11 regulatory policies with respect to dietary supplements by the enactment of the Dietary Supplement Act (DSA), led the Agency to institute its review and publish this ANPR. The ANPR noted that while many ingredients in herbal dietary supplements have not been associated with specific health concerns, some components contained in these products have been associated with adverse health effects or toxicities in animals and humans. For example, at least six documented cases of toxic hepatitis have been associated with the consumption of chaparral (larrea tridentata). There have been several cases of adverse reactions associated with the consumption of dietary supplements containing Lobelia inflata (lobelia, Indian tobacco). (genus Teucrium) has been recently implicated in at least seven cases of acute nonviral hepatitis in France. Chronic renal failure has been reported to have resulted from consumption of dietary supplements containing Stephania tetrandra and Magnolia officinalis. Germander The use of yohimbe in dietary supplements such as body building products appears to be increasing. The known pharmacologically active components of yohimbe are yohimbine and related alkaloids. Yohimbine is an approved drug and is used as a vasodilator. Other effects of yohimbine include lowering of blood pressure and antagonism of neurotransmitters and their precursors. 12 Human toxicity, including fatalities have been associated with consumption of the Symphytum (comfrey and Russian comfrey), Heliotropium, and Senecio species. The scientific literature documents the toxicity of these and other pyrrolizidine alkaloid (PA)-containing plants. There are reports that PA causes liver injury and failure secondary to veno-occlusive disease (i.e., blocking the veins that remove blood from the liver). Toxicity associated with PA-containing plants can occur, and has occurred, after relatively short use (a few weeks) and at relatively low doses. Several animal studies have demonstrated that PAs and PAcontaining plant materials (comfrey) can cause cancer in test animals. In May 1991, following the EMS outbreak associated with consumption of L-tryptophan-containing dietary supplements, the Commissioner of Food and Drugs established an internal FDA task force to review the Agency's regulatory program for dietary supplements and to recommend improvements. Known as the Dietary Supplement Task Force (the Task Force), it was composed of Agency staff with experience and expertise in regulatory, nutritional, legal, and medical issues related to supplements. The Commissioner asked the Task Force to examine a number of issues, including whether safety concerns exist regarding dietary supplements and, if so, to recommend a regulatory framework to distinguish supplements that raise safety concerns from those that do not. 13 The Task Force completed its work in May 1992 when it submitted a report with recommendations to the Commissioner. It must be emphasized that nothing in the Task Force report represents Agency policy. FDA has made the recommendation of the Task Force available for public comment. The Agency will review the comments it receives and then decide what actions appear to be appropriate. The other Federal Register document of particular interest to you is the proposed rule on health claims for dietary supplements of vitamins, minerals, herbs, or other similar substances. The Agency proposed to make claims for these products subject to the general requirements that apply to claims for other types of food. This proposed rule was mandated by NLEA. Its timing was determined by the DSA. Under NLEA, Congress for the first time authorized FDA to regulate health claims on food and dietary supplement labels and in food labeling. The new provisions amended the FDC Act by providing that a product is misbranded if it bears a claim that characterizes the relationship of a nutrient to a disease or health-related condition, unless the claim is made in accordance with the regulation that authorizes the use of the claim. 14 Congress enacted the health claims provisions of the 1990 amendments to give U.S. consumers nutritional information that may be important in maintaining their health and to protect these consumers from unfounded health claims. The House Report of June 13, 1990 states, "Health claims supported by a significant scientific agreement can reinforce the Surgeon General's recommendations and help Americans to maintain a balanced and healthful diet." In addition, the Statement of the House Floor Managers noted that "There is a great potential for defrauding consumers if food is sold that contains inaccurate or insupportable health claims." The House Report characterized the need for regulation of health claims as "compelling." While NLEA mandated a health claims standard for conventional foods, the statute ordered FDA to establish a health claims standard for dietary supplements. In November 1991, FDA proposed that health claims for dietary supplements should be based on the same standard as conventional foods, namely, significant scientific agreement. identical standards was simple: The Agency's rationale for subject to the same standard as Vitamin C in broccoli or orange juice. In the June 18 Federal Register, FDA again proposed that the health claims standard for dietary supplements should be one of significant scientific agreement. 15 While FDA did not propose any specific health claims for dietary supplements in the June 18 Federal Register, FDA does, however, contemplate further proceedings where the nutrient/disease relationships have not been resolved with respect to dietary supplements (i.e., for dietary fiber and cardiovascular disease, dietary fiber and cancer, zinc and immune function in the elderly, and omega-3 fatty acids and coronary heart disease, and antioxidant vitamins and cancer). FDA is dedicated to assisting Americans in capitalizing on the scientific advances over the last 30 years that have expanded the understanding of the relationship between health and diet and of the role that diet can play in improving the health of Americans. FDA encourages positive changes in dietary habits and recognizes that consumers' access to adequate nutrition and health information is an important part of this process. Finally, Mr. Chairman, I am going to discuss where the Agency is in regard to health claims for folic acid and antioxidant dietary supplements. Folic Acid Even though the Agency's Food Advisory Committee has not yet fully resolved certain issues involving folic acid, in an effort to progress as expeditiously as possible, the Agency will publish |