lunes, 2 de octubre de 2017

FDA Law Blog: FDA Proposes Jan. 1, 2020 as New Compliance Date for Nutrition Labeling

FDA Law Blog: FDA Proposes Jan. 1, 2020 as New Compliance Date for Nutrition Labeling

Posted: 01 Oct 2017 06:19 PM PDT
By Riëtte van Laack –

As readers of this blog know, in 2016 FDA published a final rule amending the nutrition labeling regulations. Although the industry requested more time to come into compliance with that final rule (which requires revision of virtually every food label), FDA set the compliance date for all but small companies (with annual sales of less than 10 million dollars) at two years after the effective date, i.e., July 26, 2018.

Then, on June 13, 2017, FDA announced its intent to extend the compliance date.  According to the June 13, 2017 announcement, FDA recognized that it needed more time to issue guidance to industry, and that industry also needed more time to revise labels, reformulate products, and take other actions to be able to comply with the new nutrition labeling requirements. In June, however, FDA only announced its intent to extend the compliance date, without actually setting a new compliance date.

On September 29, 2017, FDA announced (here and here) its proposed new compliance date of Jan. 1, 2020.  In the proposal, FDA asserts that it is “taking this action because, after careful consideration, we have tentatively determined that additional time would help ensure that all manufacturers covered by the final rules have guidance from FDA to address, for example, certain technical questions we received after publication of the final rules, and that they are able to complete and print updated Nutrition Facts labels for their products before they are expected to be in compliance with the final rules.” FDA does not mention the pending citizen petitions requesting a revision of certain aspects of the rule, e.g., the dietary fiber definition and requirement to declare added sugars.

FDA’s proposal to extend the compliance date evaluates the costs and benefits of the extension, and concludes that extending the date by approximately 1.5 years reduces the cost to industry by about 1 billion dollars, while it reduces the benefits to the consumer by 0.9 billion dollars. FDA acknowledges that the methodology to calculate the costs and benefit analysis has flaws. However, it is the same methodology as it used previously in the calculation of the costs and benefits of the final rule and, thus far, no party has suggested better alternatives.

Comments to the proposed rule must be submitted by Nov. 1, 2017. FDA emphasizes that comments should pertain to the extension of the compliance dates only, and not to the substance of the nutrition labeling rule itself.

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