United States: FDA And Food Safety: Arsenic In Apple Juice! Comparing Apples To Taiwan Water Wells

Last Updated: August 14 2013
Article by Michael A. Walsh

Do not confuse this for what it isn't. FDA's proposed Draft Guidance setting an "action level" for arsenic in apple juice does not mean the FDA found dangerous levels of arsenic in apple juice. What the Draft Guidance does mean for the food industry is more stringent compliance requirements and higher prices for consumers.

On July 12, 2013 the FDA announced that based on testing of apple juice, 100% of the samples were "far below" any level that could be considered harmful. According to the FDA's July 12, 2013 Press Release, the FDA found:

"100 percent of the samples were below 10 ppb for inorganic arsenic, the carcinogenic form of arsenic."

That is not to say FDA found elevated levels of arsenic. In an FDA Blog Post the Deputy Commissioner states:

"The agency has always found that the amount of arsenic in apple juice is generally low—much lower, in fact, than the levels allowed in drinking water... And in 2011, we substantially increased testing and analysis of apple juice to continue and enhance our monitoring efforts... We found that our original belief was correct, that the levels of inorganic arsenic in apple juice are too low to cause immediate or short-term health damage."

Comparing apples to apples, or apples to contaminated Taiwan water wells?

To support its proposed Draft Guidance, the FDA relies on a July 1, 2013 "Draft Report" entitled "A Qualitative Assessment of Inorganic Arsenic in Apple Juice" which concluded:

Arsenic is a ubiquitous environmental elemental contaminant that arises from natural and anthropogenic sources. Arsenic is found in a number of substrate/media, including food and drinking water, and exists in a variety of forms/species. The forms of greatest toxicological and public health concern are the inorganic forms, tri- and pentavalent arsenic. Inorganic arsenic is the primary form found in water. Organic species of arsenic are the primary forms found in food, particularly in seafood, but inorganic forms can also be found in some foods, particularly rice and in some fruit juices.

The Draft Report analyzed data from two long term studies of contaminated drinking water wells in Taiwan, projected dosage and lifetime exposures, and found a lifetime cancer risk from exposure to inorganic arsenic in a concentration of 10 ppb or more to 8 consumers per 1 million. The Draft Report is most significant for confirming that arsenic is everywhere, in everything and generally not a health concern, UNLESS there is long term, high level, chronic exposure to the form of arsenic used to kill rodents.

In explaining why the FDA is proposing an "action level" for arsenic, the FDA Commissioner stated in a Press Release:

"The FDA is committed to ensuring the safety of the American food supply and to doing what is necessary to protect public health," said FDA Commissioner Margaret A. Hamburg, M.D. "We have been studying this issue comprehensively, and based on the agency's data and analytical work, the FDA is confident in the overall safety of apple juice for children and adults."

"While the levels of arsenic in apple juice are very low, the FDA is proposing an action level to help prevent public exposure to the occasional lots of apple juice with arsenic levels above those permitted in drinking water."

The FDA is not proposing setting a standard by a rule with the force of law; it is doing so with what it calls a "Guidance":

The FDA is establishing this threshold to provide guidance to industry. The agency takes the action level into account when considering an enforcement action, if it finds a food product exceeds the threshold.

What does this mean for juice producers?

Producers of juice (at all levels of the manufacturing chain) must establish procedures for their own operations and for their suppliers to confirm that product suppliers have procedures in place and are testing for an arsenic problem FDA has confirmed does not exist. Make no mistake, even if you have procedures in place and routinely test, you cannot test every molecule and still may, in the words of the FDA Deputy Commissioner, have "occasional lots of apple juice with arsenic levels above those permitted in drinking water." Failure to have procedures in place may be the difference between a corrective measure and being subject to criminal and/or civil enforcement. In either event, establishing this new requirement for testing increases the risk of civil tort and consumer litigation.

The FDA Docket for comments closes on September 10, 2013.

The FDA has rendered the proposed new Draft Guidance bullet-proof by wrapping it in "protecting children" from poison. If you are asking, why not declare a level over which a manufacturer may not go?" The reason is fourfold: (1) when research demonstrates there is no health risk, there is no basis to conclude that testing will advance the government's mission to protect the public health; (2) increased compliance costs result in higher consumer costs and higher costs may impact dietary choices with consumers turning to less healthy and less expensive alternatives; (3) birth to more litigation; and, most importantly (4) since 1906, when the FDA began prosecuting bad actors for introducing adulterated foods into the stream of commerce, existing civil and criminal penalties serve to protect the public health.

You need to peel the apple to see the real poison in the FDA's proposal for the food industry and consumers. If you love government regulation, you will love this; if you don't, you won't. But either way, if you are a lawyer, food law is a growth area.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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