New FDA Rules - A Good Thing?
By Nurse Mark
From the weekly FDA newsletter:
Rule Finalized to Help Ensure Dietary
FDA has issued a final rule establishing requirements to ensure that
dietary supplements are produced in a quality manner, do not contain
contaminants or impurities, and are accurately labeled. The rule also
includes requirements for recordkeeping and for handling consumer
What does this mean? Is this a good thing,
or more heavy-handed FDA power-grabbing with a view to further
restricting access to natural supplements?
On the surface, this announcement and the
information that the FDA is providing to us make this look, overall,
like it has the potential to be a good thing for consumers.
The FDA says their new rule "addresses
the quality of manufacturing processes for dietary supplements and the
accurate listing of supplement ingredients. It does not limit
consumers' access to dietary supplements, or address the safety of
their ingredients, or their effects on health when proper manufacturing
techniques are used." (emphasis added)
If the FDA remains true to their word, this
is a great thing for consumers as the FDA will finally be addressing
itself to ensure standards of quality in dietary supplements - standards
that have been lacking up to now.
What is of concern is that like all laws and
rules, "The Devil Is In The Details."
The FDA is saying that it will require
manufacturers to "substantiate" the safety and effectiveness of their
products. This is fine, and has been the case since the Dietary
Supplement Health and Education Act (DSHEA) was enacted some years ago.
The concern is that the FDA could easily decide to make these rules so
difficult, time-consuming, and expensive to follow that manufacturers
simply give up.
The FDA is also saying that "adverse events"
must be recorded and reported. Again, this is not a bad thing - if there
is a trend or pattern noticed in the reporting of adverse events, like
unexpected side-effects from an herb or vitamin - this could be an
indication of something amiss and the FDA would be quite correct in
starting an investigation. The concern here is that without some careful
examination of what is being reported as "adverse reactions" supplements
could be banned based on flawed evidence. For example niacin, a B
vitamin, is very useful in controlling cholesterol - so effective it
could challenge the expensive (and profitable) statin drugs if this
little secret ever became widely known. One of the normal side effects
of taking regular niacin is what is called the "niacin flush" which is
an uncomfortable but harmless flushing feeling that can be felt with
high dose niacin therapy. Some people, if not informed about this, might
report this as an "allergic reaction" - even though it is not. Enough
such "adverse event" reports could put niacin at risk of being banned by
the FDA - and that's how the FDA could ban supplements, one at a time...
Will these concerns be realized, or will the
FDA treat the dietary supplement industry in a fair and equitable
manner? Only time will tell...
information about Niacin:
final rule on CGMPs for dietary supplements is available on the FDA Web