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FDA Proposes Lowered Lead Levels in Candy

New guidelines calls for a fivefold drop in trace amounts allowable

THURSDAY, Dec. 22, 2005 (HealthDay News) -- Federal health officials have proposed new guidelines to further reduce trace levels of lead found in certain candies.

The proposed new guidance level is 0.1 part per million (ppm) of lead. The old level was 0.5 ppm for candy products likely to be consumed frequently by children.

"The effect will be a fivefold lowering of the current level," said Michael Kashtock, senior advisor for plant product safety in the Office of Plant and Dairy Foods at the U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition.

"We believe that these steps will further reduce an already minimal risk in lead exposure in candy," Kashtock said at a news conference Thursday.

The agency's announcement followed the testing of certain types of Mexican candy products that showed lead levels significantly above those currently allowable in the United States.

Lead poisoning is associated with behavior and learning problems in children, and can also cause seizures or death. The risk is greatest in children aged 6 and younger.

Most domestic and imported candies already have lead levels of 0.1 ppm or less. Certain candies imported from Mexico, however, have higher levels, apparently as a result of ingredients such as chili powder and salt.

Those products include lollipops coated with chili and powdery snack-type mixtures of salt, lemon flavor and chili powder, the FDA said.

Kashtock would not identify which specific candies were at risk. But the FDA did identify a number of candies that had been halted from entering the United States:

  • Tamarind lollipops from Candy Pop, in Guadalajara, Mexico;
  • Lollipops from Carmen Patricia Guzman, in Mexicali, Mexico;
  • Chaca candy from Industria Dulcera, Morelia, Mexico;
  • Tamarind candy in ceramic jars from Margarita Guiltron Ramirez, Guadalajara, Mexico;
  • Chocolate-flavored lentil candy from Montes y Cia, Poncitlan, Mexico;
  • And eucalyptus-menthol candy from Storck Products, Inc., Manila, Philippines, which was shipped by two Filipino companies, CPMulti-Commodities Corp. and Pacific Isles International Trading, Inc.

Kashtock added that health officials had known about elevated lead levels for some time but did not take action because "we had to learn about where the lead was coming from." The culprit turned out to be such ingredients as chili and salt.

A certain amount of lead in foods such as candy is unavoidable, because sugar, for instance, has lead in it, Kashtock explained.

But with these guidelines, the FDA expects that Mexican manufacturers will "take additional steps in the processing of chili and salt to reduce the avoidable occurrence of lead," he added.

The guidelines, however, are just that: guidelines. Because these are not regulations, the enforcement parameters are not clear.

The FDA tends to rank candies on their "consumption potential." A candy not likely to be eaten very often but which has higher than 0.1 ppm of lead would be allowed to slip through. Those with higher levels that are eaten by children more often might be stopped.

"For candies that have significant consumption potential, we do believe that we can take enforcement action at or very near the 0.1 ppm level," Kashtock said.

There is also concern that certain manufacturing or packaging processes contribute to added lead levels.

"Candies in lead-glazed ceramic bowls could pose a hazard regardless of what the guideline is," Kashtock said. "Unless there's some way to ascertain that these are non-lead-glazed, I don't think a parent would have anyway of knowing that these products might not contain significant levels of lead."

Kashtock said that the FDA was continuing to test various products, and that lead levels are already coming down.

"That could very well be because they've simply been removed from the market, and that producers are reformulating them or making changes in the way that their ingredients are processed," Kashtock said. "Overall, we're seeing fewer products with higher lead levels than we had seen in 2003 and prior to that."

In addition to continued routine testing of candy, the FDA is in talks with the Mexican government and Mexican industry.

"We have laid out steps that we think manufacturers of these types of candies can take to comply with the guidance," Kashtock said. "We think that they're going to be well received."

The guidance will appear in the Federal Register, and public comments and suggestions will be accepted for 75 days after its publication.

More information

The draft guidance is accessible at the U.S. Food and Drug Administration.

SOURCES: Dec. 22, 2005, news conference with Michael Kashtock, Ph.D., senior advisor and special assistant, Division of Plant Product Safety, Office of Plant and Dairy Foods, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
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