FDA flags non-compliant R11 iodized salt brands

FDA flags non-compliant R11 iodized salt brands
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DAVAO CITY – The Food and Drug Administration (FDA) 11 has reminded iodized salt manufacturers, importers, distributors, and retailers to strictly comply with the mandated iodine content levels, following the discovery that several popular brands fell short of the standards set by law.

Loucene Marie Caraoa, Food and Drug Regulatory Officer of FDA 11, revealed during the Regional Multi-Stakeholder Salt Iodization and Nutrition Summit in Davao City that their quarterly post-marketing surveillance found that a few iodized salt brands sold in supermarkets across the Davao region either failed to meet or exceeded the required iodine fortification level.

“Ang market monitoring showed that some salt products did not meet the iodine fortification level required by law. Naa nata’y mga circular na gina-remind nato ang mga manufacturer unsa dapat ang guidelines, pero naga fail gihapon (Market monitoring showed that some salt products did not meet the iodine fortification level required by law. We already have circulars reminding manufacturers of the proper guidelines, but some continue to fail to comply),” Caraoa shared.

Under Republic Act 8172, or the ASIN Law (Act for Salt Iodization Nationwide), iodized salt must contain 30–70 ppm of iodine, with at least 15 ppm expected to be retained at the household level. However, Caraoa said that the FDA focuses on the 30–70 ppm standard since their testing is conducted at the manufacturer and warehouse levels.

Caraoa said that in 2024, two out of six salt brands tested did not meet the standard, while in early 2025, two out of 12 brands also failed, one for falling below and another for exceeding the required iodine level. Notably, one of the non-compliant brands had already been flagged the previous year for the same deficiency.

Because these manufacturers are outside the region, the relevant FDA cluster was notified. Notices of violation and health advisories were issued to non-compliant brands. Caraoa noted some manufacturers only temporarily comply before reverting.

“I think maybe wala pagyud kaayu nag sink in sa ila ang importance of ngano naga-iodized. Para sa ilaha trabaho, trabaho lang kay balik-balik gyud ni na makita sa salt manufacturer, mag comply sila, karon after pila ka tuig balik napod sila sa ilahang old practices (I think the importance of iodization has not really sunk in for them. For many, it’s just work as usual. This pattern is repeatedly observed among salt manufacturers; they comply for a time, but after a few years, they eventually return to their old practices),” she said. 

She added, “FDA policy will enforce stricter monitoring, testing, and the issuing of advisories and circulars to remind importers and manufacturers about mandatory iodization.”

Caraoa explained that when manufacturers are flagged for violations, the FDA does not immediately order their closure. Instead, they give a chance to the manufacturers to correct deficiencies by submitting corrective action plans with a proposed compliance timeline.

“’Di natin pwede sila ipapasara agad. We give them time to correct the deficiencies, so we give them 6 months kung kaya ba nila ma-correct lahat, kung hindi kaya within 6 months, pinapalagay natin kung kalian nila matatapos – within one year or specific month, day, and year (We cannot immediately order them to shut down. We give them time to correct the deficiencies, usually six months, to see if they can comply. If they cannot meet the requirements within that period, we ask them to commit to a specific timeline, whether within a year or by a definite month, day, and year),” she added.

Moreover, aside from ensuring that iodized salts meet the required iodine fortification level, Caraoa said that they monitor the certificate of product registration (CPR) of every iodized salt brand and the license to operate (LTO) of iodized salt manufacturers, distributors, traders, and repackers through post-licensing inspection.

Caroa stated that verifying the content of each iodized salt brand through its label ensures compliance with the legal guidelines on nutritional facts and the required iodine content. She added that consumers may also verify the license to operate of the manufacturer, distributor, trader, or repacker through the FDA’s online verification portal.

“If the FDA finds that a product is non-compliant during verification, it is automatically tagged as unregistered, which then leads to the issuance of FDA advisories. These are warnings to the general public against the purchase and use of unregistered or non-compliant products, which may pose danger to the consuming public, as found on their website,” Caroa said.

In terms of checking the manufacturers, Caraoa explained that the inspections involve examining the facility’s iodization process and testing, assessing the technical expertise of personnel handling the processing, verifying the iodine solution and other chemicals used, reviewing calibration records, and checking the cleaning and maintenance logs of the iodizing machines.

If manufacturers fail in any of these areas, they are subjected to corrective actions and are closely monitored over a period to ensure compliance.

In the Davao region, there are currently only two manufacturers of iodized salt. One has been monitored and found compliant with the guidelines, while the other is still awaiting inspection, which is expected to take place within the year. (ASO/PIA 11)

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