FDA issues new rules for dietary supplements

The U.S Food and Drug Administration announced on Friday that it is issuing new rules for dietary supplements like vitamins and herbals. The move comes after years of pressure from various sources asking the FDA to tighten the rules regarding food supplements. FDA officials announced in a teleconference on Friday that firms must test their products to ensure that they are not contaminated and that the ingredients listed on the label are included inside.

The U.S Food and Drug Administration announced on Friday that it is issuing new rules for dietary supplements like vitamins and herbals. The move comes after years of pressure from various sources asking the FDA to tighten the rules regarding food supplements. FDA officials announced in a teleconference on Friday that firms must test their products to ensure that they are not contaminated and that the ingredients listed on the label are included inside.

Robert E. Brackett, director of FDA's Center for Food Safety and Applied Nutrition, 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.” According to the new guidelines, manufacturers have to ensure that whatever claims they make about their products are substantiated by proof. To that effect Brackett said, “This is to show the claims are truthful and not misleading”

The move comes in light of the fact that certain firms had been manufacturing adulterated supplements. Associate press reported that last year, the FDA discovered undeclared ingredients in a prescription for erectile dysfunction drugs. In other cases dugs were found to have lower level of vitamin A and C than what the labels claimed.

The new safety guidelines are making critics heave with a sigh of relief since it has been argued for years that the FDA`s approach to supplements has been lax. Dietary supplements are treated as food supplements and not as drugs even thought their usage is more like drugs. Due to this reason these dietary supplements have not been under the stricter umbrella of FDA guidelines that cover drugs.

Critics feel that the move has been rather slow in the coming. Dr. Sidney M. Wolfe, director of the Public Citizen Health Research Group, said “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” Wolfe said that the new guidelines will take a year to be implemented in the larger firms and almost three years in the smaller firms. The gap will provide them enough time to make changes in order to comply with the new rules.

Janell Mayo Duncan, senior counsellor for the Consumer’s union has also expressed his unconvinced view. “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”

Vasilios Frankos, FDA's division director of the Office of Dietary Supplements has said “Under the rule, manufacturers of dietary supplements are required to evaluate the identity, purity, strength, and composition of their products”. Anything that doesn’t comply with the rules will be labelled “adulterated or misbranded” by the FDA said Frankos. The new rules will put pressure on producers to ensure that their products do not contain toxins, bacteria, pesticides, lead or other heavy metals. The rules also contain sections for quality control, construction of manufacturing plants, testing of ingredients and finished products along with record keeping and handling of consumer complaints.

The new guidelines will go into effect from August 24, 2007. Firms employing more than 500 workers are given one year to comply and firms with less than 500 employees have three years to comply. Companies with fewer than 20 employees are given a time frame of almost four years to make necessary changes.

“The rules also apply to supplements made outside the United States”, said Frankos.