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Specializing in FDA Regulatory Matters

FSMA’s Impact on Private Label Foods

by Dan Okenu, Ph.D.

FSMA is the most comprehensive statutory food safety reform since the Food Safety & Cosmetic Act of 1938. This new rule empowers the FDA with a radical shift in focus towards a more proactive science and risk-based prevention strategy, and promises to raise the bar on food safety regulatory compliance for the entire food supply chain including the manufacturers, processors, importers and retailers of private label food products.

As the FDA prepares for the full implementation of FSMA by spring of 2016, one important question for the private label food industry is how the new rules will impact their product with its growing popularity and profitability. Some of the key provisions of FSMA that should be addressed are as follows;

  • Foreign Supplier Verification Program with frequent inspection of foreign-based facilities.
  • A verifiable Supply Chain Management Program with documented evidence from accredited third party certifying entity to confirm compliance.
  • Extensive documentation and record keeping for all mandatory food safety practices.
  • Effective Traceability and Recall Program.
  • Upgrade from regular HACCP to the more advanced Hazard Analysis and Risk-based Preventive Control (HARPC).

FSMA readiness and preparedness will include a comprehensive gap analysis to identify provisions of the new rule that must be implemented to stay ahead of the curve with the new regulatory compliance and to assure customers that their favorite in-store brands were produced, processed, stored and handled in a safe manner every step of the way. While domestic manufacturers and suppliers are already covered under FSMA, retailers of private label food products manufactured in the U.S. are still advised to consistently verify that their suppliers are compliant, since retailers will also be liable for any infringement or negative outcome from such products. Overall, companies will be better off taking proactive steps in evaluating their suppliers’ food safety management system in line with the preventative control provisions under FSMA. The good news however, is that these new regulatory requirements could potentially make it more profitable for companies to manufacture their private label foods here in the U.S. instead of overseas, to avoid the rigorous foreign supplier verification requirements.