FDA issues voluntary sodium reduction guideline, wins lawsuit over its GRAS rule

USA – The U.S. Food and Drug Administration(FDA) has released voluntary sodium reduction guidelines for 163 categories of processed food, including baby food, snacks and foodservice items. 

According to a statement from the food regulator, the guidelines, which have been pending since 2016, are nonbinding recommendations for manufacturers and foodservice to follow for the next two and a half years in order to cut down on the average consumer’s sodium intake. 


Acting FDA Commissioner Janet Woodcock and Center for Food Safety and Applied Nutrition Director Susan Mayne noted in a joint statement these targets will help reduce average sodium consumption from 3,400 mg per day to 3,000 mg a day.  

While this is still more than the 2,300 mg of sodium per day recommended in the most recent Dietary Guidelines for Americans, Woodcock and Mayne said the gradual reduction will be beneficial to public health. 

Sodium consumption has been linked to several health problems, including heart disease, high blood pressure and stroke.  

According to 2016 research from the Centers for Disease Control and Prevention, 90% of children and 89% of adults consume more than the recommended sodium levels.   


Although many consumers may want to reduce their sodium intake, about 70% of the sodium we eat comes from packaged, processed, and restaurant foods, making it challenging to limit sodium. 

Ms. Woodcock is however confident that changes across the overall food supply will make it easier to access lower-sodium options and reduce intake even in the absence of behavior change.

The FDA couldn’t move forward with more stringent or mandatory salt-reduction guidelines until the proposed voluntary ones were codified.  

While these guidelines are voluntary for the next two and a half years, longer-term or mandatory guidelines could be proposed for when these expire. 

FDA wins lawsuit over its GRAS rule 

Meanwhile, a federal judge in New York has determined that the FDA lawfully exercised its authority in publishing a 2016 rule governing food substances that are generally recognized as safe (GRAS). 


Judge Vernon S. Broderick granted a motion for summary judgment to the government after finding “FDA did not unlawfully subdelegate its authority.” 

The GRAS rule provides a voluntary process for notifying the agency that a substance is GRAS under the conditions of its intended use and therefore exempt from premarket approval. 

Plaintiffs including the Center for Food Safety contended the GRAS rule fails to ensure FDA has oversight over GRAS determinations, allowing manufacturers to covertly determine whether chemical substances may be added to food.  

Critics also have argued companies’ GRAS experts may have conflicts of interest, potentially undermining the integrity of the process. 

The judge however observed that the self-GRAS process is perfectly legal, and only Congress can change it. 

He further added that the FDA has the right to disagree with a GRAS determination and may bring enforcement action against a food manufacturer. 

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