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FDA Urged to Halt Sale of Foods with Added Herbal Ingredients

The term “functional foods” refers to processed foods containing ingredients that supposedly aid specific bodily functions in addition to being nutritious [1]. In the United States, functional foods have no legal definition or separate regulatory category; the FDA regulates them under the rules it applies to conventional foods. Many companies are exploiting consumer interest in self-care and “alternative medicine” by adding herbs to their food products, which may be considered “functional foods.” On June 18, 2000, the Center for Science in the Public Interest (CSPI) petitioned the FDA to halt the sale of more than 70 such products [2] and to order manufacturers to stop making false and misleading claims. At the press conference announcing the petition, CSPI director of legal affairs Bruce Silverglade stated: …

How the Dietary Supplement Health and Education Act of 1994 Weakened the FDA

Most people think that dietary supplements and herbs are closely regulated to ensure that they are safe, effective, and truthfully advertised. Nothing could be further from the truth. Although some aspects of marketing are regulated, the United States Congress has concluded that “informed” consumers need little government protection. This conclusion was embodied in the Dietary Supplement Health and Education Act of 1994 — commonly referred to as “DSHEA” — which severely limits the FDA’s ability to regulate these products. Background History In the early 1990s, Congress began considering two bills to greatly strengthen the ability of federal agencies to combat health frauds. One would have increased the FDA’s enforcement powers as well as the penalties for violating the Food, Drug, and Cosmetic Act [1]. The …

Labling of Trans Fatty Acids Proposed

On November 17, 1999, the FDA published a proposed rule that would require the amount of trans fatty acids in a food, including dietary supplements, to be included in the amount and percentage Daily Value declared in the nutritional labeling of saturated fats [1]. When trans fatty acids are present, the declaration of saturated fatty acids would be required to contain a symbol that refers to a footnote stating the number of grams of trans fatty acids per serving. Trans fatty acids would be subject to the same limits as saturated fats for the purposes of nutrient content claims, health claims, or disclosure and disqualifying levels. The FDA also proposed to define the nutrient content claim for “trans fat free.” Terminology Dietary fats are composed …