AUGUST 2005
Food & Drug Practice
Proposed Changes to FDA and FSIS Food Standards
The Food and Drug Administration (“FDA”) and the
Food Safety and Inspection Service (“FSIS”) are the
two federal agencies responsible for establishing standards of identity for food, or “food standards.” FDA
food standards establish a food’s common name, define
the food’s nature in terms of mandatory ingredients, and
provide label requirements. FSIS food standards regulate the ingredients in meat and poultry products, how
such a product is to be formulated or processed, and the
labeling requirements. Recently, FDA and FSIS have
together issued a proposed rule establishing a new set of
general principles to modernize food standards and provide a uniform approach to the creation, revision and/or
elimination of the standards of identity for food. See 70
Federal Register 29214, 29233 (May 20, 2005).
Over the years, food standards of identity have assisted
consumers by standardizing the composition of certain
foods, leveling the playing field for industry participants, and shielding manufacturers from the burden of
having to meet different state requirements. Although
these regulations have been effective in the past, for
some time now, many in the food industry have sought
the removal of food standards. The proponents for
change complain that the current standards are outdated,
stifle innovation, and drag out the petition process for
too long. Because both agencies do not allow a product
that does not meet a food standard to represent itself as
that standardized food, a manufacturer must either conform to the food standard or sell its product under
another, non-standardized name, regardless of whether
its proposed product is healthier, easier to make, or uses
safe, but alternative ingredients.
The agencies themselves recognized that existing food
standards may impede innovation and prevent healthier
products from reaching the market. In 1996, they established a task force to discuss the current and future role
of food standards. The task force determined there were
several regulatory options including making no change
to the food standards, eliminating all food standards, or
using resources to review and revise the food standards
to protect consumers without inhibiting technological
advances in food preparation and marketing. The agencies ultimately decided to propose amending the petition
process so the standards of identity would be more internally consistent, flexible for manufacturers, and easier
to administer while ensuring product quality and uniformity to consumers.
THE PROPOSED RULE
The proposal put forth by FDA and FSIS seeks to create
a more “efficient” system for creating, amending, or
eliminating a food standard. FSIS proposes to establish
9 CFR § 410.1(a) and FDA intends to amend 21 CFR
§ 130.5(b) to reflect the general set of principles that
will establish the criteria FDA and FSIS will use in
evaluating a food standard petition. These principles,
thirteen in total, can be grouped into three main categories.
New Set of General Principles. The first group of
principles centers on ensuring product quality and food
uniformity. The principles address consumer protection
from an economic standpoint, focusing on whether the
food standard promotes honesty and fair dealing for the
protection of the public and whether consumers’ expectations of product uniformity and characteristics are
met.
The second group of principles focuses on the promotion of clear and straightforward requirements for food
manufacturers. Additionally, if a food technology is
available that would allow the food to maintain its basic
nature or essential characteristics and maintain its nutritional quality and safety, there should be more flexibility in using that food technology to the extent feasible.
The food standard should also provide for any suitable
alternative manufacturing process so long as it does not
alter the nutritional, physical, or sensory characteristics
under the traditional process.
The third group of principles seeks to promote simplicity, brevity, and consistency among food standards. The
agencies want to eliminate all the “unnecessary details”
to reduce the burden on enforcement and compliance
efforts. Therefore, the agencies want food standards
that are simple, easy to use, and internally consistent.
Since this proposed rule is being made by both FDA and
FSIS, there are some additional principles that each
agency emphasizes. While FSIS focuses on proposing
food standards based on the finished product and identifying whether it was ready-to-eat, FDA has centered its
attention on the specific requirements for foods intended
Kirkpatrick & Lockhart Nicholson Graham
LLP
for further manufacturing. FDA wants those foods
incorporated within the reference food standard rather
than as a separate food standard. Therefore, the current
FDA standards for foods-for-further-manufacturing will
be considered for elimination. For instance, the requirements stated in the food standard for cheddar cheese for
manufacturing (21 CFR § 133.114) could be included in
the standard for cheddar cheese. Additionally, this proposed principle may also apply to FDA food standards
where the differences between a standardized food and
the same food-for-further-manufacturing are minimized
by processes used to make a finished food from the
food-for-further-manufacturing.
POTENTIAL AREAS OF CONCERN
While the proposed rule offers the possibility of an easier petition process for food standards, there are still a
couple of concerns. One is how the proposal will affect
those petitions already in the pipeline. There was no
mention of their status or future status in the proposal.
Additionally, there is uncertainty as to how FDA will
apply the above enumerated principles. Separately,
there is apprehension about a provision in the proposal
that states FSIS would eliminate all informal policies in
the Food Standards and Labeling Policy Book, which is
used to address the meat and poultry content of certain
products and define processing methods, unless the
agency receives a formal petition to convert the policies
into standards.
SOLICITATION OF COMMENTS
FDA and FSIS are requesting comments on the general
principles and how best to implement them.
Specifically, the agencies would like remarks on the
usefulness of the general principles for evaluating petitions. The agencies also want to know how they might
best be able to enhance the usefulness of the principles
as a guide to external groups or individuals in evaluating
and preparing petitions. Lastly, both agencies seek
comments on the proposed petition process and the estimated time burden placed on those who are petitioning
to establish, amend, or eliminate a food standard.
Comments must be submitted, in written or electronic
form, by August 18, 2005. Please let us know if we
could be of assistance.
Vanessa W. Chandis*
Suzan Onel
sonel@klng.com
202.778.9134
vchandis@klng.com
202.778.9396
* Vanessa Chandis is currently a member of K&LNG's 2005
Summer Associate class and will be entering her third year of law
school at the University of Pennsylvania this fall.
FOR MORE INFORMATION, please visit our website at www.klng.com or contact one of the lawyers listed below.
PARTNERS
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202.778.9134
202.778.9124
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202.778.9428
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