FOOD AND DRUG ADMINISTRATION
NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD,
DRUG, AND COSMETIC ACT
[Given pursuant to section 705 of the rood, Drug, and Cosmetic Act]
4181-4200      '
DRUGS AND DEVICES
The cases reported herewith were instituted in the United States district
courts by the United States attorneys, acting upon reports submitted by the
Department of Health, Education, and "Welfare, and include, where indicated,
the results of investigations by the Department, prior to the institution of the
proceedings. Published by direction of the Secretary of Health, Education, and
Welfare.
CHARLES W. CRAWFORD, Commissioner of Food and Drugs.
WASHINGTON, D. C, July 19, 195?.
CONTENTS'1
Page
Drug actionable because of poten-
tial danger when used accord-
ing to directions 
 172
New drug shipped without effective
application 
172
Violative    sales    of    prescription
drugs.. 
 173
Drugs and devices actionable be-
cause of failure to bear ade-
quate . directions or warning
statements 
 174
Pag
Drugs and devices actionable be-
cause of deviation from official
or own standards 
177
Drugs and devices actionable be-
cause of false and misleading
claims 
  179
Index 
  182
?For omission of, or unsatisfactory, ingredients statements, see Nos. 4187, 4188; failure to bear a label
containing an accurate statement of the quantity of the contents, Nos. 4187, 4188; failure to bear a label
containing the name and place of business of the manufacturer, packer, or distributor, Nos. 4187,. 4188,4190.
171
304223-54
DRUG ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED
ACCORDING TO DIRECTIONS
4181. Misbranding of Special Formula cream.  U. S. v. 8 Jars * * *.    (F. D. C.
No. 35320.   Sample No. 58957-L.)
LIBEL FILED :   June 22,1953, Western District of Michigan.
ALLEGED SHIPMENT : On or about March 31, 1952, by Bette Knowlton, from
Miami, Fla.
PRODUCT : 8 jars of Special Formula cream at Grand Rapids, Mich. Examina-
tion showed that the article contained estrogenic hormones equivalent to
54,000 International Units (5.4 mg.) of estrone per ounce.
RESULTS OP INVESTIGATION : On or about March 23,1952, the consignee received
at Miami, Fla., from the Bette Knowlton Laboratories, a 26-page mimeo-
graphed booklet dated May 14,1951, entitled "Bette Knowlton Reference Man-
ual," to be used in the sale and use of the Bette Knowlton products. This
booklet subsequently was transported by the consignee from Miami, Fla., to
Grand Rapids, Mich. In addition, Bette Knowlton shipped from Miami, Fla.,
to Grand Rapids, Mich., on or about February 1, 1953, a number of leaflets
entitled "Bette Knowlton Fortune In Loveliness" and one booklet entitled
"Bette Knowlton Reference Notes."
LABEL, IN PAST: (Jar) "Bette Knowlton Special Formula Cream 2 Oz.
* * * Hormone & Vitamin A Formula. Contains Type A Natural Extrogenic
Substance, 50,0001. U. per oz., and Vitamin A, 10,000 units per oz."
NATURE OF CHARGE: Misbranding, Section 502 (j), the article was dangerous to
health when used in the dosage and with the frequency and duration pre-
scribed, recommended, and suggested in its labeling, namely, the jar label and
the above-mentioned leaflets and booklets, since the labeling provided for the
daily application of 1,800 International Units of estrogens as estrone over an
extended and indefinite period of time, an amount which would cause injury
to health.
DISPOSITION:   July 9, 1953.   Default decree of condemnation and destruction.
NEW DRUG SHIPPED WITHOUT EFFECTIVE APPLICATION