rBST: FDA Labeling Guidelines

S.A. Modena maildrop maildrop at csemail.cropsci.ncsu.edu
Thu Feb 24 07:40:50 EST 1994


>From:           "Basil R. Eastwood" <BEASTWOOD at cite.esusda.gov>
Organization:   Extension Service, USDA
>To:             DAIRY at 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 at ESUSDA.GOV




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