flu and pneumonia; and 502(e) (2)—the label of the article failed to bear the common or usual name of each active ingredient.

Balsam oil. 502(a)-the labeling of the article, while held for sale, contained false and misleading representations that the article was an adequate and effective treatment for earache, neuralgia, skin irritations, open wounds, sprains, eczema, swellings, bruises, and caked and sore nipples in cows; and 502 (e) (2)—the label of the article failed to bear the common or usual name of each active ingredient and the quantity and kind of alcohol present in the article.

The libel alleged also that a quantity of vanilla extract was adulterated and misbranded under the provisions of the law applicable to foods as reported in notices of judgment on foods.

QUANTITY: 48 unlabeled 1-gal. btls. and 29 individually cartoned 2-oz. btls. at Memphis, Tenn.

SHIPPED: The article was shipped in 55-gal. wooden bbls. sometime in September 1957, from Morton, Miss., by Morton Services, Inc.

LABEL IN ᏢᎪᎡᎢ : (Btl.) "Ironsol Hematinic-Tonic-Stomachic-Active Ingredients: Soluble Iron (as Ferric Sulphate), Aluminum Sulphate and traces of other minerals *** Distributed by Morton Services, Inc., Morton, Miss." ACCOMPANYING LABELING: Leaflets designated "Ironsol ** Minerals Make The Man Or Woman."

RESULTS OF INVESTIGATION:

The article in the bottles was repacked by the consignee from the barrels in which it was shipped as described above. The bottle labels and the leaflets referred to above were supplied by the shipper. LIBELED:

7-25-58, W. Dist. Tenn.

CHARGE: 502 (a)—the labeling of the article, when shipped and while held for sale, contained false and misleading representations that the article was effective in the treatment of impaired health, stomach ulcers, nervousness, "nervous indigestion," heartburn, indigestion, sleeplessness, hepatitis, poison ivy, sores in the mouth, gall bladder trouble, allergies, kidney trouble, impaired appetite, loss of weight, sour stomach, loss of vitality, lost manhood, stomach troubles, tingling of the fingers, impaired circulation, infection, and a condition of impure blood; and for producing a stomachic effect. DISPOSITION: 8-28-58. Default-destruction.

5765. Sta-Fit (Food supplement). (F.D.C. No. 41923. S. No. 2-540 P.) QUANTITY: 487 8-oz. cans and 126 16-oz. cans at Sarasota, Fla.

SHIPPED: Between 5-15-58 and 6-6-58, from Cedar Rapids, Iowa, by Professional Foods Co.

LABEL IN PART: "New 2-Way STA-FIT *** for both 1: Weight Control 2: Nutritional Supplement Ingredients: Lactalbumin and Soya Protein, Milk Solids (non-fat), Amino Acid, Casein, Methyl Cellulose, Lecithin, Essential lipids from Wheat, Rice, Bran and Soya Bean Oils, Vitamin B-12, Calcium Cyclamate, natural flavors and vitamins from food sources."

ACCOMPANYING LABELING: Folders entitled "You Mean That STA-FIT Can Really Help All of Us?"

LIBELED: 7-11-58, S. Dist. Fla.

CHARGE:

502(a)—the labeling of the article, when shipped, contained false and misleading representations that the article was adequate and effective for the treatment of obesity and for maintaining weight control. DISPOSITION: 8-12-58. Consent-claimed by Nutritional Service, Inc., Cedar Rapids, Iowa, and relabeled.

5766. Eifeler tea. (F.D.C. No. 41848. S. Nos. 3–550/2 P.)

QUANTITY: 250 ctns. bearing a label in the English language and 83 ctns. bearing a label in the German language at Takoma Park, Md.

SHIPPED: On 1-15-58 and in the latter part of April 1958, from Germany by Frau V. Glaremin.

LABEL IN PART: "Eifeler Tea for Diabetes (for the support of treatment for Diabetes) Frau V. Glaremin Julich/Rhld. Germany Walter Timpke *** Exclusive distributor for America. Directions for use."

ACCOMPANYING LABELING: Leaflets printed in the German language and in the English language entitled "Health Through Nature."

RESULTS OF INVESTIGATION: Examination showed that the article was a mixture of material having the odor and appearances of plant leaf and stem. According to the dealer the article consisted of the plants "Senecio nemorensis" and "Senecio carabinum." The above-named leaflets were printed in Germany at the direction of Walter Tempke, Takoma Park, Md. LIBELED: 6-4-58, Dist. Md.

CHARGE: 502(a)—the labeling of the article, when shipped, contained false and misleading representations that the article was an adequate and effective treatment for diabetes.

DISPOSITION: 10-31-58. Default-destruction.

5767. Dietary products.

(F.D.C. No. 41906. S. Nos. 35-469/71 P.) QUANTITY: 6 1-oz. btls., and 41 5-oz. btls. of Dr. Bronner's Organic Mineral Salt; 9 46-oz. btls., and 5 6-oz. btls. of Dr. Bronner's Organic Carrot Syrup; and 21 btls. of Dr. Bronner's Calcium Food at Schoeneck, Pa. SHIPPED: 3-14–58, from Los Angeles, Calif., by Dr. E. H. Bronner & Associates. LABEL IN PART: "Dr. Bronner's Organic Mineral Salt *** A health food derived from raw Sea & Land Plants High in ocean minerals, iodine, iron & Potassium ***Stop Tooth Decay The Edible Way *** Dr. Bronner & Assoc. *** Escondido, Cal."; "Dr. Bronner's Organic Carrot Syrup *** contains 18 times more crude minerals, trace elements, carotene Vitamin 'A' & Natural Carrot Sugar than the raw carrots from which it is solely derived * Dr. E. B. Bronner & Assoc. *** Escondido, Cal."; * "Dr. Bronner's Calcium Food made with vegetable & mineral calcium, dulse, rosehips, soya, barley yeast, lemon juice, dried Ocean Kelp, sunflower-seed-meal & Barley Malt Dr. E. H. Bronner & Assoc."

ACCOMPANYING LABELING: Leaflets entitled "Organic Mineral Salt & Bouillon” and "Dr. Bronner's Calcium Phosphorus Vegetable." LIBELED: 7-2-58, E. Dist. Pa.

CHARGE: 502(a)—the labeling of the articles, when shipped, contained false and misleading representations that the mineral salt was effective in preventing tooth decay; that the carrot sirup was effective in correcting poor eyesight; that the calcium food was adequate and effective for preventing tooth decay,

polio, bone brittleness, and loose dentures, and that the right way to prevent tooth decay is with organic-vegetable and oceanic calcium food. DISPOSITION: 9-16-58. Default-delivered to the Food and Drug Administration.

5768. Royal jelly capsules.

(F.D.C. No. 41486. S. No. 40-761 P.) QUANTITY: 2 250-capsule btls. and 1 100-capsule btl. at Seattle, Wash. SHIPPED: 2-6-58, from Los Angeles, Calif., by Healthcraft Products. LABEL IN PART: "Capsules Healthcraft *** Jell-E-Vites Royal Jelly Each capsule contains: Royal Jelly 50 mg. *** Vitamin B12 * * * 5 mcg. Vitamin B1 *** 5 mg. ** Vitamin B. * * * 1 mg. *** Calcium Panto

thenate 5 mg. *** Niacinamide 10 mg. *** Vitamin E ** 5 I.U."

ACCOMPANYING LABELING: Poster of reprints from newspapers and magazines entitled "Famous Newspapers and Magazines Report Sensational Benefits With Royal Jelly."

LIBELED: 3-25-58, W. Dist. Wash.

CHARGE: 502(a)—the labeling accompanying the article, when shipped, contained false and misleading representations that the article would prolong life, cure cancer, rejuvenate failing or worn out glandular activities in human beings, restore vigor, eliminate a feeling of tiredness, restore youthful sex function in women in the menopause, normalize growth of under-developed children, stimulate the appetite, produce a general state of well-being, improve nervous balance, increase virility and sexual energy, have a tonic effect on the mental processes, and cure the ills of old age.

COMPLAINT FOR INJUNCTION FILED: 2-26-54, S. Dist. Calif., against Wayne A. Parkinson, t/a Glandular Products Co., and also t/a Dybutol Co., Long Beach, Calif.; against Allen H. Parkinson, t/a Tide Mailing Service, Long Beach, Calif.; and against Margaret M. Willis, operating manager of the Tide Mailing Service.

CHARGE: The complaint alleged that the defendants were the interstate promoters and distributors of the following articles: Adler's Compound (Standard Strength and Super Strength), consisting of vitamins, minerals, and wheat germ oil in an inert glandular base, Vita-Glan Male Formula (Regular Strength and Double Strength), consisting of vitamins in an inert glandular base, and Bio-Glan Male Formula (Regular Strength and Double Strength) together with Bio-Glan Fortified Wheat Germ Oil consisting of vitamins in an inert glandular base and capsules of wheat germ oil; that the promotion and distribution of such articles was carried out as a mail-order business conducted in the names of the Glandular Products Co., and the Dybutol Co.; that substantially all of the normal business functions of such companies, including the printing, addressing, and mailing of labeling of the articles, the receipt and processing of mail orders for the articles, and the bottling, packaging, labeling, and shipping of the articles, in response to the mail orders, were performed or arranged for by the Tide Mailing Service.

The complaint alleged also that the defendants caused the above-named articles to be introduced into interstate commerce with labeling consisting of the labels on the bottles containing the articles, and of various folders, letters, envelopes, and order forms, including folders, entitled "New Safe Bio

Glan Male Formula"; "Amazing New Vita-Glan"; and "A Report to Physicians and the Public"; and that the articles were misbranded under 502 (a), in that their labeling was false and misleading as follows:

Adler's Compound (Standard or Super Strength)-the labeling represented and suggested

(a) That the article was highly efficacious in overcoming male sexual weakness and impotence, whereas it was not efficacious for such purposes; (b) That the article, which was distributed in the United States by Glandular Products Co., was manufactured in Germany and was available in the United States in limited supply only, whereas the article was manufactured in Los Angeles, Calif., on order of the defendants and was available here in unlimited supply;

(c) That the article was a new and amazing medical miracle developed by outstanding German pharmaceutical knowledge and ingenuity, whereas said drug was composed of commonly known ingredients and was not a new and amazing medical miracle;

(d) That the tablets comprising Adler's Compound (Super Strength), differed in composition and potency from the tablets comprising Adler's Compound (Standard Strength), whereas all of the tablets were identical in composition and potency; and

(e) That distribution of the article was licensed by the person whose photograph appeared on various items of the labeling, and who was identified there as Konrad Adler, a German specialist in glandular research, whereas the photograph was in fact that of a professional model who resided in Hollywood, Calif., years ago, when the photograph was taken.

Bio-Glan Male Formula (Regular and Double Strength), together with Bio-Glan Fortified Wheat Germ Oil-the labeling represented and suggested(a) That the article was highly efficacious in overcoming male sexual weakness and impotence, whereas it was not efficacious for such purposes; (b) That the article was marketed by Glandular Products Co., upon the advice and guidance of a medical director, John Garwood, whereas such company had no medical director and the name "John Garwood" was a fictitious one adopted by Wayne A. Parkinson, who was not trained in the field of medicine;

(c) That the tablets comprising Bio-Glan Male Formula (Double Strength), had twice the potency of the tablets comprising Bio-Glan Male Formula (Regular Strength), whereas all of the tablets were identical in composition and potency; and

(d) That the use of the Bio-Glan Male Formula (Double Strength), would create such a rapid sexual rejuvenation in males previously lacking in sexual power as to warrant the use of a double-strength anaesthetic ointment to retard the male sexual climax, whereas the use of such drug would not cause any sexual rejuvenation.

Vita-Glan Male Formula (Regular and Double Strength)—the labeling represented and suggested

(a) That the article was highly efficacious in overcoming male sexual weakness and impotence, whereas it was not efficacious for such purposes;

(b) That the article was highly efficacious in overcoming nervousness, loss of muscle tone, vague aches and pains, fatigue, irritability, headaches, dizziness, weakness, mental depression, insomnia, digestive upsets, loss of appetite, neuritis, backache, and mental dullness, whereas it was not efficacious for such purposes;

(c) That the article was marketed by Glandular Products Co., upon the advice and guidance of a medical director, whereas such company had no medical director;

(d) That the tablets comprising Vita-Glan Male Formula (Double Strength), had twice the potency of the tablets comprising Vita-Glan Male Formula (Regular Strength), whereas all of the tablets were identical in composition and potency; and

(e) That the use of the Vita-Glan Male Formula (Double Strength), would create such a rapid sexual rejuvenation in males previously lacking in sexual power as to warrant the use of an anaesthetic ointment to retard the male sexual climax, whereas the use of such drug would not cause any sexual rejuvenation.

The complaint alleged further that if the defendants were forced by an injunction to discontinue their false and misleading labeling, they would, unless further enjoined, continue their promotion and distribution of the above-named articles and similar articles by making claims for sexual rejuvenation through collateral media outside of labeling, and that, in such case, the articles would be misbranded within the meaning of 502(f) (1), in that their labeling would fail to bear adequate directions for use.

The complaint prayed for the entry of a temporary restraining order and a preliminary and permanent injunction, and also for an order directing the defendants to tender to all present and past purchasers of the abovenamed articles a refund of all amounts collected by the defendants from such purchasers.

DISPOSITION: On 2-26-54, without notice, a temporary restraining order was entered against the defendants; and on 3-11-54, after a hearing, a preliminary injunction was entered against the defendants enjoining them against the acts complained of.

On 11-5-54, the defendants having consented, a decree of permanent injunction was entered against the defendants enjoining them against introducing into interstate commerce any of the above-named articles, similar articles, or other articles offered for similar purposes, that were misbranded as alleged in the complaint. The decree also provided that the question of restitution was specifically reserved and should be subject to subsequent determination by the court.

Following the entry of the decree, briefs on the question of restitution were submitted by counsel, and, on 7-25-55, argument was held before the court on such question. On 10-21-55, the court handed down the following opinion (135 F. Supp. 208):

CARTER, District Judge: "This case poses the question as to whether the district court has power to order restitution in an injunction proceeding under the Federal Food, Drug, and Cosmetic Act [21 U.S.C.A. 331-392; Act of June 25, 1938, Chap. 675, 52 Stat. 1040].

"The case is one of first impression under the Food and Drug Laws, although the problem has been discussed recently in law reviews and journals.'

1 Rhyne, Penalty Through Publicity: FDA's Restitution Gambit, 7 Food, Drug, Cosmetic L.J. 666-680 (1952)

Noland, Section 302(a) of the Federal Food, Drug, and Cosmetic Act: Restitution Reexamined, 7 Food, Drug. Cosmetic L.J. 373-400 (1952)

Lev. The Nutrilite Consent Decree, 7 Food, Drug. Cosmetic L.J. 56, 65-67 (1952) Developments in the Law-The Federal Food, Drug, and Cosmetic Act, 67 Harv. LR 632, 718-720 (1954)

Levine, Restitution-A New Enforcement Sanction, 6 Food, Drug, Cosmetic L.J. 503-514 (1951)

Goodrich, Modern Application of an Ancient Remedy, 9 Food, Drug, Cosmetic L.J. 565-572 (1954) "Restitution in Food and Drug Enforcement," note in 4 Stan. L. Rev. 519-536 (1952),