SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC Act invoLVED IN VIOLATIONS
REPORTED IN D.D.N.J. NOS. 6581-5620

Adulteration, Section 501 (b), the article purported to be and was represented
as a drug, the name of which is recognized in an official compendium (United
States Pharmacopeia and National Formulary), and its strength differed from,
and its quality and purity fell below, the standard set forth in such compendium;
and Section 501(c), the article was not subject to the provisions of Section
501 (b), and its strength and quality differed from that which it purported or
was represented to possess.

Misbranding, Section 502(a), the labeling of the article was false and mis-
leading; Section 502(b), the article was in package form, and it failed to bear
a label containing (1) the name and place of business of the manufacturer,
packer, or distributor, and (2) an accurate statement of the quantity of con-
tents; Section 502(d), the article contained a chemical derivative of barbituric
acid, and its label failed to bear the name, and quantity or proportion of such
derivative and in juxtaposition therewith the statement "Warning-May be
habit forming"; Section 502(e) (2), the article was a drug not designated solely
by a name recognized in an official compendium and was fabricated from two
or more ingredients, and its label failed to bear the common or usual name of
each active ingredient; Section 502(f) (1), the labeling of the article failed to
bear adequate directions for use; Section 502(f) (2), the labeling of the article
failed to bear adequate warnings against use in those pathological conditions or
by children where its use may be dangerous to health, or against unsafe dosage
or methods or duration of administration or application, in such manner and
form, as are necessary for the protection of users; and Section 503(b)(4), the
article was a drug subject to Section 503 (b) (1), and its label failed to bear the
statement "Caution: Federal law prohibits dispensing without prescription."
New-drug violation, Section 505 (a), the article was a new drug within the
meaning of Section 201 (p), which was introduced into interstate commerce,
and an application filed pursuant to Section 505(b) was not effective with
respect to such drug.

NEW DRUGS SHIPPED WITHOUT EFFECTIVE APPLICATION

5581. Clarimycin. (F.D.C. No. 41325. S. No. 83-423 M.)

QUANTITY: 35 display cartons, each containing 6 btls., at Columbus, Ohio.
SHIPPED: 11-22-57, from Jersey City, N.J., by Merritt Corp.

LABEL IN PART: (Btl.) "5 drams Clarimycin Anti-Biotic Acne Lotion
Active ingredients: Neomycin Sulphate, Allantoin."

LIBELED: 1-7-58, S. Dist. Ohio.

CHARGE: 505(a)—The article, when shipped, was a new drug which may not
be shipped in interstate commerce since an application filed pursuant to law
was not effective with respect to the drug.

DISPOSITION: 8-20-58. Consent-destruction.

5582. Clarimycin. (F.D.C. No. 41372. S. No. 60–378 M.)

QUANTITY: 366 display cards, each containing 1 btl., at Detroit, Mich.

SHIPPED: 11-25-57, from Jersey City, N.J., by Merritt Corp.

LABEL IN PART: (Btl.) "Contents: 5 drams Clarimycin Anti-Biotic Acne
Lotion Active Ingredients: Neomycin Sulphate, Allantoin."

STATES OF AMERICA

3581–56201

NOTICES OF JUDGMENT

41

CHARGE: 505(a)—the article, when shipped, was a new drug which may not
be shipped in interstate commerce since an application filed pursuant to law
was not effective with respect to the drug.

DISPOSITION: Merritt Corp., claimant, having filed a motion for consolidation
and removal, the court, on 5–16–58, after consideration of the briefs of the
parties, handed down the following opinion in denial of the motion:

O'SULLIVAN, District Judge: "This cause is before the Court upon motion of
Merritt Corporation to consolidate this cause with cause No. 17780, also pend-
ing in this court, Civil Action 5184 pending in the United States District Court
for the District of Ohio, Eastern Division, and cause No. 16750, pending in the
United States District Court for the Western District of Pennsylvania, and to
remove the cases so consolidated for trial in the Southern District of New York.
After due consideration thereof, the Court does find and order as follows:

"1) The claimant, Merritt Corporation, claims that its motion has validity
by reason of the provisions of 21 USC 334 (a) and 21 USC 334 (b), or if not en-
titled to have its motion granted under those two statutes, then under
28 USC 1404 (a) or 28 USC 1404 (b).

2) The Government's libel is bottomed upon its claim that the articles sub-
ject to the libel constitute a new drug and that there is no statutory authority
for this Court in such case to remove or consolidate the causes mentioned, by
virtue of the above-mentioned statutes. The Court so finds.

“3) Claimant asserts that the cause pending in the District Court of Penn-
sylvania is, in effect, a misbranding case which would authorize the removal
sought. If such is true, then a motion might well be addressed to the Penn-
sylvania District Court to remove that cause to the Southern District of New
York, and the other causes pending in Michigan and Ohio might well be held
in abeyance pending disposition of the Pennsylvania cause so removed to New
York.

"NOW, THEREFORE, it is hereby Ordered that the motion of Merritt Cor-
poration to consolidate and remove the mentioned causes may be, and it is,
denied."

On 8-27-58, the claimant having consented, the court entered a decree of
condemnation and ordered that the product be destroyed.

5583. Royal jelly capsules.

(F.D.C. No. 40945. S. No. 69-118 M.)

QUANTITY: 500 capsules, each containing 50 mg., of royal jelly at New York,
N.Y., in possession of Reid & Cubit, Inc.

SHIPPED: 9-10-57, from Linden, N.J.

LABEL IN PART: "This Royal Jelly from selected queen cells is not more than
two days old after introducing the larvae which gives the most active con-
centration."

ACCOMPANYING LABELING: Printed matter designated "Reprints of Scientific
News Reports on Royal Jelly."

RESULTS OF INVESTIGATION: The article was shipped as described above in bulk
containers and, upon receipt at New York, N.Y., it was repackaged into small
vials and relabeled by the dealer as above described.

LIBELED: 12-10-57, S. Dist. N.Y.

CHARGE: 502(a)—the labeling accompanying the article, while held for sale,
contained false and misleading representations that the article would sexually
rejuvenate, increase the life span, and give a lift to the aged and infants; and
505 (a)—the article was a new drug within the meaning of the law, and an ap-
plication filed pursuant to law was not effective with respect to the article.
DISPOSITION: 1-6-58. Default-destruction.

DRUGS IN VIOLATION OF PRESCRIPTION LABELING REQUIREMENTS

5584. Various drugs. (F.D.C. No. 40985. S. Nos. 79-421 M, 79-423/4 M, 79426/9 M.)

QUANTITY: 10 vials of Suavitil benactyzine hydrochloride tablets, 700 tablets of Belladenal in an unlabeled btl., 1 700-tablet labeled btl. of Doriden, 1 800tablet btl. of Metamine with butabarbital, 1 850-tablet btl. of Ritalin, 1 1,000-tablet btl. of Plimasin, and 7 100-tablet btls. of Premarin, at Jersey City, N.J., in possession of Carl H. Kaplan Sales Co.

SHIPPED: Between November 1956 and October 1957, from Rouses Point, Yonkers, and New York, N.Y.

RESULTS OF INVESTIGATION: The articles, except for the Premarin tablets, consisted of physicians' samples which the consignee, Carl H. Kaplan Sales Co., had obtained from various drug salesmen, drug firms, and unknown sources, and had transported to Jersey City. All of the articles, including the Premarin tablets, were repacked and relabeled after receipt by the consignee. LIBELED: 12-2-57, Dist. N.J.

CHARGE: 502(b)—while held for sale, the labels of the Suavitil benactyzine hydrochloride tablets, Belladenal tablets, Doriden tablets, Metamine with butabarbital tablets, and Plimasin tablets failed to bear (1) the name and place of business of the manufacturer, packer, or distributor, and (2) an accurate statement of the quantity of contents; 502(d)—the Belladenal tablets and Metamine with butabarbital tablets contained chemical derivatives of barbituric acid, and while held for sale, their labels failed to bear the name, and quantity or proportion of such dervative and in juxtaposition therewith the statement "Warning-May be habit forming"; 502(e) (2)—the label of the Belladenal tablets, while held for sale, failed to bear a statement of the quantity or proportion of the alkaloids of belladonna contained therein; 502 (f) (1)—while held for sale, the labeling of the Suavitil benactyzine hydrochloride tablets, Belladenal tablets, Doriden tablets, and Metamine with butabarbital tablets failed to bear adequate directions for use; and 503 (b) (4)-all of the articles were drugs subject to 503 (b) (1), and the labels of the articles, while held for sale, failed to bear the statement "Caution: Federal law prohibits dispensing without prescription."

The libel alleged also that an article labeled "Obron" was misbranded under the provisions of the law applicable to foods, as reported in notices of judgment on foods.

DISPOSITION: 1-15-58. Default-destruction.

DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE DIRECTIONS OR WARNING STATEMENTS*

5585. Super Protein Formula "90" and Formula "90" Supplement. (F.D.C. No. 41434. S. No. 75-649 M.)

QUANTITY: 7 pkgs. containing 1 btl. of Super Protein Formula "90" and 1 btl of Formula "90" Supplement at Phoenix, Ariz.

SHIPPED: 7-10-57, from Hollywood, Calif., by Hi-Pro Products Co.

LABEL IN PART: (Btl.) "MpDs *** Super Protein Formula '90' An aid to Weight Reducing Increases Energy - Helps Reduce Weight *** MpDs is a Balanced Protein Food Supplement Contains No Calories

See also No. 5584.

180

[or '360'] tablets" and "Formula '90' Supplement Reducing sules

** 15 Cap

* an additional aid to weight reducing to be taken in conjunction with MpDs Super Protein Tablets *** Each Tablet Contains: Sodium Carboxy Methyl Cellulose.... 8 grains Phenylasitin (conc. Prune) . . . 0.5 Mg." ACCOMPANYING LABELING: Booklets entitled "Why Be Fat."

CHARGE: 502 (a)-the labeling of the Super Protein Formula "90" and the Formula "90" Supplement, when shipped, contain false and misleading representations that the articles contained no calories, would burn up extra fat, increase metabolism, and otherwise act as an adequate and effective treatment for obesity; and 502(f) (2)-the Formula "90" Supplement contained an irritant laxative, and its labeling failed to warn that it should not be used when symptoms of appendicitis were present and that frequent or continued use may result in dependence on laxatives.

5586. Trim-All capsules. (F.D.C. No. 41453. S. No. 23-306 P.)

QUANTITY: 3 drums containing a total of 41,500 capsules at North Hollywood,
Calif.

SHIPPED: 11-6-57, from Rensselaer, N.Y., by Delmar Pharmacal Corp.
LABELED IN PART: (Drum) "Lot No. 3218 ** Special Formula #2
Each capsule contains 60 mg. Phenylpropanolamine Hcl. 3 gr. Sodium Case-
inate, 50 mg. Ascorbic Acid, 0.5 mg. Acetphenolisatin."

RESULTS OF INVESTIGATION: Analysis showed that the article contained 77 percent of the labeled amount of phenylpropanolamine Hcl and 64 percent of the labeled amount of ascorbic acid, of which the article released 90 percent of both in 2 hours. The article was intended to be repackaged and relabeled by the consignee as follows: "21 Trim-All Capsules (an Appetite Depressant) Each Trim-All Timed Capsule Contains: Phenylpropanolamine Hcl 60 mg. Acetphenolis

Sodium Caseinate 3 gr. Dextrose 3 gr. Ascorbic acid 50 mg. atin 0.5 mg. In a specially prepared Timed disintegrating capsule that releases the ingredients over a period of approximately eight hours. LIBELED:

3-6-58, S. Dist. Calif.

CHARGE: 501 (c)—when shipped, the strength of the article differed from, and its quality fell below, that which it purported or was represented to possess since it contained less than the labeled amounts of phenylpropanolamine Hcl and ascorbic acid, and it failed to release its ingredients over an 8-hour period; 502 (a)—the label statements of the article, when shipped and while held for sale, namely, "Each capsule contains 60 mg. Phenylpropanolamine Hcl. * 50 mg. Ascorbic Acid” and “Each Trim-All Timed Capsule Contains: Phenylpropanolamine Hcl 60 mg. * * * Ascorbic acid 50 mg. * In a specially prepared Timed disintegrating capsule that releases the ingredients over a period of approximately eight hours," were false and misleading; and 502 (f) (2)—the article was a laxative, and its labeling, when shipped and while held for sale, failed to warn against use when symptoms of appendicitis are present and that frequent or continued use may result in dependence on laxatives. DISPOSITION: 3-26-58.

Default-destruction.

5587. Salicon tablets. (F.D.C. No. 40953. S. No. 76-626 M.)

QUANTITY: 135 100-tablet btls., 61 30-tablet btls., and 60 12-tablet btls. at Portland, Maine.

SHIPPED: 9-30-57, from Boston, Mass., by K. A. Hughes Co.

LABEL IN PART: "Salicon *** 5 Grain Tablets Active Ingredients: Acetylsalicylic acid (U.S.P. Aspirin) calcium carbonate and magnesium carbonate."

11-14-57, Dist. Maine.

LIBELED: CHARGE: 502(a)—when shipped, the label of the article contained false and misleading representations that the article was an adequate and effective treatment for nervous tension and sleeplessness; 502 (f) (1)—the labeling of the article failed to bear adequate directions for use since, in lieu of a dosage statement for children under 3 years of age, its labeling failed to state that for the 3 year and under age group a physician should be consulted; and 502 (f) (2)—its labeling failed to bear a warning against misuse by children since its labeling failed to warn that the product should be kept out of reach of children.

DISPOSITION: 1-7-58. Default-destruction.

5588. Zina-Ray oil, inhalers, and Ten Second Rub. (F.D.C. No. 41449. S. No. 24-906 P.)

QUANTITY: 1,080 1-oz. btls. and 284 3-oz. btls. of Zina-Ray oil, 26 cartons, each containing 1 gross of inhalers, and 1,065 1-oz. tubes and 265 3-oz. tubes of Ten Second Rub at Minneapolis, Minn., in possession of William R. Hall. SHIPPED: Between 1-7-58 and 1-21-58, from Chicago, Ill.

LABEL IN PART: (Btl.) "Zina-Ray Oil *** Contains eucalyptus oil, menthol, pine needle oil, peppermint oil"; (vial) "Inhaler Directions: Insert a few drops of ✶✶ ✶ Zina-Ray Oil into the end of inhaler”; and (tube) "Ten Second Rub * * Active ingredients: Lanolin, menthol, eucalyptus oil, peppermint oil, and pine needle oil."

LIBELED: 3-7-58, Dist. Minn.

CHARGE: 502 (f) (1)—while held for sale, the labeling of the articles failed to bear adequate directions for use for the purposes for which they were intended, namely, (Zina-Ray oil and inhalers) for preventing headache, pain in the gums, neuralgia, deafness, arthritis, rheumatism, formation of crystal deposits in the bones, inflammation of the ear, pneumonia, “flu”, and overcoming sinus infection and asthma, and (Ten Second Rub) for overcoming arthritis, rheumatism, and all aches and pains to which the body is subject, which were the purposes for which the articles were recommended orally by William R. Hall on 1-23-58.

DISPOSITION: 4-21-58. Default-destruction.

DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM OFFICIAL OR OWN STANDARDS⭑

5589. Chorionic gonadotropin. (F.D.C. No. 41363. S. No. 68-979 M.)

QUANTITY: 1,758 vials at New York, N.Y.

RESULTS OF INVESTIGATION: Examination showed that the article contained substantially less than 2,500 International Units of chorionic gonadotropin potency per vial.