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Are The FDA’s New Definitions And Labeling Requirements Good For Us, Or Just Empty Calories?

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By Diana R. H. Winters

[Crossposted from the Health Affairs Blog]

The Food and Drug Administration (FDA) has recently taken three steps toward providing consumers with more and better information about food products that the agency regulates. First, in response to several citizen petitions, the agency requested comments on the use of the term “natural” on food labeling. Second, the agency issued a statement in early May indicating that “in the near future” it planned to solicit comments reevaluating how nutrient content claims are regulated — including the term “healthy.” And third, the agency issued a final rule on an updated Nutrition Facts label, with which large companies must comply by July 2018.

With each of these actions the FDA is attempting to ensure that information provided to consumers by food manufacturers comports with the latest scientific understanding about food components. Indeed, the updated nutrition facts label will provide important information and potentially allow consumers to make more informed choices about what they eat. The agency, however, has set itself a far trickier task in defining words such as “natural” and “healthy.”

Act Naturally

In the past, the FDA has repeatedly declined to define the term “natural.” The Nutrition Labeling and Education Act (NLEA) of 1990 required the FDA to standardize definitions for nutrient content claims, like “fat free” or “high in fiber,” and to limit the use of health claims, like “heart healthy” (21 U.S.C. §§ 343(r)(1)(A), (B)). The word “natural,” however, does not fit into either of these categories.

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The FDA’s Determination On Artificial Trans Fat: A Long Time Coming

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By Diana R. H. Winters

[cross-posted at Health Affairs Blog]
On June 16, 2015, the Food and Drug Administration (FDA) released its final determination withdrawing the generally recognized as safe (GRAS) designation for partially hydrogenated oils (PHOs), which are the main source of artificial trans fat in processed foods. The agency gave the food industry three years, until June 18, 2018, to phase out the use of PHOs. The FDA’s order was expected based on the agency’s tentative determination that PHOs were no longer GRAS, published in November 2013.

This action is a milestone in — although perhaps not the culmination of — the FDA’s decades-long attempt to grapple with increasing scientific recognition that trans fat poses a serious health risk to consumers. The action is also unusual, in that it is quite rare for the FDA to withdraw GRAS status from a food product, a move that most likely will mean the ingredient is no longer used in foods.

What is not unusual, unfortunately, is the lengthy timeframe of this regulatory trajectory in the context of FDA action. To be sure, this action will lead to a dramatic reduction in the use of PHOs in processed foods, which in turn, will lead Americans to eat less trans fat – a good thing. What this regulatory action does not do, however, is speak to problems with the GRAS process as a whole.

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Putting Humpty Dumpty Together Again: Consolidating Regulatory Authority Over Food Safety

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By Diana R. H. Winters

[Cross-posted from the Health Affairs Blog]

The fragmented nature of regulatory authority over food in the United States is well known. More than a dozen federal agencies are responsible for the safety of the nation’s food supply. The Food and Drug Administration (FDA) and the Department of Agriculture (USDA) have the lion’s share of responsibility, together overseeing over 80 percent of the nation’s food safety.

Generally, the USDA regulates meat, and the FDA regulates everything else, but overlaps, exceptions, gaps, and therefore examples of resulting absurdities abound: the FDA regulates frozen pizza, unless it has pepperoni. The FDA regulates seafood, unless it’s catfish. The USDA has jurisdiction over packaged open-face meat sandwiches, but if the sandwiches are closed, authority shifts to the FDA.

This division in regulatory authority is neither planned nor rational. It is instead a historical accident, originating in the early twentieth century. When the Pure Food and Drug Act and Meat Inspection Act were passed on the same day in 1906, both targeting the adulteration of the food supply, their oversight was assigned to different departments within the USDA. The fissure widened when the FDA was moved out of the USDA in 1940. This divided regulatory framework is not the only reason for the fragmentation of regulatory authority over food in the US, but it is a main driver.

The President’s Proposal for a Single Food-Safety Agency

The President’s 2016 Budget, released last week, attempts to put the pieces back together and consolidate control over food safety. It proposes a new agency within the Department of Health and Human Services (HHS) that will incorporate the food safety functions of the FDA and the Food Safety and Inspection Service (FSIS) of the USDA.

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The inadequacy of voluntary measures to reduce the use of antimicrobials in animal feed

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By Diana R. H. Winters
[Cross-posted at HealthLawProf Blog.]

On Thursday, October 2, 2014, FDA released its “Summary Report on Antimicrobials Sold or Distributed in Food-Producing Animals” for 2012. The Report contains the depressing news that “domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals increased by 16%,” between 2009 and 2012, though the percentage of those labeled solely for therapeutic use rose from 28% to 32%. The other 68% are labeled for just production (growth promotion) or production and therapeutic uses.

But why is that depressing, you may ask. Isn’t this exactly why FDA issued a final-guidance document and a draft rule in December 2013, both addressing its voluntary program with drug sponsors to decrease, and eventually end, the use of medically important antimicrobials for growth promotion in animal feed? Problem identified, solution initiated—right? If only it were that simple.

FDA has a long history of delay and intransigence on this issue. I have written about that history in the past, and do so again in this forthcoming article. In 2011, FDA was sued by a group of public interest organizations for its unwarranted delay, and a federal district court ordered the agency to begin proceedings to hold withdrawal of approval hearings for certain medically important antibiotics, hearings that it had originally called for in 1977. The Second Circuit reversed this decision in July of this year (NRDC v. FDA, 760 F.3d 151).  Read More

So Much, But Yet Not Enough—The Administration’s Plan to Combat Antibiotic Resistance

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By Diana R. H. Winters
[Cross-posted at HealthLawProf blog.]

Yesterday was a big day in the fight against antibiotic resistance. The White House released an Executive Order and a National Strategy document on Combating Antibiotic-Resistant Bacteria, the President’s Council of Advisors on Science and Technology (PCAST) released a report on antibiotic resistance, and the National Institutes of Health and the Biomedical Advanced Research and Development Authority announced a $20 million prize for developing tests to identify highly resistant infections. Kevin Outterson at The Incidental Economist, Food Safety News, and the New York Times provide a good summary of these developments.

It is clear that the administration recognizes the grave threat posed by antibiotic resistance and that it intends to make combating this danger a national priority. Its approach is broad—the National Strategy includes a “Guiding Principle” that “[d]etecting and controlling antibiotic resistance requires the adoption of a ‘One-Health’ approach to disease surveillance that recognizes that resistance can arise in humans, animals, and the environment,” and the strategy pays much attention to the role of antibiotics in food production. One main objective of the strategy is to eliminate the use of medically important antibiotics at subtherapeutic levels for growth promotion (the practice of feeding animals antibiotics to make them fatter, not to make them well).

But in regards to the use of antibiotics for growth promotion in animals, the strategy does not provide the tools, or even the rhetoric, to support meaningful movement towards decreasing their use. The strategy calls for FDA to implement Guidance #213, to enhance its data collection capabilities, and to increase educational outreach on the appropriate use of antibiotics. Guidance #213, issued in December 2013, is intended to provide drug sponsors with information as to how they can “modify the use conditions” of medically important antimicrobial drug products to limit use to that “necessary for assuring animal health,” and only under veterinary supervision. Not only do guidance documents not establish legally enforceable duties, the recommendations in Guidance #213 are characterized as voluntary. FDA, moreover, has known the dangers of using antibiotics in animal feed at subtherapeutic levels for four decades, and has been sitting on the information. Swift and strong action is needed now.

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Questioning Quorn

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By Diana R. H. Winters
[Cross-posted on HealthLawProfBlog.]

There was an article a couple of weeks ago in the New York Times about “engineered foods,” and how “a handful of high-tech start-ups are out to revolutionize the food system by engineering ‘meat’ and ‘eggs’ from pulverized plant compounds or cultured snippets of animal tissue.”   The author discussed some of the business models, interviewed some of the entrepreneurs, and contemplated some of the implications of “Food 2.0.” The concerns she noted involved the nutritional impact of these foods, and the possibility of resource-intensive production.

But what sort of screening will these food products go through before they enter the food supply? How will FDA vet these new foodstuffs for toxicity or allergenic properties? It won’t. Manufacturers can self-affirm that food products are safe, based on their own studies, and market them on that basis with no prior FDA approval. This is the GRAS (generally recognized as safe) route to marketability. A manufacturer could also choose to submit to the formal food additive approval process, which is extremely time-consuming, but considering the breadth of the GRAS exception, they probably won’t. Many more GRAS notifications are filed per year than food additive petitions.  Read More

Designing policy interventions in the context of obesity—what we can learn from the effects of cigarette taxes on children’s health

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By Diana Winters (@diana3000)
[Cross-posted at HealthLawProf Blog.]

An important new study shows that a child will most likely be healthier throughout her childhood if a tax on cigarettes is in place when her mother is pregnant. Economist David Simon (who, full disclosure, is my cousin) at the University of Connecticut has extended the findings that the health of infants can be improved by a policy intervention that improves the in-utero environment, and has provided strong evidence that cigarette taxes can improve the health of children into their teen years.

It is well established that smoking during pregnancy can harm a developing fetus. In his paper, Simon cites studies that demonstrate the negative effects of taxes on cigarette smoking, and in a second paper, he collects and reviews the literature that shows that pregnant women are responsive to cigarette taxes. Simon uses a restricted-use version of the National Health Interview Survey, which the Centers for Disease Control and Prevention has used since 1957 to collect data on the health of the U.S. population, to examine medium-term childhood health outcomes for individuals exposed to a cigarette tax in-utero.  Read More

Introducing Diana R.H. Winters

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We are excited to introduce Diana R.H. Winters as an occasional contributor to Bill of Health.

WintersDiana has been an Associate Professor at Indiana University McKinney School of Law since 2012. She joined McKinney Law from Boston University Law School, where she was a Visiting Assistant Professor and the Health Law Scholar. Before that, Winters was an Assistant Solicitor General in the New York State Attorney General’s Office. Winters is also a founding board member of the Indianapolis (Indy) Food Council. She is currently researching the structure of food regulation, and the judicial review of health and safety regulation. She teaches Torts, Health Law, Environmental Law, and Food Law and Policy.

Representative Publications: Read More

SCOTUS Embraces Regulatory Synergy in POM Wonderful

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By Diana R.H. Winters

While today’s unanimous (sans Justice Breyer, who recused himself) decision by the Supreme Court in POM Wonderful LLC v. Coca-Cola Co. was certainly not a surprise, especially after the clear tenor of the oral argument, the case may have some implications for FDA law going forward. In this case, POM Wonderful sued Coca-Cola under the Lanham Act, alleging that the label on Coca-Cola’s pomegranate blueberry juice was false and misleading, and that this deception caused it to lose sales. Coca-Cola argued that because its label complied with the Food, Drug, and Cosmetic Act, POM’s Lanham Act claim should be precluded. The district court and the Ninth Circuit agreed. Read More