The Center for Veterinary Medicine (CVM) in the US Food
and Drug Administration (FDA) has long objected to use of the
terms "probiotics" and "prebiotics" on animal feed and petfood
labeling. However, at the 2010 Association of American Feed
Control Officials (AAFCO) Feed Administrator's Seminar (an
annual training program for state regulators), CVM indicated
the intent to remove its objection to that verbiage. This
should not be inferred to mean that products containing these
ingredients will have free rein with regard to labeling in
other respects, though.
"Probiotics" is a term long used to describe live
microorganisms delivered orally to the animal for the purpose
of intentional colonization of the gastrointestinal tract.
Historically, their use often has been associated with claims
regarding treatment or prevention of gastrointestinal disorders
as well as "competitive exclusion" claims (i.e., claims to
reduce the level of
or other enteric pathogens in the animal). CVM objected to
these claims as drug claims and, in doing so, considered the
term probiotic to be a drug claim as well.
That does not mean probiotics have not been allowed in
petfoods. A number of microorganisms fitting the general
description of a probiotic are sanctioned for use via AAFCO
Feed Ingredient Definition #36.14 for direct fed
Elsewhere in the
AAFCO Official Publication
are requirements for labeling products containing these
microorganisms. CVM's Compliance Policy Guide Section 689.100
outlines the criteria for which CVM would consider probiotics
to be acceptable for use in petfood.
Prebiotics are the food on which probiotics thrive in the
gastrointestinal tract. Generally, prebiotics are soluble
carbohydrates such as oligosaccharides that are indigestible by
the animal but fermentable by the microorganisms. The term
"prebiotic," coined to characterize this class of ingredients,
came into use much later than probiotics and was not as heavily
connected with disease treatment or prevention claims. Still,
their close association with probiotics led CVM to consider the
prebiotics term a drug claim, too.
It's unclear why CVM suddenly changed its policy,
though I suspect recent prominent use of one of the terms in
the labeling and promotional materials of a major petfood
company may have forced CVM's hand. Regardless, it appears to
be a prudent, reasonable regulatory position.
In FDA's draft guidance document regarding complementary and
alternative medicine products for human use, it notes (bolding
Probiotics are not defined as a regulatory product
category under the act or the PHS Act, and products that may
be considered to be probiotics
may be foods or drugs
under the act,
depending on the intended use
of the product.
From this it may be inferred FDA does not consider the term
to be a drug claim. In fact, there are a number of human food
products on the market using the term with apparent impunity.
If probiotic is not a drug claim, there's no basis to consider
prebiotic a drug claim, either.
At this time, it's unknown whether CVM intends to revise its
Compliance Policy Guide or provide other written guidance.
Despite this addition of terms to the acceptable labeling
lexicon, there's no indication CVM's policy on labeling and
claims for products containing these ingredients has changed.
So, based on information presently at hand, the following
recommendations are made:
The mid-year meeting addressed several regulatory matters affecting petfoods
Public meetings invited comments and provided updates
Committees discussed key proposals such as a possible shift in the oversight of animal feeds
--- Thank you for your patience ----
If you have any issues logging in or any other need feel free to contact us.