Sulfites; FDA limits use, broadens labeling

Sulfites; FDA limits use, broadens labeling – Food and Drug Administration

Chris W. Lecos

SULFITES: FDA Limits Uses, Broadens Labeling

FDA has taken two major steps to protect consumers who are sensitive to sulfites in food. No longer can these preservatives be used on raw fruits and vegetables. And many more processed foods that contain sulfites will have to say so on the package label. The agency also has proposed warning labels for prescription drugs that contain sulfites.

Although sulfites are not considered a hazard to most people, as many as 1 million Americans–most of them asthmatics–could suffer reactions if they consume them in food. The allergic-type reactions range from mild to severe, and in some cases can cause death. Both of FDA’s actions were proposed in 1985 (see “Reacting to Sulfites,” in the December 1985-January 1986 FDA Consumer) and made final with their publication in the Federal Register of July 9, 1986.

“Sulfites” or “sulfiting agents” are general terms used to describe sulfur-based substances that have been in widespread use for many years by the food and drug industries. They include sulfur dioxide, sodium sulfite, sodium and potassium bisulfite, and sodium and potassium metabisulfite. Although they have various permitted uses, their primary function is as a preservative or antioxidant to prevent or reduce spoilage and discoloration during the preparation, storage and distribution of many foods. For example, potatoes, mushrooms and shrimp will appear whiter and fresher when sulfites are applied. Lettuce will stay crisper and not wilt or brown as readily when treated with sulfites. Sulfites also are used in many drugs, wines and beers.

Some 10 million Americans suffer from asthma, and FDA scientists and other experts estimate that up to 1 million of them may be sensitive to sulfites. Some other scientists, however, claim the number is much lower–perhaps as few as 180,000 individuals, most of whom need strong steroid drugs to control their severe asthma.

There is some evidence that some non-asthmatics also can suffer adverse reactions to sulfites. For example, out of more than 500 reports of sulfite reactions investigated by FDA, about one-fourth involved people who had no known history of asthma.

The ban on the use of sulfites on raw fruits and vegetables–excluding potato products–became effective Aug. 8. This regulation is aimed primarily at restaurant salad bars and other food service outlets, including grocery stores and supermarkets that use sulfites on raw produce. FDA officials stressed, however, that the ban on sulfites in fruits and vegetables does not necessarily eliminate the preservatives from other foods often featured in salad bars. Such products as potato and shrimp salads, canned vegetables and fruits, dried fruit, pickled vegetables (such as peppers and cauliflower), pickles, pickle relish, and olives all may still contain sulfites.

The new labeling regulation–which goes into effect Jan. 9, 1987–further defines when the presence of sulfites must be declared in a finished food. Any food that contains at least 10 parts per million of sulfites must identify the sulfite in the ingredient list on the label.

The regulation clarifies existing FDA labeling requirements, and it will result in the disclosure of the presence of sulfites on the labels of many more foods.

FDA established 10 parts per million as the label declaration level because that is the lowerst level at which sulfites can readily be measured, although the agency stated it was “unaware of any evidence that establishes a level below which these substances will not cause a reaction in sensitive individuals.”

The sulfite-reaction symptoms most frequently reported to FDA are of the asthmatic and allergic type, such as difficult breathing, wheezing and hives, as well as gastrointestinal distress. FDA established its sulfite reaction monitoring system in 1985. By June 30, 1986, 709 complaints had been received. Of the more than 500 completed evaluations, 55 percent (274) were classified as serious reactions, including 19 deaths.

“Given the limitations of the information available to us,” a recent FDA report noted, “we have determined that 8 of these deaths are probably associated with the use of sulfiting agents, 5 . . . are possibly associated with sulfites in either foods or drugs, and 6 . . . are probably not related to sulfites.”

The foods most frequently blamed by consumers for their reactions were salad bar items and other fresh fruits and vegetables. They accounted for 32.2 and 14.7 percent, respectively, of the complaints investigated. Other products that accounted for at least 10 percent of the complaints received were seafoods, potato products and wines.

The one principal produce item not covered by FDA’s ban on sulfites in fresh fruits and vegetables is potatoes. FDA said that it would issue a separate regulation governing this use.

By last June 30, FDA had received 24 consumer complaints about alleged reactions to sulfite-treated drug products, 19 of which were classified by the agency as severe reactions.

FDA is addressing the use of sulfites in drugs through a regulation proposed on Nov. 19, 1985. The proposal would require a warning on the labeling of the approximately 1,100 prescription drugs that contain sulfites. The warning would state that sulfites may cause serious allergic reactions in some sensitive persons. It could help physicians avoid prescribing drugs and sulfites to patients known to be sulfite-sensitive.

The proposal was in response to a petition by the Center for Science in the Public Interest, a Washington, D.C.-based consumer advocacy group. The group had asked FDA to ban the use of sulfites in drugs prescribed for asthma and to either ban or require warning labels on other prescription and nonprescription drug products with sulfites.

FDA said that a ban was not warranted because of the important role that sulfites play in maintaining the potency and stability of drugs. “Prohibiting sulfite use in drug products could be justified only if acceptable alternatives [to sulfites] were available,” the agency said. FDA added that it knew of no adequate replacement for some uses of sulfites in drugs, and also “some alternative antioxidants could pose safety problems as severe or worse than with sulfites.” FDA is reviewing public comments on its response and is expected to take final action on a regulation by the end of the year.

The types of medications that may contain sulfites include antiemetics (taken to prevent nausea), cardiovascular drugs, antibiotics, psychotropic drugs, intravenous muscle relaxants, analgesics (pain-killers), anesthetics, steroids, and nebulized bronchodilator solutions used to treat asthma. (Metered-dose bronchodilator inhalers for asthma do not contain sulfites.)

FDA regulations already require that labels of injectable prescription products list inactive ingredients, including sulfites. However, this inactive ingredient listing requirement does not apply to drugs prescribed for oral use. (Relatively few oral drugs contain sulfites. The amjority are intravenous or spray-type products.)

Agency officials indicated that label disclosure of sulfites in both oral prescription and all nonprescription products also is expected through a voluntary effort initiated by various major drug industry trade groups.

Industry spokesmen reported in recent interviews that a voluntary effort to get their members to disclose sulfite uses on prescription and over-the-counter products has been successful. “It is our estimation that our industry is approaching 100 percent compliance,” said Charles Cleveland, assistant vice president of technical services for the Pharmaceutical Manufacturers Association. The association’s 112 members produce the majority of prescription drugs in the United States.

The Proprietary Association, whose 83 members make more than 90 percent of all nonprescription drugs in the United States, said that few over-the-counter products contain sulfites. “Ten to 11 companies make about 20 products that contain sulfites, and 18 of these are topical [applied to the skin] products,” which are unlikely to cause reactions, according to Mary Simons, assistant director of public affairs for the association.

COPYRIGHT 1986 U.S. Government Printing Office

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