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9 FDA Veterinarian 1 (1994)

handle is hein.animal/fdavt0009 and id is 1 raw text is: F PROPYLENE GLYCOL UNSAFE FOR USE IN CAT FOODS By David A. Dzanis, D. V. M., Ph. D., DA C VN P ropylene glycol (PG) is a substance that has been added to semimoist dog and cat foods to give these prod- ucts their unique texture and taste. It serves as a humectant, which means it helps retain water in the product. It also has antimicrobial function, provides calories, and increases palatability. Typi- cal levels of PG in commercial semi- moist pet food pet are 6 to 13 percent on a dry matter basis. However, recent studies have confirmed earlier FDA con- cerns that PG is not safe for use in foods for cats. Propylene glycol was included on the list of substances generally recognized as safe (GRAS) for use in animal feeds in 1959, before the advent of semimoist pet foods. In 1976, the European Eco- nomic Community initiated a review of additives used in pet foods. Studies were conducted on both dog and cats. In dogs, no clinical or hematological ef- fects were seen at levels of PG that were used in semimoist food. However, the presence of Heinz bodies, small clumps of denatured protein, were found in the red blood cells of cats con- suming PG. Although Heinz bodies were known to be indicative of red blood cell damage, there was no evidence at that time that PG caused anemia or other adverse clinical effects in cats. In response to continuing concerns, the Pet Food Industry Research Group (IRG), comprised of pet food companies and manufacturers of PG, was formed. Its purpose was to investigate the sig- nificance of PG and Heinz body forma- tion in cats, particularly as to how it may effect the health of cats. The IRG cooperated with FDA in meetings and progress reports on the studies. The results of the IRG studies were published in peer-reviewed scientific journals. In the first study, adult cats were fed diets containing 0, 6, or 12 percent PG on a dry matter basis over a 16-week period. Cats fed PG had a dose-related increase in Heinz bodies, and a dose-related decrease in mean red blood cell survival time. In the 12 per- cent group, there was also an increase in punctate reticulocytes, and slight changes in the packed cell volume, he- moglobin concentration, and red blood cell counts. These results indicated that the red blood cells were more suscep- tible to destruction due to PG. Peripor- tal liver glycogen accumulation, splenic nodules, and heart and kidney lesions were observed in some of the cats in the 12 percent group, and the same splenic lesions were seen in some cats in the 6 percent group. In the second study, 12 to 14-week-old kittens were fed diets containing 0, 6, or 12 percent (Continued, page 3) BST APPROVED U nder review by FDA since the early 1980s, Monsanto Company's bo- vine somatotropin (BST) product, sometribove, received approval on November 5, 1993. BST, a recombinant DNA product, increases milk production in cows by supplementing the naturally occurring BST. Milk from treated cows has the same overall nutritional value and com- position as milk from untreated cows. Recombinant BST is made in much the same way as synthetic human in- sulin, for treating diabetes. The gene for BST is inserted into special bacteria, which then reproduce, replicating the gene. The BST is collected from these bacteria and further processed. The fin- ished, sterile product is then formulated for injectable use in dairy cows. Three other companies, American Cyanamid, Eli Lilly, and Upjohn, have BST products under review. During FDA's review of BST, begin- ning in the early 1980's, there has been much public debate on safety and economic issues related to the drug. Safety Issues In the mid-1 980's, FDA determined that food products from BST-treated cows were safe for human consump- tion. This determination was based on a number of scientific findings. Be- cause it is a protein hormone, BST is broken down during digestion, which renders it biologically inactive and in- capable of having any effect in humans. (Continued, next page) In This Issue: Guilty Plea in Bulk Drug Case ................. 2 Aquanotes .............. 4 Adverse Drug Reaction Summary .............. 4 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR VETERINARY MEDICINE UNIVER511 Y Al utUrLV January/February 1994 Vol. IX, No. I EB 151994 ' Jaur/ I Ell WIS.151 I L. IVLII%,nL rtrp RIA-r #L11%1r221 AL4rr. r7

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