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5 FDA Veterinarian 1 (1990)

handle is hein.animal/fdavt0005 and id is 1 raw text is: V3 - tit-- -4 --4qo / January/February 1990 Vol. V, No. I S~FDA VETER[NAR[AN iJFDA REVIEW FINDS NO A s a result of publicity in pet maga- P'zines and newspapers, there have been inquiries about the safety of ethoxyquin. It has been suggested by some that this approved food additive is responsible for a wide range of com- mon health-related problems in dogs, from itchy skin and lethargy to thyroid and kidney problems, reproductive dis- orders, and even cancer. UPDATE ON SULFAMETH The Food and Drug Administration announced that it is moving closer to a decision on the use of the con- troversial animal drug sulfamethazine (SMZ). Recent studies at the National Center for Toxicological Research (NCTR) have shown that SMZ at high doses causes thyroid tumors in rats and mice. The Center is completing a risk assessment of SMZ after review- ing the data from the NCTR studies; a decision will be made whether con- tinued use is possible or if the drug must be restricted or banned. In a November 4, 1989 article in The New York Times, Dr. Gerald Guest, director of CVM, was quoted as fol- lows: We are proceeding on the basis that this compound causes tumors. We have several steps to complete, but I expect that in six months we will pro- pose to withdraw this drug from the market. Dr. Guest also said that the evidence was now strong enough to remove DVERSE HEALTH THREAT Ethoxyquin is a chemical preserva- tive used in animal feed to prevent ingredients from reacting with oxygen and becoming rancid. It is also used in human foods as an anti-oxidant as well as to preserve color in paprika and ground and powdered chili. Ethoxyquin and other anti-oxidants, such as BHA and BHT, have been used in animal feed for more than 25 years. FDA has published food additive regu- lations for safe levels of ethoxyquin in animal feed at a maximum of 150 parts per million-equivalent to 0.015 per- cent of the finished product. Specifi- cally, the approved animal feed uses of this additive are (1) to retard oxidation of carotene, xanthophylls, and Vita- mins A and E in animal feed and fish AZINE SMZ from the market, but there will be public notices and hearings, as required by government regulations, before the decision becomes final. I don't think there is a serious direct public health threat, Dr. Guest said. There has been a long history of use in man. But We have a law that says if you have a drug that causes tumors in animals, you have to treat it ultraconservatively. there is a study of sulfamethazine that resulted in tumors and that's a problem. We have a law that says if you have a drug that causes tumors in animals, you have to treat it ultraconservatively. An example of an ultraconservative approach to food safety is CVM's appli- cation of a 1 in 1,000,000 risk assess- ment technique when data show tumor formation in laboratory animals. (Continued, page 6) FROM ETHOXYQUIN food, (2) to retard oxidation of Vitamin E and carotene in dehydrated forage crops, and (3) to retard organic perox- ides in canned pet food. A five-year study in dogs (1959- 1964) by Monsanto Agricultural, St. Louis, Missouri, found no pathological changes attributable to ethoxyquin. A 1982 literature search by FDA's Center for Food Safety and Applied Nutrition found no evidence that ethoxyquin was carcinogenic. In 1988, a second litera- ture search carried out by FDA's Center for Veterinary Medicine found a 1987 paper that reported a 23-week study in rats. The study used a dose level of 5,000 parts per million ethoxyquin- far higher than approved levels-that suggested a carcinogenic potential. Because of this, the Agency nominated ethoxyquin for toxicity testing under the National Toxicology Program in Research Triangle Park, North Carolina. A decision on whether this testing will be undertaken is expected to be made late in 1990. To date, FDA has found no scientific or medical evidence that ethoxyquin used at approved levels is injurious to human or animal health. Also, FDA has found no documentation of the claims of harm to any animal. The Agency will continue to review any new data generated on the safety of this ingre- dient. Should any adverse health effect be documented, FDA will not hesitate to enforce the Federal Food, Drug, and Cosmetic Act to protect the health of humans and animals. E In This Issue: Proper Drug Use . . . 2 Generic Animal Drug Law . ... 3 Flea Collars Ineffective ...... 4 Tissue Residues Update ..... 7 Category I-Revised Approval . 8 Recall of Atropine Sulfate . .. 13 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR VETERINARY MEDICINE

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