Your Food Additives May Need GRAS

As innovative food companies develop an array of products to satisfy a discerning consumer, the question of whether food additives intended for use in those products are safe for their intended uses.

According to FDA, “GRAS” is an acronym for the phrase Generally Recognized ASafe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive. Product development teams must take into account the specific ingredients used and whether those ingredients are GRAS for their intended uses. Those food additives for which GRAS has not been established require a determination of safety for that ingredient through scientific procedures. 

Are your food additives GRAS? EAS can help you make that determination. If you need to establish GRAS, EAS can help with the design and execution of safety studies, data organization and preparation of the dossier. Our team of toxicologists and microbiologists have assisted countless EAS clients with GRAS and we’d be glad to discuss your product and its ingredients. Contact Cathryn Sacra to ensure your product innovation meets FDA requirements.

EAS offers QMS Services for Medical Devices

Quality Management Systems (QMS) for medical devices are cumbersome as layers upon layers of critical checks ensure the safety and effectiveness required for the consumer. However, in an effort to reduce overly burdensome recordkeeping processes FDA has announced a voluntary QMS switch from 21 CFR 820 to ISO 13485:2016. CFR 820 is and will remain the law, but this move to ISO 13485:2016 would harmonize the FDA Quality Systems and supplant the existing requirements with the specifications of an international consensus standard for medical device manufactures. ISO uses an improved risk management and risk-based decision-making approach in all processes of the quality management system. FDA expects to fully transition to standard ISO 13485:2016 for medical devices sometime in 2019.

It’s important for medical device firms to get this QMS transition right. EAS offers expertise and assistance in moving from CFR 820 to ISO 13485, facilitating a smooth transition and ensuring compliance. If you missed our recent webinar on the new QMS system, we invite you to view it on-demand here. For more information on our services or to discuss your regulatory challenges please contact Bryan Coleman, Senior Director for Pharmaceuticals and Medical Devices.

EAS Offers OTC Labeling Review and Design in Compliance with FDA Monograph Regulations

Did you know that the current regulations for labeling of Over-the-Counter (OTC) drug products were initiated in 1972 as part of the OTC Drug Review? That’s over 50 years ago and the monograph system that arose from that process has not yet come to completion in terms of finalizing regulations for all OTC products.

The monographs establish conditions (for each therapeutic category) under which OTC drug products are generally recognized as safe and effective. These conditions include labeling requirements such as indications, warnings, directions as well as any required testing.

Some monographs are final and codified in the regulations while others are “tentative” in that the monograph was proposed but has not yet been finalized. Marketing a product under a tentative monograph is allowed through FDA’s enforcement discretion as long as it meets the conditions in that monograph. OTC drug products that do not meet the requirements under the monograph system are considered new drugs and must be submitted to FDA through the application process for approval to market.

In addition to the requirements of the monographs, numerous other laws have passed over time and new regulations issued further complicate your labeling.

These myriad requirements can make compliance confusing, not to mention that the industry is still awaiting Senate passage of the Over-the-Counter Monograph Safety, Innovation, and Reform Act which may address some of these issues.

EAS offers review of OTC product ingredients and claims to ensure they are in compliance with Federal regulations. Our experts are also able to assist with the required drug listings and registrations for OTC products. To learn more about our services visit our webpage. You may also wish to view our On-Demand webinars on OTC regulations, also found on our webpage under the Resources tab.

EAS Assistance Simplifies FDA Registrations, Listings and Renewals

The FDA requires firms that manufacture foods, pharmaceuticals and medical devices to register their facilities on an annual or biennial basis, depending on the product category. Keep in mind, FDA assesses a Medical Device establishment registration user fee annually. Drug products and medical device products must also be listed with the FDA.

Any changes or updates to a facility’s information, such as address, contact information, or designated U.S. Agent, should the location be based outside of the U.S., must be reported in a timely manner. Changes to a drug listing must also be updated as soon as possible. The agency dictates these changes be reported, at the very least, the June or December following such a change.

FDA uses facility registration and product listing information as part of their compliance reviews for cross referencing product listings and forms at U.S. ports of entry. Discrepancies can cause products to be considered misbranded and / or potentially lead to the detaining of goods. Additionally, FDA may at any time make announced or unannounced inspections at registered facilities, so it is imperative that all information uploaded into the FDA system is done with care and accuracy.

EAS offers registration and listing services to our clients, as well as appointment as the U.S. Agent for foreign clients. Our comprehensive services enable your firm to outsource these important, yet cumbersome, administrative tasks to our experts. EAS helps you to keep track of compliance deadlines, applicable user fees and acts as a conduit of information between your firm and the FDA.

For more information, we invite you to view our website and Video Shorts which offer quick snapshots of many of EAS’s services. For more information on our registration and listing services specifically, you may wish to view the “Registrations and Listing Services” video found in the third row. For a more detailed look at many FDA compliance requirements we invite you to view our On-Demand regulatory webinars which offer regulatory information on a variety of topics. More information on U.S. Agent requirements can be found here.

Contact EAS with any questions on registration and listings or to engage EAS as your U.S. Agent. The process is simple, and the benefits can be endless.

EAS Offers Internationally Recognized Training Programs to Ensure Compliance Success

Training is an important component for all levels of employees – from managers who must understand the overarching requirements and FDA expectations, down to the line employees and facilities staff who must also execute them. There is no level of responsibility that is exempt from training, no matter the industry.

EAS offers publicly available trainings held around the country and at industry trade events. Recent examples include the GMP workshop held at the AHPA Cannabis-Hemp Congress and the seminar on sanitary equipment held at this summer’s Snaxpo Conference. Upcoming events include Dairy Processing which will be held at the Process Expo in Chicago and a training on OTC monographs at the upcoming CHPA OTC Academy in Wilmington, DE, not to mention the many technical sessions our experts present around the world. Additionally, our public Food and Dietary Supplement Labeling and Dietary Supplement GMP seminars are being held in Irvine, CA in November, and our Dietary Supplement GMP one-day refresher will take place on Long Island.

EAS also offers custom-tailored programs to meet your in-house training needs. Whether we build that program around one of our already designed and internationally recognized events or create a training based on your specific requirements, EAS and our over 150 expert independent consultants offer in-depth and personalized educational events to ensure your company’s compliance with FDA training requirements as well as your staff’s understanding of their unique responsibilities. Contact us for more information and to discuss bringing our in-house experts to you.

Did you know? EAS Consulting Group Offers Preparatory Assessments Against VQIP Requirements for Firms

The Voluntary Qualified Import Program (VQIP) enables qualified importers of food and food products into the U.S. an expedited review and entry. However, meeting the stringent requirements of the VQIP program requires a thorough demonstration of documented safety of foreign suppliers of human and animal foods as well as an unblemished history of imports.

FDA uses its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) import screening tool to recognize shipments of food that are part of an approved VQIP application. The technical application requirements to achieve VQIP status can be time-consuming and complicated, but the end result is a smoother facilitation of imports. Many firms find VQIP to be of benefit to their operations and that of their customers in the US. In some cases, firms wishing to apply for VQIP seek an independent third-party certification of assurance of compliant practices.

EAS Consulting Group offers preparatory assessments against VQIP requirements for firms seeking approval into the program directly or through third-party certifications. EAS ensures that all processes and procedures are compliant with the rigorous safety requirements and identifies any gaps which must be addressed, ultimately better positioning firms when seeking FDA recognition into the VQIP program.

Contact EAS today for a desk assessment of SOPs and review of safety documentation, including that of suppliers, or bring EAS consultants in-house for a mock third-party certification audit prior to undergoing the official inspection. Thorough preparation for VQIP recognition will make for a smoother inspection process and ultimate certification, saving your business time and money by getting your products to the consumer in an expedited manner. For more information contact EAS today. You may also wish to view our recent on-demand webinar on VQIP requirements or search VQIP in the search bar of the EAS website to learn more about the program and our services.

EAS Offers Pre-Clinical Safety/Tox Study Services for GRAS and NDI Submissions.

EAS offers holistic and cohesive services for clients looking to submit GRAS and NDI submissions to FDA. From the assessments to design of early feasibility studies, ongoing study oversight with the Contract Research Organization, strategy meetings with FDA and the preparation and dossier submissions, EAS’ expert toxicologists, microbiologists and chemists work closely to ensure prioritization of your study needs and execution. 

Choose EAS for:

  • Determination of required performance outcomes and appropriate studies 
  • Development of study design and protocols
  • Identification of an appropriate Contract Research Organization (CRO)
  • Coordination of the study initiation and management oversight with the CRO
  • On-going monitoring of study protocols and outcomes
  • Input of appropriate data for inclusion in study reports
  • Support the writing of the dossier for FDA submission

Did You Know? EAS Offers Verification and Validation Services of Electronic Signatures Under 21 CFR Part 11

Increasing usage of electronic methods to capture and produce critical data, which are subject to regulatory scrutiny led to the effect of Title 21 CFR Part 11. This part of the Code of Federal Regulations establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures.

The aim of this regulation is to define the criteria under which the agency will consider electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

The FDA released a guidance document in 2003 to clarify how part 11 should be implemented and enforced. This has been updated many times, partly due to the fast-emerging changes in technology. In June 2017, the FDA also issued a draft guidance on the use of Electronic Records and Electronic Signatures in Clinical Investigations.

The FDA takes accountability of electronic signatures very seriously and upon inspection of these records deficiencies may result in a warning letter.

These constantly evolving rules can be daunting to understand and implement. EAS’ team of experts is available to assist your firm in understanding your requirements under 21 CFR Part 11 as well as assess your compliance.  Areas in need of strengthening will be addressed giving your firm a detailed action plan for maintaining compliance for both signatures and storage of electronic data.

A Successful Expert Witness is One Who can Demonstrate Expertise While Connecting with a Jury

An effective Expert Witness is more than one who can write expert opinions, be deposed or provide testimony in court. Experts must represent your company accurately, independently and objectively in matters of legal proceedings and do so in a manner that enables them to communicate to, connect with, and convince the decision maker, whether that decision will be made by a jury or mediator. Agencies, judges and juries want to hear from well-respected and knowledgeable expert witnesses. Whether the issue is recalls, labeling claims, safety audits, or almost any other challenge to a facility or a product, having a competent expert by your side can make all the difference.

EAS independent advisors and consultants are routinely called to serve as an expert witness in a variety of cases. Our team of over 50 former high-level FDA officials and industry executives who act in an expert witness capacity average over 25 years of regulatory experience and include some of the most well-known and highly respected names in the industry. These experts have the knowledge, qualifications, and experience necessary to explain and clarify issues to our clients and the courts while establishing credibility and persuasiveness as witnesses.

If EAS can be of assistance as you prepare for your next litigation or mediation challenge, please reach out to Dean Cirotta, President and COO directly. EAS will assure that the specific needs and requirements of your case will be matched with an expert whose knowledge and experience enhances your client’s legal standing.

Strategic Product Development a Key Component of Regulatory Compliance

Did You Know?

Product development is more than just labeling, it is a holistic approach from ideation through commercialization that strategically looks at the category in which the product is intended to be marketed and those regulatory requirements surrounding it. Are there claims being made which have legal definitions? Is the product competing against similar products but with a unique competitive advantage? Does the product contain a new ingredient for which a GRAS submission must be filed?

Once the product idea is born, the strategic and often difficult decisions begin. EAS Consulting Group’s product development team works with companies to best position new and relaunched products in the marketplace. We can review your labels, claims and marketing materials for regulatory compliance, and assure the study design, results and dossiers demonstrate safety of the ingredients and packaging. In addition, we can also assist GMP and Food Safety Modernization Act compliance during production.

If your company is thinking of a new product, product line extension or even repositioning an already existing product, contact EAS Consulting Group for a consultation about your project and how our product development capabilities can help you meet your business goals. EAS’ product development team consists of former attorneys, microbiologists and toxicologists, labeling and claims specialists and experts in packaging and food safety. For more information, contact Allen Sayler, Senior Director of Food Consulting Services at 571-447-5509 or asayler@easconsultinggroup.com.

Slack Fill – EAS Experts are Here to Help

There has been an increasingly growing volume of litigation in the slack fill area. This is a daunting issue for food manufacturers and is complicated by a dearth of clear guidance which ultimately leads to a lack of understanding of the many competing requirements and increases a company’s risk for legal challenges. In fact, there are at least five levels of law where one should look for guidance with slack fill, including international, federal, state, local and common law. Answers on how to interpret and piece the various laws and rulings together is not found on the FDA website, and moreover, it is very difficult to predict how a consumer attorney will interpret them as they attempt to bring suits against the industry.

If you are one of the many who have questions concerning how to find, understand, interpret and implement policies and practices regarding slack fill, call EAS’ team of experts who can assist in navigating this very complicated and confusing issue.