FDA should ‘expedite evaluation’ of NuTek potassium salt petition, says GMA

GMA to FDA: Sodium reduction guidance must be re-worded or industry will face a tidal wave of 'frivolous litigation'

GMA to FDA: We need more time to meet sodium reduction targets

Two years isn’t enough time for food manufacturers to make the kind of reductions in sodium that the FDA is asking for, says the Grocery Manufacturers Association (GMA), which also urges the agency to tweak the wording of its guidance in order to avoid “a wave of frivolous litigation.”

In a lengthy response to the FDA’s short-term (two-year) and long-term (10-year) voluntary sodium reduction targets (issued as draft guidance in June 2016), the GMA says that many of the short-term targets are achievable, but not in a two-year timeframe.

This is primarily due to a “need for a more gradual change than proposed, changing consumer use of products in the category, and/or the lack of available technologies to replace the multiple functions of sodium: taste, texture, storage, microbial control and stability,” explains the GMA, which argues that members need “at least four years” to meet the FDA’s short-term goals.

Not all crackers, processed cheese or nuts and seeds are the same, says the GMA

It also urges the FDA to subdivide some categories based on the different roles that sodium plays within the category, revise the figures for several foods, and then re-open the revised guidance for further public comment.

For example, the GMA found some of the FDA categories to be “excessively broad,” such as ‘Nuts and Seeds’ – a category in which there are “significant differences in the sodium concentrations of seeds with shells and those without shells due to differing manufacturing processes and labeling requirements.”

Meanwhile, ‘Frozen/Refrigerated Dough and Batter’ should also be broken down into sub-categories, such as products that are leavened with and without yeast, says the GMA: “Sodium salts are important for flavor and dough development in both types of product, but have additional leavening roles in non-yeast leavened products. The latter products have a higher sodium concentration.”

Similarly, the ‘Processed Cheese’ category should also be divided up into shelf-stable products (which require more sodium for food safety reasons), and refrigerated products, says the GMA, while crackers should also be subdivided into filled crackers and unfilled crackers, which have “significantly different sodium concentrations” due to a difference in required water activities for shelf stability.

It also suggests revised targets for multiple products, including blue cheese, feta cheese, soup, selected dips, popcorn, chips and frozen meals “primarily due to lack of available technology and inability to achieve the indicated change in sodium concentration while maintaining consumer product preference or acceptability.”

Salty taste perception

The sodium taste receptor is much less understood than sweet, bitter, and umami receptors. A greater understanding is required to help reach the draft achievable short-term goals.”

Grocery Manufacturers Association (GMA)

FDA should ‘expedite evaluation’ of NuTek potassium salt petition

The GMA filing doesn’t go into detail on the tools its members are using to replace or reduce sodium, but does urge the FDA to ‘expedite evaluation of’ a citizen’s petition recently filed by NuTek that would allow food manufacturers to use ‘potassium salt’ on food labels as an alternate name for potassium chloride – a leading salt replacer.

“Manufacturers need to balance the desire to decrease salt and sodium content with the simultaneous consumer demand for fewer ‘chemical-sounding’ ingredients," says the GMA.

"Therefore, FDA should expedite evaluation of citizen petitions requesting more consumer-friendly common or usual names for ingredients that can partially replace salt, e.g. potassium chloride to be renamed potassium salt.”

'A WAVE OF FRIVOLOUS LITIGATION?' Statements in the FDA draft guidance describing the UBC (upper bound concentration) sodium targets as “standards” that are “intended to function as de facto regulatory limits on levels of use,” or offer “the ability to see which manufacturers are the greatest offenders of using excess sodium in foods,” could potentially cause legal headaches for manufacturers, warns the Grocery Manufacturers Association (GMA).

“There is a high likelihood that statements such as those quoted above will be misinterpreted and misused to suggest that the UBC targets speak to the safety and/or regulatory status of individual products that exceed those targets. This could needlessly result in substantial consumer confusion, as well as a wave of frivolous litigation.

“We therefore ask that FDA explicitly acknowledge in any final guidance that neither the UBC nor SWM [baseline sales weighted means] targets speak to the safety or regulatory status of any product that exceeds the UBC or SWM targets.”

Conditions of use for nutrient content claims around sodium reduction need updating

It also recommends that the FDA revises the conditions of use around nutrient content claims about sodium reduction, which are only currently permitted where manufacturers have made cuts of 25% or more vs a reference product.

“Some flexibility regarding appropriate reference products and the ability to communicate changes of a lesser magnitude, even as low as 5%, could help encourage purchase of reduced sodium products.”

Salt Institute: Guidance is impractical, misinformed, and will lead to lawsuits

While some individual food manufacturers - including industry giants Nestlé, General Mills and Unilever - have welcomed the guidance, albeit with certain caveats, other commentators remain resolutely opposed.

The Salt Institute, which has urged the FDA to "abandon its efforts to finalize the draft guidance," is the most vocal in its criticism, arguing that the guidance mischaracterizes the science on sodium, and could trigger a tidal wave of opportunistic class action lawsuits.

It adds: "FDA inspectors, non-governmental organizations (NGOs), and class action lawyers would view the upper bound targets as the maximum quantity of sodium that could be present in individual food products... we believe it is disingenuous for the agency to assert that the proposed target average and upper bound levels for sodium in foods are voluntary and not binding."

AMERICAN FROZEN FOOD INSTITUTE: "We ask that FDA set only voluntary targets for average sodium levels for each category, and not finalize the upper bound targets. If FDA does finalize the upper bound targets, we ask that FDA redefine the upper bound targets to clarify that these are not maximum allowable levels of sodium. Although the draft guidance is positioned as non-binding, in practical effect, the standards may not be merely voluntary...Dozens of class action lawsuits have been filed against food companies citing FDA draft guidance as the basis for claiming that a labeling practice is misleading."

NATIONAL RESTAURANT ASSOCIATION: "Our members are committed to developing lower sodium food options, but they face numerous challenges in this regard...We hear from our members that many major brands have reduced levels of sodium- some in public fashions through commitments while others in more of a stealth manner and have suffered customer backlash and slump in sales... Additionally, the costs required for sodium reduction are not typically offset with any incremental sales."

THE SALT INSTITUTE: "FDA’s sodium reduction policy is impractical, misinformed, and based on inconclusive science... Food manufacturers have offered lower sodium foods for many than 20 years and have found that sales generally plummet following reformulation... Even if FDA itself does not enforce the targets as mandatory upper limits, other parties may seek to do so and the end result is that FDA’s recommendations will have mandatory effect despite lacking legal authority and not being issued through an appropriate process."

AMERICAN HEART ASSOCIATION: "We believe that the target values proposed by the FDA can be achieved within the two‐year timeframe, especially since the reductions are relatively modest in nature... We urge the Agency to resist any calls to extend the implementation timeline for the short‐term targets beyond two years. To get a greater percentage of the population down to 3,000 mg in two years and 2,300 mg within 10 as the FDA intends, more aggressive targets may be necessary."

CENTER FOR SCIENCE IN THE PUBLIC INTEREST (CSPI):  "It is critically important that the upper bounds for categories be maintained because they are the one element of the FDA proposal that provides specific guidance on individual products, and because they ensure that foods do not contain unsafe levels of sodium...Many restaurant meals contain one or even several days’ worth of sodium, although the amount of sodium per 100g might meet FDA’s targets. Therefore, the FDA should set maximum sodium levels for a whole serving..."

AMERICAN BAKERS ASSOCIATION:  "We urge FDA to wait to issue final guidance on sodium reduction until after the DRI [Daily Reference Intake for sodium] has been published [by the IOM] and can be used to develop appropriate sodium reduction targets."

Read all the comments on the FDA's voluntary sodium reduction targets HERE.

Read the comments on the NuTek ‘potassium salt’ petition* HERE.

*To date, the CSPI, Unilever, OSI Group, Newly Wed Foods, the American Bakers Association, Westin Foods, Monogram Foods, and FDMR have backed NuTek’s petition, while the Salt Institute opposes it (click HERE). An anonymous commentator has also opposed it on the grounds that it was self-interested and potentially confusing to consumers (click HERE).

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