Supreme Court of the United States

In Re: Genetically Engineered Food Right-to-Know Act of 2015

Case No. 15–05, 100 M.S.Ct. 104

The Chief Justice delivered the opinion of a unanimous Court.

We are called to consider a challenge to B023, the Genetically Engineered Food Right-to-Know Act (“RTK Act”), which was signed into law by then-president Didicet on March 31, 2015. The RTK Act amends the Food, Drug, and Cosmetic Act (codified at 21 U.S.C. §§301 et seq.) (hereinafter “FDA Act” after its most well-known progeny) to require that any food that has at least 0.9% or greater “genetically engineered content” per ingredient be labeled as such. The Act goes on to define “genetically engineered” to mean “(1) an organism produced through the intentional use of genetic engineering, or (2) the progeny of intended sexual or asexual reproduction (or both) of one or more organisms that is the product of genetic engineering.”

Petitioner challenges this law primarily based on the vagueness of this definition, arguing that it does not adequately put companies on notice as to what types of products they must label. The challenge also asserts that the RTK Act does not adequately consider the historical context. Since this definition of genetic engineering could include cross-breeding of different subspecies, Petitioner argues, the RTK Act would require virtually all foods to be labeled as containing genetically engineered content. In the alternative, the Petitioner asserts that the definition of “genetic engineering” is a tautology, and that it is unclear what constitutes “genetic engineering” since that term is used in its own definition.

Ultimately we hold that neither of these is as problematic as Petitioner contends. However, there are far more troubling provisions, such that the RTK Act cannot pass constitutional muster.


We turn to Petitioner’s allegations briefly. While they are not ultimately the issues on which this decision turns, we nonetheless think some discussion is warranted.

Petitioner first states that we must overturn the RTK Act because the broader definition of the term “genetically engineered” is not well-defined. As we have explained in the past, however, we generally assume that laws are written using words in their “natural and ordinary signification.” In re: The Controlled Substances Act, 100 M.S.Ct. 102 (internal quotation marks and citations omitted). Thus while Petitioner may very well be correct in asserting that this term could refer to ordinary cross-breeding of subspecies and the like, this is not the standard usage, and it is not what the typical reader or judge would think the term means. See, e.g. Random House Webster’s Unabridged Dictionary (defining genetic engineering as “the development and application of scientific methods, procedures, and technologies that permit direct manipulation of genetic material in order to alter the hereditary traits of a cell, organism, or population”) (emphasis added).

Petitioner’s second argument addresses humankind’s long history of cross-breeding plants and animals, stating that the RTK Act ignores this. Regardless of whether this is true, this is a policy-based argument that is not within this Court’s bailiwick. As we explained in upholding the Controlled Substances Act, “[n]othing in the Constitution gives this Court the authority to substitute its judgment for that of Congress. . .” 100 M.S.Ct. 102. Thus we cannot overturn a law simply because we disagree with its purpose or with its aims, provided the rights guaranteed by the Constitution are not overrun.


There are other issues with the RTK Act, however, and because of these it cannot survive.


It is important at the outset to recognize that we are dealing with a criminal 3 No. 15–05 statute. The FDA Act establishes certain actions that are prohibited; as relevant here, this includes misbranding “any food, drug, device, tobacco product, or cosmetic” that is sold in interstate commerce. 21 U.S.C. §331. Under its rule-making authority (see 21 U.S.C. §371), the Secretary of Health and Human Services may promulgate regulations for the enactment of the FDA Act’s more general provisions. This the Secretary has done, including practices in food and drug labeling that must be followed. See, inter alia, 21 CFR Part 101 (food labeling), Part 201 (drug labeling).

The FDA Act also provides various penalties that may be imposed. Among others, these include an injunction to prevent further prohibited conduct and the seizure of any products that run afoul of the FDA Act or the regulations promulgated thereunder. 21 U.S.C. §§332, 334. But, and most importantly for our analysis, this also includes criminal penalties for violation of the Act, up to and including jail time. 21 U.S.C. §333.

The Constitutional requirement of Due Process can arise in a variety of contexts. For example, this Court recognized that someone otherwise entitled to old-age benefits under the Social Security Act had sufficient interest “to fall within the protection from arbitrary governmental action afforded by the Due Process Clause.” Flemming v. Nestor, 363 U.S. 603, 611 (1960). But these protections are doubly important in the case of criminal prosecution, where someone faces the most severe penalties that exist within our legal system. And it is under that framework that we consider the RTK Act’s provisions.


In seeking to define what is and is not allowed under the RTK Act, Congress gave various definitions. Regrettably those do not always coincide, but as explained in Part I above, this is not necessarily fatal. But we must look carefully, particularly in the case of a criminal statute (which this clearly is as explained above), to ensure that those subject to the law can clearly know what specifically they are forbidden from doing. As the Court explained almost a century ago,

That the terms of a penal statute creating a new offense must be sufficiently explicit to inform those who are subject to it what conduct on their part will render them liable to its penalties is a well recognized requirement, consonant alike with ordinary notions of fair play and the settled rules of law, and a statute which either forbids or requires the doing of an act in terms so vague that men of common intelligence must necessarily guess at its meaning and differ as to its application violates the first essential of due process of law.

Connally v. General Construction Co., 269 U.S. 385, 391 (1926). Put another way, a criminal statute must “define the criminal offense [1] with sufficient definiteness that ordinary people can understand what conduct is prohibited and [2] in a manner that does not encourage arbitrary and discriminatory enforcement.” Kolender v. Lawson, 461 U. S. 352, 357 (1983).

In Connally, the Court was called to address an Oklahoma statute that required state employers to pay their employees “not less than the current rate of per diem wages in the locality where the work is performed shall be paid.” Id. at 388. This Court struck down the law as impermissibly vague, since the term “current rate” included the minimum paid to those doing a given job, the maximum, and all those rates in between. “[T] o direct the payment of an amount which shall not be less than one of several different amounts, without saying which, is to leave the question of what is meant incapable of any definite answer.” Id. at 394. Another, more recent example comes from Coates v. Cincinnati, 402 U.S. 611 (1971). In that case, this Court was asked to consider a Chicago ordinance that prohibited congregating on sidewalks if doing so was “annoying” to passersby. In addition to finding that this law impermissibly penalized assembly under the First Amendment, the Court found that the question of what was “annoying” was too vague to comport with the Due Process Clause. Since one person may be annoyed by something that another would not, “the ordinance is vague not in the sense that it requires a person to conform his conduct to an imprecise but comprehensible normative standard, but rather in the sense that no standard of conduct is specified at all.”

Section 2 of the RTK Act deems as misbranded “any food that has been genetically engineered and contains 0.9% or greater genetically engineered content per ingredient in each food item, unless such information is clearly disclosed.” It is on the second provision that the RTK Act must fall.

The broader term “genetically engineered” is defined by the RTK Act (see §1), as is the term “genetically engineered ingredient” at §4. What is not set out, however, is what “genetically engineered content” means for the purposes of potentially depriving someone of their physical liberty. See 21 U.S.C. §333(a).

To be clear, it is not the term itself that is problematic necessarily, but rather how that term is defined in this context. As explained above, if the ordinary usage of a term is clear, then the law will likely pass muster. This is also true where a term has a specific, technical meaning that may not be understandable to everyone, but would be clear to anyone likely to be subject to it. See, e.g., Hygrade Provision Co. v. Sherman, 266 U.S. 497, 502 (1925)(finding that the term “Kosher” with respect to food advertising had “a meaning well enough defined to enable one engaged in the trade to correctly apply it at least as a general thing.”)

But such allowances do not apply here. Because the problem lies not in saying that the statute applies to a product with “0.9% genetically engineered content per ingredient” but with the fact that food producers are not told how that figure will be determined. Will it be based on mass of the ingredient? That could be, but how is the mass of the “genetically engineered content” to be determined? Is it the mass of the genes themselves? The proteins that they produce as a result? The cells?

Larger creatures, such as cows, chicken, or fish, raise further questions. Even assuming that some way of determining the percentage were clear, would it apply to the animal at the time of slaughter, at a random time during its life, or to the individual product on the shelf? In other words, would it apply to an entire chicken or just the thighs? But even these questions, which would themselves make the law unconstitutionally vague, are predicated on the more fundamental problem that there is simply no way for a food producer, farmer, or distributor to know whether a given product would run afoul of §2.

The dividing line between what is lawful and unlawful cannot be left to conjecture. The citizen cannot be held to answer charges based upon penal statutes whose mandates are so uncertain that they will reasonably admit of different constructions. A criminal statute cannot rest upon an uncertain foundation. The crime, and the elements constituting it, must be so clearly expressed that the ordinary person can intelligently choose, in advance, what course it is lawful for him to pursue.

Connally, 269 U.S. at 393. A food producer here would be left in just such a position, and would face criminal penalties if they happened to guess differently from what a court thought best. We have already explained that a court’s substituting its judgment for that of the Legislature is often anathema to our system of government, and it would be especially true in these circumstances.

Finally, we find that as this provision falls, so too must the RTK Act as a whole. The other sections provide (insufficient) detail about what Congress intended, and allow a good-faith exception to its penalties under certain circumstances. But without the basic provision of what additional content must be done in the realm of product labeling, the law is meaningless. The other provisions either give definitions or exempt certain conduct from penalty, but exceptions only apply where there is a more general rule. Since the general rule fails, the exceptions are become empty and so the entire RTK Act cannot be preserved.

It is so ordered.

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