WASHINGTON - Although reform of the U.S. Food and Drug Administration appears unlikely before the November elections, the FDA and the Society of the Plastics Industry Inc. have reached agreement on substances in packaging that come in contact with food. Washington-based SPI lawyer Jerry Heckman said the FDA- industry agreement caps a 40-year effort.
Instead of requiring a complete pre-marketing approval process, the agreement would allow manufacturers of additives to food-container materials - and those added directly to food - to market their products within 120 days of notifying the agency. FDA would have the option to reject the additive. The difference is that instead of waiting for explicit FDA approval, companies can go ahead unless they receive an explicit agency rejection.
According to Heckman, formal food-additive petitions have been necessary for all plastics additives for food-contact applications. Delays often have prompted manufacturers to market their products overseas, where regulatory review periods are shorter.
Congress, now in recess, has little legislative time this session to confront FDA legislation now in committee in both Houses. The agreement needs blessings of both Congress and the White House. Major House FDA reform legislation, sponsored by U.S. Rep. Scott Klug, R.-Wis., would also eliminate the 48-year-old ``Delaney Clause'' from the Food, Drug and Cosmetic Act. Considered a legislative sticking point, the clause prohibits contact of processed food with packaging bearing any trace of a known cancer-causing element.