FROM THE FILES OF THE FBI 313
HEALTH, EDUCATION, AND WELFARE
FOOD AND DRUG ADMINISTRATION
April 2, 1957
Mr. Kenneth D. Barrett
The Distribution Center, Inc.
Silver Spring, Maryland
Dear Mr. Barrett:
In Mr. Cook's absence, I am replying to your letter of February 26
We understand from your letters that the Dianazene label will recommend
that three tablets be taken per day and will name ferrous gluconate as the
ingredient supplying the iron.
If three tablets (the recommended daily dose) supply an amount of ferrous
gluconate equivalent to 100 milligrams of elemental iron, we would have no
objection to the proposed use for [?]oming iron-deficiency anemia. In
this connection, we point out that since the iron content of ferrous
gluconate is approximately 12 percent, three tablets of Dianazene would
have to contain approximately 0.8 gram [sic] of ferrous gluconate in order
to provide a daily intake of 100 milligrams of elemental iron.
Assuming that, as finally marketed, the article will provide the
equivalent of 100 milligrams of elemental iron in the daily dose and that
the only claims made for the article in all of its promotional material is
that it is for overcoming iron deficiency anemia and deficiencies of
vitamins, B1, B2, C, and nicotinic acid, we have no other significant
comment [sic] to offer.
[signed] H.L. Yakowitz
Assistant to the Director
Bureau of Enforcement