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Mandatory Compliance Date for
Trans Fat and Allergen Food Labeling Approaches
by Karen C. Duester, MS, RD
December 1, 2005
December is the season to be
jolly unless there is an unfinished project hanging over
your head; then it might be the season to be busy. This
year, the jolly season of December immediately precedes
FDA's January 1, 2006, mandatory compliance date for trans
fat and allergen food labeling requirements. Calls to Food
Consulting Company suggest that not every food label is
ready and so December is the season to be busy for some.
The trans fat regulation
that is effective on January 1, 2006, was published as a
final rule in the July 11, 2003, Federal Register. This
regulation is the first significant change to the Nutrition
Facts panel since the Nutrition Labeling and Education Act (NLEA)
became law in 1993. Consequent to the regulation, the
Nutrition Facts panel for nearly all FDA-regulated foods
must be revised to include the trans fat content. Even
products that contain no fat or no trans fat are required to
list the absence of trans fat on the label, unless
the product qualifies to bear a "simplified Nutrition Facts"
and has a 0 value for total fat and does not declare
a value for saturated fat. If however the label lists
saturated fat or includes saturated fat in the "not a
significant source of" statement, then the label must be
modified to meet the 2006 labeling requirements.
The allergen labeling law
(Food Allergen Labeling and Consumer Protection Act of 2004
- FALCPA) was signed by President Bush on August 2, 2004,
and also becomes effective January 1, 2006. The law
identifies eight major foods or food groups (milk, eggs,
fish, Crustacean shellfish, tree nuts, peanuts, wheat and
soybeans; industry refers to these as the "Big 8") that if
present in a packaged food must be listed by their common or
usual name in either the ingredient statement or in a
separate "contains" (allergen) statement; the law does not
require the "contains" statement as long as the ingredient
statement uses the common or usual name of the allergen.
FALCPA does not address the
use of a "may contain" statement to indicate the possible
presence of unintended ingredients that might result from
the manufacturing process, however FDA discourages the use
of such statements as substitutes for good manufacturing
practices.
The allergen law does require
that labels declare if flavorings, colorings, and other
additives are derived from or have been in contact with a
major allergen at any time during the manufacturing process.
Previous ingredient labeling regulations did not call for
this.
Using Old Label Inventories
It is important to understand
what exactly is required on the January 1, 2006, effective
date. Food companies can use this information to plan
strategies for exhausting "old label" inventories. The two
new labeling regulations have different definitions for
compliance.
The compliance definition for
trans fat labeling is "entry into interstate commerce." Thus
the Nutrition Facts panel on all products that enter
interstate commerce on or after January 1, 2006, must
include the trans fat information. Products that enter
interstate commerce on or before December 31, 2005, can bear
old labels. Companies with large label inventories can
devise a strategy to get products labeled with old labels
and moved across state lines prior to 12:00am January
1, 2006.
The compliance definition for
allergen labeling is "labeling of products." Therefore all
products labeled on or after January 1, 2006, must include
allergen information as specified by the FALCPA. This means
that all products labeled prior to January 1, 2006,
including large inventories in the warehouse, will not
violate the allergen law when they enter the market anytime
after the effective date.
A point that needs to be
understood, is that for both allergen and trans fat
labeling, products bearing "old" labels can legally be on
store shelves for some time after January 1, 2006; once food
companies have met the compliance definitions explained
above, there is no need to be concerned with products that
are already in commerce.
FDA Will Consider
Extensions
FDA announced in the September
1, 2005, Federal Register that businesses may request FDA
approval to use label stock that does not comply with the
trans fat final rule after the effective date. FDA will
consider the requests on a case-by-case basis.
At first this late breaking
option might seem like a good way to buy more time to get
labels in shape. But the wording in the Federal Register
announcement does not promote such a "lazy" choice. Rather
FDA believes that most businesses, including small
businesses, should not have difficulty meeting the January
1, 2006, effective date.
Another consideration before
choosing to request an extension is that FDA has only
announced that the Agency will consider the extension for
trans fat. The FDA announcement did not include possible
extensions for allergen labeling; compliant allergen
labeling is still mandatory on January 1, 2006.
Companies wanting to make an
extension request should refer to the September 1, 2005,
Federal Register announcement. The Agency's criteria
includes:
-
whether
products contain 0.5 gram or less trans fat
-
why the
request is being made
-
number of
existing labels the firm is requesting to
use
-
dollar amount
associated with the labels to be used
-
estimate of
time needed, not exceeding 12 months, to
exhaust existing labels
Consequences of
Non-Compliance
A company may be subject to
civil sanctions, criminal penalties, or both under the
Federal Food, Drug, and Cosmetic Act if one of its packaged
food products does not comply with United States labeling
requirements. FDA may also request seizure of food products
where the label of the product does not conform to
requirements. In addition, FDA is likely to request that a
food product containing an undeclared allergen be recalled
by the manufacturer or distributor.
2006 Compliant Labels are
Good until 2008 and Possibly Longer
Labels that meet the January
1, 2006, requirements will require no additional changes
until at least January 1, 2008, which is the next uniform
compliance date. FDA sets uniform dates (historically
January 1, of even numbered years) to lessen the economic
impact that labelers would experience if changes were
mandatory upon publication of new regulations.
Any labeling changes that are
required on the January 1, 2008, date will be final rules
that are announced by FDA between January 1, 2005, and
December 31, 2006. FDA's Center for Food Safety and Applied
Nutrition (CFSAN) is working on the development of new
labeling rules that most likely will affect nearly all
labels at some time in the future, however it is very
unlikely that the prerequisite steps will be completed in
time for the January 1, 2008, compliance date.
Food Consulting Company
Specializes in Labeling
Some companies, mostly large,
have staff people who follow FDA food labeling regulations
and so most aspects of meeting new regulations are managed
in-house. For companies that cannot devote a staff position
to following FDA actions, staying informed on requirements
can take a great deal of skill and time. This year, 2005,
has been challenging for both large and small companies
because of the mandatory label changes that affect almost
all labels. Food Consulting Company has helped companies of
all sizes prepare 2006-compliant labels either by customized
label help or through the Company's free monthly Food Label
News that is delivered by email on the first Friday of the
month. It is not too late to get help for 2006 requirements
and it is a great time to stay informed on upcoming FDA
actions that affect food labels. Companies can do both by
visiting
www.foodlabels.com for services and to subscribe
to Food Label News.
Karen C. Duester, MS, RD, is president of
Food Consulting Company, the largest outsource
provider assisting food companies in meeting FDA
labeling requirements. The company offers a full
range of food labeling services and can be
reached at
www.foodlabels.com or by calling
800-793-2844.
© Food
Consulting Company, 2005
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