Food & Nutritional Regulatory Support Services
Our food and nutrition specialists in our US and EU offices have extensive experience in the food industry, government, and consulting, and recognized expertise in risk assessment, food science, nutrition, microbiology, toxicology, chemistry, and product recall and regulatory support. Exponent’s senior members have gained national and international reputations advising government agencies, non-governmental organizations including FAO, WHO and the World Bank, trade associations, and multinational companies. Our consultants are internationally recognized as leaders in the development of analytical methods and tools for risk analysis, dietary intake and nutritional assessment. Our former FDA regulators and scientists and our medical experts help respond to regulatory inspections, investigations, and warning letters, perform health hazard evaluations on microbial, chemical, and physical hazards, conduct or review outbreak investigations, assist on recall decision making and management. We perform root cause analyses and advise on the reformulation of products and revalidation of processes.
In today’s rapidly changing regulatory environment, firms need to turn to experienced advisors who can navigate through complex compliance issues pertaining to foods and food ingredients. Exponent provides US, EU and international regulatory strategy support and conducts safety assessments for food and color additives, generally recognized as safe (GRAS) substances, food contact substances, and new dietary ingredients. We prepare scientific substantiation for claims, including health, nutrient content, and structure/function claims. We also provide dietary intake estimates for the U.S., EU and other countries to support regulatory submissions and other safety assessments for components in the diet.
Whether the issue is on the plant floor or in the nation’s capital, Exponent’s scientists and regulatory consultants have the knowledge and the skills to efficiently address your most pressing pre- or post-market regulatory needs. We have expertise in foods and beverages, dietary supplements, medical foods, infant formula, bottled water, and cosmetics, spanning from the grower to the retailer and beyond. Our medical, human factors, public health and nutrition expertise provides Exponent with the expanded capability to evaluate consumer behavior, intake and exposures, and well as adverse reactions.
Nutritional and Dietary Analysis
Exponent’s Food and Chemicals scientists are internationally recognized as leaders in the development of methods and tools for dietary intake estimation. Intake assessments are a cornerstone of safety evaluation for ingredients, contaminants, and pathogens. Our nutritional and dietary analyses also include assessments of nutrient intake adequacy, modeling the potential dietary impact of various fortification scenarios, and customized estimates of dietary components. Our clients are finding these assessments increasingly valuable for guiding decision making in these times of shrinking resources - for prioritizing issues, identifying promising product development opportunities, and avoiding unforeseen consequences. Exponent scientists have designed statistically based surveys to collect samples of fresh foods (e.g. milk, pork), processed commodities (e.g., juices, potato chips) as well as prepared foods and infrequently consumed items. These surveys can be designed for several purposes, including analyses of nutrient content for food labeling, compliance assessment under California’s Proposition 65, market research, and acute and chronic exposure assessment for pesticides and contaminants. Similar surveys can be designed for other non-food products.
Outbreaks and Product Recall
Foodborne hazards include chemical, microbiological, physical and radiological agents that can contaminate products and can result in harm. As scientific breakthroughs improve analytical method sensitivity and provides better traceability of products across the supply and distribution chain, growers, processors, retailers and food service operators need to have at their disposal assets to address allegations that their products made people sick. Exponent has the experience, skills, and staff to address these foodborne illness allegations, having worked on many of the recent high visibility outbreaks. Our team that addresses all foodborne hazards includes medical and public health, scientific, technical, and regulatory professionals.
There will be times when a company needs to voluntarily withdraw or recall a product. Exponent’s experienced regulatory, medical, scientific, and technical consultants can help ensure that recall decision making, plan development, implementation, and termination are conducted successfully.
Vulnerability Analysis and Food Safety Programs
Exponent’s scientific and regulatory consultants can conduct vulnerability assessments of regulatory and safety systems, perform compliance audits, and carry out due diligence projects. We conduct in-plant evaluations for food hazard identification, Good Manufacturing Practice compliance and Hazard Analysis Critical Control Point adequacy. In addition, we review process and quality systems documentation, validate preventive control technologies, review Food Safety Modernization Act preparedness, and develop process models to verify product safety. Often working with clients’ in-house technical staff or counsel or outside law firms, Exponent provides the scientific, technical and regulatory capabilities needed for time-sensitive and issue-sensitive work that is critical for business success.
The environment in which food companies and their suppliers operate is changing rapidly with more stringent regulations, increased demand for state-of-the-art food safety systems, and consumer trends toward more natural and organic products. Exponent offers custom-tailored, food safety programs for the food industry. These programs are individually designed to meet a client’s unique needs, from a single program designed to address a specific situation, to a complete food safety evaluation to help insure that brands are protected from harmful contaminants and microbes, and are in compliance with regulations.
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