10890. Adulteration and misbranding of vitamin B complex tablets.    IT. S. v.
S. C. Barnes and Son. Plea of nolo contendere on 2 counts; fine, $50. 
Plea of not guilty on 2 counts. Tried to the court. Judgment of 
guilty; fine, $400. Total fine, $450. (F. D. C. No. 15517. Sample Nos. 
55525-F; 81779-F, 81994-F.)
INFORMATION FILED: July 30, 1945, Southern District of California, against 
S. C. Barnes and Son, a partnership, Gardena, Calif.
ALLEGED SHIPMENT : Between the approximate dates of February 22, 1943, and 
June 22,1944, from the State of California into the States of Washington and 
New York.
LABEL IN PART: "McCoUum Vitamin B Complex Tablets * * * Distrib- 
uted by McCoUum Laboratories, Inc. Hollywood, California," or "JXL Vita- 
min B Complex * * * Prepared for and distributed by John X. Loughran 
Gardena, Calif."
NATURE OF CHARGE: Count 1, adulteration, Section 402 (b) (1), valuable con- 
stituents of the article had been in whole or in part omitted or abstracted 
therefrom, since the article was represented to contain in 2 tablets 350 Inter- 
national Units of vitamin Bi, 2,000 gamma of vitamin B2 (G) riboflavin, and 
10 miUigrams of niacin, whereas it contained in 2 tablets not more than 175 
International Units of vitamin Bi, not more than 0.44 miUigram (440 gamma) 
of vitamin B2, and it contained niacin in amounts ranging from 0.3 to 3.15 
milligrams per 2 tablets.
Count 2, misbranding, Section 403 (a), (same lot as involved-in count 1) 
dismissed.
Count 3, adulteration, Section 402 (b) (2), tablets of a laxative drug had 
been substituted in whole or in part for vitamin B complex tablets, which the 
article purported and was represented to be.
Count 4, adulteration, Section 402 (b) (1), a valuable constituent had been 
in whole or in part omitted or abstracted from the article since it was repre- 
sented to contain in each tablet 1,670 gamma of niacin, whereas it contained 
not more than 1,222 gamma of niacin per tablet.
Count 5, misbranding, Section 403 (a), (same lot as covered by count 4) 
the label statement "Each tablet * * * contains the following * * * 
1,670 Gammas Niacin" was false and misleading, and the label statements 
"Each tablet contains * * * 335 Gammas B2, 45 Gammas Be, 124 Gammas 
Pantothenic Acid, 1,670 Gammas Niacin" were misleading since they created 
the impression that the article contained large amounts of all of the vitamin 
substances named, whereas the article contained insignificant amounts of 
vitamin B2, vitamin Be, and pantothenic acid; Section 403 (j), the article 
purported to be and was represented for special dietary uses by reason of its 
vitamin properties in respect to vitamin Be and pantothenic acid, and its label 
failed to bear, as required by the regulations, a statement that the need for 
vitamin B8 and pantothenic acid in human nutrition has not been established; 
and, Section 403 (f), the statements required by Section 403 (j) relating to 
the proportion of the minimum daily requirement for vitamin Bi, riboflavin, 
and the amounts of vitamin Be, pantothenic acid, and niacin in a specified 
quantity of the article were printed vertically on the side panel of the label, 
and the quantities of certain vitamin substances were declared in gamma 
which would not be readily understood by the ordinary individual under 
customary conditions of purchase and use.
DISPOSITION : Count 2 having been dismissed on motion of the Government, a 
plea of nolo contendere was entered on behalf of the defendant to counts 1 and 
3, and a plea of not guilty was entered on counts 4 and 5. On October 4, 1945, 
the issue raised by the plea of not guilty came on for trial before the court. 
The trial was concluded on October 13, and the defendant was found guilty on 
the said counts. The court imposed fines of $25 on each of counts 1 and 3, 
$390 on count'4, and $10 on count 5. In pronouncing sentence, the court 
delivered the following opinion:
HARRY A. HOLZE^, District Judge: "I think, when all is said and done, this 
is the situation which confruits a court hearing the trial of a case of this 
nature. The evidence is essentially expert and particularly unusual in that 
it relates to a field in which the court is seldom called upon to take proof. 
It would be a very easy course to pursue to conclude that, because we have 
two sets of scientists who, let us assume, radically disagree, we should, to 
paraphrase a passage in Shakespeare's Romeo and Juliet, say, 'a plague on 
both your houses,' and find that the evidence is of such an intricate character 
that the lay mind can't follow it and, therefore, conclude that the government 
hasn't made out and in fact cannot make out a case. As we said a few 
moments ago, the evidence here isn't easily followed and understood but we 
think that certain passages of the testimony have been illuminating and pro- 
vide what might be termed the guide posts and the lighthouses that should 
point the way.
"Admittedly, we are dealing with a product whose ingredients can only be 
determined through some one or more scientific procedures, commonly referred 
to as assay methods.
"As we understand the evidence, it establishes, beyond the peradventure of a 
doubt, that there are at least two scientific publications which are recognized 
as authoritative, and these two have been referred to during the trial. They 
consist of the United States Pharmacopeia and the publication of this Asso- 
ciation of Official Agriculturalists. I may not have its exact title but I think 
we all understand the publication to which we are now referring. And all of the 
scientific literature that has been referred to here by any of the witnesses bears 
out the fact that for some years research has been conducted with a view of 
determining, among other matters, the most satisfactory assay method for de- 
termining the niacin content in various products and that, after years of re- 
search and exchange of reports and discussions among the scientists interested 
in the subject, one of these recognized scientific publications, namely, the U. S. P.,
oflacially published a certain assay method which, unquestionably, was the 
method applied by the government's employees. That method, through the pub- 
lication thereof in the U. S. P., has been given sanction of a type which this 
court may and properly should respect. It has been criticized here by defend- 
ant's experts. The reasoning upon which those criticisms were advanced, as we 
construe the testimony, doesn't harmonize. One of the defendant's experts, Dr. 
Osman, advanced a theory which he admitted has never been called to the 
attention of the recognized authorities who are so vitally interested in improv- 
ing the methods in this category and it strikes us as rather strange that, if an 
expert were convinced of the validity of his theory, he would, so to speak, keep it 
in hiding. In the absence of any recognition of his theory upon which he based 
his criticism of the method applied by the government experts, we feel com- 
pelled to discard the reasoning of Dr. Osman.
_ "More than that, it seems to us that, in the course of his testimony, he pointed 
to at least one of the weaknesses of the defendant's procedures. I do not have 
in mind the exact details but, under cross examination, he undertook to approve 
that particular procedural step applied in the defendant's laboratory which 
had to do with the measuring of the niacin content, and went on to explain that 
-the measurement was made at that particular stage of the manufacturing process 
because later on the same quantity of niacin might not be found or shown to 
be present by the method which the defendant was employing and that there 
might be a loss through I think what he called oxidation or through oxidizing. 
Whether we have caught or grasped the full import of that statement I am not 
altogether certain but, when we recall that the defendant's own analysis of a 
portion of the accused product, the analysis made in September of this year, 
showed a marked difference in the niacin content as compared with the claimed 
quantity incorporated in the product, it strikes us that there is something wrong 
with the procedure that is applied in the defendant's laboratory because, when 
all is said and done, the law is not concerned with what niacin content is intro- 
duced into the defendant's product in defendant's laboratory if, when that 
product leaves the laboratory, it meets the requirements, but is concerned with 
the niacin content in the finished product as distinguished from the niacin content 
in the unfinished product. Whether Dr. Osman's explanation points to a vulner- 
able procedural step or not seems to us of only passing moment. What is of con- 
sequence here is that, when we come to assaying a finished product such as we 
have here, the reasoning which has been supplied by Dr. Kline impresses us 
as the logical and the sound analysis and explanation of the method which should 
be applied in determining whether or not the defendant's product meets the 
legal requirements.
"We could go on perhaps at considerable length but it would lead merely to 
the accumulation of circumstances which, to our mind, establish, beyond all rea- 
sonable doubt, that the government has found an assay method by which to 
measure the niacin content of such products as we are dealing with here. The 
application of that method demonstrates that not only was there a failure to 
meet the requirements of the law, as charged in count 4, but also as charged in 
that portion of count 5 which is to be found on page 7, lines 7 to 17, a count be- 
ginning at line 29, page 7, and ending at line 10 on page 8. Under these circum- 
stances, we find the defendant guilty on counts 4 and 5. May I inquire whether 
there is something further to be brought to the court's attention with reference 
to what penalty should be imposed here?"