Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -138

Accepted - Volume 298

Comment Record
Commentor Mr. Michael Bova Date/Time 2003-03-08 09:41:16
Organization West Coast Wellness
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments The marketing of dietary supplements is my business and included in this business is one proeudct that contains ephedra. I personally take this product on a daily basis with no adverse side effects. The American public has been told by the Food and Drug Administration (FDA)in the late 1990s that up to 100 milligrams of ephedra taken in a 24 hour period is within safe usage. Our product contains approximately one-third of this amount. Our federal, state, and local goverments should unite and pass legislation for 'truth in labeling' of all natural food supplement products. Our company has done so for the past ten years and our satisfied customers and their results speak for themselves. In a country where legislating any new law can take years, it is ludicrous to observe this very same government attempting to ban a substance based on one tragic incident with many other significant factors relating to the death of one athlete. Safety begins with responsible consumer usage of any dietary supplement or over-the-counter and prescription medication. Ephedra, as with any other substance or supplement, can be abused when improperly taken by the consumer purchasing it. This is where the FDA should advocate legislation for the 'truth in labeling'of ephedra. Any reputable company in the all-naturaly, food supplement industry would welcome this type of action. Insted, by proposing to ban the use of ephedra, the FDA and federal government will again address a symptom and not theproblem. The problem being twofold. One, force 'truth in labeling'and pharmaceutical grade consistency production of all food dietary supplements not just ephedra. If the concern is truly for the health of the American public, this would be step one in ensuring everyone's safety of all products. Two, begin a massive ad campaign (with PSAs) urging consumers to be smart and not purchase products that follow strict FDA guidelines of production and labeling. THese two steps of action would send a clear message to the American public about the concern the government has for their health instead of attempting to ban a most effective, all-natural substance for weight management and overall health whose only true fault is that it cannot be patented by the pharmaceutical companies. (Phen-Phan was their synthetic analog answer to the safe, all-natural ephedra.)FInally, the issue of banning ephedra once again serves to demonstrate to the American public that their health is the biggest polictical(PACs-Political Action Committees)footballs ever because it effects and incites every American as it is the one true issue everyone has a stake in. I urge our federal government to act as responsibly as it is telling its citizens to do and that is to only use those products that are safe and effective. 'Truth in labeling' will give us all 'peace of mind.'




EC -138