Page 137 - Microsoft Word -Cow Book 10-06-09 final update.doc

 Aloe Vera:

FDA has received complaints that aloe vera is being promoted for
use as a treatment for mastitis and calf diarrhea, a cure for high
somatic cell counts, and as an aid for increasing milk production.
FDA is aware that firms are selling containers of aloe vera with no drug
claims on the label to dairy producers and then providing the drug use
claims either orally or by other printed materials or graphics (labeling).

No aloe vera product has been approved for the treatment of these serious
diseases conditions or to increase milk production. Aloe vera products for
animals bearing these types of claims are unapproved new animal drugs.
Aloe vera products intended for animal use that do not bear adequate
directions for animal use are Amisbranded@. The use of unapproved drugs
violates Item 15r of the PMO.

D. Drugs Packaged for Injection or Udder Infusion but Labeled for Oral
or Topical Use:

FDA has received several complaints about products packaged and
labeled for oral, topical, or other routes of administration that are packaged
in a manner customarily considered to be for parenteral (injection or udder
infusion) administration. Among these are aloe vera products labeled
for topical use packaged in surjets/squeeze jets (squeeze tubes
routinely used for intra-mammary infusion); probiotic and whey blend
products labeled for oral use packaged in syringes with sterile
diluents in vials with udder infusion cannulas and alcohol pads or
packaged in sterile vials closed with a metal ring and rubber injection
stopper.

FDA’s Compliance Policy Guide (CPG) 7125.39, entitled “Drugs packaged
for Infusion or Injection for Food-Producing Animals” is available for
guidance on this issue.

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