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 legisla-
tion 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.
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 cov-
By Todd Harrison & Michelle Jackson
Here’s a primer on the U.S. law that mandates a national standard for disclosing bioengineered foods.
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: firstname.lastname@example.org.
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.