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August, 2001
Dear CRYSTALYX® Brand Supplement
Customer:
The manufacturer of CRYSTALYX®
Brand Supplements, Ridley Block Operations,
would like to clarify its policy regarding
the use of prohibited mammalian protein ingredients
in the manufacturing of CRYSTALYX® Brand
Supplements.
In 1997, the Food and Drug Administration
("FDA") enacted a regulation (21
CFR 589.2000) which prohibits the use of specific
mammalian proteins in the manufacture of feeds
for ruminants. This enactment was taken as
a precautionary step in the prevention of the
disease Bovine Spongiform Encephalopathy ("BSE").
While the regulation covers many
protein by-products derived from mammalian
tissues, it does exempt some protein by-products
derived from mammals. Some of these exempt
products are rendered blood meal, milk products,
rendered porcine (pork) or equine (horse) meat
and bone meal. Non-mammalian protein products
that are exempt include hydrolyzed feather
meal, fish and vegetable products. Other rendered
products, such as tallow and dicalcium phosphate,
are also exempt.
| Ridley Block Operations does not
use any prohibited ingredients in
any of its manufacturing locations,
nor do any products we sell contain
prohibited ingredients. Most CRYSTALYX®
products contain no animal protein
products, which can be identified
by reviewing the labels. Furthermore,
Ridley Block Operations uses hydrolyzed
feather meal as its only source of
animal protein. All CRYSTALYX®
products do not contain any
mammalian protein. All Ridley Block
Operations facilities are FCI Certified. |
As part of its enforcement of
the regulation, the FDA has been inspecting
feed mills and rendering plants to ascertain
that the regulations are being enforced. This
letter is to advise you that a FDA inspector
may require you to show proof that Ridley Block
Operations products are compliant with the
FDA regulation.
Please retain and present this
letter to validate that the product(s) you
have received from Ridley Block Operations
is/are free of prohibited mammalian protein,
as defined by the regulation. If the FDA requests
further verification you may contact Ridley
Block Operations at (605) 269-2248 or (507)
388-9488. If you have any further questions,
please feel free to contact us.
Sincerely,
Mark Robbins
Formulations / Research Coordinator
Ridley Block Operations
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