FDA supplement regulation update

Ever since the Food and Drug Administration released its 'final rule' on the manufacture of dietary and herbal supplements, herbalists have been wondering exactly how some of the byzantine record-keeping requirements might be enforced, and whether small-scale or one-time batches of custom formulas might be exempted, or at least overlooked.
This is a special concern for practitioners who, despite Ernst's protestations, continue to blend individual formulas for individual clients. There has been concern that these formulas might be subject to the same rules of production (not in your kitchen - unless you just installed that negative pressure fan and have no pets or food in there) and record-keeping (samples of batches for years) that large supplement companies now have to follow.
Well, apparently Vasilios Frankos, Ph.D. (Director of FDA's Division of Dietary Supplements) clarified the situation a little at a recent workshop in Washington, D.C. on Traditional Chinese Medicine. He was speaking in reference to a direct question on the requirements for practitioners of herbal medicine working in one-on-one consultations. Here are some quotes:
'We are not going to be enforcing the GMP for practitioners in
one-on-one consultations'.

'We are going to stay out of the individual practitioner relationship'.

Seems like a decent turn of events: we're still breaking the rules, but they promise to leave us alone (for now). Because, of course, the FDA still retains 'enforcement discretion'.

No comments: