FDA and FTC Tell Monsanto to Quit Bellyaching (Part 1)

How do you say "shove it" in Bureaucratese?

Two letters to Creve Coeur-based Monsanto -- one from the U.S. Food and Drug Administration, the other from the Federal Trade Commission, ought to give you an idea.

Earlier this year Monsanto petitioned the two federal agencies to bitch-slap milk producers who have made "deceptive" claims that say or imply dastardly things about Posilac, a.k.a. rBST, a.k.a. recombinant bovine somatotropin, a.k.a. bovine growth hormone.

In an April 4 press release, Monsanto had bemoaned how "certain milk labels and promotions that differentiate milk based on farmer use of POSILAC bovine somatotropin (bST) are misleading to consumers and do not meet the standards set by laws and regulations for either the Federal Trade Commission or the Food and Drug Administration."

I wrote about the chemical company's wadded knickers here and here.

Monsanto's complaints fell into three categories. The first two were relatively straightforward:

• Some producers were labeling their product with claims like "No Hormones" or "No Hormones Added." Such assertions, Monsanto's attorneys pointed out, are patently false, because 1) all milk contains naturally occurring hormones, and 2) the vast majority of milk sold in this country is augmented with vitamin D, which is itself a hormone.

• Other labels said things like "rBST-free," "No Artificial Hormones" and "Does Not Contain Artificial Growth Hormones." Because rBST is administered to cows and not added to milk, no milk can be said to "contain" rBST.

It was the third category of alleged violations that rammed Monsanto's stout ship of argument up against the pointy shoals of common sense. To wit:

• Monsanto attorneys objected to claims such as "Produced Without the Use of Artificial Hormones" and "Farmer's Pledge: No Artificial Growth Hormones."

Conceding that such claims were (probably) accurate, Brian Robert Lowry, Monsanto's associate general counsel for the Office of Policy, Stewardship, Regulation and Government, argued that they should still be prohibited because they imply that dairy farmers who don't use rBST produce more healthful milk than the farmers who do use the Monsanto product.

Wrote Lowry:

"Although such claims may be literally true -- provided that the dairy processor can establish that it has followed practices and procedures deemed by experts in the field to be sufficient to ensure that the milk is in fact produced by non-supplemented cows, and that the milk is never commingled with milk produced from rBST supplemented cows either before or during processing -- they are still misleading to consumers because they suggest that the milk is safer, healthier or of a higher quality than other milk."

Writing on behalf of the FDA, chief counsel Sheldon T. Bradshaw expends the first two paragraphs of his four-paragraph letter, dated June 27, reiterating Monsanto's argument and then noting that most of the company's complaints of violations fall under the purview of the FTC, not the FDA. As for "those claims that actually appear on milk labels," Bradshaw notes that his agency issued a pertinent "guidance" way back in 1994 and is not inclined to revise it. Sincerely, etc., etc.

Mary K. Engle, associate director of the FTC's Division of Advertising Practices, is a little more expansive in her August 21 letter to Monsanto and its attorneys, which runs to three pages. But in terms of rhetoric, Engle plods along the same path Bradshaw trod, only more slowly.

Engle cites the FDA's 1994 guidance, noting helpfully that it can be viewed in its entirety online (see for yourself here). And, she says, what goes for labeling applies to advertising: Milk producers are welcome to advertise the fact that they don't use rBST "but should be careful not to suggest a human health or safety benefit."

Further, Engle writes, her staff has examined the labels, ads and websites Monsanto complained about and "did not find any examples of national or significant regional advertising campaigns that made express or implied claims linking rBST to human health and safety." They did find "a few instances of companies making unfounded health and safety claims about rBST" and "conveyed its concerns to the companies," which are now "in the process of revising their marketing materials."

And that, says Engle, is that.

Funny thing, though: You wouldn't know it from Rachel Melcer's story on the Business page of yesterday's St. Louis Post-Dispatch.

But that's a topic for another post.

-Tom Finkel

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