US tightens oversight of food packaging materials amid health concerns

USA – The United States is ramping up regulatory scrutiny of materials used in food packaging and processing amid rising worries about chemical migration and long-term health risks.

The U.S. Food and Drug Administration (FDA) regulates food contact substances (FCS), a broad category that includes packaging materials, containers, adhesives, and equipment, to ensure they do not contaminate food or pose dangers to public health.

However, growing criticism of loopholes in the current oversight system prompts calls for reform.

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), any substance expected to come into contact with food is treated as a food additive and must receive premarket approval from the FDA unless it is considered Generally Recognized As Safe (GRAS) by qualified experts.

Approval requires rigorous scientific evaluation, including toxicological studies and migration testing, to confirm that exposure levels are within acceptable safety limits.

One of the primary mechanisms for approval is the Food Contact Notification (FCN) process, introduced in 1997.

Through this process, manufacturers submit safety data to the FDA for review. If the agency raises no objections within 120 days, the substance is deemed authorized for its specified use.

However, FCNs are manufacturer-specific—other companies must file separate notifications for the same substance.

Critics argue that the GRAS exemption allows companies to bypass FDA review by self-certifying the safety of their substances.

This has led to concerns about potentially unsafe materials entering the market, particularly as new research links certain chemicals to serious health issues.

Among the most controversial are per- and polyfluoroalkyl substances (PFAS), widely used for their grease-resistant properties in food packaging.

These substances have been associated with cancer, immune system disruption, and hormone interference.

Recent studies have identified over 3,600 chemicals from packaging and processing materials in human biological samples, raising alarms about the cumulative exposure risk.

Calls for reform are gaining momentum. Robert F. Kennedy Jr., head of the U.S. Department of Health and Human Services, has pledged to close the GRAS loophole and increase transparency. Proposed changes would require companies to inform the FDA of any new ingredients or formulation changes, including safety data, before bringing products to market.

“There is growing consensus that the current system needs to evolve to protect consumers better,” Kennedy said. “Mandatory disclosures and independent review are essential to ensure food safety.”

The debate also highlights discrepancies between U.S. and international food safety regulations. Some substances banned in the European Union remain permitted in the U.S., prompting calls for regulatory harmonization.

As federal agencies consider reforms, the FDA continues to monitor food contact substances and review new safety data.

Industry stakeholders are urged to adapt to evolving requirements and ensure that their packaging materials meet the highest standards for health and safety.

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