Just as with products intended for human use, FDA’s Center for Veterinary Medicine (CVM) regulates products, sold in the US and intended for use with animals and in animal feed. Animal food includes both livestock feed and pet food. CVM manages the FDA medicated feed and pet food programs and monitors and establishes standards for animal food additives. In addition, CVM approves drugs for use in food-producing animals which assures any residue of the drug remaining in edible tissue is safe for human consumption.
Just as with products for human use, products regulated by CVM undergo the same scrutiny and have similar regulatory requirements, including GRAS, Food Additive Petitions, New Animal Drug Applications, Medicated Feed Mill Licenses and more. Our auditing services include pet food/feed and animal drug manufacturers and distributors.
EAS offers regulatory solutions for all FDA veterinary needs through our team of highly skilled independent consultants.
CVM approval for drug products is a complex and technically challenging process. Our toxicologists which specialize in animal products can answer questions such as whether certain antibiotics are safe in food-producing animals as well as the safety of pet food and animal feed products as well as the acceptability and safety of animal food/feed ingredients. We can help prepare submissions for FDA review and approval.
- NADA (New Animal Drug Application): Similar to NDAs for human foods, NADA sponsors may petition the FDA for approval of a new pharmaceutical for sale and marketing in the U.S. through a New Drug Application using the data gathered during the animal studies.
- ANADA (Abbreviated New Animal Drug Application or generic drug): Similar to ANDAs for human use, ANADAs are generic drug “abbreviated” applications because they are generally not required to submit preclinical and clinical data to establish safety and effectiveness. Instead, generic applicants must demonstrate bioequivalence.
CVM approval for food products, both pet food, and animal feed, is a complex and technically challenging process. Our toxicologists which specialize in animal products can answer questions such as whether certain antibiotics are safe in food-producing animals as well as the safety of pet food and animal feed products as well as the acceptability and safety of animal food/feed ingredients. We can help prepare submissions for FDA review and approval.
- 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.
- Food Additive Petitions: Food additives used in animal food are usually characterized based on their composition and intended use. An animal food additive is generally intended to supply nutrients, add aroma/flavor, aid stability, or alter a food’s characteristics. A manufacturer or other sponsor may petition the FDA for approval of a new animal food additive or they may petition for a new use of an already approved animal food additive. To demonstrate that the additive is safe for the proposed use in an animal food, the sponsor submits a food additive petition (FAP).
Good Manufacturing Practices are critical to the safety of CVM regulated products. Those who participate in the Manufacturing, Packaging, Labeling or Holding Operations for these products must follow certain practices to ensure quality.
GMPs are a system of procedures and documentation, written or analytical, to ensure the product produced has the identity, strength, quality, and purity which it purports or is represented to possess. Firms must maintain appropriate operating procedures and records for the running of the physical plants and grounds, equipment and utensils, various production process control systems as well as holding and distribution and handle customer complaints and more. Sanitation, pest control, employee training, and supervision are also covered under GMPs.
EAS Consulting Group, LLC. assists clients with compliance with the GMP regulations as well as conducting mock FDA audits. Our team of expert GMP regulatory consultants can conduct a thorough facility inspection and provide clients with a summary of necessary improvements and help to develop an action plan for any areas where FDA compliance is lacking. Finally, EAS can provide detailed GMP training to management and staff as required by the regulations.
EAS Consulting Group, LLC. assists clients in navigating the CVM regulatory process and provides US Agent to foreign firms, as well as registration and product listing services. 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.
Food facilities producing foods for pets, as well as animal feeds, must register their facility with FDA, with renewals occurring every other year. EAS can register your facility on your behalf, including foreign firms.
EAS’ labeling team offers services to the pet food, animal feed as well as veterinary drug and OTC industries. Much like products for human use, products for animals are tightly regulated ensuring safety throughout the food chain.
The Food Safety Modernization Act is the largest change the food industry has seen since the inception of FDA and it is also applicable to pet foods and animal feed. FSMA legislation strengthens 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.
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.
A product recall is a time-consuming and expensive endeavor but is required whenever a regulated product is found to be either defective or potentially harmful. While drug recalls are generally caused by a failure of a product to meet FDA regulations, the FTC may request a recall if label or website claims do not meet appropriate levels of substantiation, or the CPSC may determine that a product’s packaging is not in compliance. Whether the recall is voluntary or requested by these agencies, the recalling firm must have a procedure in place to ensure all violative product is removed from the marketplace.
EAS can 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 advise on the recall process to ensure compliance and act as a conduit of information between your company and the FDA. or other government agency.
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.
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.
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 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. Or join us at one of our upcoming training programs coming to a city near you.
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.