IA#66-20,    9/22/92 REVISED


TYPE OF ALERT:  Automatic Detention

PRODUCT      :  Mexican Folk remedies such as Azoque, Greta,
                Azarcon, and other similar products

PRODUCT CODE :  66V--99

HARMONIZED
CODE         :  N/A

PROBLEM      :  New Drug without an approved New Drug Application
                (NDA) (DNRD) and labeling lacks adequate
                directions for intended use (DVDW)
PAC FOR
COLLECTION   :  56008H

COUNTRY      :  Mexico, (MX,595), and others from which similar
                products are shipped.

MANUFACTURER/
SHIPPER      :  All

MANUFACTURER/
SHIPPER I.D.#:  N/A


IMPORTER'S
I.D. #       :  N/A

CHARGE       :  "The article is subject to refusal of admission
                within the meaning of Section 801(a)(3) in that
                it appears to be a new drug without an approved
                New Drug Application (NDA) [Unapproved New Drug,
                505(a)]; and the labeling fails to bear adequate
                directions for use for its intended purpose
                [Misbranded, Section 502(f)(1)]."

RECOMMENDING
OFFICE       :  CDER/Office of Compliance, Health Fraud Staff,
                (HFD-304)

REASON FOR
ALERT        :  The Food and Drug Administration received
                information from the California State Health
                Department that they had seized containers of a
                Mexican folk remedy called "Azoque" being offered
                for sale at a San Jose store specializing in
                Latin American Imports.  Other similar Mexican
                folk remedies called "Greta", "Azarcon", "Rueda",
                "Coral", "Alarcon", "Liga", and "Maria Luisa"
                were previously known to be offered for sale in
                the Hispanic communities throughout the U.S.,
                predominantly among migrant workers in south
                Texas, California, and Florida.

                These products reportedly are recommended for the
                treatment of empacho (a general Spanish term for
                indigestion, diarrhea, and other stomach and
                intestinal illnesses) and are primarily given to
                infants and children.  There is some adult use.

                Azoque, is the Spanish term for mercury which is
                poisonous.

                Mercury and its salts are absorbed through the
                mucous membranes and are toxic, especially to
                persons exposed to them for extended periods of
                time.  Azarcon and Greta are orange and yellow
                powders containing lead which pose significant
                hazards especially to children.  Greta, for
                example, is approximately 99 percent lead oxide.
                "Rueda", "Coral", "Alarcon", "Liga", and "Maria
                Luisa" are also believed to be lead containing
                compounds.  Use of these products may result in
                neurological disturbances including seizures,
                coma, and death.

INSTRUCTIONS :  Detain, without analysis, shipments of "Azarcon",
                "Rueda", "Coral", "Alarcon", "Liga", and "Maria
                Luisa" or any other products that the district
                determines to be similar either from Mexico or
                other countries when presented for entry.

PRIORITIZATION
GUIDANCE     :  N/A

FOI          :  No purging required

KEYWORDS     :  Folk remedy, Azoque, Greta, Azarcon, Alarcon,
                Rueda, Coral

PREPARED BY  :  Linda A. Wisniowski, DIOP, 301-443-6553.