrilene Hydrochloride,
Methapyrilene Fumarate, Thenyldiamine
-2-
B) Nasal Decongestant Drug Products - Allyl Isothiocyanate, Turpentine
Oil, Camphor (Lozenge), Creosote-Beechwood (Oral), Eucalyptol (Lozenge),
Eucalyptol (Mouthwash), Eucalyptus Oil (Lozenge), Eucalyptus Oil
(Mouthwash), Menthol (Mouthwash), Peppermint Oil (Mouthwash),
Thenyldiamine, Thymol, Thymol (Lozenge), Thymol (Mouthwash)
(7) Dandruff/Seborrheic Dermatitis/Psoriasis Drug Products: Boric Acid,
Colloidal Oatmeal, Cresol Saponated, Mercury Oleate, Resorcinol, Sodium
Borate, Alkyl Isoquinolinium, Allantoin, Benzalkonium Chloride, Benzethonium
Chloride, Calcium Undecylenate, Captan, Chloroxylenol, Ethohexadiol,
Eucalyptol, Juniper Tar, Lauryl Isoquinolinium, Menthol, Methylbenzethonium,
Methyl Salicylate, Phenol, Phenolate Sodium, Pine Tar, Povidone-Iodine,
Sodium Salicylate, Thymol, Undecylenic Acid
(8) Digestive Aid Drug Products: Bismuth Sodium Tartrate, Cellulase,
Dehydrocholic Acid, Duodenal Substance, Garlic-Dehydrated, Glutamic Acid,
Homatropine, Ox Bile Extract, Pancreatin, Pancrelipase, Papain, Pepsin,
Sorbitol, Calcium Carbonate, Dihydroxyaluminum, Hemicellulase, Magnesium
Hydroxide, Magnesium Trisilicate, Peppermint Oil, Sodium Bicarbonate, Sodium
Citrate
(9) Exocrine Pancreatic Insufficiency Drug Products: Hemicellulase
(10) External Analgesic Drug Products:
(A) Analgesic and Anesthetic Drug Products - Chloral Hydrate,
Methapyrilene Hydrochloride, Aspirin, Chlorobutanol, Cyclomethycaine
Sulfate, Eugenol, Hexylresorcinol, Salicylamide, Thymol
(B) Counterirritant Drug Products - Chloral Hydrate, Eucalyptus Oil
(C) Male Genital Desensitizer Drug Products - Benzyl Alcohol,
Camphorated Metacresol, Ephedrine Hydrochloride
(11) Ingrown Toenail Relief Drug Products: Chloroxylenol, Urea
(12) Laxative Drug Products:
(A) Bulk Laxatives - Carrageenan (Degraded), Agar, Carrageenan
(Native), Guar Gum
(B) Saline Laxative - Tartartic Acid
(C) Stool Softener - Poloxamer 188
(D) Stimulant Laxatives - Calomel, Colocynth, Elaterin Resin, Gamboge,
Ipomea, Jalap, Podophyllum Resin, Aloin, Bile Salts/Acids, Calcium
Pantothenate, Frangula, Ox Bile, Prune Concentrate, Prune Powder,
Rhubarb-Chinese, Sodium Oleate
(13) Nailbiting and Thumbsucking Deterrent Drug Products: Denatonium
Benzoate
-3-
(14) Oral Health Care Drug Products: (Nonantimicrobial): Antipyrine,
Camphor, Cresol, Dibucaine, Dibucaine Hydrochloride, Lidocaine, Lidocaine
Hydrochloride, Myrrh Tincture, Pyrilamine Maleate, Tetracaine, Tetracine
Hydrochloride, Eucalyptol, Methyl Salicylate, Sorbitol, Sugars, Thymol
(15) Topical Otic Drug Products for the Prevention of Swimmer's Ear: Acetic
Acid.
(16) Poison Treatment Drug Products: Ipecac Fluidextract, Ipecac Tincture,
Zinc Sulfate
(17) Skin Bleaching Drug Products: Mercury-Ammoniated
(18) Skin Protectant Drug Products:
(A) General: Sulfur, Tannic Acid
(B) Wound healing products: Allantoin, Zinc Acetate
(19) Smoking Deterrent Drug Products: Clove, Coriander, Eucalyptus Oil,
Ginger Jamaica, Lemon Oil-Terpeneless, Licorice Root Extract, Menthol,
Methyl Salicylate, Quinine Ascorbate, Silver Nitrate, Thymol