Meeting Compliance for Trans Fat Labeling

Meeting Compliance for Trans Fat Labeling
by Karen Duester

Decemberis the season to be jolly, unless there is an unfinished project hanging overyour head; then it might be the season to be busy. This year, the jolly seasonof December immediately precedes the Jan. 1, 2006, mandatory compliance date setby the Food and Drug Administration (FDA) for trans fat food labelingrequirements.

The trans fat regulation was published as a final rule in theJuly 11, 2003, Federal Register.This regulation is the first significant change to the Nutrition Facts panelsince the Nutrition Labeling and Education Act (NLEA) became law in 1993.Consequent to the regulation, the Nutrition Facts panel for nearly allFDA-regulated foods must be revised to include the trans fat content. Evenproducts that contain no fat or no trans fat are required to list the absence oftrans fat on the label, unless theproduct qualifies to bear a simplified Nutrition Facts andhas a zero value for total fat anddoes not declare a value for saturated fat. If,however, the label lists saturated fat or includes saturated fat in the not asignificant source of statement, then the label must be modified to meet the2006 labeling requirements.

It is important to understand what exactly is required. Foodcompanies can use this information to plan strategies for exhausting oldlabel inventories. The compliance definition for trans fat labelingis entry into interstate commerce. Thus, the Nutrition Facts panel on all products that enterinterstate commerce on or after Jan. 1 must include the trans fat information. Products that enter interstate commerce on or before Dec. 31,2005, can bear old labels. Companies with large label inventories can devise a strategyto get products labeled with old labels and moved across state lines prior to12:00 a.m. on Jan. 1.

A point that needs to be understood is that for trans fatlabeling, products bearing old labels can legally be on store shelves forsome time after Jan. 1, 2006; once food companies have met the compliancedefinitions explained above, there is no need to be concerned with products thatare already in commerce.

FDA announced in the Sept. 1, 2005, FederalRegister that businesses may request FDA approval touse label stock that does not comply with the trans fat final rule after theeffective date. FDA will consider the requests on a case-by-case basis.

At first, this late breaking option might seem like a good wayto buy more time to bring labels up to code; but the wording in the FederalRegister announcement does not promote such a lazychoice. Rather FDA believes most businesses, including small businesses, shouldnot have difficulty meeting the Jan. 1 effective date.

Companies wanting to make an extension request should refer tothe Sept. 1, 2005, Federal Register announcement.FDAs criteria include:

A company may be subject to civil sanctions, criminalpenalties, or both under the Federal Food, Drug, and Cosmetic Act if one of itspackaged food products does not comply with U.S. labeling requirements. FDA mayalso request seizure of food products on which the label does not conform torequirements.

Labels that meet the Jan. 1, 2006, requirements will requireno additional changes until at least Jan. 1, 2008, which is the next uniformcompliance date. FDA sets uniform dates (historically Jan. 1 of even numberedyears) to lessen the economic impact that labelers would experience if changeswere mandatory upon publication of new regulations.

Any labeling changes that are required on the Jan. 1, 2008,date will be final rules announced by FDA between Jan. 1, 2005, and Dec. 31,2006. FDAs Center for Food Safety and Applied Nutrition (CFSAN) is working onthe development of new labeling rules that most likely will affect nearly alllabels at some time in the future; however, it is very unlikely that the prerequisite steps willbe completed in time for the Jan. 1, 2008, compliance date.

Some companies have staff people who follow FDA food labelingregulations and manage most aspects of meeting new regulations in-house. For companies that cannot devote a staff position to followingFDA actions, staying informed on requirements can take a great deal of skill andtime. This year, 2005, has been challenging for both large and small companiesbecause of the mandatory label changes that affect almost all labels. Firms such as Food Consulting Co. can help companies of allsizes prepare 2006-compliant labels either by customized label help or throughthe companys free monthly Food Label News that is delivered by e-mail of thefirst Friday on the month. It is not too late to get help for 2006 requirementsand it is a great time to stay informed on upcoming FDA actions that affect foodlabels.

Karen C. Duester, M.S., R.D., is president of Food ConsultingCo., the largest outsource provider assisting food companies in meeting FDAlabeling requirements. The company offers a full range of food labeling servicesand can be reached at www.foodlabels.com or by calling (800) 793-2844.