By now, most people are aware that Congress passed and the President signed into law a requirement that the U.S. Department of Agriculture (USDA)—not FDA—establish a national, mandatory bioengineered food disclosure standard (GMO labeling standard). The law gives USDA two years to develop the mandatory GMO labeling standard and generally preempts non-identical state statutes (but not any remedy created by a state or federal statutory or common law right). 

The legislation contains two separate preemption provisions, section 293(e)1 and section 295.2 While one provision (section 293(e)) references USDA’s future standard (and could arguably be read to not preempt state laws until the USDA standard is established in two years), the second preemption provision (section 295)—which defines food more broadly than it is defined in the remainder of the legislation—is contained in an entirely different section and subtitle from the timeline for the issuance of the standard. As such, it is reasonable to conclude that the preemption contemplated in section 295 is not dependent upon the USDA standard and that the preemption of state and local laws relating to the labeling of whether a food is genetically engineered (including portions of Vermont’s Act 120) goes into effect immediately.

What Products Are Affected?
The GMO labeling standard will apply to the labeling of “food,” as defined in section 201 of the federal Food, Drug, and Cosmetic Act (FD&C Act, or the Act) (21 U.S.C. § 321), that is intended for human consumption (i.e., it will not apply to animal food). Per the FD&C Act, a dietary supplement is “deemed to be a food” except for two limited exceptions (section 321(g) (the definition of drugs) and section 350f (the reportable food registry requirements)). (See 21 U.S.C. § 321(ff)(3).)

Accordingly, and because the legislation does not specifically exclude dietary supplements from the forthcoming GMO labeling standard, we presume they are also covered by the law. However, we will need to wait and see how USDA interprets the term “food” as it creates the standard.

The GMO labeling standard would apply to: 1) foods subject to labeling requirements under the FD&C Act (presumably including dietary supplements); and 2) foods subject to labeling requirements under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act, but only if the most predominant ingredient (excluding broth, stock, water, or a similar solution) would independently be subject to labeling requirements under the FD&C Act. The legislation would not cover food served in a restaurant or similar retail food establishment, and would not apply to very small food manufacturers.

What’s Considered Genetic Engineering?
The definition of “bioengineering” in the legislation is also important. The term refers to a food 1) that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and 2) for which the modification could not otherwise be obtained through conventional breeding or found in nature.

It is not yet clear how USDA will interpret this definition, but opponents of the law see this as a potential loophole. It could be argued that only those foods that contain genetically modified material in their finished forms would be covered by the labeling standard, whereas foods that contain ingredients derived from genetically modified crops but that no longer contain genetically modified material after processing would not be covered. Again, it will be up to USDA to interpret the legislation.

Disclosure Methods
To the extent a food is covered by the legislation, manufacturers would be required to disclose to consumers the presence of genetically modified material in their products in one of a few ways: via a textual statement; by including a symbol on food packaging; or by use of an electronic digital link (e.g., a Quick Response (QR) Code). In addition to these three options, small manufacturers would be able to use a phone number or website to provide consumers with additional information on genetically modified material in their food products.

Finally, if a food is certified under the National Organic Program established under the Organic Foods Production Act of 1990 (7 U.S.C. § 6501 et seq.), the certification will be considered sufficient to make a claim regarding the absence of bioengineering in the food (e.g., “not bioengineered,” “non-GMO,” or another similar claim). NW

References
1. STATE FOOD LABELING STANDARDS—Notwithstanding section 295, 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 requirement relating to the labeling or disclosure of whether a food is bioengineered or was developed or produced using bioengineering for a food that is the subject of the national bioengineered food disclosure standard [i.e., USDA’s future standard] under this section that is not identical to the mandatory disclosure requirement under that standard. 

2. FEDERAL PREEMPTION—No State or a political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food or seed in interstate commerce any requirement relating to the labeling of whether a food (including food served in a restaurant or similar establishment) or seed is genetically engineered (which shall include such other similar terms as determined by the Secretary of Agriculture) or was developed or produced using genetic engineering, including any requirement for claims that a food or seed is or contains an ingredient that was developed or produced using genetic engineering.

---

Todd Harrison
Venable

Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.

Michelle Jackson
Venable

Michelle Jackson’s practice is focused on regulatory counseling concerning the development, formulation, manufacture, distribution and promotion of foods, dietary supplements, drugs, medical devices and cosmetics.