Prime Label's Monthly e-Newsletter
November 2013
Dear Colleague,

BREAKING NEWS: Food Chemical News reports today that FSIS released the final rule on generic labeling. We're excited to bring you the story in this edition of Label Alert. And in light of the announcement, Prime Label is launching an introductory offer on its Generic Label Report!
The Wait Is Over: FSIS Releases Final Rule On Generic  Labeling

Friday November 1 2013


The kinds of new product labels that can be used without first submitting them to USDA's Food Safety and Inspection Service for review will increase, thanks to a final rule published online this morning ( and set to publish next week in the Federal Register.


Labels with negative or special claims, like "gluten-free," will still have to be submitted, but other claims for which a regulation has been established, like "low fat," can be generically approved under the new system, which will take effect 60 days after publication of the final rule.


The rule has been a long time coming. The proposal was published in December 2011 and received nearly 50 comments (see FCN March 9, 2012, Page 15), many of them in favor of the changes because it will streamline the approval process and leave FSIS' labeling department staff of 18 technical and administrative specialists free to examine only those labels with special claims, says Rachel Edelstein, assistant administrator in the agency's Office of Policy and Program Development.


The labeling office, led by Rosalyn Murphy-Jenkins, director of the labeling and program delivery staff, has been working on guidance, published along with the final rule (, to help the food industry determine when labels must be submitted and when a generic approval is possible.


The final rule was sent to the White House Office of Management and Budget in July (see FCN July 12, 2013, Page 3), and was released back to USDA for publication on Sept. 13.


Edelstein explains that the rule wasn't immediately published because the agency  wanted to discuss it with other agencies within USDA and make sure all offices were prepared and aware of the change. Then the two-week government shutdown further delayed the rule's publication.


The final rule is not greatly changed from the proposed version, she confirms.


"We analyzed all the comments, and this document responds to all the comments," Edelstein says. "It makes a few clarifying changes, but largely it's consistent with the proposal."


Companies that want to submit a label that can be generically approved can still do so, but those labels won't be prioritized for expedited review, she adds. The benefit of the expanded criteria for labels that can be generically approved is that companies won't have to wait for the green-light from FSIS to begin using it.


Expanding the situations in which a label can be generically approved should reduce the number of submissions landing in the labeling staff's inbox, Edelstein explains. "It will allow the labeling staff to focus on the really complicated labels, the labels with special claims, or [ones] that may have some public health implications."


Murphy-Jenkins and her staff have been working on guidance that will be published with the rule, in addition to updating existing guidance on the kinds of labels that do not need to be reviewed before use.


There will be a list of labels that can be generically approved, in addition to claims that must be submitted, Murphy-Jenkins says. "It's a list that will be updated periodically. Companies are coming out with new types of statements on labels all the time."


Guidance should help alleviate concerns


While the industry has been waiting anxiously for the publication of the final rule, Murphy-Jenkins admits there's been some uncertainty over whether FSIS inspectors conducting label examinations will accept labels that have been generically approved.


In most scenarios, this is likely to come down to "distinguishing between what is a special statement or claim and what is not," but the final rule helps draw a bright line on this topic, she says.


There will be a 60-day implementation period that should help the labeling staff continue working to clear out the backlog of labels that resulted from the government shutdown. Some of the labels submitted during that time could be generically approved under the current regulations, Murphy-Jenkins says.


"Expanding the reg gives us an opportunity, and gives the industry the opportunity, to be more familiar with the regulations," she says. "Hopefully our guidance will help clarify some of that... and give us a little more consistency in focusing on special claims and statements that are not defined. Nutrition regulations, for example, are very, very prescriptive. People who take the time to sit down and read the regulations should be ready to apply."


Expanding the generic approval system, combined with the Label Submission and Approval System (LSAS), should help streamline operations at FSIS' labeling department, which envisions an eventual transition to a completely electronic operation, Murphy-Jenkins adds (see FCN April 26, 2013, Page 17). LSAS, which was introduced in May 2012, will be updated in light of the final rule. Until then, users can still access its generic labeling advisor to determine what can be generically approved under the existing regulation, she says.


In addition to the guidance that will be published with the final rule, FSIS' labeling staff will be offering webinars to further explain the new generic approval system, Edelstein says.


Look for reaction to this rule in next week's Food Chemical News Week in Review and online at -- A. Healy


Reproduced with permission from Food Chemical News. For more breaking news like this, subscribe to Food Chemical News at

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