New FDA Rules - A Good Thing?

06/26/07

By Nurse Mark

From the weekly FDA newsletter:

Rule Finalized to Help Ensure Dietary Supplement Quality
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 complaints.

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...

Read more information about Niacin:

References:

Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html
Backgrounder: http://www.cfsan.fda.gov/~dms/dscgmps7.html
Fact sheet: http://www.cfsan.fda.gov/~dms/dscgmps6.html
The final rule on CGMPs for dietary supplements is available on the FDA Web site.