Reformulating is only one obstacle in the war on trans fat; meeting the January 1, 2006 Food and Drug Administration (FDA) deadline for listing trans fat on nutritional labels also will present a challenge for many companies.

First, trans fat and food allergens share the same labeling compliance date, but the trigger dates differ from each other, says Lee Sanders, vice president of regulatory and technical services for the American Bakers Association (ABA).

“For allergens, it’s the date of production, so anything that’s made January 1 forward would have to be packaged [to meet allergen labeling requirements],” she explains. “Technically speaking, it is actually a little later than those products entered into interstate commerce by January 1, which is the trigger for trans. So meeting the deadline would be a bigger issue for trans, especially for longer-shelf-life products where you really had to switch the labeling out by this summer.”

In February, ABA and 13 other trade associations sent a letter to FDA asking the agency to harmonize the trigger dates for trans and allergens, notes Sanders. In response, FDA sent a letter stating that its workload was too heavy to do so, and that it also was not going to be allowing any enforcement discretion on the issue.

Based on the agency’s response, ABA and others assumed FDA would not be allowing extensions or enforcement discretion, says Sanders, and the baking industry became “very concerned.”

In September, she says, the Office of Management and Budget (OMB) sent ABA a notice seeking information as to whether companies would be applying for extensions.

“In their opinion, they thought that maybe between 50 and 60 small companies [across the whole food industry] would be applying for extensions,” she says. “We thought that was grossly underestimated.”

When ABA held its Food Technical Regulatory Affairs Committee (FTRAC) meeting in September, the association discussed this issue — as well as separate trans fat labeling issues stemming from Hurricanes Katrina and Rita.

“Several of the packaging suppliers had voiced concern that the resin suppliers that they get their resins from had, in effect, filed force majeure,” says Sanders, “so from that, the packagers weren’t sure if they would be able to meet their contract demands. ... We were also concerned that the trans replacer supplies would be disrupted because many of them are imported, and most of those come into the Port of New Orleans. Even though that port has reopened, the transportation disruption with the rail lines in that area is very concerning.”

Yet another issue is the environmental impact associated with the disposal of huge amounts of packaging that will no longer meet labeling requirements. One ABA member calculated it would need to discard nearly 78 million bread bags — or 1.3 million lb. of material with a value of $2.1 million — if it fails to get an extension beyond the January 1 date, notes Sanders.

“I think the environmental impact is really key because this was an issue with the Nutritional Labeling and Educational Act back in 1993 when that legislation became effective, and ABA was able to get a six-month extension for the baking industry based on the fact that FDA had not completed an environmental impact analysis. ... I’m not sure if that will play out the same way this time.”

On October 3, ABA sent comments to FDA on behalf of its members stating and supporting that:

•“FDA underestimates by orders of magnitude the number of firms that will submit written requests for extensions.”

•“A solely case-by-case approach to requests would be unduly burdensome to both industry and FDA.”

•“FDA should not limit its consideration of enforcement discretion to factors enumerated in the Federal Register notice.”

•“FDA should grant an industry-wide six-month extension for the labeling of grain-based foods.”

Although OMB had asked for companies to file individual requests for extension, ABA told OMB that a request for a blanket extension would make more sense, since the majority of its members indicated they would file for an extension, says Sanders.

“But I also encouraged our members to send in individual letters of request, just in case our approach does not prevail,” she says. “And in talking with FDA [on November 2], they said that people should still continue to send those requests in. They have had such an overwhelming number of companies ask for requests at this point that they set up a special mailbox (extension.trans@fda.gov).”

At press time, ABA had sent a follow-up letter to FDA asking for enforcement discretion. In the letter, the association repeated its six-month industry-wide extension request and stressed that the agency must be sensitive to the impacts from Hurricanes Katrina and Rita. ABA also noted that enforcement discretion for six months would be an acceptable and judicious approach.

Sanders says that ABA remains “hopeful” that FDA will grant an extension.