Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -71

Accepted - Volume 1

Comment Record
Commentor Mr. Cl Montgomery Jr Date/Time 2002-05-29 23:35:08
Organization Usana Health Sciences
Category Dietary Supplement Industry

Comments for FDA General
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? I would answer yes to the first question as drugs are formulated to treat or correct specific human health conditions. Persons who have been prescribed medicine(s) by a health professional or doctor have come to a designation of being a Patient not a customer. A 'patient' places his or her life in the hands of drug companies, via the training and experience of their doctor. Retail customers, through word of mouth, product information labels and professional advice are not facing life and death situations. They are making educated choices as informed consumers to maintain or improve good personal health. All too often, patients are buying drugs that never improve their health conditions. Most popular drugs today are designed to allow the patient to manage their health conditions, not treat them. Patients are taught to live with diabetes, cardiovascular disease, and Parkinson's. People are becoming smarter than this. When you ad all the bits and pieces of information concerning the benefits to human health of nutritional supplementation, you would think some of these high-end products would carry the FDA statement of approval on their labels, especially those required to be listed in The Physician's Desk Reference. I also believe the FDA should recognize the fact that consumers are being more and more educated through releases from JAMA, NEJM and others and the information is widely disseminated. The disclaimer, These statements have not been evaluated by the FDA, make the FDA appear uninformed, out-of-date and behind the times. Consumers will eventually make that purchase after unconsciously deciding to wait for a sign that the FDA has checked it out first, which never happens. I vote for consumer's choice. I also think my choice should not be discouraged unless there is actually a safety concern regarding the use of a health product. The speech, for example; Crest has been shown to be an effective decay preventing dentifrice when used in a conscientiously applied program of oral hygiene and regular professional care, is a necessity for the consumer. The consumer must understand the what, who, how and when a product can be benefitial to him or her. You can ONLY use CREST toothpaste and still get cavities, but it's the cavities your dentist DOESN'T see that count. The same standard should be applied to health supplements. As evidence, I am a Black male, 50+ years of age, and through the daily use of a comprehensive, scientifically formulated health product, my blood pressure s now normal, my asthma is in remission for over three years, my arthritic hip doesn't hurt and I no longer suffer from back pain. I used to be lactose intolerant and with low energy and lacked normal muscle strength. It all changed right before my doctors eyes and I'm a healthier, happier person today because I ignored the FDA disclaimer on the label.

EC -71