There may be an earthquake coming to the world of health claims in the US, courtesy of a surprisingly activist Food and Drug Administration (FDA).

The FDA is signaling the potential for massive changes in the regulation of claims like ‘natural’ and ‘healthy’, re-defining industry standards of identity, and even allowing specific food ingredients to be renamed so they are more consumer-friendly.

Consumers are confused

Consumers are already confused about what health claims really mean. When asked what ‘healthy’ means to them, global consumers in a 2017 Q4 GlobalData consumer survey had trouble deciding. Of 14 possible options, seven different answers were selected by a third or more of respondents, ranging from ‘natural’ and ‘balanced nutrition’ to ‘organic’ and ‘low in calories’. Defining ‘healthy’ is like trying to pin down gelatin.

The FDA’s aggressive new regulatory approach for food was foreshadowed by its shocking new proposed tobacco regulations. Less than a year ago, the FDA proposed regulating the nicotine content in cigarettes down to non-addictive levels, a world-first.

Bringing ‘fuzzy’ health claims into focus

If FDA Commissioner Dr Scott Gottlieb follows through on ideas articulated in a late-March 2018 speech at the National Food Policy Conference in Washington, DC, the US may be the first nation to regulate fuzzy terms like ‘healthy’ for food marketing.

Is such regulation really within the purview of the FDA? Gottlieb interprets the core mission of the FDA as reducing the burden of chronic disease, especially that related to poor diets. This broad mandate makes almost anything fair game, and will keep food formulators up at night.

Diets can influence chronic disease. According to the American College of Cardiology, over a fifth of US deaths as recently as 2015 were attributable to poor dietary factors. Adult obesity in the US has increased from 33.7% in 2007-08 to 39.6% in 2015-16. Childhood obesity rose from 16.8% to 18.5% over the same period, according to statistics quoted by Gottlieb.

With the FDA already regulating 80% of the US food supply, the agency may be well positioned to effect better health outcomes. The FDA’s new Nutrition Innovation Strategy “takes a fresh look” at steps that could improve health outcomes. The FDA will hold a public meeting this summer to advance proposals intended to modernise the agency’s approach to regulating label claims, ingredient labels, sodium levels and standards of identity.

‘Healthy’ is ripe for change

According to Gottlieb, “‘healthy’ is one claim that we believe is ripe for change.” That could mean de-emphasizing nutrients in food to tout food itself and food groups seen as inherently beneficial to health (like fruits, vegetables, low-fat dairy, and certain oils). Out-of-favour food groups like meat, confectionery and soft drinks could be in trouble if this approach prevails.

Ultimately, the FDA may develop a “standard icon or symbol for the word ‘healthy’” for use on food packages. Using such an icon or symbol may be contingent on whether a specific product contains a “meaningful amount” of a preferred food group like fruits or vegetables.  Expect lots of debate over what a “meaningful amount” actually means.

Re-evaluating ingredient information on food packages provides yet more potential surprises. “We’re considering what changes could make [ingredient information] more consumer friendly,” said Gottlieb. This includes “considering whether simpler alternative names for certain ingredients could be used so they are more understandable”.

One change under consideration is allowing potassium chloride to be re-named ‘potassium salt’ on labels. The petitioner for the change – NuTek Food Science – believes the change could help cut sodium consumption by eliminating confusion. Consumers have a tendency to associate the term “chloride” with chlorine beach, a no-no in today’s clean label era.

This issue also impacts food standards of identity. Certain cheeses cannot use salt substitutes to lower sodium contents. The FDA thinks that it may be time for a re-think on this.

Sodium may be the first place where the average US consumer will experience a more activist FDA. The agency plans to release updated short-term targets for sodium reduction in food products in 2019. The FDA would like to reduce daily sodium intake in the US to 3,000 milligrams per day from the current average intake of over 3,400 milligrams a day.

Putting the brakes on ingredient-led innovation

Longer-term, an activist FDA could cool a hot market for packaged food and drink innovation where companies often incorporate key iconic food ingredients that tap emerging health trends.  Ingredients like turmeric and CBD are two recent examples, with the former emerging across the food spectrum, while the latter pushes into beverages.

If ‘healthy’ is defined in a more holistic and specific way, the days of food companies adding non-efficacious amounts of trendy functional food ingredients – think probiotics – to products in order to enjoy the healthy halo effect may be over.