Sunday, September 18, 2011

Food Law & Apple Juice: Integrating Dr. Oz and FDA into the Classroom

The adage "never a dull moment" could easily be applied to my efforts to teach my Food Law & Policy class.

This week, our syllabus guided us into the rather technical area of ingredient labeling. The massive Food & Drug Law casebook by noted scholars Peter Barton Hutt, Richard Merrill, and Lewis Grossman has an excellent unit on the Regulation of Food Labeling.  I supplemented it with specific materials and a presentation on the use of the term "organic" (defined and regulated under the National Organic Standards) and the term "natural" (largely undefined and the subject of much litigation and consternation).  The evening before class, as I was putting my final touches on a PowerPoint presentation, I made one last visit to the FDA website. There, flashing on the FDA news screen was an enticing photo of apple juice being poured into a glass, with the intriguing caption, Questions & Answers: Apple Juice and Arsenic.  I clicked on the link, and in addition to the Questions and Answers, there were prominent links to letters from FDA to Dr. Oz, both dated this week.   As we always begin class by discussing food law news stories, I had to investigate.

For those of you (surely there must be some out there) who are not familiar with Dr. Oz, he is a wildly popular cardiothoracic surgeon turned day-time celebrity. His daily television show focuses on medical issues and personal health, and there is often a good deal of drama. Last week, his show, Arsenic in Apple Juice, revealed private test results that showed levels of arsenic in apple juice that exceeded the U.S. national standards for arsenic in drinking water (10 ppb).  There is currently no specific standard for levels of arsenic in apple juice, although FDA has reportedly set 23 ppb as a level of concern.

In an effort to allay consumer concerns, FDA challenged both Dr. Oz's actual test results and his methodology.  FDA stated that their testing showed the products all well within the 10 ppb level, and in addition, claimed that his numbers reflected total arsenic levels as opposed to inorganic levels.  The FDA explains this difference as follows:
There are two types of arsenic: organic and inorganic. The inorganic forms of arsenic are the harmful forms, while the organic forms of arsenic are essentially harmless. Because both forms of arsenic have been found in soil and ground water, small amounts may be found in certain food and beverage products, including fruit juices and juice concentrates.
See also, FDA: Apple Juice is Safe To Drink, Levels in Water explanation.

All of this discussion went on "in real time," before and after the broadcast, with an almost frantic pace in the media. Google "apple juice arsenic" to see what I mean.  The story continues on with groups lining up on one side or the other.

As a consumer, I was of course interested to learn more about apple juice safety. As law professor, the story seemed a perfect opportunity to explore the complexities of food regulation. This story involves agriculture and how our food is produced; different standards for production in different countries; the regulation of potentially toxic substances in food; the division authorities in the regulation of our food system; the question of acceptable risk; the difficulty of translating scientific analysis into sound policy; and the impact of the media on consumer choice, and eventually on the marketplace.

Here is some background, some related information that seems relevant, and some of my own commentary.

Arsenic is naturally occurring and widely dispersed in the environment. Many forms of arsenic contamination of wells used for drinking water results from natural sources in the environment. See, Dartmouth Toxic Research Superfund Program, Arsenic FAQ.  In addition, however, arsenic has had many commercial uses.
Arsenic has a long history as a poison- a rodent poison in particular - and great lore as a homicidal agent. Humans have exploited its toxic properties in weed killers, fungicides and insecticides, especially in vineyards, apple orchards, and cotton and tobacco fields. Arsenic has also been used as an embalming agent, to preserve specimens in taxidermy and to defoliate cotton for harvesting.
The regulation of arsenic levels is thus particularly complex because it is both naturally occurring and occurring as a result of commercial use.

It is also complex because we do not fully understand how arsenic affects human health.  For a fascinating overview of issues regarding arsenic and health, see The Facts on Arsenic published by the Dartmouth Toxic Metals Superfund Research Program.  There is, however increasing and well documented evidence of the link between long term arsenic exposure and serious health problems, including cancer. The EPA reports that:
Non-cancer effects can include thickening and discoloration of the skin, stomach pain, nausea, vomiting; diarrhea; numbness in hands and feet; partial paralysis; and blindness. Arsenic has been linked to cancer of the bladder, lungs, skin, kidney, nasal passages, liver, and prostate.
Arsenic levels in groundwater have been a concern in the U.S. for some time, prompting the EPA under the Obama administration to revive its 10 ppb maximum tolerance under the authority of the Safe Drinking Water Act.  This level is widely supported in the scientific community and was enacted during the Clinton administration. It was withdrawn in 2001 by the Bush administration.  

Regarding the inorganic and organic arsenic issue, the FDA correctly asserts that research indicates that inorganic arsenic is much more toxic than organic forms of arsenic.

However, the most recent research also indicates that the lesser toxic organic arsenic can be transformed into the more toxic inorganic form after ingestion.

This research was the basis for the June 2011 FDA announcement that Pfizer would "voluntarily suspend" the sale of the arsenical animal drug 3-Nitro® (Roxarsone).  This announcement did not receive a lot of media attention, nor do most consumers realize that arsenic-based animal drugs are approved for use in chickens, turkeys, and pigs, with Roxarsone commonly used in poultry production.  See FDA FAQ regarding its announcement; NY Times article, Pfizer Suspends Sales of Chicken Drug With Arsenic.

The FDA assures consumers that while inorganic arsenic was found in livers of the chickens who received Roxarsone, no human health risk was associated with chicken consumption.

While Pfizer has suspended sale of Roxarsone in the U.S., it continues to manufacture and export roxarsone overseas. The FDA reports that it is "taking steps to alert our international partners about our research findings. They will then make their own decisions regarding what actions to take, if any, with respect to this product within the context of their own communities and regulatory systems."

The use of arsenic in poultry production has resulted in problems with arsenic levels in manure applied as fertilizer.  USDA research has confirmed that fields where poultry litter is applied can accumulate significant levels of arsenic.

Concerns about arsenic in juices sold in the U.S. have been raised previously by several consumer food groups and by academic researchers.
  • A 2009 study published in the American Journal of Environmental Science, Presence of Arsenic in Commercial Beverages reported that many commercial beverages contained levels of arsenic that exceeded the 10 ppb standard for drinking water.
  • Independent testing commissioned by the St. Petersburg Times in Florida revealed levels of arsenic that ranged from 0 to as high as 35 ppb in the apple juice they tested.  Arsenic in apple juice: How much is too much?  "More than a quarter of the 18 samples tested by the Times contained between 25 and 35 parts per billion of arsenic — amounts that surpass the Food and Drug Administration's 'level of concern' for heavy metals in juices.
In light of these concerns, the FDA reports that it has been tracking total arsenic contamination in apple and other juices for about six years, since foreign producers started gaining an increasing share of the juice market. According to its website posting, FDA: Apple Juice is Safe To Drink, Hunting Inorganic Arsenic:
The agency searches for potential contaminants in fruit juices and fruit juice concentrate in three ways:
  • FDA issues import alerts to keep potentially dangerous products from other countries out of the U.S. marketplace. The agency has issued a specific alert that requires importers to prove their fruit juices and concentrates are safe for consumption before they are allowed to enter the U.S.
  • As part of the FDA Total Diet Study program, the agency annually tests baby foods and apple juice samples for the presence of arsenic.
  • The agency collects and tests food and beverage samples in another program that looks for harmful substances in foods. Apple juice is one of the targeted products because investigators want to check for total and, if necessary, inorganic arsenic.
I personally found Dr. Oz's show (available online on his website) to be overly dramatic, with too much emotional discussion of poisoning our children. Knowing that FDA would be challenging his test results, he should have verified his numbers with a second, objective series of tests. And, he should have discussed the risk level in an objective context.  On the other hand, his show has been remarkably effective in generating interest in issues that deserve our immediate and focused attention.
  • An increasing percentage of food consumed in the U.S. is imported, and it is produced in ways that are not in keeping with our standards for food safety. 
  • The FDA does not have the resources that it needs to implement necessary protections in an increasingly complex global food system. 
  • Despite some calls for decreased regulation, increased regulation is needed to set minimum standards for arsenic contamination and other contaminants. Without a regulatory floor, companies with lax ingredient standards will continue to drive other companies out of business or force them to compete at the lower level of quality.
  • Our food system continues to reward "cheap" at the expense of quality.  Consumers need to demand higher quality and reward the individuals and the companies that produce it.
  • We need to consider contaminants from combined sources and evaluate cumulative effects rather than evaluating each item individually.
  • We should stop the exportation of arsenic-based animal drugs and encourage other countries to ban its use.
  • We should eliminate the use of arsenic-based chemical pesticides.  While the EPA published its notice announcing a phase-out of the use of of organic arsenicals as pesticides for most uses, it is still allowed in cotton production.
And, finally, in keeping with my class' study of food labeling, Dr. Oz was correct in his instruction to his audience that they should look at their product labels.  He was also correct in noting that it may be hard to find where the country of origin information is located.  Mandatory country of origin labeling is required under the Tariff Act of 1890 and regulated by the U.S. Customs Service.  However, the courts have held that this information need not be listed on the main product display panel.  I'd like to see that changed as well.


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