«VITAMINS SUMMARY OF THE PANEL'S RECOMMENDATIONS ON VITAMINS AND MINERALS. 1. The following vitamin may be sold only on a prescription: Vitamin K

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1 SUMMARY OF THE PANEL'S RECOMMENDATIONS ON VITAMINS AND MINERALS NOTE: The panel reviewed the uses of vitamins and minerals only as nonprescription drugs. The panel did not address the use of vitamins and minerals as dietary supplements. «VITAMINS 1. The following vitamin may be sold only on a prescription: Vitamin K Vitamin K could be hazardous to individuals taking anticoagulant drugs. It should be taken only when a physician has determined the need for such therapy. 2. The following four vitamins shall not be sold as single-ingredient over-the-counter drug products because deficiency is virtually nonexistent. However, vitamin E and pantothenic acid may be used in certain vitamin combinations designated by the panel. Biotin Biotin is available in the diet from numerous sources and is synthesized by intestinal microorganisms which assures against a biotin deficiency. Choline Choline is fully manufactured in the body using a number of dietary sources as precursors. Vitamin E Although safe, Vitamin E has no proven therapeutic value as a single ingred ient drug. However, at a daily dose of 30 I.U. (international units) it may be added to combination drugs designed to prevent multiple vitamin deficiencies. There is no evidence that it increases fertility or is useful against cardiovascular disease, peripheral vascular disease, cr leg cramps.

2 Pantothenic Acid A single ingredient drug is not needed, because deficiency is rare. Pantothenic acid may be included in doses of 5 to 20 milligrams in combination drugs used to prevent multiple vitamin deficiencies. 3. The following nine vitamins may be sold as nonprescription drugs, and should be taken only when a physician has determined the need for ch therapy. Vitamin C (Ascorbic Acid) Doses of 50 to 100 milligrams daily are sufficient to prevent deficiency. Daily doses to treat deficiency are 3UO to 500 milligrams. High doses of vitamin C usually more than 1,000 milligrams a day may cause kidney and bladder problems. They also can produce false results in some diagnostic tests, such as the test for sugar in the urine of diabetics. Manufacturers should not claim that vitamin C is useful for treating such conditions as the common cold, atherosclerosis, allergy, mental illness, cornea! ulcers, thrombosis, anemia, or pressure sores. Ni aci n Niacinamide or niacinamide ascorbate are the forms of niacin that should be used in nonprescription drugs, because they are less toxic than the other form, nicotinic acid. Daily doses of niacinamide should range between 10 and 20 milligrams for prevention of deficiency and 25 to 50 milligrams for treatment of deficiency. Vitamin B g (Pyridoxine) Daily doses of 1.5 to 2.5 milligrams are recommended for preventing deficiency and 7.5 to 25 milligrams for treatment. Patients taking L- dopa for Parkinsonism should not take this drug without a doctor's

3 supervision. There is no evidence that vitamin 3 g is useful for preventing kidney stones or controlling vomiting in pregnant women. Viamin B«(Riboflavin) Recommended daily doses are 1 to 2 milligrams for prevention of deficiency and 5 to 25 milligrams for treatment. Vitamin B^ (Thiamine) The panel recommended daily doses of 1 to 2 milligrams to prevent deficiency and 5 to 25 milligrams for treatment. There is no proof that thiamine helps stimulate mental response or is useful in treating such conditions as skin disease, multiple sclerosis, infections, cancer, or impotence. Vitamin A May be sold as a nonprescription drug for the prevention or treatment of deficiency. It should be taken only when a physician has determined the need for such therapy. Daily preventive doses should range from 1,250 to 2,500 I.U. (international units) and treatment doses from 5,000 to 10,000 I.U. Drugs for treatment of deficiency should warn that excessive doses may be harmful. Very high levels -above 2 million I.U. can cause acute toxicity, characterized by severe headache, dizziness, nausea, and red and swollen skin. Long term use of vitamin A can cause enlarged liver and spleen, painful swelling under the skin, and in its most serious form, permanent liver damage and stunted bone growth. There is no proof that vitamin A is of any value against plantar warts, acne and other skin diseases, dry and wrinkled skin, stress ulcers, respiratory infections, or eye disorders. Nor is there any evidence that naturallyoccurring vitamin A is superior to the synthetic kind. Labels making such claims should not be permitted.

4 Vitamin B^ Daily dose to prevent deficiency is 3 to 10 micrograms for most people. Folic Acid Daily doses to prevent deficiency is 0.1 to 0.4 milligrams for most people. For pregnant and lactating women and persons who consume alcohol to excess, the daily dose is 1 milligram. Vitamin D A daily dose of 400 I.I), (international units) is sufficient to prevent deficiency in healthy infants and growing children up to 18 years of age. For most other adults over 18 years of age, the recommended daily dose is 200 I.U. Some studies indicate that doses greater than 1,000 to 1,200 I.U. daily may contribute to kidney stones and heart attacks. There is no reliable evidence that vitamin D lowers blood cholesterol levels or prevents or cures osteoporosis in the elderly. The panel said the following should not be sold as over-the-counter drugs because deficiency is rare: copper, fluoride, iodine, magnesium, manganese, phosphorus, potassium. High doses of copper, iodine, and manganese also pose some risk of toxicity. Treatment of deficiency requires prescription status and a doctor's supervision. The panel said the following three minerals can be sold as nonprescription drugs: Calcium The panel recommended specific doses for five different age groups and for pregnant and lactating women when the need for such therapy has been determined by a physician. Taking more than 2,500 milligrams

5 daily may produce excessive calcium in the blood and rapid deterioration in kidney function. Iron Deficiency is more likely to occur among menstruating, lactating, and pregnant women and children under age five. The panel recommended specific daily doses for these groups, as well as for other adults and children over five when the need for such therapy has been determined by a physician. Since there is some evidence of iron deficiency among both men and women over 60 and among adolescent males, the panel said that a nonprescription drug containing a daily dcse of 10 to 20 milligrams of elemental iron should be made available on a provisional basis for five years. If additional studies confirm that deficiency does occur among 10 percent of these people and it can be prevented by a nonprescription drug, the drug would be approved as "safe and effective." Zinc Zinc sulfate currently is the only safe and effective form of elemental zinc for use in a nonprescription drug to prevent deficiency when the need for such therapy has been determined by a physician. The daily dose is 10 to 25 milligrams.