Next Upcoming Seminar: FDA Nutrition Labeling Facts and Impacts on Food Label Claims – July 13, 2017

Specializing in FDA Regulatory Matters

Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act is the largest change the food industry has seen since the inception of FDA. FSMA legislation was designed to strengthen the safety of the U.S. food supply by requiring preventative controls at all levels, from the grower, supplier, manufacturer, distributor, importer and so on. Each and every area will be touched in some level by FSMA. As FDA finalizes implementing regulations, industry is assessing current systems against the proposals to understand the impact and costs of FSMA changes needed to protect their business and the food supply.

With more than 50 years of experience assisting clients in developing regulatory strategies, implementing quality assurance programs, filing regulatory submissions and ensuring compliance with FDA regulations, EAS is poised to assist food firms with the significant implications of the FSMA. EAS provides a full spectrum of services conducted by our consultants who have spent their professional careers either working at FDA or working in industries regulated by the Agency. It is this first-hand experience and expertise that sets EAS apart from others in this industry.

Auditing

The question of which FSMA rules apply is a critical one for the food industry. The answer depends on what functions operate within the company – from grower, to manufacturer to distributor to supplier; and each category has industry specific rules which apply. EAS provides auditing services which consist of a thorough company review and assessment of which FSMA rules must be met, which documents, policies and procedures require updates as well as a regulatory pathway for meeting detailed demands of FSMA.

FSMA places the responsibility on importers to verify that the food products they import are in full compliance with FDA requirements. The Voluntary Qualified Importer Program (VQIP) which is designed to assist in the ease of entry of food shipments for companies meeting certain rigid requirements. EAS assists importers in a wide variety of areas and can provide a conduit of information between the agency and company.

Choose EAS to lead your firm through the new FSMA regulatory requirements:

  • FSMA Readiness Assessments
  • Hazard Analysis and Risk-based
  • Preventive Control (HARPC)
  • Qualified Individuals
  • Food Safety Plans
  • Documenting and keeping records of food safety practices
  • Verifiable Supply Chain Management Program
  • Foreign Supplier Verification Program
  • Traceability and Recall Program
  • Allergen Controls