DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
VIA FEDERAL EXPRESS
555 Winderiey Pi., Ste. 200
Maitland, FI 32751
WARNING LETTER
FLA-00-66
July 11, 2000
Mr. Alan R. Figueroa
President and CEO
Catalysis Corporation
8185-2 N.W. 155th Street
Miami Lakes, Florida 33016
Dear Mr. Figueroa:
This letter is in reference to your firm’s marketing and distribution
of the products, Blue Cap, Kalsis, Herpigen spray, Herpigen lip cream,
Viusid, and Diamel. Labeling for these products makes therapeutic
claims which cause the products to be drugs [section 201(g) of the
Federal Food, Drug, and Cosmetic Act (the Act]. Labeling is not
limited to the immediate product containers, but includes all
promotional material, printed or otherwise, connected to the products
which you distribute.
Blue Cap spray, cream and shampoo are labeled as containing the active
ingredient, zinc pyrithione. These products are sold over-the-counter
(OTC) and promotional material for these products offers them for the
treatment of dandruff, seborrheic dermatitis, and psoriasis.
Blue Cap products are subject to final regulations on Drug Products for
the Control of Dandruff, Seborrheic Dermatitis and Psoriasis [Title 21,
Code of Federal Regulations, Section 358.701 to 750] that became
effective on December 4, 1992. This product fails to meet all the
requirements of the final regulations. Since a claim for psoriasis
treatment is not permitted for the active ingredient, zinc pyrithione,
the product is a new drug [section 201(P) of the Actl. A new drug may
not be legally marketed in the United States without an approved New
Drug Application [section 505(a) of the Actl. These products are also
misbranded since the labeling does not include the complete "“statemnt
of identity"” and adequate directions for the condition for which it is
offered [section 502(f)(l) of the Act]. The labeling for these
products is false and misleading because it suggests that the products
are safe and effective for their intended uses, when in fact, this has
not been established [section 502(a) of the Act].
Furthermore, Blue Cap spray and cream are adulterated because
FDA laboratory analysis confirmed the presence of undeclared
corticosteroids, i.e., betamethasone 17-propionate 21-butyrate in the
spray product and betamethasone 17-propionate 21-stearate in the cream
product. The presence of either of these corticosteroid active
ingredients in an OTC product causes the article to be a new drug which
is not approved by FDA for sale in the United States as well as causing
it to be adulterated [section 501(c) of the Act]. Also, these products
are misbranded [section 502(e)(l)(A)(ii) of the Act] since the label
fails to bear the established name of each active ingredient.
Objectionable claims for the other products include the following:
Kalsis
“osteoporosis treatment,” “improve and accelerate the reconstruction of
the bone structure,” “results have been confirmed by densitometry in
osteoporosis patients”;
Herpigen Spray and Lip Cream
“genital herpes simplex virus,” “alternative medicine and product,” “all
natural alternative to treatingintimate problems with a prescription,”
“maximum effectiveness for the most intimate problems,” “all natural drug
free product,” “clinical studies available upon request”;
The product name “Herpigen” associated vaginal or lip products represents
an implied Herpes claim.
Viusid
“increase of the immunological defenses in all those processes that cause
immunodeficiencies,” “eliminate the negative effects of the free radicals
that appear in all the infectious processes,” antiviral, reduces the
infections, helps with...healing of wounds, antitumoral, treatment of
gastic hyperactivity, protects against cancerigenic agents, prevention of
many viral and bacterial infections, HIV, prevents appearance of buccal
ulcers, analgesic, cicatrization [healing or scar formation] of wounds;
Diamel
All references to diabetes or diabetics including those found in the
bibliography, glucemia, regenerate the production of insulin, “my glucose
level went down from 380 to an average of 100/103...My insulin level also
went down,” “Natural Drug Free Formula,” “Natural Medicine Breakthrough
Product,” “clinical studies available upon request”.
These products are “new drugs” [section 201(p) of the Act]. Therefore,
they may not be legally marketed in this country without approved New
Drug Applications (NDAs) [section 505(a) of the Act].
These drugs are also misbranded because their labeling fails to bear
adequate directions for the conditions for which they are offered
[section 502(f)(l) of the Act] and their labeling is false and
misleading because it suggests that the products are safe and
effective for their intended uses when in fact, this has not been
established [section 502(a) of the Act].
This letter is not intended to be an all inclusive review of all
labeling and products your firm may market. It is your responsibility
to ensure that all products marketed by your firm are in compliance
with the Act and its implementing regulations.
We request that you take prompt action to correct these violations.
Failure to promptly correct these violations may result in enforcement
action being initiated by the Food and Drug Administration without
further notice. The Federal Food, Drug, and Cosmetic Act provides for
the seizure of illegal products and for injunction against the
manufacturer and/or distributor of illegal products.
Please notify this office in writing within fifteen (15) working days
of receipt of this letter as to the specific steps you have taken to
correct these violations and to prevent the recurrence of similar
violations. If corrective action cannot be completed within fifteen
working days, state the reason for the delay and the time within which
corrections will be completed.
Your response should be sent to the Food and Drug Administration,
Florida District office, 555 Winderley place, Ste. 200, Maitland.
Florida 32751, Attention: Martin E. Katz, Compliance Officer.
Sincerely,
[signed]
Emma R. Singleton
Director, Florida District
The Original Blue Cap Warning Letter in Adobe Acrobat .pdf format The FDA summarized the banned Blue Cap products from Catalysis Spain with this June 29, 2000 import alert:
Catalysis, S.I. Blue Cap Spray Spain
Zurbano 39 Blue Cap Cream 6/29/00
Madrid, Spain 28010 Blue Cap Shampoo
FEI# 3002989319
Product Codes:
Blue Cap Spray (100 ml, 3.33 fl oz): 62SAQ99, 61SAQ01, 61HBQ05,
53E[][]06, 53J[][]02, 53L[][]06
Blue Cap Cream (50 g, 1.6 oz): 62SAJ01, 53E[][]06, 53L[][]03,
53L[][]06
Blue Cap Shampoo (150 ml, 4.99 oz): 61HBL05, 63SAL01, 53E[][]06,
53L[][]06
These Catalysis import alerts provide some details: Catalysis
Madrid LOS-DO T76-0823467-2 1 1
53LA-03 SKIN MEDICATION - AEROSOL SPRAY
Detain w/o Exam 10-AUG-2000 UNAPPROVED
Catalsis
Madrid FLA-DO XXX-0027392-1 1 1
66VCL99 BLUE CAP MEDICATED SHAMPOO
Detention 15-JUN-2000 I267814 UNAPPROVED
Spain WIG-2010456-6 1 1
Catalysis
Madrid FLA-DO
61HBQ05 MEDICATED DERMATOLOGICAL AGENT
Detention 12-JUN-2000 I267251 UNAPPROVED
Catalysis
Madrid FLA-DO
62SAQ99 ANTIDANDRUFF, SEBORRHEIC AND DERMATITIS SPRAY.
Detention 09-JUN-2000 I265429A LABELING
UNAPPROVED
Spain XXX-0024208-2 1 1
Catlysis
Madrid FLA-DO
62SBQ99 Blue Cap Spray
Detention 09-JUN-2000 I244854A NO ENGLISH
UNAPPROVED
Catalysis
Madrid FLA-DO WIG-2010053-1 1 1
66VAY99 SKIN CREME
Detention 02-MAY-2000 I263685 NOT LISTED |
