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Insight Report Vol. 5 No.7
The turtle that wins the race…. Or
The slow moving FDA gets the final say
Every once in a while you see an advertisement on the TV or in a
magazine and you say to your-self, “How they can sell that in that way?
They’re making medical claims and I can’t believe that the FDA is letting
them get away with it!”
Over the years we have seen the slow reacting FDA take its time getting
products off the market. Examples of this are with the ‘Anti-snoring
devices’ – and yes, a claim to eliminate snoring is a medical claim - but
most recently and more blatantly, it was the electronic ab machines
and the electronic face lift units (these last two devices are electronic
muscle stimulators and are classified as a class II medical device and are
only allowed to be sold under a prescription.)
So how can it be that you see these devices being advertised on
infomercials continuously, month after month and sometimes year
after year? Well, simply said, it’s because the turtle (the FDA) takes a
long time to reach its goal of consumer protection; but, it will
ultimately win, though possibly after many people have been “taken” or are
possibly injured by what they assume to be a safe, FDA approved device
that is being pitched over the television…. How else could they do it,
right?
Unfortunately, the FDA just does not have the staff to keep up with all
of the “snake-oil” salesman. Yet, you can rest assured that sooner or
later the FDA will sneak up on them and strike in the name of consumer
protection.
Recently, six Warning Letters crossed my desk. All addressed the
same problem on web sites. They had the same date -- June 13th, 2002
-- and were addressed to the President/Owner (they did not have the actual
name) of the company whose name was on the website.
Each of these websites marketed a product under various brand names,
that contained among other things norephedrine HCL. The Warning Letters
went on to state that,
“Statements found on your Internet web site indicate that this product
is intended to be thermogenic and helps “burn” fat.
Although your website represents this product as a dietary supplement ,
for example by statements such as,, “…sports and bodybuilding
supplements…” and “… the best supplements on the market…”, it cannot be so
considered because the norephedrine HCl used in your product appears to be
a synthetic compound that is not derived from any botanical source.
Synthetic norephedrine HCl is not plant-derived and cannot, therefore, be
considered a constituent or extract of a botanical source. Consequently,
FDA has determined that synthetic ephedrine alkaloids are not “dietary
ingredients” as defined in the Federal Food, Drug and Cosmetic Act [the
Act, Section 201 (ff)(1)]. Therefore, products containing synthetic
ephedrine alkaloids do not fall under the dietary supplement regulatory
scheme.”
The FDA went on to explain that these products are considered new drugs
and that it may not be marketed in the US and its continued distribution
violates section 505 of the Act.
I visited several of these websites to see if the receipt of the FDA
Warning Letter and the desired effect of making these companies take off
these products. In all but one case the product was removed from their web
site. So, though the FDA takes its time it gets its desired effect.
Why does it take the FDA so long to respond to what would appear to be
consumer safety issues when it is obvious that what is being promoted and
sold to the American public? It appears the FDA can and does react
expeditiously when they are prodded by a Congressional inquiry. You see
the FDA has to answer to the Congressional Subcommittee and if they don’t
ask how high to jump when a Congressman tells them to jump, they have to
answer why they didn’t jump.
Fortunately, though the FDA is slow to act, when they finally take the
action they are ready to back-up their actions with their enforcement
powers. The FDA Act is a powerful set of regulations and we should be
grateful for that. Let’s hope that the agency will learn how to address
problems when they initially discover them and not wait for months or
years to take the appropriate action, causing unnecessary expense and
possible harm to the public they are mandated to protect.
The next Insight Report – To Be Announced
If you
have any comments on these INSIGHTS we hope that you let us hear them. If you have any of
your own INSIGHTS that you feel would be of value to other companies, we would be pleased
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on this site for others to learn from.
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