Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1340

Accepted - Volume 326

Comment Record
Commentor Dr. Francisco Garcia Date/Time 2003-04-04 12:20:52
Organization Advanced Nutritional Biosystems, Inc.
Category Health Professional

Comments for FDA General
Questions
1. General Comments Thank you for the opportunity to comment on this proposed amendment to DSHEA. As a physician since 1987, I have been exposed to many patients using many drugs (medicines)for the prevention, as well as for treatment, or curing, of disease. Essentially every drug I have prescribed has had known side-effects. These side-effects, in the majority of cases, if not all, were dose-dependent. In the majority of cases, patients got into trouble by not taking these drugs at the prescribed dose, time, or frequency. Just as with prescribed drugs, nutritional supplements need to be taken as directed, by those without contraindications to the products. As the labels on the supplements state: As with all diet and exercise programs, please consult your physician first. This is to protect individuals from performing activities, or taking supplements, which could potentially be harmful to them. I see these as actions that already help to protect public safety. If someone fails to yield at a red light, and causes an accident, does that mean that there is something wrong with law regarding traffic lights? People have to be responsible when they use supplements, just as when they use medicines, come to an intersection with a red light, etc. More rules and regulations only put more burdens on growing companies, reduces competition by eliminating those small companies that cannot afford lengthy approval processes, thereby also reducing the number and variety of products available to responsible consumers. The FDA already has the necessary legal authority to protect the public. Former FDA commissioner, Dr. Jane Henney, testified before Congress that DSHEA provides the FDA with the necessary legal authority to protect the public health. The FDA has already begun to implement their authority by taking aggressive action against unsubstantiated dietary supplement claims, as well as by recently issuing a proposed rule on good manufacturing practices for supplements. Public education is probably a better place to focus to decrease adverse affects of supplements as well as medicinal drugs. Again, I thank you for this opportunity to comment. Regards, Francisco Garcia, MD




EC -1340