EAS has scheduled our spring training seminars in Long Island next year. Join us April 14-15, 2020 for Dietary Supplement Labeling Compliance, April 16-17 for Food Labeling Compliance, and April 16-17 for the Dietary Supplement GMP seminar. Each of our flagship trainings are taught by our internationally recognized consultants and provide an excellent opportunity to not only learn the specific requirements but to do so in a small group setting with plenty of opportunities to practice skill improvement.
As 2019 comes to a close, it is my honor to thank you for your interest in EAS Consulting Group and convey my appreciation for your dedication to improving your understanding of FDA regulatory requirements through our EASeNews, the many articles published in trade magazines and websites, our webinars and regulatory compliance seminars. It has been another banner year for EAS, and it goes without saying, we value the trust you place in us to help you ensure your GMP and FSMA regulatory compliance is sound, your products are appropriately labeled, your technical submissions such as GRAS, DMF, 510(k) and others are prepared with the diligent attention to detail that you, and FDA, expects. Thank you for the trust you place in EAS each day and we will always strive to ensure that trust is well placed.
In particular, as we have received such good feedback on the utility (and, of course, the price) of our complimentary compliance seminars, I am pleased to say we upped our game and by year’s end will have offered 23 webinars hosted by our many talented independent regulatory consultants (most now available on-demand) ranging in topics from GMP observations for dietary supplements and pharmaceuticals to FDA’s move to a new QMS for medical devices, to what exactly is GRAS and what goes into the preparation of a dossier and more. Thousands registered for our webinars this year, which is an amazing accomplishment and indication that we are on the right track ensuring that you have an understanding of FDA requirements.
As always, when more information was needed or additional questions were raised, EAS consultants answered the call, by planes, trains and automobiles, as well as the good old-fashioned telephone, providing worldwide assistance, in many cases on very short notice. We helped firms to thwart or respond to a crisis and provided routine and actionable recommendations for improvements to a variety of issues such as SOPs, SDS, equipment sanitation, labeling challenges and more. Our in-house trainings saw a banner year as clients contracted EAS to dedicate focused training opportunities for some of their most pertinent challenges. We are pleased that more and more firms are taking a proactive approach to regulatory compliance as it is always easier to correct an issue before it becomes a full-blown problem.
I wish you a safe and happy holiday season. If ever EAS can be of assistance, please know we are always just a phone call or email away.
EAS will host two complimentary webinars in December and we invite you to join us for some great regulatory compliance information. First, on December 4, Senior Directors Allen Sayler and Tara Couch, Ph.D. will co-present a webinar on FSMA’s applicability to the dietary supplement industry. This will be a fantastic presentation as Allen specializes in FSMA compliance and Tara that of dietary supplement GMPs. You may remember an earlier article co-written by the two on the subject published in EASeNews.
On December 13, Priya Jambhekar, and expert on pharmaceutical submissions, will present a webinar on streamlining the Drug Master File (DMF) process. Learn what documentation is required in a DMF, and how much detail, as well as companies commonly run into during the FDA’s review of their issues.
Join Allen Sayler and EAS Independent Consultant Richard White on January 16, 2020 for a review of how Codex, or internationally harmonized standards, can enhance your company’s trade opportunities by facilitation of food and food ingredient exports. Learn just what Codex standards are and how building your food safety programs around them can ease your export practices.
Food Quality and Safety Magazine published an article written by EAS Independent Consultant Robert Kapp Safety Data Sheets (SDS) covering their importance and utilization in manufacturing operations. SDS, are a critical component, required by law, containing all the basic information about a chemical or product which will help to ensure the user’s safety and health all stages of its manufacture, storage, use, and disposal.
If you missed our recent webinars you are now able to view them free on-demand on the EAS website. Our Expert Witness bootcamp, presented by EAS Independent Consultant and General Counsel at Herrick Feinstein, Ronald Levine, and his colleague at Herrick, Leah Kelman, provided a great opportunity to learn what is involved in acting as an expert in legal proceedings and how to market your skills for doing so. EAS is considering a full-day training on becoming and strengthening skills necessary to be an expert witness. If you be interested in participating in an event like that please contact us.
The EAS webinar on Dietary Supplement GMP Observations and Trends presented by Independent Advisor for Quality and Compliance, Robert Fish, offered a detailed look at FDA observations and discussed trends in FDA’s focus as well as tips for compliance.
FDA has stated all color additives are synthetic, so “natural colors” in cosmetic products must be an inherent color of an ingredient, not added for coloring, says John and Catherine Bailey, EAS Independent Consultants and experts on cosmetics. Their article on natural claims was published in the Natural Products Insider.
By Amy Scanlin, M.S.
As we began the third year of the current administration many wondered what priorities FDA would have in 2019. Without question, one of the most urgent became the challenge of identifying the cause of vaping illnesses and deaths that continue to confound the Centers for Tobacco Products. Thankfully as of this writing an initial window into a possible cause has been opened and certainly, this is an unfortunate reminder of the multitude of challenges that plague the safety of all our FDA regulated industries. With increasing globalization comes increasing demands on vigilance – placed on all of us – no matter our role, to ensure the products we produce, the methods by which they are sourced, manufactured, packaged, held and transported is done so with a laser focus on regulatory compliance. The adage of “if you see something, say something” is as crucial here as it is in any industry. We all have a role to support FDA’s commitment to safety.
The medical device industry is surely pleased with FDA’s focus on streamlining the incredible burden of bringing new products to market, particularly those that are predicated on earlier products or those that have similar safety and performance. Numerous guidance documents and draft guidance documents were released in 2019 which facilitate more innovation, strengthen security of connected devices, better define appropriate labeling and more. We look forward to the evolution of this industry and playing a supportive role as manufacturers streamline their own processes to work within FDA’s new mechanisms. To that end, EAS added a number of new regulatory consultants with medical device expertise this year who take clients through the process of clinical trials to commercialization to include operational readiness and audit preparation. We are very pleased with our medical device team and hope that if you are not already partnered with EAS as your regulatory consultant you will reach out to Bryan Coleman to learn more about our capabilities.
As you might expect, FDA released a number of food safety guidance documents this year. As the bulk of FSMA compliance dates are behind us with upcoming dates focusing primarily on smaller firms and farms, FDA is moving to an enforcement-based approach of safety. While the industry saw an increased number of recalls, in many cases those recalls were not preemptive, indicating a need to further strengthen our commitment to FSMA’s focus on prevention. Our Team FSMA, led by Senior Director for Food Consulting Services, Allen Sayler is tasked daily with food safety compliance requirements for both domestic and international clients. EAS consultants spoke at trade shows, conducted webinars and authored numerous articles on FSMA throughout the year. An easy way to access those articles, and many others is on the EAS in the News section of our website.
Of great importance to the pharmaceutical industry this year was FDA’s draft guidance which changes the submission organization that FDA will require going forward for Drug Master Files which house the CMCs for Active Pharmaceutical Ingredients (API) or a finished drug dosage form and maintain confidentiality of sensitive intellectual property, while allowing multiple pharmaceutical companies to collaborate in the development of new products. A timely EAS-hosted discussion of DMFs is scheduled December 13, 2019 when Priya Jambehkar, one of our esteemed consultants working with our pharmaceutical clients, will conduct a web-based training on the DMF process with Q&A time at the end.
While the dietary supplement industry did not receive new guidance documents this year, the Agency still had its hands full with enforcement of GMPs, as well as labeling and claims for products. Independent Advisor for Quality and Compliance Robert Fish conducted a very successful and very informative webinar on the subject in November, (found on the EAS On-Demand Webinars page) which discussed some of the more common Agency findings as well as information on strengthening manufacturing compliance. Did you know that some aspects of FSMA also apply to dietary supplements as they are a category of Food? If not, or you would like more information on compliance please join our webinar on the subject December 4, 2020.
As the year 2020 comes into focus, know that we at EAS are staying vigilant in our review and analysis of FDA requirements. Our consultants offer the proactive regulatory solutions in the best interests of EAS clients and we look forward to continuing to serve you and the industry in the coming year.
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 As Safe. 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.
REMINDER: we are at the end of the renewal period (1 Oct – 31 Dec) for medical device & drug establishment registrations, as well as drug listing certifications. Please factor holiday schedules as well as the potential of a U.S. government shutdown into your renewal timing.
EAS would like to bring to our clients’ attention, the FDA Announcement regarding a Phishing scam fraudulently using the FDA name. The current known scam is directed at food companies. We remind you to stay ever vigilant. If you receive something claiming to be from the FDA that does not come from an fda.hhs.gov domain, we advise you to immediately alert your IT department and permanently delete the communication. Never click on a link, open an attachment or forward an email from an unknown source.
On 22 Nov 2019, the FDA published the most recent batch of Product-Specific Guidances for Generic Drug Development. The batch of 105 PSGs is made up of 64 complex products; 45 products with no currently approved ANDAs, 26 of which are complex products; 78 revised PSGs; and 27 new PSGs including 5 for non-complex New Chemical Entity products and 1 for a complex NCE. While most of the revisions to this batch of PSGs are minor or editorial in nature, the FDA makes them available for feedback via comments. Please see the website for more specific information.
Guidance Document updates on the FDA website
- Transdermal and Topical Delivery Systems – Product Development and Quality Considerations This guidance provides recommendations to applicants and manufacturers of transdermal and topical delivery systems (TDS) regarding the pharmaceutical development and quality information to include in new drug applications (NDAs) and abbreviated new drug applications (ANDAs)
- Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention The purpose of this guidance is to assist sponsors in the clinical development of drugs for treatment or prevention of smallpox (variola virus) infection.
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 This guidance provides stakeholders information regarding FDA’s implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) under Title III of the FDA Reauthorization Act of 2017. Because GDUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.
- Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of chronic hepatitis D virus (HDV) infection.
CDER & CBER
- Electronic Submission of IND Safety Reports Technical Conformance Guide This document represents the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this topic.
- Providing regulatory Submissions in Electronic Format: IND Safety ReportsThis draft guidance describes the electronic format sponsors will be required to use when they electronically submit to the Food and Drug Administration (FDA or Agency) investigational new drug application (IND) safety reports for serious and unexpected suspected adverse reactions that are required under 21 CFR 312.32(c)(1)(i).
CDRH & CBER
- Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices This guidance describes the information that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), in collaboration with the Office of Regulatory Affairs (ORA), will provide to a person whose request for a CFG for a device is denied, and the process for seeking review of such a denial.
- Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff Draft for comment purposes only
- #256 Compounding Animal Drugs from Bulk Drug Substances This draft guidance is intended for veterinarians, State-licensed pharmacies, and Federal facilities interested in compounding animal drugs from bulk drug substances for use in nonfood-producing animals or for use as antidotes in food-producing animals under limited circumstances when no other medically appropriate treatment options exist.