FDA Bans Sulfites on Fresh Fruits, Vegetables
WASHINGTON (AP) _ The Food and Drug Administration on Tuesday banned the use of sulfite preservatives on fresh fruits and vegetables, including those in restaurant salad bars, because of potentially fatal reactions.
The FDA also ordered expanded labeling requirements for packaged goods containing detectable levels of sulfites.
The regulation, which takes effect next month, was based on a government study of some 500 reports of severe allergic reactions, including 13 deaths. Most involved restaurant foods.
″Salad bars have been associated with most of the serious problems, and the idea of posting signs in restaurants when sulfites have been added has not been universally accepted,″ FDA Commissioner Frank E. Young said in a statement. ″Thus, we believe we must ban the sulfites in this use.″
Sulfite preservatives have been used for decades to make fresh fruits and vegetables look more attractive. Sulfites keep lettuce from wilting, for example, and prevent apple slices from turning brown.
They are harmless for most people. But an estimated 500,000 sensitive people, mostly asthmatics, can suffer an allergic reaction to the preservatives.
Most reactions are not severe, resulting in such symptoms as nausea, hives, diarrhea or shortness of breath. But severe reactions can send a person into shock and constrict the air passages, causing suffocation.
The National Restaurant Association and the Produce Marketing Association say most restaurants have stopped using the preservatives because of the hazard. The trade organizations have endorsed bans on the substances to catch the few holdouts.
But the FDA said the number of complaints indicates increased use of sulfites. In 1983, the agency said, it recorded only 50 complaints about sulfites in restaurant and supermarkets. That number increased to about 300 in 1984, it said.
The FDA said the regulation was based in part on studies conducted by a scientific panel on sulfite hazards which recommended a ban, as well as on its own studies.
The agency also was under pressure from Congress. A hearing on the issue last year featured emotional testimony by the parents of a 10-year-old Oregon girl who died after eating sulfited guacamole in a restaurant.
The FDA regulation affects six sulfite preservatives: sulfur dioxide, sodium sulfite, sodium and potassium bisulfite and sodium and potassium metabisulfite.
All have been listed since 1959 on the FDA’s list of food additives generally recognized as safe. All will be removed from the so-called GRAS list when the regulation takes effect, 30 days from Wednesday’s publication in the Federal Register.
In addition, the FDA ordered a new disclosure requirement for some packaged food, to take effect in six months.
Disclosure labels already are required when sulfites are added as preservatives in many packaged foods, such as dried fruit, lemon juice, maraschino cherries and some canned soups.
The new requirement orders label for smaller amounts of sulfites sometime used in baking and other processes if any sulfites are detectable in the final product.
The FDA said the additional labeling requirement is needed because there is no known level at which sulfites do not pose a health risk for susceptible people.
The agency said other non-packaged foods used in restaurants, such as potatoes and seafood, will be covered by later regulations.
Sulfites also are used in wine and beer. The FDA noted they fall under jurisdiction of the Bureau of Alcohol, Tobacco and Firearms, but said ATF has proposed that they also carry a warning label.