FDA Issues New Dietary Supplement Safety Rules

(HealthDay News) -- After years of pressure from consumer advocates to do so, the U.S. Food and Drug Administration announced Friday that it was tightening up its oversight of dietary supplements.

Firms that make vitamins, herbals and other supplements must now test their products to ensure they aren't contaminated and must include the ingredients listed on the label, FDA officials said.

"This is a critical component of FDA's implementation of the Dietary Supplement Health and Education (DSHEA) act that was passed by congress in 1994," Robert E. Brackett, director of the FDA's Center for Food Safety and Applied Nutrition, said during a late morning teleconference.

Under the act, manufacturers are responsible for making sure that their claims about their products are substantiated by adequate evidence, Brackett said. "This is to show the claims are truthful and not misleading," he added.

The move comes on the heels of recent scandals centered on adulterated supplements. Last year, the FDA discovered that some supplements contained undeclared active ingredients found in prescription Erectile dysfunction drugs, according to the Associated Press. In other cases, supplements were found to have lower levels of vitamins A or C than what was claimed on the label.

In the past, critics have slammed the FDA's approach to supplements as woefully ineffective. Since dietary supplements are considered food supplements and not drugs, they do not fall under the stricter FDA guidelines for drug safety and efficacy -- even though many people use them like drugs, or instead of drugs, to stave off or treat illness, with sometimes deadly consequences.

Consumer groups described the FDA's new efforts to rein in the $22 billion supplements industry as too little, too late.

Friday's move "not only is 13 years late but will not do anything to ensure that dietary supplements are safe or effective -- a critical necessity," Dr. Sidney M. Wolfe, director of the Public Citizen Health Research Group, said in a statement. Wolfe noted that, under the new rule, large manufacturers have a year to comply, and smaller firms have been given a three-year window.

And another advocacy group, Consumers Union, which publishes Consumer Reports, was similarly unimpressed. "This new rule requires dietary supplement makers follow procedures to ensure that their products contain the type and amount of ingredients on the label. However, consumers still have no idea if a given product works, or whether it is dangerous," the group's senior counsel, Janell Mayo Duncan, said in a statement.

The FDA's Brackett said that since the 1994 rule, supplement makers have been required to meet FDA standards set for food manufacturers. However, these new regulations are designed specifically for the supplement industry, he said.

"These rules also apply to supplements made outside the United States," Vasilios Frankos, the FDA's division director of the Office of Dietary Supplements, added during the teleconference.
"Under the rule, manufacturers of dietary supplements are required to evaluate the identity, purity, strength, and composition of their products," Frankos said. Should supplements contain contaminants or not contain the ingredients they say they contain, the FDA would consider these products to be "adulterated or misbranded," he said.

The purpose of the rule is to prevent manufacturers from including wrong ingredients or too much or too little of a dietary ingredient, Frankos noted. In addition, the rule puts the burden on manufacturers to be sure that their products are not contaminated by toxins, bacteria, pesticides, glass, lead and other heavy metals, or improperly packaged or labeled, he said.

In addition, the rule includes requirements for quality control procedures, designing and constructing manufacturing plants, and testing ingredients and finished products. It also includes requirements for record-keeping and handling of consumer complaints.

The FDA is also issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the good manufacturing practices requirement for 100 percent testing of specific dietary ingredients used in the processing of dietary supplements.

Under the proposed rule, manufacturers may be exempted from the dietary ingredient testing if there is documentation that reducing the frequency of testing still ensures the identity of the dietary ingredient.

The final good manufacturing practices and the interim final rule go into effect Aug. 24, with a three-year phase-in period. Companies with more than 500 employees have until June 2008 to comply; companies with fewer than 500 employees have until June 2009 to comply; and companies with fewer than 20 employees have until June 2010 to comply, Frankos explained.

One group representing industry, the Council for Responsible Nutrition, is cautiously optimistic about the new FDA rule.

"We are optimistic that these new dietary supplement good manufacturing practices will enhance consumer confidence in these popular products by raising the bar on production standards, helping ensure quality, and leveling the playing field for all dietary supplement companies," Steve Mister, the groups president and CEO, said in a prepared statement.

"I'm sure we won't agree with everything in the rule, but we are pleased that the new good manufacturing practices are here, as it's a step forward for our industry," he added.

More information
For more information on dietary supplements, visit the U.S. Food and Drug Administration.