E-Letter responses to:

p-forum: Steven H. Zeisel HEALTH: Regulation of "Nutraceuticals" Science 1999; 285: 1853-1855 [Summary] [Full text]

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Published E-Letter responses:

Nutraceutical Research and Education Act

Debra Bass   (22 November 1999)

Desperate FDA

Zen Robert   (1 October 1999)

Nutraceutical Research and Education Act 22 November 1999
Debra Bass, attorney Foundation for Innovation in Medicine Respond to this E-Letter: Re: Nutraceutical Research and Education Act	Dr. Zeisel is on target. A new Bill has been introduced to Congress. On September 27,1999,Congressman Frank Pallone of New Jersery introduced the Nutraceutical Research and Education Act. The stated purpose is to promote research into the health benefits of nutraceuticals, as defined by the Act. This Bill is an alternative regulatory track for companies that want to make claims about their products. The objective is to stimulate clinical research into the health benefits of foods, medical foods, and dietary supplements.A company that does the clinical research to prove their product produces a health benefit that reduces the risk of disease, prevents the onset or manages the symptoms of a disease or condition, and is safe for that use when used as directed, will be rewarded with a marketing exclusivity for the claim. Presently too much is spent on promotion and not enough on the science behind the products. FDA has prematurely stated that they do not think the Bill is necessary.But the present regulatory scheme is piecemeal at best. The Bill will help consumers, doctors and insurance companies define what works and how to cover the costs. With the move to self care, consumers want this information, doctors need it and insurance companies will cover it. Read the NREA at www.fimdefelice.com. Other new legislation introduced to the 106th Congress includes: A Bill to require FDA to bring its labeling regulations in line with the FTC Act to provide for certain types of advertisements for dietary supplements; A Bill to amend the Food Stamp Act to permit participants to use food stamps to purchase nutritional supplements; and a Bill to amend the IRS code to provide that amounts paid for foods for special dietary use, dietary supplements and medical foods be treated as medical expenses. Congressman Dan Burton, of Indiana, Chairman of the House Commerce Committee on Government Reform has held numerous hearings on Alternative and Complementary Medicine. The intent is to open the doors to well researched therapies that the American public wants access to. I urge everyone to get involved. Medicine for the new Millennium will unite patients and their health care providers to focus on health and well being. Debra Bass J.D., L.L.M. dbass@en.com
Desperate FDA 1 October 1999
Zen Robert, Retired Respond to this E-Letter: Re: Desperate FDA	The FDA, having lost several important legal cases recently, costing taxpayers millions of $, is desperate to make health supplements look dangerous. It is about time that tax payers STOP paying for the FDA to harrass supplement manufacturers and distributors and turn their attention where it belongs and where there is a real danger to public health: the inspection of FOOD. Few people realize that the FDA has cut way back in food inspection in an era when food is increasingly contaminated. They need to put the focus where it belongs.