November 2, 1989
FDA REVIEW FINDS NO ADVERSE HEALTH THREAT FROM ETHOXYQUIN
As a result of publicity in pet magazines and newspapers, there have
been inquiries about the safety of ethoxyquin. Some have suggested this
approved food additive is responsible for a wide range of common
health-related problems in dogs, from itchy skin and lethargy to thyroid and
kidney problems, reproductive disorders and even cancer.
Ethoxyquin is a chemical preservative 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. The following may be used to answer
questions:
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
regulations for safe levels of ethoxyquin's use in animal feed at a maximum
of 150 parts per million -- equivalent to 0.015 percent of the finished
product. Specifically, the approved animal feed uses of this additive are
(1) to retard oxidation of carotene, xanthophylls and Vitamins A and E in
animal feed and fish food, (2) to retard oxidation of Vitamin E and carotene
in dehydrated forage crops and (3) to retard organic peroxides in canned pet
food.
-MORE-
Page 2
A five-year study in dogs (1959-1964) by Monsanto Agricultural of St.
Louis, Mo., 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
literature search carried out by FDA's Center for Veterinary Medicine found
a 1987 paper that reported on a 23-week study in rats. The study used a
dose level of 5,000 ppm 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, N.C. 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
ingredient. 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.
| |