The federal government's 90 day moratorium on the sale ofMonsanto's recombinant bovine growth hormone (rBGH) Posilacexpires today, leaving the company free to begin marketing theproduct. Posilac, a bovine somatotropin (bST) derived from anaturally occurring hormone found in milk, is intended toincrease milk production in dairy cows.

Monsanto (NYSE:MTC) plans to begin selling the product onFriday at an introductory price of $5.00 per dose. Cows requireone dose every 14 days, a company spokesperson said. Theregular price of the product will be $6.60 per dose, or about 50cents per cow per day. According to the St. Louis company, theproduct can increase milk production in cows by up to 20percent.

The controversial hormone has come under fire by a number ofconsumer groups. FDA's Veterinary Medicine AdvisoryCommittee, which recommended approval of the drug lastApril, concluded that use of the product led to a slightlyincreased incidence of mastitis in cows, but said this bacterialinflammation of the teats was manageable.

Because the inflammation is treated with antibiotics, however,some organizations, including the U.S. General Accounting Office(GAO), have suggested that rBGH could indirectly lead toincreased levels of antibiotics in milk and other dairy products.Some consumer advocacy groups, including the Pure FoodCampaign, an affiliate of Jeremy Rifkin's Foundation onEconomic Trends, also have raised concerns about humaningestion of rBGH. Monsanto convinced FDA that these factorsdo not pose significant health risks.

A report by the U.S. Office of Management and Budget releasedin January noted that milk is tested for drug residues beforebeing released on the market, and concluded that "diaryproducers who experience an increased incidence of mastitiswould likely reevaluate their use of bST."

Nonetheless, several organizations have sought to haveproducts from rBGH-treated cows labeled, either on amandatory or voluntary basis. According to Monsantorepresentative Karen Marshall, at least some school districts inWisconsin and the city of Los Angeles have banned the use ofproducts from rBGH-treated cows. At various times during theregulatory review of the agent, Vermont, Wisconsin, Minnesotaand Maine imposed moratoriums on rBGH. Maine's moratorium,which according to representatives at the State Department ofAgriculture, expired on February 1, was the last state-levelbarrier to the sale of Posilac. That moratorium was put in placelast summer.

In approving rBGH, FDA announced that dairy products madefrom cows not treated with rBGH can be labeled as such as longas the labeling is "truthful and not misleading."

The National Association of State Departments of Agriculture(NASDA), an association representing the interests ofcommissioners of state departments of agriculture, has in thepast opposed mandatory or voluntary labeling of dairyproducts to distinguish whether they came from cows treatedwith rBGH. The association is still pursuing clarification of FDA'spolicy on rBGH labeling.

Mark Nestlen, Manager of Legislative and Regulatory Affairs atNASDA, told BioWorld that the association would like moreguidance from FDA on what constitutes "truthful and notmisleading." He observed that some independent legal counselhave suggested that any "rBGH free" label is misleadingbecause it indicates there is a difference between milk fromcows treated with rBGH and untreated cows. "There is nodifference," he said.

Little Public Concern

A survey released this week by the Grocery Manufacturers ofAmerica, however, indicates that the general public may notshare activists' concerns. In a random telephone survey of1,004 consumers, respondents given a definition of rBGH wereasked to rate the "acceptability" of products from rBGH-treatedcows on a scale from one to 10 (with one representingunacceptable and 10 representing acceptable). Respondentsrated rBGH between 4.5 and 6.2, depending on what they weretold about the agent (e.g., about its acceptance by such groupsas the American Medical Association and the NationalInstitutes of Health, or that rBGH is a naturally occurringhormone).

-- Karl A. Thiel Associate Editor

(c) 1997 American Health Consultants. All rights reserved.