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.