Washington Insider -- Tuesday

FDA Tries to Define Natural

Here’s a quick monitor of Washington farm and trade policy issues from DTN’s well-placed observer.

Companies Call for Increased Funding for Antibiotic Resistance Programs

Tyson Foods Inc. and Wal-Mart Stores Inc. joined public health organizations in asking House and Senate appropriators to increase funding for programs combating antibiotic resistance.

The budget deal that became law Nov. 2 raised discretionary spending caps, and additional money should be allocated to USDA and Food and Drug Administration to reduce the use of medically important antibiotics in livestock and poultry, the companies wrote in a letter also signed by the Pew Charitable Trusts and the Infectious Disease Society of America.

The companies hope that the federal funding would help efforts to phase out the use of medically important antimicrobials for growth promotion in food-producing animals, enhance systems for monitoring antimicrobial drug use in food-producing animals, evaluate new antibiotics for patient treatments, and streamline the development process for new antibiotics.

While the companies expressed appreciation for the proposed funding levels in the Fiscal Year 2016 budget from both the Obama Administration and Congress, they urge that additional funding is critical to assess and develop a system for monitoring antibiotic use through periodic collection of nationally-representative on-farm data use and resistance and implementing a feed compliance program.

The companies would like increased federal funding for the following initiatives:

USDA supported research to enhance understanding of the development of antimicrobial resistance and the spread of resistance genes in animals and humans;

Support for expanded dissemination of science-based knowledge to veterinarians and producers;

Use of voluntary surveys to measure antibiotic use in animal agriculture;

Support for USDA’s National Institute of Food and Agriculture’s Antimicrobial Resistance efforts;

Increased USDA data collection in order to increase transparency of antibiotic use in animal agriculture, understand what antibiotics are being used for what purpose, evaluate the effectiveness of stewardship efforts; and

Assessments of associations between antibiotic use practices and resistance.

“We are deeply concerned that the growing threat of antimicrobial resistance puts many people at risk for serious and life threatening infections with few or no treatment options,” the letter said. “Combating this threat will require increased and sustained federal investments in biomedical research and public health infrastructure.”


Coalition of Food Safety Ask Federal Government to Rework Coordinated Framework for Regulation of Biotechnology

The Center for Food Safety, Friends of the Earth, Pesticide Action Network and Water Watch on Nov. 16 sent comments to President Barack Obama and the FDA asking for mandatory, genetically engineered plant/animal-specific regulation; protections from increased pesticide use; protections for non-GE farmers; mandatory safety testing; and mandatory labeling of foods that contain genetically modified organisms.

The groups are asking the administration to rework the existing guidelines, known as the Coordinated Framework for Regulation of Biotechnology. They claim the framework is outdated since it was initiated in 1986 before biotech crops and livestock were commercially viable. The groups also believe the framework in its current iteration fails to protect consumers and the environment from the harmful effects of the pesticides used on genetically engineered crops.

“In sharp contrast with much of the rest of the world, the U.S. has prioritized the rapid commercialization of genetically engineered organisms over core governmental duties, such as protection of public health, the environment and the interests of agriculture,” George Kimbrell, senior attorney at the Center for Food Safety, said in a news release. “This negligence must end.”

The comments are in response to the White House Office of Science and Technology Policy, which announced in July that it planned to overhaul the regulations. The groups are now calling for commonsense reforms that include safety-testing, food labels and restrictions on how and where biotech crops may be grown.


Washington Insider: FDA Tries to Define Natural

Almost everybody agrees that our language should be clear and use well-known definitions, and so we are trained from our earliest days what thousands of names mean. Perhaps a natural instinct, you say.

Well, maybe. Bloomberg reported recently that the Food and Drug Administration wants public comment on the term “natural” as it relates to labels for food products and it is not asking for distinctions between foods that are genetically engineered and others. Still, there are serious questions about whether such a term can be found.

Right now, FDA has no formal definition for the term “natural,” Bloomberg says and that is causing consumer confusion and is leading to litigation about the labels on many foods. “We are taking this action in part because we received three citizen petitions asking that we define the term ‘natural’ for use in food labeling and one citizen petition asking that we prohibit the term ‘natural’ on food labels,” the agency said.

Additionally, the FDA noted that some federal courts, as a result of litigation between private parties, have requested administrative determinations from the agency regarding whether food products containing ingredients produced using genetic engineering or foods containing high-fructose corn syrup may be labeled as “natural.”

The agency has confronted this problem before. In 2014, it declined an invitation to determine whether foods containing genetically modified ingredients may be labeled natural. The agency ducked those requests on the grounds of budget constraints and higher priorities. And, it added, strangely, that if it were to formally define “natural,” it wouldn’t likely do so in the context of private litigation.

Actually, the FDA’s positon on the term is more than a little mysterious. As long ago as 1991, the agency had given notice of a proposed rulemaking for various food labeling issues, including the term “natural.” It issued a final rule in 1993 but said it would “maintain its current policy that the term meant that nothing artificial or synthetic (including all color additives regardless of source) has been added to a food that would not normally be expected to be in the food.”

Of course, this satisfied no one and has led to consumer confusion and dozens of class action lawsuits against products made from biotech crops like corn, soy and sugar. In addition, the Grocery Manufacturers Association (GMA) which represents food and beverage giants like ConAgra Foods Inc. and Nestle SA, petitioned the FDA in 2014 to issue a regulation actually allowing biotech food to be labeled as “natural.”

The GMA also is fighting a law in Vermont that would mandate that bioengineered food disclose that information on its packaging and prohibit a “natural” label, which other states also are considering.

“We’ve certainly reached a tipping point in the number of parties asking [the FDA] to do this,” Ivan Wasserman, a partner in the Washington office of Manatt, Phelps & Phillips, told Bloomberg. “But what the FDA has done doesn’t obligate them to do anything other than review the comments they’ve asked to be submitted.” Wasserman also thinks that it is unlikely that FDA will finalize a definition of “natural” any time soon because the issue is highly political and “the agency prioritizes its funding on public health and food safety.”

Apparently, much of the confusion is in the way the definition is perceived. For example, USDA has ruled that “natural” means products that don’t contain artificial ingredients and are minimally processed. The definition doesn’t discuss how animals are raised. Now, FDA says it is working with USDA to see where the agencies can “coordinate.”

A more specific definition could prevent some of the class action lawsuits that have led some manufacturers to remove the term from their products, an attorney that defends food and beverage companies in class action lawsuits told Bloomberg. “Ambiguity is what leads to these lawsuits,” he said, and that FDA would do well to work with USDA “because it already has a definition of natural, and we haven’t seen these lawsuits with meat and poultry products.”

Well, perhaps. The term clearly serves well as a powerful brand even when it is undefined. It seems unlikely that FDA will find a new, magic term in this year’s list of public comments any more than it did in the early 1990s, or that USDA’s “hear no evil” approach will solve the problem. Cynics suggest that convincing consumers that a given food product is close to nature will always be a difficult, competitive job and that litigation also is something of a natural component of that picture, Washington Insider believes.

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