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Proposed Federal Bill Would Prevent States, FDA, And Anyone Else From Informing Consumers Whether Food Is Bioengineered


By Eric Awerbuch

In April, 2014, five members of Congress introduced a bill, H.R. 4432 (hereinafter “the Bill”) seeking to regulate, among other things, the labeling of bio-engineered food products.[i]  The Bill, also known as the “Safe and Accurate Food Labeling Act of 2014,” is remarkable in that it:  1) prohibits the States from regulating the labeling of bio-engineered foods; 2) gives the FDA the sole authority to regulate the labeling of bio-engineered foods, but severely restricts how the FDA can regulate the labeling of bio-engineered foods; 3) allows companies to voluntary label their products as bio-engineered when they so desire, subject to very few restrictions; and 4) prohibits under any circumstances the FDA’s ability to decide in the future whether bio-engineered foods are less safe than foods not bio-engineered.  Each of these points is discussed in detail below.

First, if the Bill passes, States will not be able to enact any laws regulating the labeling of bio-engineered foods.  Section 104(c) of the Bill explicitly states that:

No State or political subdivision of a state may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirements for the labeling of a food by virtue of its having been developed using bioengineering, including any requirements for claims that a food is or contains an ingredient that was developed using bioengineering.

The quoted language would have the effect of nullifying efforts in at least 20 states to require mandatory labeling for foods that contain genetically modified organisms.[ii]  For example, Vermont enacted a law, effective July 1, 2016, that will require foods produced from genetic engineering be labeled as such.[iii]

Instead of allowing states to regulate the marketing of bio-engineered foods, the Bill purports to give the FDA such authority.  However, the FDA’s authority to regulate labeling of bio-engineered foods is greatly restricted by the terms of the Bill.  Specifically, the FDA may only require bio-engineered food labeling when it determines that 1) there is a “material difference” between the bio-engineered food and its comparable marketed food, and 2) where that difference “is necessary to protect health safety” or to prevent false or misleading labeling.[iv]  Even if those two elements exist, the FDA can only require specific labeling that “would adequately inform consumers of such material difference.”[v]  Stated differently, not only can the States not require genetically modified foods to be labeled as genetically modified, the FDA cannot even require that labeling, unless the FDA can meet the two elements identified above.  Even where the FDA can meet those two elements, the mandatory labeling must be narrowly tailored to inform consumers of the specific “material” difference between the bio-engineered food and its similar, non-bio-engineered counterpart.

What exactly is a “material difference” requiring that companies inform consumers of the difference?  The bill provides three types of differences which are considered to be material.  The first type of “material difference” is a difference that “significantly alters the characteristics, including the functional or compositional characteristics, of a food, such that the common name no longer adequately describes the food.”[vi]   It is difficult to know when such a situation would arise because “significantly alters” is not defined.  Therefore, should the Bill pass, the FDA would be entitled to a great amount of discretion to determine whether or not a bio-engineered product is “significantly altered.”  See Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 843 (1984) (explaining that an agency’s construction of a statute it administers is owed deference when “the statute is silent or ambiguous” on the issue).  Given the FDA’s conclusions that there is no material difference between bio-engineered food and non-bio-engineered food, it is highly unlikely that the FDA would ever require mandatory labeling when left to their discretion.[vii]  Indeed, while the statute does not define differences that are not material, it does state that the “use of bio-engineering does not, by itself, constitute a material difference.”  Id. at § 424(e).

Furthermore, even if there was such a material difference, given that the labeling must only “adequately inform consumers of such material difference,” this requirement could be met, for example, if the company selling the bio-engineered product simply markets the product in a different name than the “similar” non-bio-engineered product.  It seems that sweet and firm, bio-engineered “tomatoes” would be able to be marketed as “specially formulated sweet and firm tomatoes.”  That label would inform consumers of the material difference—that the new tomatoes are sweet and firm—without even revealing the fact that they are bio-engineered.

The second type of “material difference” is a difference that “results in a significantly different nutritional property in the food produced from, containing or consisting of the bio-engineered organism.”[viii]    Once again, given that the labeling must only “adequately inform consumers of such material difference,” a company could label bio-engineered corn with higher protein content than non-bio-engineered corn as “high protein corn,” without ever revealing the fact that the corn is bio-engineered.

The third difference resulting in a “material difference” is where the bio-engineered food contains an allergen that consumers would not expect to be present based upon the name of the food.[ix]  A company could simply label the product with a warning such as, “warning: this product contains [allergen.]”  Again, the company would not have to disclose the fact that the product is bio-engineered.  Indeed, given that the labeling must only “adequately inform consumers of such material difference,” it is likely that the FDA will never be authorized to require that companies disclose the fact that a product is bio-engineered when narrower labels adequately inform consumers of the material differences.

While mandatory labeling is allowed only in narrow circumstances under the Bill, companies would have great opportunity to voluntarily label their bio-engineered products as they so choose.  The Bill prevents the FDA from prohibiting persons “from disclosing voluntarily on the labeling of food developed with the use of bio-engineering the manner in which the food has been modified to express traits or characteristics that differ from its comparable marketed food.”[x]  Thus, a company is free to market the differences between their bio-engineered product and similar, non-bio-engineered foods. For example, a company selling bio-engineered tomatoes may claim that “our bio-engineered tomatoes benefit the environment more than non-bio-engineered tomatoes because our tomatoes consume less water during the growing process than non-bio-engineered tomatoes.”  Companies will also be free to voluntary advertise, other than in labeling, that the food was developed with the use of bio-engineering.[xi]

The Bill also regulates the labeling of foods that are not bio-engineered.[xii]  It explicitly prohibits the labeling of non-bio-engineered foods from suggesting that “foods developed without the use of bio-engineering are safer than foods produced from, containing, or consisting of a bio-engineered organism.”[xiii]  In a day and age where courts routinely defer to agencies because agency’s have “expertise” in certain, factual issues, see Marsh v. Oregon Natural Resources Council, 490 U.S. 360, 377 (1989) (explaining that the Court defers to the agency’s analysis when the issue requires a high level of technical expertise), it is alarming that, through the Bill, Congress is making a scientific determination that non-bio-engineered foods are not safer than bio-engineered foods.  While the FDA does not currently consider non-bio-engineered to be safer than bio-engineered foods,[xiv] the Bill prevents FDA from ever reconsidering that opinion.

The Bill will have the ultimate effect of keeping Americans in the dark about information they may deem material to their purchasing decisions.  By legislating that the fact that a food is bio-engineered is not per se material, without any supporting evidence, the Bill seeks to foreclose any opportunity for a party to prove with empirical evidence that, in fact, the fact that a food is bio-engineered is indeed material to consumers’ purchasing decision.  It is plausible that, if the Bill passes, no federal agency or any other governmental entity would be allowed to require companies to disclose the fact that their product is bio-engineered in any circumstances.  The Bill will act to, at best, fail to inform consumers that they are consuming bio-engineered products, and, at worst, mislead consumers into believing that there are no bio-engineered products on the market.

[i] See H.R. 4432, 113th Cong., 2d Sess. (2014), available at

[ii] Jenny Hopkinson, GMO labeling bill would trump states, Politico (Apr. 9, 2014, 4:57 PM),

[iii] See 9 V.S.A. §§ 3043(a)–(b).

[iv] H.R. 4432, supra note 1, at § 104(c).

[v] Id. at § 424(e).

[vi] Id. at § 424(g)(4)(A).

[vii] See Draft Guidance for Industry Voluntary Labeling Indicating whether Foods have or have not been Developed using Bioengineering, 2001 WL 34768203 (F.D.A. Jan. 17, 2001), available at

[viii] Id. at § 424(g)(4)(B).

[ix] Id. at § 424(g)(4)(C).

[x] Id. at § 425(b)(3)(A).

[xi] Id. at § 425(b)(3)(B).

[xii] See generally, Id. at § 425.

[xiii] Id. at § 425(a)(2)(C).

[xiv] See supra, note vii.

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