4764. B-amino-complex (B-amino-BAC-complex or Unitone) tablets.   (Inj. No.
267.)
COMPLAINT FOR INJT;I?3TIOK FILED: 9-28-53, S. Dist. N. Y., against Barrows
Chemical Co., Inc., and Unitone Corp., both of New York, N. Y., and against
Joseph Barrows, president of the corporations, to enjoin the interstate shipment
of an article in tablet form known by the trade names of "B-Amino-Complex,"
"B-Amino-BAC-Complex," and "Unitone." Amended complaint filed on or about
10-30-53.
LABEL IN PART : *'B-Amino-Complex [or "B-Anrino-BAC-Complex" or "Unitone"]
* * * VITAMINS Daily dose of 6 tablets contains: Vitamin Bi (Thiamine
Hydrochloride) 18.0 mg. Vitamin Ba (Riboflavin) 27.0 mg. Niacinamide 180.0
mg. Vitamin B? {Pyridoxine Hydrochloride) 3.0 mg. High Potency Yeast
200.0 mg. Brewer's Type Yeast 200.0 mg. Inositol 60,0 mg. Choline Hydro-
chloride 60.0 mg. Panthenol (Equal to Cal. Pantothenate 30 mg.) 26.1 mg.
AMINO ACIDS (Vitagenic Accelerators) as contained in Yeast Protein Enzy-
matic Hydrolysate 1.0 Gm. Fortified with Nucleic Acid 100.0 mg. Glutamic
Acid 50.0 mg. Glycine 50.0 mg. Cysteine Hydrochloride 25.0 mg. DI AND
TRI-VALENT MINERALS Iron (Ferric Citro Pyrophosphate Soluble) 28.8
mg. Copper (Copper Sulfate) 2.1 mg. Magnesium (Magnesium Sulfate) 5.9
mg.   Zinc (Zinc Sulfate) 1.4 mg.   Cobalt (Cobalt Sulfate) 1.3 mg."
CHARGE : The complaint alleged that the defendants were engaged in the business
of manufacturing, distributing, and selling the above-mentioned article and
that, for the purpose of explaining the uses of the article and promoting its
distribution, the defendants caused the article to be accompanied by labeling
consisting of leaflets entitled "Amazing Medical Discovery," "If Your Body
Could Talk It "Would Say," and "A Revolutionary Advance in Nutrition,"
placards entitled "Amazing Discovery Checks Deafness, Helps Restore Hearing,
Clinically Tested-Come in For Free Booklet," "BAC," and "For the One in
Five Who is Hard of Hearing," and publications entitled "Nutritional Guide
Better Nutrition Better Health" and "Health and Nutrition News Spring
Summer 1953."
The complaint alleged further that the defendants were violating the Act by
causing the introduction and delivery for introduction into interstate commerce
of the article which was misbranded as follows:
502 (a)-the label of the article and the above-mentioned accompanying label-
ing contained false and misleading representations that the article was an ade-
quate and effective treatment for deafness; that it was a new and amazing
discovery and a revolutionary advance as a food supplement which, when used
as directed, would supply an important quantity of protein; that it was needed
to activate the eyes, ears, lungs, liver, intestines, muscles, brain, heart, stomach,
kidneys, and the entire body; that it would supply vitamins, proteins, and min-
erals in the correct proportions, and balanced amounts to stimulate the body to
work as nature intended; that it would endow the user with vibrant life, health,
and energy; that it would enable the liver to convert more than normal amounts
of carbohydrates into energy; that it would supply increased energy to the
heart, lungs, muscles, liver, and other important organs; that it would supply
missing enzymes necessary to carry on body functions, such as growth, repro-
?See also No. 4761.
duction, secretion, nerve conduction, muscular contraction, etc.; that it would
transfer fatigue to quick energy, prevent and correct dysfunction in the energy
conversion chemistry of body functioning; and that it would reactivate all
enzyme systems necessary for healthy body functioning and would activate the
body cells to function as nature intended;
502 (a)-the following statements in the accompanying leaflet entitled "If
Tour Body Could Talk It Would Say," namely, "'Unbalanced B. Vitamina
May Be Dangerous' . . . says The Journal of the American Medical Associa-
tion in an Editorial of September 1,1945. They say further . . . 'Extensive
scientific evidence has revealed that if B Vitamins are administered in other
than balanced proportions they may create Vitamin Deficiencies rather than
cure them' . . . still quoting the JAMA, the Editorial continues 'Many B-
Complex preparations available to the physician and public today are definitely
unbalanced . . . either too much thiamine or not enough riboflavin, niacin,
or pyridoxine,'" were false and misleading since the quotations contained in
such statements did not appear in an editorial in the September 1,1954, issue of
The Journal of the American Medical Association; and,
502 (f) (1)-the labeling of the article failed to bear adequate directions
for use in the treatment of deafness, which was the condition for which the
article was intended to be used and for which it was offered in the accompany-
ing labeling described above and in advertising matter.
The complaint contained also allegations concerning the misbranding of
the article under the provisions of the law applicable to foods, as reported in
notices of judgment on foods, No. 22449.
DISPOSITION: 11-18-54. The defendants having consented to the entry of a
decree, the court entered a decree of permanent injunction. The decree en-
joined the defendants against introducing into interstate commerce the above-
mentioned article or any similar article accompanied (1)" by the above-
mentioned leaflets and placards or (2) by any written, printed, and graphic
matter representing that the article was a new and amazing discovery and
a revolutionary advance as a food supplement which, when used as directed,
would supply an important quantity of protein; that the article was needed to'
activate the eyes, ears, lungs, liver, intestines, muscles, brain, heart, stomach,
kidneys, and the entire body; that it would supply vitamins, proteins, and
minerals in the correct proportions, and balanced amounts to stimulate the
body to work as nature intended; that it would endow the user with vibrant
life, health, and energy; that it would enable the liver to convert more than
normal amounts of carbohydrates into energy; that it would supply increased
energy to the heart, lungs, muscles, liver, and other important organs; that
it would supply missing enzymes necessary to carry on body functions, such
as growth, reproduction, secretion, nerve conduction, muscular contraction,
etc.; that it would transfer fatigue to quick energy, prevent and correct dys-
function in the energy conversion chemistry of body functioning; and that it
would reactivate all enzyme systems necessary for healthy body functioning
and would activate the body cells to function as nature intended; or (3) by
written, printed, and graphic matter representing that the article would
check, cure, or be an adequate and effective "treatment for deafness or hard
of hearing. The decree provided, however, that the defendants could intro-
duce the article into interstate commerce if it was accompanied by written,
printed, or graphic matter clearly limiting and describing the use of the article
only as follows:
For cases in which the cause of deafness has been medically diagnosed
as hearing nerve deafness due to carbohydrate metabolic disturbance as
indicated by high pyruvic acid level in the blood (higher than 2 mg. per
100 cc. under basal conditions), this product may be of value when used
in conjunction with other suitable treatment prescribed by your physi-
- cian. A blood test is necessary to determine whether the level of pyruvic
acid in the blood is high.
The decree further enjoined the defendants against introducing the article
, into interstate commerce unless it was accompanied by written, printed, or
graphic matter which clearly stated and enumerated every disease, condition,
 -symptom, and purpose for which the article was intended to be used and for
-which it was represented by any means to the public.