FDA Clean Manufacturing Act

[Guest guest]

All,

Recently I was at a symposium attending Marilyn Allen's latest HIPAA lecture. During the lecture she said in an aside that the latest rule change by the FDA regarding dietary supplement [herbal] manufacturing practices proposes a serious danger to the herbal clinician. On the surface, the rule change seems to be a good thing as it aims to ensure labeling accuracy and safety in an industry where any problem gets trumpeted to the heavens. What Marilyn Allen claimed was that somebody supposedly in the know told her that the law change will mean that anyone who makes up a formula in their office and sells it to a patient will technically be a manufacturer and thus subject to the same rules as herbal companies. That is, we will have to have clean rooms, assaying equipment, tons of paperwork and documentation, etc., etc. and God knows what all.

 

I do not know if this is true. After spending a lot of time on the net searching for the truth about this, I have come up empty-handed. I wonder if anyone out there in cyber-land is able to shed any light on this. I did find some articles on the subject, but they did not get to the nitty-gritty about whether I as a small herbal clinician will be subject to the same rules as herb companies. By the way, I did discover that anyone who wishes to electronically attend the meeting to be held on May 4 from 5-7pm in Washington regarding this proposed rule change may do so by either logging onto www.supplysideshow.com/fda or by calling 1-800-454-5760 to register for teleconferencing.

Joseph Garner