Food and Drug Administration

Questions have arisen as to whether a less refined, less expensive carrageenan--a food additive derived from red seaweed--manufactured in the Philippines should be imported and sold in the United States. U.S. carrageenan manufacturers estimate that their revenue losses to the Philippines could exceed $170 million over four years. On the basis of its food additive regulations for traditionally refined carrageenan, the Food and Drug Administration (FDA) classified Philippine natural grade carrageenan as carrageenan, which is an approved food additive. As a result, Philippine manufacturers were not required to submit a food additive petition to FDA. A new food additive petition would have required FDA to approve conditions under which the Philippine product could be used in foods. In determining that the Philippine carrageenan complied with its food additive regulations, FDA concluded that there were no major qualitative differences between Philippine natural grade carrageenan and traditionally refined carrageenan, including the safety of processing. However, allegations of illegal pesticide use have prompted FDA to test Philippine natural grade carrageenan for unapproved pesticide residues, specifically ethylene oxide.

GAO found that: (1) FDA based its classification of the additive on its regulations for traditionally refined carrageenan which do not require the additive's manufacturers to submit a food additive petition; (2) FDA determined that the additive was safe and there were no significant qualitative differences between the additive and traditionally refined carrageenan; (3) in response to manufacturers' questions about the propriety of the classification and the additive's safety, FDA requested and reviewed data on the additive's safety and again concluded that it was safe; (4) traditional manufacturers have petitioned FDA to change its regulations so that the additive would be named and marketed differently from carrageenan; and (5) in response to allegations, FDA is testing the additive for unapproved pesticide residues.