EAS Consulting Group has the vast expertise through is technical staff and over 150 Independent Consultants to provide assistance to food manufacturers by partnering to evaluate current food safety, food defense, food labeling, operational and formulation/ingredient/packaging programs and determine regulatory “risk”. In addition, EAS offers rapid response capabilities when a food manufacturer finds themselves under local, state, FDA, USDA or EPA scrutiny or regulatory actions. EAS specializes in all types of regulatory services related to food production and processing and has unique capabilities with beverage (including bottled water), seafood, infant formula, medical foods, all types of dairy products as well as animal feed and pet foods.
EAS capabilities extend to food additives including GRAS and FCS assessments, feasibility studies and full GRAS and FCS notifications to FDA and USDA. EAS offers expert toxicology and scientific consultation in the areas of food safety and compliance with conventional and organic foods as well as food derived from biotechnology.
Finally, EAS’ FSPCA-recognized “Lead Instructors” can assist and guide both domestic and foreign food manufacturers and their US-based FSVP Importers in complying with all parts of the FDA FSMA regulations. Some examples of EAS FSMA compliance services include on-site operational assessments, desk reviews of written food safety and operational programs, assisting in the writing or updating of FSMA compliance and general food safety programs, serving as a US FSVP Importer’s “Qualified Individual”, conducting supplier verification assessments, food defense challenge assessments, sanitary transport assessments, recall program assessments and full label reviews including all types of labeling claims. EAS also has experience in submitting to FDA and USDA requests for Temporary Marketing Permits, GRAS and FCS notifications, New Infant Formula notifications and APHIS animal and plant import permit applications are just some of the areas in which our compliance specialists provide expert assistance.
A food company’s most important communication link with the consumer is the food label. EAS’ team of label experts can assist food companies in ensuring that their labels meet with FDA’s regulatory requirements while still meeting your marketing goals. Services include:
Review of basic label formatting elements, statement of identity, net contents, name and place of business, nutrition facts panel, ingredients list, allergen statements, type-size
Review of all stated and implied claims, the safety of ingredients, compliance with food standards of identity, front-of-pack labeling etc.
our consultants can also assist with those foods that fit into special categories such as
- Medical Foods,
- Foods for Dietary Uses,
- Dietary Supplements and
- Infant Formulas
And assist with
- temporary marketing permits applications
- design clinical studies to substantiate label claims.
Before a substance can be legally added to food in the U.S., with rare exceptions, it must be either an approved food additive, prior-sanctioned, or determined to be generally recognized as safe (GRAS) for use in food. Today, many people choose the GRAS option as the way to meet this requirement.
The GRAS route offers two options, GRAS Notification, where a prepared notice is submitted to FDA for review and comment; or Independent (self) GRAS conclusion where the stakeholder makes the determination that the use of the substance is GRAS.
EAS Consulting Group, LLC has a long and successful history of leading companies through the GRAS process. EAS has expert consultants in the areas of toxicology and regulatory requirements to take you through the steps of a GRAS determination.
If the GRAS option is not feasible or preferred, EAS can help you with other options, e.g., food additive petition, food contact notification, the threshold of regulation, etc.
The Food Safety Modernization Act (FSMA) is the most significant regulatory change/challenge the food industry is facing since the inception of FDA. This new law gave FDA many new “tools” to enforce the seven (7) major FSMA regulations including civil penalties and suspension of the FSMA permit in addition to the existing warning letters, consent decrees, etc. This legislation was intended 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.
Critical questions for food manufacturers to answer are whether their existing written and operational food safety programs comply with FSMA and its new regulations. EAS is available to provide answers to these important questions, based on an evaluation of the food manufacturer’s current operational mode to determine compliance with the FSMA “Preventive Controls for Human Foods”, “Preventive Controls for Animal Feed/Food” as well as the Produce Safety, Food Defense and Sanitary Transport regulations. This EAS assistance extends from growers to food manufacturer to warehouses, distributor, and retailers, with each category having industry-specific rules that apply. EAS provides on-site assessment services which consist of an in-depth review of current manufacturing facility norms versus FSMA requirements. This assessment includes documents, policies, and procedures with written recommendations on improvements benchmarked against FSMA requirements and industry best practices to provide a regulatory pathway for meeting detailed demands of FSMA.
In addition, EAS offers services in the area of the FSMA Foreign Supplier Verification Program (FSVP) which requires new regulatory systems for US-based “Importers” to have the foreign food manufacturer’s food safety documents available at the Importer’s US office for FDA inspection, upon request. Of interest to larger food importers may be 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 Controls (HARPC)
- FSVP Qualified Individual Requirements
- Food Safety Plans
- Documenting and maintaining records of food safety practices
- Verifying Supply Chain Management Program
- General FSVP compliance
- Voluntary Qualified Importer Program assessments
- Food Traceability and Recall Program
- Allergen Controls
The Food Defense rules provide a foundation for prevention as directed by FSMA and each facility covered by this rule are required to prepare and implement a written and actionable food defense plan:
- Protect against intentional adulteration
- Improved standards for produce safety
- Foreign supplier verification program for importers
- Third party accreditation auditors to conduct food safety audits and issue certifications of foreign facilities which supply food for human and animal consumption.
EAS consultants, experts in food defense, food safety and developing effective import procedures, can help companies to comply with proposed FDA regulations in the preparation of:
- Prepare actionable process steps to identify facility specific vulnerabilities
- Prepare strategies to mitigate the identified risks of adulteration of foods
- Establish and implement focused mitigation procedures, including the frequency with which they are to be performed
- Determine any necessary corrective actions
- Develop steps to verify appropriate monitoring of activities, mitigation strategies, and corrective actions
- Appropriate training of personnel and supervisors
- Establish and maintain appropriate record keeping protocols including the written food defense plan; records documenting monitoring, verification activities and corrective actions, and documentation related to the training of personnel.
A product recall can be one of the most upsetting and frustrating occurrences for a business. EAS can help with recall prevention strategies through audits of Good Manufacturing Practices (GMPs), review of labeling and health or disease claims on packaging and marketing materials as well ingredient and toxicology reviews and appropriate filings and documentation. EAS can also assist with the performance of a mock recall to assess your readiness to execute an actual recall.
In the unfortunate event of a recall, EAS consultants can help walk your company through the steps of the recall process to ensure FDA compliance. Whether the infraction is a Class I, II or III recall, EAS can assist in making this challenging process more streamlined and act as a conduit of information between your company and FDA.
EAS offers import entry assistance for foreign firms whose products are in detention. Our consultants work with FDA and Customs Border Patrol to determine the reason for detention and assist clients in developing and executing a remedy allowing for the expedited release of affected products. Working as a foreign company’s US Agent, EAS offers the best in regulatory solutions for your most pressing import needs.
A Food Canning Establishment (FCE) registration must be filed with the FDA before selling canned food products within or exporting canned foods into the U.S. This filing requirement is on top the requirements placed on international facilities by the FDA’s Bioterrorism Act Food Facility Registration requirement.
In addition to name and location of processing facilities required on the Scheduled Process form, commercial processors of Low Acid Canned Foods (LACF) must also include the processing method and a list of foods processed in each establishment. Those companies processing Acidified Foods (AF) must include scheduled processes for each AF in each container size. These forms must be filed electronically through the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) prior to manufacturing or exporting into the U.S. Upon completion and acceptance of the registration filing, FDA provides a Scheduled Process Identification Number (SID) for each. Once the SID has been obtained, any modifications in the manufacturing process including equipment and packaging require the FCE to submit updated SID forms.
EAS provides assistance to FCEs both in the U.S. and those exporting into the U.S. through the filing of registration forms, answering any questions during the FDA’s review process, as well as updating any modifications to the processes once the SID has been obtained.
FDA has oversight of the safety of bottled water sold in the U.S. This includes Good Manufacturing Practices (GMPs) specifically designed for bottled water and covering processing, bottling, holding and transporting under sanitary conditions. This ensures bottled water is free from bacteria, chemicals, and other contaminants.
FDA monitors and inspects bottled water products and processing plants under its food safety program ensuring the plant’s product water and operational water supply are obtained from an approved source; inspects washing and sanitizing procedures; inspects bottling operations; and determines whether the companies analyze their source water and product water for contaminants.
EAS offers expertise in the area of bottled water with a keen eye to the specific requirements of this industry. We assist with bottled water bills, assessments of product and manufacturing safety and offer peace of mind that this highly regulated product is being manufactured in accordance with strict GMPs.
EAS serves dairy and infant formula plants and processors offering in-depth regulatory compliance assistance pertaining to regulations covered by the state, FDA and USDA Agricultural Marketing Service requirements.
EAS’ services to the dairy industry include all applicable requirements of the FDA Food Safety Modernization ACT (FSMA) regulations as well as a number of the Global Food Safety Initiative’s (GSFI’s) Third Party Certification schemes such as Safe Quality Foods (SQF), British Retail Consortium (BRC) and Food Safety System Certification (FSSC) 22000 as well as current food Good Manufacturing Practices (cGMPs) and Hazard Analysis and Critical Control Points (HACCP) /Hazard Analysis and Risk-Based Preventive Controls (HARPC). EAS experts provide a detailed analysis of a firm’s state of readiness as well as thoughtful and practical strategies for improving compliance.
EAS covers all aspects of the dairy and infant formula industries from:
- Raw milk and finished dairy product chemistry, microbiology, functionality
- Milk components including milk and whey proteins, milkfat fractions and their byproducts
- Processing technologies including drinking milk; standard and non-standardized cheeses; ice cream, heat-based pasteurization, membrane filtration, heat-concentration, drying and aseptic processing
- Technical guidance for building dairy plant quality assurance and food safety programs
- Plan review including simple remodeling, processing line additions to full green-field builds
- An overview of the US regulatory environment and specific government requirements
- FDA’s FSMA & the Preventive Controls for Human Foods and how these regulations impact the dairy industry
“Medical food” is a commonly misunderstood term as it is used on FDA regulated products. Many manufacturers want to market their products as medical foods because medical foods are exempt from the disease statement limitations for health and structure/function claims and are allowed to name the diseased population for whom they are designed. Outside of medical foods that have been developed for dietary management of rare diseases, FDA has considered most products marketed as medical foods, not to meet the definition of a medical food. EAS consultants can help you determine if your product meets the FDA definition of a medical food and assist with labeling and claims as appropriate.
The United States Department of Agriculture (USDA) is charged with protecting the safety of many areas of the U.S. food supply, including processing and distribution of meats, poultry, and eggs. Many of the principals that apply to FDA regulated products, production and transportation apply also to USDA regulated products, such as the importance of Good Manufacturing Practices, accurate labels and claims and allergen controls. In some cases, such as the transporting of live animals to be used in human and animal food, a completely new set of rules apply.
In addition to FDA regulated products, EAS Consulting Group, LLC. assists clients in the full spectrum of rules and regulations governed by USDA, including matters from Hazard Analysis Critical Control Point (HACCP) and Sanitation Standard Operating Procedure (SSOP) plans and importing products into the U.S..
Whether the question is the acceptability of the use of the term organic, the development of a label or HACCP plan and recall assistance, EAS Consulting Group, LLC., is able to assist with your company’s needs.
EAS can assist with:
- FDA and USDA regulatory issues
- Recall assistance
- Labeling and Claims
- Food defense plans
- Good Manufacturing Practices
- SSOP development and training programs
- HACCP plan development and training
- Allergen controls
- Import assistance and Foreign Supplier Verification Program (FSVP)
EAS advises domestic and foreign produce growers, importers, packing houses, produce warehouses and shipping companies on the US Produce Safety and related regulatory requirements. These EAS services can range from questions that can be answered via simple phone calls to highly time-sensitive and urgent problems such as a company and its produce being placed on an FDA “Import Alert” list, prohibiting any entry of produce into the US. In order to minimize regulatory issues with FDA, EAS can conduct an on-site assessment of the grower’s Good Agricultural Practices (GAPs) as well as evaluation of the produce packing house or produce warehouse for compliance with GMPs. EAS can determine whether your commercial farm, harvesting, packing and/or warehouse facilities meet FSMA’s Produce Safety requirements for GAP and GMP programs.
FDA is responsible for ensuring that the nation’s seafood supply, both domestic and imported, is safe, sanitary, wholesome, and honestly labeled. Efforts to that end include Hazard Analysis and Critical Control Points (HACCP) regulations, the National Shellfish Sanitation Program and other FSMA guidances. EAS experts in seafood assist our international client base with all matter of safety and GMP regulations as well as import assistance as required.
Seafood HACCP regulations require importers of certain seafood products to comply with requirements designed to help ensure that these imported products are processed in accordance with the seafood HACCP regulation. FSMA offers some exemptions related to the seafood HACCP regulation. EAS helps seafood processors, transporters, holders and manufacturers to understand and comply with required regulations facilitating a safe product for consumers.
EAS Consulting Group provides registration and listing assistance as well as US Agent services to international clients in all FDA regulated areas. US Agents are required by FDA to act as an intermediary between foreign firms and FDA. By quickly responding to questions and concerns in a timely manner EAS helps clients get their compliant products to the U.S. marketplace as quickly as possible.
In the case of foreign food firms that manufacture, process, package or hold foods exported into the U.S., in addition to a designated US Agent, facilities must be registered with FDA in accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. This registration must be renewed every other year, and the FDA may suspend that registration if it determines that that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals.
EAS Consulting Group provides a US Agent and origin Food Facility registration assistance service and can serve as a conduit for communications between FDA and the foreign facility.
FDA must be permitted to inspect the facility at any time in accordance with the FD&C Act to determine compliance with FDA regulations for safety and to identify any potential problems before the products enter the U.S. marketplace.
EAS Consulting Group is available to provide a mock FDA inspection of foreign facilities to determine deficiencies and/or to develop a corrective action plan either before FDA makes its initial inspection or if FDA finds deficiencies that need correction.
EAS’ Safe Quality Foods (SQF) Compliance Center fields a group of SQF recognized consultants with a combined total of almost 100 years of food safety, food processing, and regulatory compliance experience. We assist food processors and customers of food processors in their preparations for third-party certification audits and the achievement and maintenance of compliance with SQF requirements.
EAS expertise extends beyond SQF and into FSMA’s Preventive Controls for Human Foods, the Preventive Controls for Animal Feed, the Produce Safety regulation and other FDA-enforced food safety regulations which include readiness assessments and strategic planning to meet the challenges of food safety compliance.
EAS provides the most up-to-date and thorough analysis of the latest SQF code as well as the use of industry-tested models linked to practical methods for achieving compliance.
EAS’s strategic consulting service will provide solutions to companies confronting daunting product development and labeling issues by taking a holistic approach that considers a company’s marketing objectives and the current regulatory, compliance, and enforcement environment at the federal, state and local levels. The service is most often provided by a small team of expert consultants with complementary backgrounds.
Clients are guided through the various regulatory processes at each level of government including government affairs strategies, how to best effectuate policy changes and file official comments as necessary.
Our consultants help address questions such as: Should your company disclose GMO ingredients, create a “non-GMO” product line, or stay the course? What are the risks of self-defining “natural” foods including the risk of class action litigation challenging such claims? How can your company make undefined claims such as “Handcrafted” while minimizing risk from federal and state regulatory authorities and more?
Let EAS help develop proactive solutions for:
- GMO Labeling
- “Natural” Foods and Claims
- Undefined Claims
- New Threats Posed by FDA Warning Letters
- FTC v. FDA
- Trending Claims
- Nutrition Labeling
- Competitive Challenges
- Crisis Management
- Long-Term Planning
- Submissions Assistance
- In-House Training
In the event that FDA issues a 483 or warning letter or the Department of Justice files a consent decree, EAS can assist with a timely and appropriate response. EAS also assists as a third-party expert for review, audit, and evaluation of facilities and documentation, and can formulate a remediation plan and response in compliance with FDA requirements.
EAS is staffed with former FDA investigators and industry auditors that are available to audit firms that your clients are either considering purchasing or have an interest in having contract work performed by. Before they invest in such a firm, EAS can assess their current level of compliance with FDA Good Manufacturing Practice regulations and identify what it will take to bring these facilities into compliance. By having EAS on their due diligence team, costly mistakes can often be avoided.
EAS is frequently requested to bring our popular public training programs in-house, offering a dedicated training for employees and customizing the content as-needed to focus on specific areas of need. Let bring one of our in-house training programs to your facility, customized for your specific needs, or join us at one of our upcoming training programs coming to a city near you.
- FDA Nutrition Labeling Revisions and Impact of Food Label Claims
- USDA Labeling Compliance Seminar
- FSMA Part 117: Preventive Controls for Human Foods for Manager
- FSMA Part 117: For Dietary Supplements
- Food Labeling Compliance Seminar
In the industries regulated by FDA, such as those in the pharmaceutical, medical device, food, dietary supplement, and cosmetic business, compliance issues are of great importance. When disputes arise, the regulatory compliance status of a product or facility is often a key issue and can make a significant difference in how the matter will be resolved. In such cases, it is critical to have the assistance and advice of experts who are both experienced and knowledgeable in FDA regulations and industry practices, and who will be perceived as independent and objective. Whether a dispute is resolved via mediation or litigation it is imperative to have a well-respected and knowledgeable expert witness acting on your company’s behalf. EAS independent advisors and consultants are routinely called to serve as expert witness in a variety of cases and provide the in-depth, detailed attention required in these cases.
EAS offers one of the most experienced groups of consultants available on FDA regulatory compliance issues. We offer a team of former high-level FDA officials and industry professionals who will share their expertise with our clients. Our consultants have an average of over 25 years of regulatory experience and include some of the most well-known and highly respected names in the industry. As new standards and regulations proliferate, EAS keeps abreast of the changing regulatory landscape, allowing us to deliver up-to-the-minute policy advice to our clients. Our experts have the knowledge, qualifications, and experience necessary to explain and clarify the issues to our clients and the courts while establishing credibility and persuasiveness as witnesses.
EAS offers assistance in adjudicating insurance claims and servicing as an expert in depositions and civil litigation cases. With high-level experts in all areas of FDA regulations, EAS is well recognized as representing the industry in all manner of court cases.