Authors: David Robinson Simon
However, that's where the process both started and ended. The FDA never held any required public hearings, and it never took further action to withdraw approval of the drugs. In fact, in December 2011, the agency simply canceled the drug withdrawal processes it had started in 1977, citing its expectation that industry would voluntarily phase out subtherapeutic animal drug use.
19
A few months later, the FDA issued a report containing nonbinding suggestions to industry. The report
recommended
, but did not require, that antibiotics of medical importance to humans be used in farm animals only to treat illness and only under a veterinarian's supervision.
20
Notwithstanding the FDA's 1977 warnings that subtherapeutic use of penicillin, chlortetracycline, and oxytetracycline in animals is “not shown to be safe,” and despite its recent recommendations to cease such practices, the drugs are still approved to promote growth in farm animals and are still being actively used for that purpose. The only material recent development is that in 2012, a coalition of consumer and scientist groups won a lawsuit forcing the FDA to resume the withdrawal process it started thirty-five years earlier. The FDA appealed the decision, and the case is still being litigated as of this writing. In any event, even if the appeals court requires the agency to resume its withdrawal process, the outcome of the process will depend on the agency's ultimate findings as to the drugs' health risks.
What changed after 1977? Why did the FDA abandon the withdrawal process? And why did it take a lawsuit to try to make the agency resume its statutory duty? What happened is that, unable by themselves to convince FDA officials to halt the withdrawal process, industry lobbyists asked congressional lawmakers to lean on the FDA. From 1978 to 1981, in response to pleas from industry, House and Senate committees three times insisted that the FDA pause its withdrawal process for the three drugs.
21
Despite the seven years of study that preceded the FDA's 1977 withdrawal notices, and despite a significant body of published clinical studies, the congressional committees
told the FDA to conduct more research—a handy, euphemistic device for delay (and in this case, abandonment).
Theodore Katz, the federal magistrate who in 2012 required the FDA to resume the withdrawal process, noted this congressional noise and blamed it for sidetracking the agency from its duties in the seventies. “Importantly,” wrote Katz, “none of these [congressional] recommendations was adopted by the full House or Senate, and none was passed as law.”
22
Remarkably, even as the matter winds its way through the courts, and maybe ultimately through the FDA, the US Department of Health and Human Services (HHS, which oversees the FDA) publicly acknowledges “a preponderance of evidence that the use of antimicrobials in food-producing animals has adverse human consequences.”
23
Yet farm animals in the United States continue to be routinely dosed with these and other growth-promoting antibiotics.
Remember Doctor Dolittle? One of the more interesting animals the fictional doctor met in his worldly travels was the pushmi-pullyu (pronounced “push-me pull-you”). With a gazelle's head at one end and a unicorn's head at the other, the animal's every attempt to move results in a struggle but little real progress. The USDA is a bit like this two-headed beast, pushing itself in one direction while pulling in the other. The persistent problem lies in the agency's conflicting goals, which lead to internal clashes and often, confusing advice for consumers.
One of the USDA's chief aims is to help industry sell food to consumers—in its words, “enhancing economic opportunities for agricultural producers” and “getting products from producers to . . . consumers.”
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But other branches of the USDA are charged with
protecting
consumers by giving nutritional advice, keeping food safe and free of contaminants, and ensuring that food advertising and labeling are accurate. When sales promotion and consumer protection go toe-to-toe, as they often do, the results can be truly bizarre.
Every five years, the USDA and HHS partner to release
Dietary Guidelines for Americans
, a set of nutritional recommendations that
form the basis for federal dietary policy. Like a modern-day set of Mosaic commandments, these guidelines govern all federal nutritional programs and dietary guidance publications. They serve as the basis for the USDA's food plate—a colorful image intended to recommend food proportions. In short, the guidelines affect—directly or indirectly—practically every American.
The first clue that the nutritional advice in
Dietary Guidelines for Americans
might be based more on marketing than science lies in the membership of its drafting group. Nine of the thirteen panelists on the latest Dietary Guidelines Advisory Committee are linked to industry, having served as advisors or consultants to corporations such as Dannon, McDonald's, Kellogg's, Tropicana, General Mills, and others.
25
Because of industry influence via such committee membership and elsewhere in the process, the Harvard School of Public Health dismisses the
Dietary Guidelines
as the product of “intense lobbying efforts from a variety of food industries” and criticizes its recommendations as the flawed result of the “tense interplay of science and the powerful food industry.”
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Not surprisingly for the product of a nutritional committee dominated by industry veterans, the
Dietary Guidelines
contain some notably mixed messages. The advisory committee apparently sought to discourage consumption of unhealthy foods without offending the businesses that produce those foods by couching its recommendations in vague, technical terminology that few laypeople understand. Thus, the report routinely resorts to scientific jargon instead of simple terms like
beef
and
pork
when advising against consumption of animal foods. For example, the guidelines advise us to reduce “cholesterol” and “solid fats,” but fail to provide examples of foods that contain these substances (translation: meat, fish, eggs, and dairy).
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The guidelines also urge us, bewilderingly, to reduce “saturated fatty acids by replacing them with monounsaturated and polyunsaturated fatty acids” (translation: eat fewer animal foods; eat more plant foods). The average American has little idea what these terms mean or the kinds of food associated with them. It's like telling a child, “You're prohibited from prevaricating,” instead of just saying, “Don't lie.” This drafting
method is particularly strange in light of the guidelines' use of concrete examples in many areas to tell us the foods we
should
eat, such as “vegetables, beans, and peas.”
28
The confusing language in the
Dietary Guidelines
led the Physicians' Committee for Responsible Medicine (PCRM) to file a lawsuit against USDA and HHS in 2011.
29
The lawsuit charges that the agencies violated federal statutes requiring them to publish “nutritional and dietary information and guidelines for the general public” and to base their dietary guidelines on “the preponderance of the scientific and medical knowledge which is current at the time the report is prepared.”
30
At this writing, PCRM's lawsuit was still pending.
The USDA's messaging on cheese provides another remarkable example of how internal conflict can lead to consumer confusion. The agency's nutritional arm urges us to reduce saturated fat intake by eating less cheese, telling us, for example, to “ask for . . . half the cheese” on pizza.
31
At the same time, the USDA's promotional arm aggressively tries to sell us more cheese. Dairy Management, a checkoff-funded group created by USDA delegates in 1995 to promote dairy sales, has a budget of $136 million and 162 employees. The USDA appoints some of its board members, approves its marketing campaigns and major contracts, and reports to Congress on its work.
32
The USDA also provides funds to the group from time to time, including $5 million in 2009.
33
In 2010, Dairy Management teamed with Domino's Pizza to develop and promote a pizza with 40 percent more cheese—the “Wisconsin”—with six cheeses on top and two more in the crust. Just half of a modest, twelve-inch Wisconsin pizza contains 86 ounces of saturated fat. That's 20 percent more than the USDA's recommended daily saturated fat maximum of 70 ounces—and the pizza is just one meal.
Don't expect the USDA's nutritional team to win this battle anytime soon: with a 2012 budget of only $13 million, the USDA's Center for Nutrition Policy and Promotion is poorly equipped to compete in the battle for consumers' hearts and minds—and arteries. As we've seen above, the National Dairy Promotion and Research Board,
marketing mouthpiece of the USDA and parent of Dairy Management, boasts a financial arsenal of $389 million in annual checkoff funding.
34
“Don't tell me where your priorities are,” said educator James W. Frick. “Show me where you spend your money, and I'll tell you what they are.” The USDA's priorities are complicated, it seems. The agency's inherent conflict of interest in nutritional matters led former US Senator Peter Fitzgerald (R-IL) to propose in 2003 that responsibility for nutritional advice should reside solely with HHS. “The USDA food pyramid [precursor of the food plate] probably has more to do with diabetes and obesity than Krispy Kremes,” Fitzgerald said. He unsuccessfully urged his colleagues to strip the USDA of responsibility for dietary advice and leave it to pursue its “main mission . . . to promote the sale of agricultural products.”
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As another symptom of industry influence, the USDA is sometimes as hard-pressed to protect food from contaminants as it is to promote healthy eating practices. In response to a 1993
E. coli
outbreak at Jack in the Box restaurants, the agency implemented a new meat inspection method known as Hazard Analysis Critical Control Points (HACCP). HACCP changed the focus of inspection to critical control points in meat plants, but in response to heavy industry pressure, it also transferred many inspection duties to the meat industry. HACCP also allowed plants to build walls blocking USDA inspectors from seeing the slaughter area.
The USDA's watchdog arm, the Office of Inspector General (OIG), has noted numerous problems with HACCP. For example, in one report, the OIG found that large meat producers, who have delegated to themselves the authority to determine whether the presence of
E. coli
in their meat is a hazard “reasonably likely to occur,” are routinely unsuccessful at making this determination.
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The OIG found that
E. coli
is typically found at meat plants only by “happenstance,” and that meat producers are largely ineffective at self-testing for its presence.
37
Another OIG report noted that inspectors receive inadequate
training and oversight and are too few in number to conduct inspections properly. (There are 7,500 USDA food safety inspectors, but with 30 million land animals killed in the United States each day, they're spread a little thin.) This report also found “inherent vulnerability to humane handling violations” because of the lack of continuous inspector surveillance.
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Another result of industry's influence on the USDA is in the department's lack of authority to issue a mandatory recall of meat—even when it's contaminated with
E. coli
, pesticides, heavy metals, or veterinary drugs. All the USDA can do is
recommend
that meat producers voluntarily initiate a recall on their own. That's right—the main US regulatory agency for animal food safety lacks the ability to recall tainted food and must rely on companies who sell dangerous food to issue recalls at their sole discretion. It's as if the FAA lacked real authority to direct air traffic and could only politely suggest that pilots stay out of one another's way.
The threat of a lawsuit may encourage some producers to voluntarily recall contaminated meat. But this threat lacks the force and urgency of a mandatory recall, and in any event, lawsuits take years and require plaintiffs to prove both causality and damages—something not everyone has the time or money to do. A 2010 OIG report found that the USDA's inability to recall meat, coupled with a lack of processes to detect and determine safe levels of chemical residues in meat, led to quantities of meat entering the food supply containing pesticides, drugs, and heavy metals like arsenic.
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These substances can cause a variety of human illnesses, including stomach, nerve, and skin diseases.
As we saw with the FDA, food labeling is an area where agency policy can have an enormous effect on consumers' ability to make informed choices. At the USDA, industry influence has led to watered-down labeling standards, and as a result, food labels are often less than forthcoming. For example, the USDA is charged with enforcing correct use of the term
organic
, but lobbyists have succeeded in convincing both
Congress and the USDA to adopt numerous loopholes in the term's legal definition. Foods can now contain any of nearly three hundred nonorganic substances and still be labeled “USDA Organic.” These include a variety of synthetic substances, such as artificial colorings, flavorings, starches, casings, gelatin, and hops.
Industry players sometimes use their influence to bypass inconvenient labeling restrictions altogether. Consider an example from the organic baby food market. USDA staff members determined that baby formula containing synthetic fatty acids could not use the term
organic.
Among other concerns, the synthetic fats are often produced using hexane, a neurotoxin. However, after industry lobbyist William Friedman contacted USDA Deputy Administrator Barbara Robinson to argue his clients' position, Robinson overruled her staff and allowed the baby food with the synthetic ingredients to receive the coveted organic designation.
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In an interview with reporters, Robinson defended her actions by explaining the USDA's main purpose is to “grow the industry.”
41
At the time of this writing, Robinson held a management position in the USDA's National Organic Program.
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