State of Washington
DEPARTMENT OF AGRICULTURE
P.O. Box 42560 * Olympia, Washington 98504-2560 * (360) 902-1800

June 11, 2002

Dear Mr. Teel:

The Washington State Department of Agriculture's (WSDA) Food Safety Program is investigating concerns about a new dairy product label and advertising campaign being used by your company. The program has been reviewing the new label and is concerned about labeling claims, such as no antibiotics, no added hormones, free-farmed, etc., that may be misleading to the consuming public.

Vitamilk's new label and recent TV and radio advertising appear to create the false and misleading impression with the consuming public that these dairy products are somehow different from other milk or that these cows are healthier than other cows.

Your labeling statement of "Contains No Added Hormones" is inconsistent with the FDA rbST guidelines [Docket No. 94D-0025 as published in the Federal Register, Vol. 59, No. 28, February 10, 1994, page 6280] relating to milk from cows not supplemented with rbST, which specifically states:

"A food is misbranded if statements on its label or in its labeling are false or misleading in any particular… the presence and absence of information are relevant to whether labeling is misleading… Thus, certain labeling statements about the use of rbST may be misleading unless they are accompanied by other information… Because of the presence of natural bST in milk, no milk is "bST-free," and a "bST-free" labeling statement would be false. Also, FDA is concerned that the term "rbST free" may imply a compositional difference between milk from treated and untreated cows… the concept would better be formulated as "from cows not treated with rbST"… However, even such a statement, which asserts that rbST has not been used in the production of the subject milk, has the potential to be misunderstood by consumers. Without proper context, such statements could be misleading. Such unqualified statements may imply that milk from untreated cows is safer or of higher quality than milk from treated cows. Such an implication would be false and misleading… Proper context could be achieved… with the statement that "No significant difference has been shown between milk derived from rbST-treated and non-rbST-treated cows."

Also, with regards to hormones, many dairies in Washington State use a variety of reproductive therapies to facilitate artificial insemination. These therapies often include injections of hormones such as prostaglandin, estrogen, oxytocin and gonadorelin. If rbST or other hormones are in fact not being used by any of your producers, do you have documentation to support this fact? Are they being required to sign a company affidavit? Does your company have a verification process in place to monitor the non-use of such hormones?

Your company's label statement of "No Antibiotics" gives the impression that there is no use of any type of antibiotic products when in fact virtually all commercially available artificial insemination products include the addition of antibiotics such as Gentamycin. In addition, under the state's current drug residue-monitoring program, which your processing plant and producers participate in, the profram only tests for the presense of beta-lactum drugs. Is your company verifying that no other antibiotics are in fact being used by any of your producers?

Vitamilk Dairy also has a history of purchasing raw milk from a "pool" of dairy producers. This means that the raw milk supply is received from sources other than just Vitamilk producers. Our program documentation shows that milk has bee received from other producer sources such as Northwest Dairy Association and Safeway producer groups. In fact, your company has a contract with Safeway to manufacture your cottage cheese products. WSDA understands that these producer and processor groups are not part of the "Free Farmed" program.

Your advertising and labels do not clarify that there are Vitamilk products which are not processed out of the same "Free Farmed" program supply source which again is confusing and misleading to the public. In your labeling and advertising, you are implying that all Vitamilk products are produced from milk that meets the "Free Farmed" program requirements.

WSDA's review of the "Free Farmed" program information indicates that the organization is not promoting products by members of their program to be free of added hormones or antibiotics. The "Free Farmed" organization is promoting the fact that animals are treated humanely and that products certified through their program are no more or less safe than natural or organic foods. Please be advised that the WSDA Organic Foods Program should be contacted for certification requirements if organic claims are made.

WSDA is considering whether or not your current labeling statements are in violation of RCW 69.04.016 and 69.04.250 of the Intrastate Commerce in Food, Drugs and Cosmetics act, which state:

RCW 69.04.016:
"If any article is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading, then in determining whether the labeling or advertisement is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, sound, or any combination thereof, but also the extent to which the labeling or advertisement fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual."

RCW 69.04.040:
The following acts and the causing thereof are hereby prohibited:
(1) The sale in intrastate commerce of any food…that is…misbranded.
(2) The misbranding of any food…in intrastate commerce.
(3) The receipt in intrastate commerce of any food…that is…misbranded, and the sale thereof in such commerce for pay or otherwise.
(4) The dissemination within this state, in any manner or by any means or through any medium of any false advertisement."

RCW 69.04.250:
A food shall be deemed to be misbranded (1) if its labeling is false or misleading in any particular; or (2) if it is offered for sale under the name of another food; or (3) if it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated; or (4) if its container is so made, formed or filled as to be misleading."

RCW 69.04.710:
An advertisement of a food…shall be deemed to be false, if it is false or misleading in any particular.

We request that within fifteen (15) days of the receipt of this letter that you furnish the department information on how Vitamilk validates the use or lack of rbST and other hormone products on the producer farm and in addition to beta-lactam residues, what other antibiotic testing is being performed prior to processing.

The WSDA Food Safety Program works to provide technical assistance and educational information to the regulated food industry and consumers within the state of Washington. We will continue to monitor the labeling concerns and work with other state, local and federal agencies in implementing effective regulatory strategies for protecting the consuming public.

If you have any further questions or would like additional information, please contact me at 360-902-1905.

Sincerely,

FOOD SAFETY, ANIMAL HEALTH & CONSUMER SERVICES DIVISION

Claudia G Coles, Program Manager
Food Safety Program

Cc:

Jim Presseley, Assistant Program Manager
Steve Matzen, Washington Dairy Products Commission
Jay Gordon, Washington State Dairy Federation
Alice Blado, Assistant Attorney General
Deanna Fales, Food Safety Officer
Rudy Opiniano, Food Safety Supervisor
File (Dairy Labeling)