By Amy Scanlin, M.S.
As we reflect on 2018, we are again honored that so many look to EAS as their regulatory solution to a complicated world of FDA requirements. FDA’s continued focus on safety as well as the industry’s embrace of regulations that often challenge their old methods of doing business can only mean continued improvements and communications in the name of public health. In 2018, the Food Safety Modernization Act (FSMA) again dominated the news as numerous compliance dates arrived. We received questions from all over the world, particularly on issues pertaining to the Foreign Supplier Verification Program (FSVP). As of June 1, 2018, FDA had completed 256 inspections of foreign firms resulting in the issuance of 483s. Based on that, one of the primary concerns our callers have is understanding what constitutes an FSVP in FDA’s eyes and whether their documentation or documentation they were in the process of preparing, would qualify as compliant. Questions on what is a Qualified Individual and how EAS can assist in that regard with foreign suppliers are also a concern.
Our Independent Advisor for FSMA, Charles Breen, stayed busy preparing updates on FSMA compliance as part of our EAS-e-News monthly column “FSMA Perspective” and he, as well as all of our consultants who work in Foods, collaborated on numerous webinars and articles helping the industry to gain a greater understanding of FDA expectations. We even conducted our first webinar in Spanish presented by Gustavo Gonzalez, Ph.D., “FSVP – What Does it Mean for Your Business?” which is available on-demand free of charge on the EAS website. More recently, Charles presented a webinar on FSVP for the National Customs Brokers and Forwarders Association of America.
It wasn’t just FSMA that got industry’s attention. New labeling regulations for food and dietary supplements have kept food and supplement manufacturers busy. From sugars to fibers to new requirements of what and how to include nutritional information, our Food Labeling and Dietary Supplement Labeling seminars have been very well attended. (Our spring series is scheduled for Philadelphia and hyperlinks here point to registration information should you be interested in joining us). In addition, EAS published articles on the subject and is pleased to be in the final preparation stages for a webinar on December 6th where James Hoadley, Ph.D. one of our expert labeling consultants and trainers will discuss the new dietary fiber regulations with two members of FDA’s CFSAN for the Institute for Food Technologists. These labeling issues are requiring firms to rethink how products are not only labeled but marketed and our Product Development and Labeling team is enjoying the challenge of helping firms navigate new requirements as they find solutions that meet both business and FDA expectations.
The dietary supplement industry continues to be challenged by GMPs dictated in 21 CFR 111 as evidenced by 2018 statistics indicating the top observations issued are still Specifications and Testing, Master Manufacturing Records and Batch Production Records, Quality Unit Responsibilities, and Complaints; the same as they have been since 2010 when the 21 CFR 111 regulations applied to all sizes of dietary supplement firms. Following is a graph prepared by the Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., which summarizes the posted FDA statistics through 2017 and clearly illustrates this never-ending trend. If there is one bright spot, it is that the percentage of firms getting an Official Action Indicated (OAI) or Voluntary Action Indicated (VAI) is down to 54%. It has been significantly higher in previous years.
TOP FDA Observations: 2010 - 2017
|Rank||Citation||Description||Number of Times Cited|
|1||21 CFR 111.75||Testing||54||111||226||287||188||144||195||216||1421|
|2||21 CFR 111.70||Specifications||32||104||176||234||204||154||214||251||1369|
|3||21 CFR 111.205||MMRs||28||53||94||117||82||67||87||94||622|
|4||21 CFR 111.255||BPRs||18||52||74||93||71||71||72||87||538|
|5||21 CFR 111.103||QU Operations||18||43||47||66||47||45||55||76||397|
|6||21 CFR 111.553||Product Complaints||15||34||42||70||36||28||31||63||319|
|7||21 CFR 111.453||Holding & Distribrution||6||18||29||47||32||27||30||46||235|
In medical devices, FDA’s decision to expand the use of the De Novo submission pathway was welcomed by industry. De Novo applications are appropriate in cases where it appears that the device meets the statutory standards for classification into Class I or Class II under section 513(a)(1) of the FD&C Act, and when the sponsor has determined that the device does not fall within any existing classification regulation. EAS authored an article for MedTech Intelligence on the subject.
EAS expanded its services into the area of cannabis GMPs in 2018. This newly evolving industry, regulated by some states as a food, others a dietary supplement and in some cases as a pharmaceutical, is challenged in many regards with how to set up, validate and verify a quality system. Quality is one of EAS’ many strong capabilities and our team of consultants is rising to the challenge of assisting this newer industry. Tara Couch presented a webinar “Quality Systems for the Cannabis Industry” and for the first time, we incorporated cannabis applicability into our two-day dietary supplement GMP seminar for a special presentation. We were also frequent contributors to the Cannabis Industry Journal including Gabe Miller who authored an article on Food Safety in the cannabis industry and Celia Schebella who discussed designing cannabis edibles in the state of California.
As we look ahead to 2019 there are a few notable things on the horizon that EAS consultants are watching for:
On the Tobacco front, the Center for Tobacco Products’ director Mitch Zeller, announced at the annual Tobacco Merchants Association (TMA) meeting that the agency is actively working on developing its own set of GMP protocols for the tobacco industry, called Tobacco Product Manufacturing Practices (TPMPs). In an effort to help tobacco firms begin forward thinking in these terms, EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. and President and COO, Dean Cirotta presented a webinar in partnership with TMA (now available on-demand) on how to prepare for these TPMPs based on the long-standing GMPs for the dietary supplement industry.
In addition, OTC Monograph reforms have been underway for some time and it is anticipated that 2019 will bring these new requirements to light. Independent Consultant Norma Skolnik prepared an article for EAS-e-News on expectations earlier in the year and EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, will present a five-part webinar series on the subject starting January 16. She’ll discuss why these reforms are necessary, are being undertaken now, and how OTC drug companies can expect those changes to impact their labels.
In the Dairy world, FDA has fast-tracked a review of how the words “milk” and “cheese” are used in dairy substitutes. The Dairy industry is also anticipating enforcement of the new Appendix T of the PMO which will implement FSMA-like requirements aimed at preventive measures to improve safety. More information on both of these as they unfold.
On the home office front, the EAS staff was very pleased when the extensive expansion and renovation of our office space was complete, and we think it looks great! This new area enables EAS training hosted in the DC area to move in-house and offers enhanced meeting capabilities, both in-person and remote. If you are in the D.C. area, we invite you to come by! In addition, we completed a major redesign of our website, found at easconsultinggroup.com. We hope you’ll agree that this new digital space is not only improved in appearance but provides easier access to not only information about EAS services and seminars, but also regulatory information prepared by our independent consultants and distributed through a variety of professional trade journals and organizations.
We also welcomed 24 new consultants, re-welcomed three consultants who returned to EAS after a stint in the industry and brought on a new office manager, Jodi Burns. EAS is only as strong as our professional network of skilled and knowledgeable consultants, directors and support staff. We feel we have some of the best in the business!
If it seems like EAS consultants have a wide-reach of educational support, you are right. All told EAS presented 13 two-day public seminars, will have conducted 19 webinars by the end of 2018; published 40 articles, and spoke or moderated at 25 industry events such as IFT, Food Safety Consortium, Supplyside West and a variety of FDLI-hosted events. We also exhibited at important trade shows such as IFT, Supplyside West, Food Defense Conference, IAFP and others.
One trade show event, nearest and dearest to our hearts was the 2018 AdvaMed MedTech Intelligence conference in Philadelphia where Ryan Steele, granddaughter of Chairman and CEO of Ed Steele, and daughter of CFO Brett Steele, was an invited speaker on the main stage sharing her story as just one many who has been positively impacted by the innovation of science and technology, in Ryan’s case with the implantation of a vertical expandable prosthetic titanium rib, which is the only FDA approved device to treat thoracic insufficiency syndrome.
It is stories such as hers that brings home why we all do what we do, designing products that fill a need and a niche and do so safely and effectively. While FDA regulations may feel cumbersome at times, it is those instances, where important decisions with critical outcomes are in front of us, that we can all appreciate FDA’s diligent focus on ensuring only compliant products are available to the US consumer. Here at EAS, we support firms working in all FDA regulated commodities to do just that and we take great pride in our ability to meet their needs.
Thank you for journeying with us in 2018 and we look forward to a peaceful and prosperous 2019. Have a very happy holiday and New Year!