IA #66-38, 3/6/90, ATTACH A 9/12/94 & ATTACH B 9/12/94
TYPE OF ALERT: INTENSIFIED COVERAGE
PRODUCT : Skin Care Products
PRODUCT CODE : 66VBJ99
PROBLEM : New Drug Without an Effective New Drug Approval
(DRND)
COUNTRY : All
MANUFACTURER/
SHIPPER : All
CHARGE : "The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears
to be a new drug without an effective new drug
application (NDA) as required by Section 505(a)."
RECOMMENDING
OFFICE : CDER, Health Fraud Staff (HFD-304)
REASON FOR
ALERT : There are numerous skin care products on the market
with exaggerated "anti-aging" claims which cause
the products to be unapproved new drugs. Examples
of such claims are that the products "counteract",
"retard", or "control" the aging process. Claims
that the product will "rejuvenate", "repair", or
"restructure" the skin may also be drug claims. A
claim such as "molecules absorb and expand,
exerting upward pressure to 'lift' wrinkles
upward" is a claim for an inner structural change
that would usually cause a product to be a drug.
Between April 17 and June 17, 1987, Regulatory
Letters were sent to several manufacturers of skin
care products labeled with these types of claims.
By letter of March 24, 1988, the Associate
Commissioner for Regulatory Affairs informed these
manufacturers that "Beginning 30 days after the
date of this letter, any products found to be in
substantial violation of the new drug and
misbranding provisions of the act may be subject to
regulatory action without prior notice."
This Import Alert (IA#66-38), originally issued on
June 8, 1988, listed in Attachment A those
manufacturers that had received Regulatory Letters.
Since then additional manufacturers have been sent
Regulatory Letters. Attachment A now lists those
firms FDA believes may be importing these skin care
products with drug claims.
Attachment B lists those firms that FDA believes
may be manufacturers or shippers of these products.
Import Alert #66-38 Page 2
INSTRUCTIONS : All entries of skin care products imported by the
firms listed in Attachment A or manufactured/shipped by
the firms on Attachment B should continue to be checked
for drug claims until a district is convinced the firm's
products are in compliance. Surveillance of entries of
skin care products from other importers is also
indicated.
For additional guidance, Roma Jeanne Krause of HFD-304
(295-8070) may be contacted.IA #66-38 Attachment A REVISED 9/12/94
Manufacturers/Importers of Skin Care Products
Adrien Arpel
521 Fifth Avenue
New York, NY 10175
Aesthetics Complete, Inc.
411 E. Lancaster Avenue
Wayne, PA 19037
Almay, Inc.
850 Third Aveenue
New York, NY 10022
Avon Products. Inc.
9 West 57th Street
New York, NW 10019
Beauty Center of Palm Beach 10/30/90
5612 S. Dixie Highway
West Palm Beach, Florida
BelNature Cosmetics, Inc.
1850 Coral Way
Miami, Florida 33145
Biotherepeutic Computers
4822 California Avenue, SW
Seattle, WA 98116
Biotherm
Division of Cosmair, Inc.
575 Fifth Avenue
New York, NY 10017
Botanical Garden
800 N.E. 62nd Street
Suite 304
Fort Lauderdale, FL 33321
Chanel, Inc.
9 West 57th Street
New York, NY 10019
Christian Dior Perfumes, Inc.
9 West 57th Street
New York, NY 10019
Clarins, USA, Inc.
540 Madison Avenue
New York, NY 10022Import Alert #66-38 Attachment A Page 2
Cosmair, Inc.
575 Fifth Avenue
New York, NY 10017
Coty Division of Pfizer
235 East 42nd Street
New York, NY 10017
Elizabeth Arden, Inc.
55 East 52nd St.
New York, NY 10055-0191
Estee Lauder
767 Fifth Avenue
New York, NY 10153
Frances Denney, Inc.
437 Madison Avenue
New York, NY 10022
Gadol Distributors
2383 Collins Avenue
Miami Beach, FL 33139
Germaine Monteil Cosmetiques Corporation
40 West 57th Street
New York, NY 10019
Image XII International
8340 S.W. 8 Street
Miami, FL 33165
Jason Natural Cosmetics
8468 Warner Drive
Culver City, CA 90232-2488
JENEVE Cosmetics
Blaine, WA
La Prairie, Inc.
40 Wast 52nd Street
New York, NY 10022
Lendan USA Co
7924 N.W. 65th Street
Miami, FL 33166
Matis U.S.A., Inc.
305 Kingston Avenue
Daytona Beach, FL 32014
Import Alert #66-38 Attachment A Page 3
Max Huber Research Labs, Inc.
5341 - Derry Avenue
Agoura, California 91301
Mira Linder Inc. Night Corrector Regenerating
29935 Northwestern Highway Cream
Southfield, MI (12/18/91)
48034
Neyda E. Avila
1645 S. Miami Avenue
Miami, Florida 33129
Noblesse International Ltd., Dist
1129 Northern Boulevard
Manhasset, N.Y. 11030
Orlane/Caron Group
16 East 52nd St.
New York, NY 10022
Parbel, Inc.
2335 N.W. 107 Avenue
Miami, Fl 33172
Princess Marcella Borghese, Inc.
767 Fifth Avenue
New York, NY 10153
Rachel Perry, Inc.
9111 Mason Avenue
Chatsworth, CA 91311
Revlon, Inc.
625 Madison Avenue
New York, NY 10022
(Importer)
Samuel Meisel & Co. Evolution Skin Care Products
6691 Baymeadow Drive 9/12/94
Glen Burnie, MD
Sanofi Beauty Products
New York, NY
Shiesido Co., Ltd.
900 Third Avenue
New York, NY 10022
Skin Culture Inst., Inc.
38 West 32nd Street
New York, NY
Import Alert #66-38 Attachment A Page 4
Swiss Skin Care
13401 NE Bel Red Road
Bellevue, WA 98005
The Skin Research Group
Prince Matchabelli, Inc.
33 Benedict Place
Greenwich, CT 06830
Yves Rocher, Inc.
West Chester, PA
Attachment B - IA #66-38 REVISED 9/12/94 Page 1
Manufacturers/Shippers of Skin Care Products
Arnaud Laboratories, S.A.
124, Bd de Verdun
92400 Courbevoie Cedex
Paris, France
BelNature Cosmetics International
San Bernardo 97-99
Madrid, Spain
C.E. Jamieson
2051 Ambassador Drive A-Retinol Anti-aging
Windsor, Ontario, Canada Moisturizing Complex
Chantelet Laboratories
Santa Leonor, 48
Madird, Spain
Claude Bergere - SACHA
Cosmeticos E. Produos
Farmaceuticos, Ltd
San Paulo, Brazil
Dr. Babor GBMH & Co.
Made in West Germany
Ella Bache
87 Rue Marceau
Montreuil, France
Fleur de Sante
Made in Denmark Skin Renew Products
Gerda Spillman International 5/15/90
Neugasse 6
CH-8005 Zurich, Switzerland
Germaine De Capuccini
Mallorea 81, Bajos Royal Jelly Milk
03029 Barcelona, Spain Royal Jelly Mask, Royal Jelly
Cream, Elastin Nourishing Cream
Guerlain Western Hemisphere Co. 9/12/94
P.O. Box F-52
Freeport, France
MID# FRGUEWES52FRE
Attachment B - IA 66-38 Revised 9/12/94 Page 2
Helena Rubinstein
PBI Parfums Beaute Int.
BP433
94155 Rungis Cedex, France
Helena Rubinstein
Made in Germany Skin Life Products
Idesco/Selvert
Costa Brave 30
Barcelona, Spain
Jean d'Estrees
Paris, France
JENEVE Cosmetics
Richmond, B.C., Canada
Julian Jill
RCS AIX-EN Provence 86 B 100
Avenue LaMartine
Z.A. de L'Agavon
BP 22 13751 Les Pennes Mirabeau Cedex
Korff
Made in Germany
Laboratories Dr. N.G. Payot
10, Rue De Castiglione Authentique (Payot) Products
Paris, France
Laboratories Sintyl International
23 Route Des Junns S
Geneva, Switzerland
Laboratorios Carreras S.A. 5/15/90
200 Norte y 125 Este del Joron
Desamparados, San Jose, Costa Rica
Lendan Iberica, S.A.
Barcelona, Spain
L'Oreal Division of cosmair Inc.
Made in France
LoShi Ltd
Made in Japan
LoShi 24 Gold Cosmetics
Matis S.A.
5, Rue Scribe
75009 Paris, France
Attachment B - IA #66-38 Revised 9/12/94 Page 3
Mira Linder Inc. Night Corrector Regenerating
108 Ave Road Cream
Toronto, Ontario, (12/18/91)
Canada M5R 2H3
Narhex Ltd., Hong Kong
Manufactured in Japan
Distributed by:
Laboratoire De Narhex
Paris, France
Nutra Reasearch
Richmond, B.C., Canada
Parfums Lancome
14 Rue Royale
Paris 8 France
Paul Sceiri
Geneva, Switzerland
Profumi E. Cosmetici Italiani 10/30/90
Via Aurelia KM. 300 Ladispoli
Rome, Italy
S.A. Laboratories B.L.C.
Thalgo Cosmetic Ogive, Complex Liposomes
83520 Roquebrune Anti-Wrinkle Extract
S/Argens, France (Renovatrices)
Sothys
Paris, France Sothys-formule exygenante
products
SRL/Skin Research Laboratories
Toronto, Ontario, Canada A-Retinol Anti-aging
Moisturizing Complex
Stendhal
Paris, France
Sum Spec Canada
Burnaby, British Columbia, Canada Retinol (anti-aging cream)
Terme di Saturnia
Milano, Italy
Yves Rocher SA
Paris, France
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