FDA unveils new strategy to protect food from deliberate adulteration

USA – The Food and Drug Administration of the United States has announced new advanced steps to protect food products from intentional adulteration or contamination.

According to FDA, the new measures supports the agency’s compliance with the intentional adulteration (IA) rule set forth under the FDA Food Safety Modernization Act (FSMA) to prevent intentional adulteration intended to cause wide scale public health harm.

They target to help manufacturers implement additional activities that can help identify and mitigate the risk of intentional food adulteration.

In line with this, FDA has released a revised draft guidance called Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry to further highlight significant vulnerabilities.

The action plans in the guidance reinforces the IA rule, which is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause widespread harm to public health.

IA rule requires that certain facilities, both domestic facilities and foreign facilities that export to the U.S, develop and implement food defense plans that assesses their potential vulnerabilities to deliberate contamination.

Shifting focus to prevention rather than cure

Unlike other FSMA rules which address specific foods or hazards, IA rule shifts its focus from responding to foodborne illness to preventing it.

The draft guidance issued today outlines two, flexible methods for how facilities can conduct vulnerability assessments to identify their areas of highest risk and provides information about requirements for education and training.

It highlights key information such as Key Activity Type method, vulnerability assessments, mitigation strategies, and food defense monitoring procedures.

FDA said it plans to provide a third installment of this draft guidance that will include additional information on corrective actions, verification, records maintenance and reanalysis requirements.

The provisions are aimed at helping the food industry implement the IA rules in a flexible and cost-effective way.

FSMA was enacted by the Congress in response to dramatic changes in the global food system and prevalence of foodborne illnesses.

“When it comes to modernizing our approach to food safety, our core aim is to shift the FDA’s focus from reacting to food safety problems to preventing them from occurring in the first place.

To help secure this goal when it comes to the risk of intentional adulteration and acts of terrorism, today we’re providing additional draft guidance to help producers implement the rule’s protective standards, identify their biggest risks, and mitigate these risks from those who might try to use food products to cause deliberate harm to American consumers,” said FDA Commissioner Scott Gottlieb, M.D.

According to Centers for Disease Control and Prevention, about 48 million people in the U.S. (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases.

In 2016, FDA put forth a rule outlining smart, risk-based steps food production facilities must implement to help protect food from intentional adulteration.

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