Added Substances | jgersen | February 10, 2016


Added Substances

by jgersen Show/Hide
The FDCA does not define added. Because the burden the FDA must carry is higher under the may-render-injurious standard, obviously the agency often prefers to use the ordinarily-injurious-to-health standard associated with “added” substances. FDA regulations define added broadly. A substance is added if it is not an inherent constituent of the food; is the result of environmental, agricultural, industrial, or other contamination; or if the natural amount of the inherent substance has been increased to abnormal levels by mishandling or other intervening acts. See 21 C.F.R. 109.3. Must the presence of a substance be attributable in whole or in part to an act of man? The following cases offer conflicting approaches to this question. EDIT PLAYLIST INFORMATION DELETE PLAYLIST

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  1. 1 Show/Hide More United States v. Anderson Seafoods, Inc.
    Original Creator: jgersen
    1. Section 342(a)(1) of the Act provides:  A food shall be deemed to be adulterated —(a)(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.
    2. As the Court says, the statute does not define “added substance” but much turns on this term. The evidentiary showing that the FDA must make to succeed in an enforcement provision turns on it. If a substance is an added substance, then the Agency need show only that it “may render [the food] injurious to health” in order to regulate consumption of the food containing the substance. The “may render” standard has been interpreted to mean that there is a reasonable possibility of injury to the consumer. If a substance is not “added” then the Agency must make a higher showing, that the substance would “ordinarily render [the food] injurious to health.” Why would such a legal regime make sense?
    3. The government’s view in the cases was that an “added substance” is one that is not “inherent.” There are two types of “poisonous or deleterious” substances on this view. Those that are “naturally occurring” are those that are not introduced into the food as a result of environmental, agricultural, industrial, or other contamination. An “added poisonous or deleterious substance” is not “natural occurring.” Yet when a naturally occurring poisonous or deleterious substance increases beyond a certain level, it then becomes an “added poisonous or deleterious substance.” On this view all mercury in fish is an added substance.
    4. Anderson’s theory was that a substance is not an added substance unless it is proved to be present as a result of the direct agency of man. And, only that amount of a substance the lineage of which can be so traced is “added.” If some mercury in swordfish occurs naturally, and some is the result of man-made pollution, only that percentage of the mercury in fish proved to result directly from pollution is an added substance. There is something intuitively appealing about this theory in that is corresponds to a common-sense view of the term added.
    5. Under the court's theory, if a de minimis amount of the mercury in swordfish is shown to result from industrial pollution, then all of the metal in the fish is treated as an added substance and may be regulated under the statute's “may render injurious” standard. The court was ultimately convinced by this theory. Was the court convinced as a matter or policy or law or both? Is it a concern that under this theory, materials naturally occurring and that naturally occurred in food are magically transformed into an “added poisonous or deleterious substance”? As the court noted, the House Report on the 1906 statute said that “added” meant “attributable to the acts of man” and “not-added” meant attributable to the events of nature.” H.R. Rep. No. 2118, 59th Cong., 1st Sess. 6, 7, 11 (1906).   Senator Heyburn, discussing this issue offered a sensible defense of the Act’s framework. Simply because a substance that could be harmful exists in a food ought not create immunity for someone who adds more of that poisonous or substance to the food.
    6. United States v. Anderson Seafood forced the FDA and the courts to confront the relationship between food law and environmental law. We consider this issue more directly elsewhere in this book. Note, however, this specific example of the more general problem. Mercury is a naturally occurring element that is present in the environment, in plants, and in animals. Various industrial activities like utility plants and waste incinerators add significant mercury to the air, ultimately water, and then small fish, which are eaten by larger fish. This process is known as “bioaccumulation” in the larger fish, and it is why larger fish are generally more dangerous to eat than smaller ones. Humans who infest mercury are at greater risk of reproductive difficulties and nervous system disorder. See EPA’s Mercury Factsheet, available at How should food law respond to environmental law’s failure to adequately control mercury emissions or vice versa? Precluding mercury from ever being considered an added substance would allow for the consumption of fish with dangerously high levels of mercury simply because some mercury is present in fish naturally. Yet, isn’t it likely that this sort of environmental addition of a substance—not by the producer or seller of food—but by industrial activity in general isn’t quite what the drafters of the FDCA had in mind when they used the term “added substance”? If so, then should the court update the FDCA? Should the legislature? What is the relevance of changing factual circumstances that render an old legal framework insufficient to address a core food-related danger?

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March 16, 2017

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