FDA (Federal Drug Administration) and FTC (Federal Trade Commission)...
October 2010, Warren Matthews
Prior to the Supply Side West show in Las Vegas last week, I went to the Natural Products Expo East in Boston. The show was quite disappointing compared to the Natural Products Expo West which is held in Anaheim.
Prior to the Supply Side West show in Las Vegas last week, I went to the Natural Products Expo East in Boston. The show was quite disappointing compared to the Natural Products Expo West which is held in Anaheim. The attendance was down as were the number of exhibitors... perhaps a sign of the economic times.
However, there were some interesting workshops that I attended in which there were senior officials present from both the FDA and FTC.
Both of these organizations can often bear the brunt of criticism from both consumers and industry alike. Like many organizations there are both good and bad people within them.
Over the last few years I have been in a number of workshops/presentations by the FTC and FDA and I have to say they are not, in my experience the 'ogre's that they are sometimes made out to be, certainly in the area of dietary supplements. I think that the FDA has a lot to answer for in the area of drug enforcement... but, that is a different subject for a different day... but, in the case of dietary supplements they are doing a lot of good work to help clean up the industry.
And... it is a big task to clean up the industry. I was talking to an FDA official who told me that they believe that the majority of US dietary supplement manufacturers are still not compliant with the US FDA GMP rules. I was astounded to hear that a large percentage of manufacturers are still not even doing basic ID testing for their raw ingredients!
That was amazing news given that all manufacturers were required to be compliant by June this year.
It is a big job I know to be compliant. It took 5 people in our QA department almost 2 years to put everything in place for GMP. By far the biggest component of this was the preparation of the specifications and testing of raw ingredients. This goes way beyond just identifying the ingredient... which I will expand on in another blog post.
The main point I wanted to get across in this post is that the FTC and the FDA are working together not only with each other but also with responsible members of the industry and that they are not unfair and unreasonable as many think they are... they just want truth in product presentation and quality in the products manufactured and the products to be true to label. In other words they want to ensure that the consumer receives what they are expecting to get.
No responsible manufacturer has anything to fear from these two agencies. From a consumer perspective, compliance does add cost, but most manufacturers have over the last couple of years tended to absorb those costs as we have.