Since 1998, Horse Journal has tracked the Herculean efforts of the American Association of Feed Control Officials AAFCO) to classify nutraceuticals, which were under fire as “illegal” feed ingredients because they didn’t have a generally-recognized-as-safe (GRAS) status or an official AAFCO definition. Some states even made moves to prohibit sales, worrying horseowners who relied on products like glucosamine to keep horses in work.
AAFCO’s task force worked with fervor to classify the ingredients while keeping them on the market, but in the end they disbanded “due to a number of liability issues,” said AAFCO’s John Breitsman. He summed up AAFCO’s current direction as a “move toward an enforcement strategy.” This is consistent with what AAFCO really is: an association of feed-control officials.
Since AAFCO isn’t a regulatory body, it can’t make laws. AAFCO’s attempt to establish a conditional status for some ingredients, allowing sales to continue while they developed GRAS status/AAFCO definition, could have been viewed as an unofficial sanction, which is essentially illegal. Only the FDA can accept safety and efficacy data. Until then, the ingredient is, by definition, unapproved.
Manufacturers have always had the option of following established pathways for getting their ingredients accepted by the FDA. However, there’s still the dilemma of which pathway to take: approval as a drug or a nutrient supplement. A drug is defined as any substance claimed to “cure, treat, prevent or mitigate a disease condition or makes structure or function claims.” But getting approval as a drug is expensive and difficult, and brings with it additional regulations.
On the other hand, getting an ingredient approved as a nutrient supplement is no easy task either. The ingredient must be shown to be an essential part of the diet and prove it is safe in the amounts proposed. Frankly, many nutraceuticals don’t fit either category very well.
We’re back at square one, but it’s not AAFCO’s fault. The FDA’s policy regarding these supplements has a gaping hole. It can be filled either by precise new guidelines or the adoption of the provisions of the human Dietary Supplements Health and Education Act (DSHEA).
Where does this leave the future availability of your favorite supplements’ Right where it has always been — between the crosshairs.
’Til Next Month,
-Eleanor Kellon, VMD