3372. Misbranding of Lang's Mineral Iron and Aluminum Sulfate. U. S. v. 15
Pounds, etc (F. D. C. No. 30343. Sample Nos. 86437-K to 86440-K,
incl.)
LIBEL FILED :   December 19,1950, Southern District of California.
ALLEGED SHIPMENT :    On or about October 7 and 25, 1950, and on other dates in
1950, by Margaret Lange, from Portland, Oreg.
PRODUCT :   Lang's Mineral Iron and Aluminum Sulfate.   15 pounds in bulk;
25 envelopes, each containing ? ounce; 21 boxes, each containing 12 capsules;
and 12   12-ounce bottles containing the product in solution, at Lang's Mineral
Wonder, Los Angeles, Calif.
Also in the possession of the consignee were 8,000 empty envelopes, 200 labels
for the capsules, 1,000 labels for the solution, and 1,000 copies of a folder
entitled "Lang's Mineral Wonder."
RESULTS OP INVESTIGATION : The product was shipped, labeled as described
below. The consignee repackaged the article into envelopes, each containing
? ounce; into boxes, each containing 12 capsules; and into bottles, each con-
taining 12 ounces of a solution consisting of 1 pound of the article to 5 gallons
of water. The consignee also caused the printing of the envelopes, the box
and bottle labels, and a folder entitled "Lang's Mineral Wonder." This folder
was given to prospective customers at the consignee's place of business and
was mailed in response to inquiries.
LABEL, IN PART: (Bulk shipment) "Lang's Mineral Iron and Aluminum Sul-
fate"; (repackaged, in envelopes) "Lang's Mineral Wonder * * * Net Con-
tents: ? oz."; (repackaged, in boxes) "Lang's Mineral Wonder * * *
Lang's Female Capsules" ; and (repackaged, in bottles) "Lang's Mineral Won-
der   *    *    *   Net Contents:   12 oz."
NATURE OF CHARGE: Misbranding (bulk shipment), Section 502 (f)(1), the
labeling failed to bear adequate directions for use since the labeling bore no
directions for use. The article was misbranded in this respect when intro-
duced into, and while in, interstate commerce.
Further misbranding (repackaged drug in envelopes, boxes, and bottles),
Section 502 (a), certain statements in the accompanying folder entitled
"Lang's Mineral Wonder" were false and misleading. These statements rep-
resented and suggested that the article would be effective as a treatment for
physical troubles; that it would help reach the cause of a wide variety of
conditions; that it would end conditions that bring pain and distress; and
that it would furnish the system with minerals essential for it. The article
would not be effective in the treatment of the conditions and for the purposes
stated and implied.
Further misbranding, Section 502 (a), certain statements on the label of the
?boxes of capsules were false and misleading since the statements represented
And suggested that the article would be effective as a treatment for diseases
of females, whereas it would not be effective as a treatment for diseases of
lemales.
Further misbranding (envelopes, boxes, and bottles), Section 502 (a), the
statements which appeared on the envelopes "Silica (SK)2), Sodium & Potas-
sium Oxide (NA20 & K20), Phosphates (P208), Iron Oxide (FEj03), Aluminum
Oxide (ALsO,), Sulphates (SO,), Moisture @ 105? C, Water (Combined) (By
T>ifference)" and the statements which appeared on the label of the bottles
?containing the solution-
Part8 per?Grains per
million
gallon
Silica   (Si02)
         5.0
.29
Iron Oxide
. (FE203)
   5120.0
299.00
Aluminum Oxide (Al2Os)
   1332.0
77.79
Sulphuric Anhydride (SOa)
   9720.0
567.65
Total Solids
16177.0
944.73
"were misleading in that they failed to reveal the material fact that, when
taken as directed, the article would supply no therapeutically useful sub-
stance ; and the statements on the label of the boxes containing the capsules
"Silica (Si02) 0.08? Sodium & Potassium Oxide (Na20 & K>0) trace, Phos-
phates (PaO?) trace, Iron Oxide (FejO>) 6.26?, Sulphates (S03) 39.92-
Moisture @ 105? 014.02?, Water (Combined) (By Difference) 19.50?" were
misleading since they failed to reveal the material fact that the iron and
aluminum sulfates were the only constituents of the article that, when taken
as directed, would produce any significant physiologic effect. The product in
the envelopes, boxes, and bottles was misbranded while held for sale after
shipment in interstate commerce.
DISPOSITION : February 8, 1951. Florence Potter, also known as Florence Wil-
son, trading as Lang's Minerals, Los Angeles, Calif., claimant, having consented
to the entry of a decree, "judgment of condemnation was entered and the court
ordered that the product be released under bond to be relabeled, under the
supervision of the Food and Drug Administration.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM
OFFICIAL OR OWN STANDARDS