Fw: [EquineCushings] URGENT - Nutraceuticals threatened - second half of Part 1

["Jeanne Slominski" <EnduranceMorgan1@attbi.com>]

Second half of Part 1:

 
> Things started heating up though about 4 years ago, and in some
> respects the manufacturers have only themselves to blame for a lot
of
> the current regulatory furor.  In an attempt to discredit a certain
> highly effective joint nutraceutical product, some manufacturers
> decided to raise trouble by complaining to the FDA about an alleged
> undisclosed ingredient, safety of said undisclosed ingredient,
> labelling issues, etc..  I know for a fact that this went on
because
> one of these manufacturers, in an attempt to convince me that these
> (proven false) allegations were true, actually faxed me background
> information on the alleged undisclosed ingredient from a fax
machine
> that originated inside the FDAs office building!  What these
> manufacturers failed to take into consideration was that ALL such
> joint nutraceuticals, including their own products, were illegal
for
> sale.  They also caused some trouble with state regulatory bodies
by
> sniffing around to see if the product they were attempting to
> discredit was licensed for sale in all the states.  (Companies must
> have licenses in each state where they sell, distribute or ship
their
> products.) In the end, the product they were trying to discredit
came
> off smelling like a rose, fixed its labelling so that it is now the
> ONLY product of its kind that is likely to be legal for sale and
the
> result of all the pot stirring was to annoy/aggravate the FDA and
> state regulatory officials enough to draw their attention to the
> scope of sales of illegal ingredients.
>
> AAFCO now enters the picture.  AAFCO is the Association of American
> Feed Control Officials.  It is NOT a regulatory agency, NOT even a
> government agency.  It is a private association of state feed
control
> officials. Membership in AAFCO is limited to feed control
officials,
> state or federal, but industry/private interests may sit on
> committees as liasons and advisors.  The purpose of AAFCO is to act
> as a liason between the state feed control officials (and
affiliated
> departments, like laboratories) and the FDA, to assist members in
> methods for uniform implementation of laws regarding animal feeds,
> etc.  AAFCO itself has no power beyond that of suggesting courses
of
> action to its member states.  In other words, they can try to
create
> a ground swell in favor of moving against illegal ingredients but
it
> is up to the individual states to actually take any action.  No
> change in laws is necessary to ban these products.  They are
already
> illegal.  Texas has already refused licensing of these products. 
> What's going on in other individual states I'm not really up on but
> last year AAFCO organized a web search to identify companies
selling
> illegal supplements.  This information is then made available to
> member states and in the current game plan the states will send
> warning letters to violators, then follow ups to check to see if
they
> complied and if not regulatory action can follow, including store
> seizure of illegal products, fines, etc..
>
> This is a very, very abbreviated version of the whole story and the
> players in it.  I will post in the files my draft copy of the last
> Horse Journal article, and any past ones I might still have on file.
> Refer to those for a more in-depth account.
>
> Shortly after the manure originally hit the fan regarding these
> supplements, there were two AAFCO committees organized to see how
> some of these supplements and herbals might be best incorporated
into
> the existing framework and made "legal".  To make a long story
short,
> that attempt has been abandoned because, as above, they simply
don't
> fit into a feed/food category and are by current definitions drugs.
> This is very different from the situation with human nutraceuticals
> and herbals.  In 1994, after an unprecedented grass roots campaign
in
> favor of legalizing over the counter sales of nutraceuticals and
> herbals for people, President Clinton signed into law the DSHEA -
> Dietary Supplements Health and Education Act.  This ensures at
least
> a minimum of good manufacturing practices in the production of
these
> products, restricts manufacturers from making blatant
health/medical
> claims but in essence allows people to choose for themselves
whether
> they want to use these products.  The provisions of DSHEA, however,
> do NOT extend to animals.  As I see it, the best and only recourse
we
> have is to get the provisions of DSHEA extended to horses.  There
is
> already a movement afoot to extend it to pets, under consideration
at
> the moment by APPMA (American Pet Products Manufacturers
> Association).  Adding horses onto this is a possibility but because
> of the potential for horses to enter the human food chain this must
> be addressed and APPMA may not want to hassle with it.  All that
> really needs to be done though is to assure that the warning "Not
for
> use in horses intended for food" appears on the label.
>
> I'll post that file now and part two of this saga will be who to
> contact, what to say, and why.
>
> Eleanor