6816. Facializer device, Derma Culture Formula No. 102, and Derma Culture 
Formula No. 103.    (F.D.C. No. 46436.    S. No. 87-086 R.)
QUANTITY : 6 devices, 46 1-oz. btls. of Formula No. 102, and 34 2-oz. btls. of 
Formula No. 103, at Dallas, Tex., in possession of Milady's Clinic.
SHIPPED : Between 1-1-61 and 7-10-61, from Beverly Hills, Calif., by Derma- 
culture, Inc.
LABEL IN PAST: (Device) "Facializer Model * * * Dermaculture, Ltd. * * * 
Los Angeles" and "Manufactured by Gomco Surgical Mfg. Corp. Buffalo, 
N.Y." ; and (btl.) "Derma Culture Formula No. 102 A topical detergent solu- 
tion powder for use with negative galvanism. Directions: Add one oz. powder 
to Yz gallon water. Apply to skin with cloth packs" and "Derma Culture 
Formula No. 103 A topical detergent astringent solution powder to use with 
positive galvanism."
ACCOMPANYING LABELING : Post cards entitled "Be Skin Happy"; leaflet entitled 
"Dermaculture Patrons Remember These Things."
RESULTS OF INVESTIGATION : Investigation indicated that the "Facializer" was a 
device containing electric circuiting and a vacuum pump, equipped with ex- 
terior controls and mechanical and chemical components, all designed and 
contrived to apply galvanic electric current and vacuum to the person of the 
user.
"Formula No. 102" and "Formula No. 103" were white crystalline materials 
containing a few yellow crystals.
The accompanying labeling had been prepared by the dealer to promote use 
of the article.
LIBELED :   9-25-61. N. Disk Tex.
CHARGE: Facializer device, 502(a)-when shipped and while held for sale, the 
accompanying labeling contained false and misleading representations that the 
device was adequate and effective to remove blackheads, white heads, and 
tissue debris; correct enlarged pores, dry skin and oily skin; smooth wrinkles 
and facial lines; clear acne and pimples; increase circulation and tissue nutri- 
tion ; vitalize nerve, gland, muscle and skin structure; restore natural, lovely 
skin health and beauty; tighten saggy cheeks and chin, and correct skin 
problems.
Derma Culture Formula No. 102 and Derma Culture Formula No. 10S, 
502(b) (1)-when shipped and while held for sale, the articles of drug failed 
to bear a label containing the name and place of business of the manufacturer, 
packer, or distributor; and 502(e) (2)-the labels of the articles of drug failed 
to bear the common or usual name of each active drug ingredient.
DISPOSITION : 10-11-61. Consent-the devices were claimed by the shipper and 
the articles of drug were claimed by Jewel Holmes joined by her husband, 
Herbert W. Holmes, t/a Milady's Clinic. The articles were released to the 
claimants subject to the provisions of a consent decree which provided for the 
destruction of the articles of drug and the postcards and leaflets .