FDA grants more time for Phase II sodium reduction feedback – but is it enough?
In August, FDA gave stakeholders through Nov. 14 to comment on its voluntary Phase II sodium reduction targets in 163 commercially processed, packaged and prepared food categories.
If achieved, the agency says this reduction would help Americans lower their sodium intake to about 2,750 milligrams per day – which is still a far cry from the cap of 2,300 milligrams per day recommended by the Dietary Guidelines for Americans older than 14 years.
Stakeholders now have through Jan. 13 to comment on the draft guidance, according to a notice published yesterday in the Federal Register. When FDA published the proposed guidance in late August, it characterized the proposed reductions as “achievable” and argued they would not compromise food safety or consumer acceptance but would align with public health goals.
The extra time comes at the behest of a coalition of industry trade groups that asked for an additional 90 days to provide FDA with “more thoughtful, data-driven feedback.” They argued this would help ensure the final guidance is “practical and achievable without compromising product quality or consumer satisfaction.”
In a letter to FDA, 16 trade groups, including the Consumer Brands Association, FMI – The Food Industry Association, the National Retail Federation and several product specific associations, reiterated their commitment to “making meaningful progress in sodium reduction … to align with FDA’s public health goals.” But, they argued, the “the sheer volume of products and formulations that need to be reviewed both against the draft Phase II targets and FDA’s preliminary progress report and 2022 baseline data – makes it challenging to fully assess the impact of the guidance within the current timeframe.”
They added: “Each product category requires careful consideration of technical feasibility, supply chain limitations and consumer acceptability.”
The extension also will allow the industry to incorporate into their responses insights from ongoing research projects regarding sodium levels in foods, according to the groups.
Finally, they argued, the extension is necessary because they simultaneously are “managing multiple critical initiatives from the FDA in the coming months, including the anticipated final rule on the nutrient content claim ‘healthy’ and the proposed rule for the Front-of-Package Nutrition Labeling.”
The International Food Additive Council (IFAC) echoed this sentiment in separate comments, noting, “it is essential that the FDA avoid making unnecessary regulatory changes during their development of an enhanced systematic process for post-market assessment of chemicals in food that could increase the regulatory compliance burden for both ingredient and end-product manufacturers; as this would greatly impact the food industry’s ability to invest in research and development for voluntarily reducing sodium levels in products.”
IFAC: Industry needs more time to hit Phase II targets
IFAC also asked FDA to extend the compliance timeline for the Phase II sodium reduction goal – not just the deadline to finalize comments.
IFAC argues in a Sept. 23 letter sent to FDA that industry needs five years – not three as proposed by FDA – to comply with the reduction goals once the Phase II targets are finalized.
It argues “the average product reformulation can take anywhere from 18 to 36 months to fully develop, test and commercialize to market,” and while this ostensibly would fall within FDA’s current time range, IFAC adds industry needs more time to develop and scale new sodium reduction technologies to help hit the Phase II targets.
“Reducing sodium in commercially processed, packaged and prepared foods requires innovative approaches, especially where sodium plays a key role in food safety, preservation, texture or flavor. Therefore … we emphasize the need for technological flexibility and ingredient innovation to meet these targets,” IFAC writes.
IFAC also reiterated its call for increased flexibility to use salt substitutes to reduce sodium in standardized foods. For example, it notes, cheese currently is not permitted to use salt substitutes according to its regulated standard of identity. However, FDA has proposed – but not yet finalized – a rule that would allow the use of salt substitutes in select foods without violating their standards of identity.
