16387. United States v. 48 Bottles of Fulton's Compound, RX 1, et al. Hear- 
ing- on exceptions to libel. Distx-ict Court rules for clainiant. 
Libel ordered dismissed. Appeal by Government to x-uling-s. Cir- 
cuit Court of Appeals rules for Government, reversing lower 
court. Consent decree of condemnation, forfeiture, and destruc- 
tion.    (F. & D. No. 22928.    I. S. Nos. 0201, 0202.    S. No. 995.)
On August 3, 1928, the United States attorney for the Western District of 
Washington, acting upon a report by the Secretary of Agriculture, filed in the 
District Court of the United States for said district a libel praying seizure and 
condemnation of 48 bottles of Fulton's Compound RX 1 and 24 bottles of 
Fulton's Compound RX 2, remaining in the original unbroken packages at 
Seattle, Wash., alleging that the articles had been shipped by the John J. 
Fulton Co., from San Francisco, Calif., and transported from the State of 
California into the State of Washington, arriving at Seattle on or about July 
2, 1928, and charging misbranding in violation of the food and drugs act as 
amended.
Analysis of a sample of the article by this department shov^ed that it con- 
sisted essentially of sodium and calcium compounds, nitrates, sulphates, borates, 
extracts of plant drugs including uva ursi, a laxative drug, and glycyrrhiza, 
salicylic acid, a trace of alkaloid, alcohol, and water.
It was alleged in the libel that the articles were misbranded in that the 
following statements regarding the curative and therapeutic effects of the said 
articles, (Fulton's Compound Rx 1, bottle label) "We have received many 
letters from Physicians reporting in cases * * * of * * * Bright's 
Disease * *? * Albuminuria * * * Nephritis, that the use of this Com- 
pound was attended with decrease in the Albumen in the urine, or improve- 
ment in the physical condition of the patient, or both. * * * If stomach is 
weak take half closes until tone of stomach is improved * * * Write for 
free copy of the Renal Digest presenting epitomes of many Professional 
reports, (wrapper) "We have received many letters from Physicians report- 
ing in  cases   *    *    *    of    *    *    *    Bright's  Disease    *    *    *    Albuminuria,
* * * Nephritis, that the use of this Compound was attended with decrease 
in the albumen in the urine, or improvement in the physical condition of the 
patient, or both," (circular) "We have received many letters from Physicians 
reporting in cases * * * of * * * Bright's Disease * * * Albumi- 
nuria and * * * Nephritis, that the use of this Compound was attended 
with decrease in Albumen in the urine, or improvement in the physical con- 
dition of the patient, or both. We mailed copies of the Renal Digest conta'ning 
epitomes of several hundred of these reports, with ingredients and Rationale, to 
the Physicians of the United States and will mail copies upon application to all 
interested. * * * Where the heart is involved or there is dropsy and the 
patient is on helpful heart treatment, elimination or tonics it is common prac- 
tice to advise continuance of same with the Compound until no longer neces- 
sary. * * * The late Dr. P  of California, who had important ex- 
periences with this treatment, stated he relied almost solely on the compound 
and appropriate diet. Another very successful Physician aided it by pre- 
scribing  for  the   most   troublesome   symptoms.    Both   reported   good  results.
* * * But from a large mass of correspondence it seems probable that a 
great majority of the cases were simply on the Compound and diet. Patience 
is necessary for many professional reports do not begin to record decreasing 
albumen until after the tenth to fifteenth days, the physical improvement 
gradually following. Occasionally this is reversed, some reports recording 
physical improvement before the albumen shows much response. Hence as 
above stated, patience is necessary. Directions. Mild Cases * * * More 
Advanced Cases * * * Advanced or Extreme Cases * * * If stomach 
is too weak take half doses in a little hot water till full dose can be taken.
* * * Test for Albumen Simple formula for making quantitative tests for 
albumen, so the changes may be compared, will be mailed free on application. 
John J. Fulton Co., 88 First St., San Francisco, Cal.," (Fulton's Compound 
RX 2, bottle label) " We have received many letters from physicians reporting 
in cases designated therein as Diabetes that the use of this Compound was 
attended with decrease in the sugar in the urine, or improvement in the 
physical condition of the patient or both.    *    *    *    If stomach is weak, take
half doses until tone of stomach is improved. Write for free copy of the 
Diabetic Digest presenting epitomes of many Professional reports on the results 
following the use of this Compound," (wrapper) "We have received many let- 
ters from Physicians reporting in cases designated therein as Diabetes that 
the use of this Compound was attended with decrease in the sugar in the urine, 
or improvement in the physical cond-tion of the patient, or both," (circular) 
"We have received many letters from Physicians reporting in cases d??s gnated 
therein as Diabetes that the use of this Compound was attended with a de- 
crease in the sugar in the urine, or improvement in the phys cal condition of the 
patient, or both. We mailed copies of the Diabetic Digest recapitulating and 
summarizing several hundred of these reports, with ingredients and Rat onale, 
to the Physicians of the United States and will mail copies upon application 
to all interested.    If you desire a copy, send your address.    *    *    *    The late
Dr. P  of California, who had important exper ence with the treatment,
states he relied almost solely on the compound and appropriate diet. Another 
very successful Physician aided it by prescribing for painful or troublesome 
symptoms. Both reported good results. * * * But from a large mass of 
correspondence it seems probable that a great majority of the cases were s mply 
on the Compound and Diet. * * * Patience is necessary, for many profes- 
sional reports do not beg.n to record decreasing sugar until after the tenth to 
fifteenth day, the physical improvement gradually following. Occasionally this 
is reversed, some reports recording physical improvement before the sugar shows 
much response. Hence, as above stated, patience is necessary. * * * Mild 
Cases . * * * More Advanced Cases * * * Advanced or Extreme Cases 
* * * and with same will include instructions for making sugar tests so 
the changes may be compared," were false and fraudulent, since the articles 
contained no ingredients or combinations of ingredients capable of producing 
the effects claimed.
The John J. Fulton Co., San Francisco, Calif., entered appearance as claim- 
ant for the property and filed exceptions to the libel. On September 10, 1928, 
a hearing was held before Judge Neterer, who sustained the exceptions of the 
claimant, to which ruling the Government excepted. On October 5, 1928, the 
Government petitioned for a rehearing on the said exceptions, which petition 
was denied. On November 7, 1928, an order was entered by the court dis- 
missing the libel. On January 21, 1929, the Government filed notice and petition 
for appeal from said rulings and dismissal of the libel.
On June 14, 1929, the Government's appeal came on for argument before 
the Circuit Court of Appeals for the Ninth Circuit, Judges Rudkin, Dietrich, and 
Wilbur sitting. On July 1, 1929, the Circuit Court of Appeals handed down the 
following opinion sustaining the Government and reversing the lower court 
(Dietrich, F. S.) :
"Appellant filed a libel of information against 48 hottles of an article of 
drugs labeled in part ' Fulton's Compound RX 1' and 24 bottles of another 
article of drugs labeled in part ' Fulton's Compound R X 2,' which it alleges 
were shipped in interstate commerce from San Francisco to Seattle and which 
it charges were misbranded in violation of Paragraph Third of Section 8 of 
the Food and Drugs Act, as amended (21 USCA Sec. 10). By that provision 
it is declared that an article of drugs shall be deemed to be misbranded, ' If 
its package or label shall bear or contain any statement, design, or device, 
regarding the curative or therapeutic effect of such article or any of the 
ingredients or substances contained therein, which is false and fraudulent.' 
In the libel are exhibited the labels, wrappers, and attending circulars, fol- 
lowed with the averment that the bottles were so misbranded in that the 
labels, wrappers, and circulars ' are false and fraudulent since the articles con- 
tain no ingredient or combination of ingredients capable of producing the 
effect claimed.' Sustaining an exception to the libel upon the ground that it 
failed to state sufficient facts to constitute a cause of action, the court below 
entered a judgment dismissing it, and libelant appeals.
" The point of the exception is that nowhere in the label, wrapper, or at- 
tending circular does the proprietor or shipper make any direct statement or 
representation that the drugs are of curative or therapeutic value. In each 
case there is the statement ' We have received many letters from Physicians 
reporting,' followed by what is represented to be the substance of such 
'reports,' which admittedly would tend to engender a belief to persons suf- 
fering from diabetes or Bright's disease that the use of the drugs would 
likely afford them relief. Unless we discredit their mental competence, such, 
we must presume, was the intent and expectation of the proprietors.    Their
contention is that they have such letters or reports and that that fact con- 
stitutes a complete defense whatever may be the character of the drugs. But 
if, as is alleged, the drugs are worthless the proprietors cannot escape re- 
sponsibility by hiding behind the phrase 'the doctors say.' Couched in such 
language undoubtedly the printed matter makes a more persuasive appeal to 
the credulity of sufferers from these diseases than if the representations thus 
implied were made directly upon the authority alone of the proprietors, and 
for that reason they are not less but more obnoxious to the law. The charge 
is that they are not only false but fraudulent, thus implying bad faith on 
the part of the appellee, and of course we are presently concerned only with 
the sufflciency of the charge and not at all with the character or degree of 
proof required to substantiate it. The point does not require extensive review 
of the decided cases for conclusive, we think, is the principle of construction 
set forth in the following quotation from the opinion of the Supreme Court in 
United States v. 95 Barrels of Vinegar, 265 U. S. 438: ' The statute is plain and 
direct. Its comprehensive terms condemn every statement, design and device 
which may mislead or deceive. Deception may result from the use of state- 
ments not technically false or which may be literally true. The aim of the 
statute is to prevent that resulting from indirection and ambiguity, as well 
as from statements which are false. It is not difficult to choose statements, 
designs and devices which will not deceive. Those which are ambiguous and 
liable to mislead should be read favorably to the accomplishment of the pur- 
pose of the act.'"
The case was thereupon remanded to the United States District Court foi 
the Western District of Washington for trial. On September 19, 1929, the 
claimant having consented to the entry of a decree, judgment of condemnation 
and forfeiture was entered", and it was ordered by the court that the product 
be destroyed by the United States marshal.
ARTHUR M. HYDE, Secretary of Agriculture.