hydrochloride and chondroitin sulfate have been ingredients in petfoods
for most of the last 20 years. However, neither ingredient ever has been formally
approved or otherwise sanctioned for that purpose. This has resulted in
inconsistent regulation in the US among states, causing a great deal of difficulty
for industry in its attempts to be in nationwide compliance.
the January 2006 issue of Petfood
Industry, I commented on this regulatory morass and suggested that an
effort be made to overlook the reported shortcomings in documented utility and
safety and to rely on the notable history of apparent safe use of GH and CS so the
Association of American Feed Control Officials could define them for use in
petfood. Six years later, the regulatory confusion has only gotten worse.
From the US Food and DrugAdministration’s perspective, both GH and CS are unapproved food additives when
added to animal feed, which in turn renders a product containing either
ingredient subject to enforcement action as an adulterated feed. I am sure FDA
has conveyed this opinion a number of times in correspondence to both industry
and state feed control officials. However, I am not aware of a case where FDA
took direct enforcement action against a petfood based solely on the fact that
a product contained either of these ingredients.
FDA’s viewpoint, most states allow for the inclusion of GH and CS in petfoods
provided certain conditions are met — namely, that the label does not bear “drug”
claims relating to their inclusion, guarantees are declared and a “not an
essential nutrient” disclaimer accompanies the guarantees.
Office of the Texas State Chemist published Memo #3-17 in 1999 that imposes
additional restrictions on species, lifestage and inclusion rates (http://otscweb.tamu.edu/Laws/Policy.aspx).
The Ohio Department of Agriculture has codified regulations pertaining to the
use of these ingredients as well (http://codes.ohio.gov/oac/901%3A5-7-22).
Although the majority of states may
not have formal policies in place, historically, most considered products that
were in compliance with Texas’ memo as sufficient. In recent years, though, a
few states appear to be deviating from that informal consensus. For example,
one has begun requiring the guarantee to be in terms of glucosamine content
only instead of GH.
that is a logical requirement, since in fact glucosamine is the nutrient
component of the ingredient GH (in the same way you declare thiamine
mononitrate in the ingredient list but guarantee just thiamine). However, the
Texas policy sets upper inclusion rates specifically for the complete GH
molecule. GH is about 83% glucosamine. So without a guarantee for GH, one would
have to further document that the glucosamine guarantee was set so GH as a
whole would be compliant with the policy.
least one other state has recently been asking for maximum GH and CS guarantees
instead of minimums. That makes sense if the only purpose of the guarantees is
to ensure compliance with the restricted rates of inclusion as stipulated in
the Texas memo. However, from a nutritional point of view, a minimum guarantee
is much more helpful to the purchaser. Also, the Ohio regulations specify
minimum guarantees. So, to be compliant with all states, both minimums and
maximums would appear necessary.
state had also been requiring a label caution statement regarding use in
animals with various health conditions such as bleeding disorders and to
administer after feeding to reduce risk of gastrointestinal upset. I think the
latter advice might be prudent when given in dosage form, but I’m unclear as to
the practicality or need to feed the animal something else before feeding a petfood
containing GH and CS. With regard to safety of use under certain health
conditions, those are valid concerns when fed at high doses. However, I am not
aware of reports of adverse effects when given in amounts as stipulated in the
understand why states have different policies. From their perspectives, these
ingredients are not approved, so compliance with these additional restrictions as
a condition of acceptance seems reasonable to them. However, with states having
varying requirements, it becomes extremely difficult to produce a label that
one can reasonably expect to be acceptable in all states.
Six years ago, I suggested that
the long history of use of GH and CS in petfoods without apparent adverse
effect at current inclusion rates merited consideration for placement in the
AAFCO feed ingredient definitions. That never happened, and in light of FDA’s
current concerns regarding procurement of “legal homes” for all ingredients, it
is unlikely to ever happen. However, despite the technically unapproved status
of these ingredients, if states are to continue to allow for their inclusion in
petfoods, there should be an effort to set down conditions so states can act in
a consistent manner.
In the mid-2000s, FDA made mention of its
intent to publish a guidance document on use of GH and CS in petfoods. However,
that topic was unceremoniously and without notice removed from the list of
pending guidance documents a couple of years ago.
FDA’s position (or lack thereof) should not preclude interested states from
meeting (through AAFCO or otherwise) and agreeing to uniform labeling
requirements. Otherwise, the only means to ensure consistent state regulation
is for states to follow FDA’s view that GH and CS are unapproved food additives
and take action accordingly.
more columns by Dr. Dzanis at www.petfoodindustry.com/petfoodinsights.aspx.
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Do you believe that, if there were some consistent mid/long-term clinical trial with the use of GH and CS in petfood, would help regulators to have a clear position about this subject?
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