Science and Traditional Use Demonstrate Safety of Herbal Ingredients

WASHINGTON, D.C., June 7, 2001—FDA’s warning letters to food companies about herbal ingredients in beverages, and the attendant media coverage, are bound to confuse American consumers. This is unfortunate, because those consumers deserve clear, factual information that is not misleading.

There is a technical legal issue involved. Herbals in commerce prior to October, 1994 were grandfathered for use in dietary supplements. However, for conventional foods, including beverages, ingredients must either be GRAS (Generally Recognized as Safe) or FDA approved prior to use. Because these herbs are not alternatively FDA approved, we have a situation where the exact same substances (ginseng, ginkgo, echinacea) are regarded as safe for supplements (otherwise FDA would have taken steps to remove them from the market), but have an undetermined status in conventional foods.

"Sadly, the implication of these media reports will only add unnecessarily to consumer confusion about the safety of herbals," said Dr. John Cardellina, CRN VP for Botanical Science. "There should be no confusion or question about the safety of echinacea, ginseng, and ginkgo. These botanicals have a long history of safe use and extensive supporting scientific data; the only substantive concern with any of these is that ginkgo should not be used in conjunction with blood thinning agents."

"CRN has just convened an Expert Panel to review and assess the safety and benefit of the top selling botanicals," added John Cordaro, President and CEO of CRN. "The panel gave high marks to all three botanicals in question, noting the one narrow caution for ginkgo. Perhaps the more important question is whether the dose provided in these beverages is appropriate to achieve the desired benefit."

The Council for Responsible Nutrition (CRN) was founded in 1973 and represents approximately 100 companies in the dietary supplement industry, including bulk ingredient suppliers as well as finished product manufacturers. Members include manufacturers of national brands of dietary supplements as well as several large manufacturers of the store brands available in most supermarkets, drug stores, health food stores, and super stores. CRN members adhere to a strong Code of Ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.