From: "Basil R. Eastwood" <BEASTWOOD@cite.esusda.gov>
Organization: Extension Service, USDA
To: DAIRY@ESUSDA.GOV
Date sent: Wed, 23 Feb 1994 12:38:29 EST
Subject: DAIRY UPDATE-FDA Guidelines-BST Labeling
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The following information provided by Cornell University was sent by
the International Dairy Foods Association (Milk Industry Foundation,
National Cheese Institute, International Ice Cream Association) to its
members on February 8, 1994. IDFA, 888 Sixteenth St NW, Washington DC 20006.
FDA ISSUES RIGOROUS GUIDANCE ON BST CLAIMS
FDA has issued stringent guidelines regarding bST claims. Few
companies will be able to make truthful and nonmisleading claims
which meet the labeling, monitoring, and certification requirements
that FDA is publishing in the Federal Register.
The following are the key points from the FDA notice. This
reflects FDA's interpretation of the Food, Drug and Cosmetic Act, and
may be relevant to States' interpretation of their own similar
statues.
KEY POINTS FROM THE FDA NOTICE ON bST LABELING
On February 8, 1994, FDA published interim guidance to the states
on the labeling of milk and milk products from cows that have
not been given supplemental bST (rbST).
The FDA notice reconfirms that rbST is safe and effective for cows,
that milk from cows given rbST is safe for human consumption,
and that there is no compositional difference between milk from
treated and untreated cows.
Because trace amounts of natural bST are present in all milk, a
"bST free" statement about milk in labeling or advertising would
be false.
A statement that a milk product is "rbST-free would be misleading,
because it would falsely imply a compositional difference
between milk from treated and untreated cows.
A statement that milk is 'from cows not treated with rbST' could be
misleading because it falsely implies that milk from untreated
cows is safer or of higher quality than milk from treated cows.
The misleading implication of the statement "from cows not treated
with rbST" might be avoided by an accompanying statement "No
significant difference has been shown between milk derived from
rbST treated and non-rbST treated cows."
FDA indicates that some other explanatory statement (other than
safety or quality) might be used, but it gives no examples of
such statements that would not be false or misleading.
States should evaluate any rbST labeling statements in the context
of all labeling and advertising for the product. (Store signs
and posters, menus, pamphlets, store handouts, and the like are
labeling and thus subject to FDA and state enforcement.)
Because there is no way to differentiate analytically between
naturally occurring bST and supplemental bST, states could
require that firms making any rbST claims should establish a
plan and maintain records to substantiate the claim.
Companies making rbST claims must be able to demonstrate that milk
and all milk-derived ingredients are from cows not treated with
rbST. This may include establishment of a third-party
certification program to assure accuracy of claims.
If rbST claims are made, milk from non-rbST herds must be kept
separate at every stage from other milk, as verified by a valid
paper trail.
Additional Comments
The FDA notice is quite clear and demanding for producers,
processors and distributors that choose to make rbST claims in
labeling and advertising. The anticipated widespread use of rbST by
many producers will assure that virtually all milk in commercial
distribution, including dry milk or other concentrated dairy
ingredients, will include milk from some cows that were given
supplemental bST. Accordingly, any rbST claims should raise
questions concerning their reliability and accuracy.
The FDA explicitly contemplates that state officials will be
enforcing state food and drug laws on the basis of the FDA notice.
It is quite unlikely that enforcement officials will tolerate the
fraud on consumers and unfair competition that will unavoidably
result from false, misleading or unsubstantiated rbST claims in labeling
or advertising. We also anticipate that enforcement officials will
question any company efforts to avoid enforcement action by making
false or misleading claims about their product in publicity releases
or statements to the press.
The FDA notice provides a 30-day period for public comment on
the interim guidance document. IDFA will submit comments and
encourages its members to do so.
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BASIL R. EASTWOOD USDA-Ext. Service Ph. (202) 720-6486
Prog. Leader-Dairy 3334 South Bldg. Fax (202) 720-7714
Washington DC 20250 BEASTWOOD@ESUSDA.GOV