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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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