Editorial Comment Publisher/Editor



FDA Reorganizes; Now It Needs
To Re-Energize

Dick Groves
Cheese Reporter

June 14, 2024

The US Food and Drug Administration reached what it called a “significant milestone” last month with approval of its reorganization involving the creation of a unified Human Foods Program and other modernization efforts. Now what the agency needs is a re-energization effort.

As reported on the front page of our May 31st issue, FDA said this reorganization will enable the agency to be more efficient, nimble and prepared for the ever-changing and complex industries it regulates, including the dairy industry.

FDA’s Human Foods Program is headed by Jim Jones, who joined the agency last September as its first Deputy Commissioner for Human Foods. FDA has produced a video blog series, “On the Road with Jim” which captures Jones’s insights as he travels the US to listen to and learn from stakeholders and FDA field staff.

As Jones gets settled into his job, and as FDA implements its reorganization (currently targeted for Oct. 1, 2024), it is our hope that the unified Human Foods Program can get to work on some long-overdue dairy-related undertakings.

For example, FDA has yet to issue a final rule on a proposal to permit the use of fluid ultrafiltered milk in the manufacture of standardized cheeses and related cheese products.

Not that there’s any hurry on this proceeding; after all, another six months and we’ll be “celebrating” the 25th anniversary of the American Dairy Products Institute’s petition requesting that FDA amend the definition of “milk” in its regulations to include fluid ultrafiltered milk.

It has, of course, been a long haul to get this final rule across the finish line. It may be recalled that FDA, in October of 2005, published a proposed rule to amend its regulations to provide for the use of fluid UF milk in the manufacture of standardized cheeses and related cheese products.

A little over two years later, FDA reopened the comment period to seek further input on two specific issues raised by the comments concerning the proposed ingredient declaration. That reopened comment period lasted until April 2008.

And then...nothing. That is, until August of 2017, when FDA notified manufacturers who wished to use UF milk in the production of standardized cheeses and related cheese products of the agency’s intent to exercise enforcement discretion regarding the use of fluid UF milk in the production of standardized cheeses and related cheese products, provided that the physical, chemical, and organoleptic properties of the cheese or cheese product aren’t affected.

FDA also stated its intent to exercise enforcement discretion with respect to the labeling of fluid UF milk and fluid UF nonfat milk, but encouraged industry to identify these ingredients as “ultrafiltered milk” and “ultrafiltered nonfat milk” to the extent feasible and appropriate.

Next, in December of 2019, FDA reopened the comment period for the proposed rule that had been published back in 2005. That new comment period was eventually extended to August of 2020.

It would seem that FDA has received enough input over the past 19 years (or 24-plus years, if you count the petitions that FDA received prior to publishing its proposed rule) to finally issue a final rule.

The good news here is that, according to the federal government’s “Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions,” FDA will issue a final rule in this proceeding sometime this month.

The bad news is that, according to the spring 2023 unified agenda, a final rule in this proceeding was to have been released in October of 2023. So at best we’re cautiously optimistic that we’ll see a final rule on this matter anytime soon.

Meanwhile, FDA in April of 2023 published a proposed rule that would amend the agency’s standard of identity regulations that specify salt (sodium chloride) as a required or optional ingredient to permit the use of salt substitutes in standardized foods, such as many cheeses.

As the International Dairy Foods Association noted in its comments on that proposal, it will likely be several years after publication of a final rule before standardized foods that utilize salt substitutes enter the market. So the sooner FDA issues a final rule, the sooner industry can potentially start to use these salt substitutes in its products.

FDA way back in 1995 announced that it intended to review its standards of identity regulations. Almost 10 years later, FDA and USDA’s Food Safety and Inspection Service published a proposed rule to establish a set of general principles for food standards.

Almost 18 years later, FDA and FSIS in February 2023 decided to withdraw that 2005 proposed rule to reconsider how best to approach general principles and food standards modernization. A joint FDA and USDA effort to publish a new proposed rule on principles for food standards modernization has been included in several Unified Agendas, but so far no proposal has been released.

FDA has lots on its plate these days, some of which has been aging for years. Now that its reorganization is finalized, it’s time to get productive.


Dick Groves

Dick Groves has been publisher/editor of Cheese Reporter since 1989. He has over 45 years experience covering the dairy industry. His weekly editorial is read and referenced throughout the world.
For more information, call 608-316-3791 dgroves@cheesereporter.com

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