Drug and Device Corner 2018 October

The FDA has announced their FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA, please follow link for full information.

Please see the FDA webpage for updates on valsartan recalls.

Guidance Document updates on the FDA website:

All centers:





Remember to keep up with CDER Product – Specific Guidances for Generic Drug Development. October had 2 new guidances and 23 revisions.

Meet Issue of the Month Author

Bryan Armentrout is an expert in dairy, quality, system development, Safe Quality Foods, (SQF), Hazard Analysis and Critical Control Points (HACCP), design control, auditing, troubleshooting, recall, and crisis management, and process improvement. Prior to consulting he was the Vice President of Quality Assurance and Food Safety with Boulder Brands and the Vice President of Quality Assurance and Food Safety at CSC Sugar, LLC. He has a history of benchmarked success leading companies to more efficient and compliant processes.

EAS Leads Efforts of Regulatory Compliance Training

Dear Readers,

Edward A. SteeleWelcome to the November edition of EAS-e-News, the free newsletter for industries regulated by FDA.

I am pleased to say that our three October webinars, on Responsibilities of Own-Label Distributors, Preparing for Tobacco TPMPs and Problems with Data Integrity are now available on-demand on the EAS website. These webinars, as well as all of our regulatory webinars, are a great opportunity to dig into a particular topic and do so in under an hour. Feel free to peruse our current offerings and join us for one of our newly scheduled webinars:

  • Declaring Dietary Fiber in Nutrition Information (presented along with FDA for IFT)
  • Foreign Supplier Verification and How to Protect Your Business (presented for NCBFAA)

Learn more in the EAS-in-Action section of this issue.

We have just announced our Spring compliance seminars which will take place in Philadelphia, PA. Food Labeling will take place March 12-13; Dietary Supplement Labeling will take place March 14-15 and Dietary Supplement GMP will take place April 2-3. With FDA’s new requirements for food and dietary supplement labels including fiber, there have been many questions on how to comply. Additionally, FDA’s continued enforcement of GMPs requires hyper-vigilance by industry. We hope you’ll join us!

We welcome two new consultants and a new regulatory intern from Georgetown University. Welcome to consultants Charlotte Peyton who is an expert on cannabis GMPs and Steven Kurtz, an expert in dairy. In addition, our new regulatory intern Neha Mookuparambil is completing an M.S. in Biotechnology.

EAS just completed a major office expansion and redesign which includes photographs of our hometown, historic “Old Town” Alexandria, VA, taken by award-winning photographer, Carol Jean Stalun. I invite you to learn more about Ms. Stalun in this issue as well as stop by our newly redesigned offices whenever you are in the D.C. area.

As FDA is increasing its numbers of FSMA and FSVP inspections as well as issuing warning letters and 483s, we focus our attention on the subject of FSMA in our Issue of the Month, written by Bryan Armentrout who discusses common pitfalls when choosing new testing methods; Ask the Expert on how to respond to food recalls under FSMA; as well as our FSMA Perspective, where Charles Breen shares more information on FDA’s decision to release retailer information in some circumstances during a food recall. The industry is certainly a-buzz now that the effective date of the new FSMA rules has passed, (minus some very small businesses), and firms are assessing which rules apply to them and how to comply. If EAS can help with your FSMA readiness please feel free to reach out me.

I am very pleased to announce that EAS President and COO Dean Cirotta was an invited speaker to the United Nations, speaking to the SIDS DOCK IWON on EAS regulatory capabilities. Dean was accompanied to the UN by Tara Lin Couch, Ph.D., Senior Director of Dietary Supplement and Tobacco Services and Heather Fairman, EAS Independent Consultant and SIDS DOCK IWON Advisor and Technical Coordinator and Lisa Cirotta, who assists in EAS accounting department. If you have not already read our press release, it is included in this issue for your information.

Thank you as always for choosing to subscribe to EAS-e-News. We invite any comments that you may have and feel free to share this issue with colleagues.



EAS to Exhibit, Present at SupplySide West in Las Vegas

EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., Independent Consultant Heather Fairman and President and COO, Dean Cirotta will represent EAS at the upcoming Supplyside West show November 6-10, 2018 in Las Vegas. You may find EAS at booth #5641. EAS is also well represented in the SupplySide West technical sessions as Tara will discuss Effectively Partnering with a Contract Laboratory as part of a panel on Wednesday, November 7 from 1:30–4:30 pm; and Tara and Heather together will present on Contract Manufacturing scheduled for Saturday, November 10 from 8:30 am–11:30 am. In addition, President and COO, Dean Cirotta will moderate a panel as part of the 7thannual AHPA Botanical Congress in Cooperation with ABC on how 21 CFR 111 applies to the Dietary Supplement industry.

EAS to Present Two Sessions at Food Safety Consortium

EAS will be presenting two sessions at the upcoming Food Safety Tech’s Food Safety Consortium taking place November 13-15, 2018 in Schaumburg, IL. Independent Consultant Andrea Yablunoksy will present on Recall Readiness: Understanding Requirements, Similarities & Differences in a USDA and FDA Program and Kathy Knutson, Ph.D. will discuss Lessons Learned in Food Safety and Applied to Cannabis-infused Edibles as part of the Cannabis Quality track. Both presentations take place on November 15th.

How to Prioritize Planning for Food Safety Emergencies

By Charles Breen

Charles Breen

This month’s Ask the Expert is on how to prioritize planning for food safety emergencies, particularly in light of the challenges of not only the emergency itself but recovering from it with your company’s reputation intact. It is answered by Charles Breen, EAS Independent Advisor for FSMA and Stacey Stevens, a Senior Vice President at FoodMinds, a division of Padilla. FoodMinds is EAS’ newest cooperative partner, and together our services help our clients working in the food industry to tackle regulatory and public relations challenges.

Question: As part of FSMA I am working to develop our company’s food safety contingency plans. How do I prioritize and plan for the first steps we need to take – investigations, recall communications and managing our public relations?

Answer: Great question and one worthy for all companies to consider, especially, as you point out on the regulatory side, FSMA mandates include both a hazard analysis risk assessment and if hazards in need of control exist, a recall plan. In addition, every company strives to mitigate harm to its reputation in the face of public scrutiny. So, how does one go about developing a comprehensive plan and assigning tasks on both sides of the coin? First, on the safety front:

In the interest of public safety, whenever a food safety issue has been reported, whether by FDA, another food safety authority or the public, unless you can unequivocally rule out your product as the culprit, initiate a recall. While the FDA and other food safety authorities could be wrong, they very rarely are. This will help to limit further harm, particularly in the case of Class 1 recalls which have a high likelihood of injury or death. Make sure management, as well as legal representatives, are informed of the decision to recall.

Next, per regulation, file a Reportable Food Registry report on FDA’s website. This must be completed within 24 hours of learning of the problem. It’s OK to have incomplete information to start, you must update the file as more information becomes available.

Keep good records and implement your Trace Back and Trace Forward action plan – match ingredients and sources with bills of lading so that you can attempt to identify the source of the problem. Establish the last documented evidence before the problem arose, the time the problem became known, and documentation that it was controlled. You’ll also need to identify recipients of the product and alert them directly. If those recipients cannot be accurately identified, the recall will grow exponentially larger, more expensive, and harder to manage.

Next, on the communications front, remember to take control of the messaging and communicate early and often. The public will want to know what you are doing to protect them now and how you will do things differently in the future. Be empathetic, forthcoming, and express an understanding of the seriousness of the situation. Don’t forget social and on-line media, websites and microsites – post brief updates in real time to keep everyone informed from line employees to key stakeholders and consumers.

In many cases, companies involved in a food safety emergency will enlist the assistance of qualified and experienced third-party consultants to help them through the crucial regulatory and safety steps as well as strategic public relations messaging.

Meet New EAS Intern, Neha Mookuparambil

EAS is very pleased to welcome our new intern from Georgetown University, Neha Mookuparambil, who is completing an M.S. in Biotechnology.  Her career interests include the fields of Drug Regulatory Affairs, Clinical Research, and Biopharmaceutical Business Development. Prior to Georgetown, she completed a PharmD degree at the Bharati Vidyapeeth University in Pune, India.  She has worked as a healthcare blogger and intern clinical pharmacist at the Bharati Hospital and Research Centre. 

Overcoming Seafood Fraud – a Free EAS Webinar Presented by Tim Hansen

Seafood is largely accepted based on how it is labeled or listed on a menu. This is true for seafood wholesalers, distributors as well as retailers. The financial incentive for unethical practices is huge but measures can be adopted by processors, wholesalers, and retailers to protect product identity and integrity. Join EAS Independent Consultant, and former head of NOAA Fisheries, Tim Hansen, for a discussion on various types of fraudulent activity in the seafood industry including where and why fraud can occur in the supply chain. He’ll discuss how seafood operators, buyers, and consumers can protect themselves as well as regulatory issues and possibly short, medium and long-term solutions.

Join Tim on December 5, 2018, at 1:00 pm Eastern for his discussion. Reserve your seat today!

EAS to Offer Five Part Webinar Series Looking at OTC Monograph Regulations

Join EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, as she explores the history of OTC Monographs, why reforms are necessary and being undertaken now, and how OTC drug companies can expect those changes to impact their labels in the future in a five-part series starting January 16, 2019.

Part 1 of the series, OTC Drug Monographs, Past, Present, and Future will discuss what a Monograph is and how it is used. She’ll dive into reading and interpreting the different sections of the monograph and discuss what the future might hold as Congress considers changes to the system. Join Susan on January 16, 2019, at 1:00 pm Eastern for part 1.

Later sessions will include topics such as what makes a drug an OTC and the Monographs Compliance System; OTC Labeling requirements and Drug listings responsibilities; Understanding the FDA and FTC Labeling and Claim Requirements for Cosmetic products, Homeopathic products in the OTC market; as well as OTC Drugs and Your GMP Obligations – Understanding how the GMPs are Applied and Preparation for FDA Inspection.

FDA Proposes Releasing Retailer Names in Most Serious Recalls

Charles BreenBy Charles Breen, Independent Advisor for FSMA

In an effort at greater transparency as well as consumer safety, FDA issued Draft Guidance this month proposing how and when FDA would publicize the identities of retail consignees that may have received recalled human or animal foods. This release of retailer information would only occur in cases where a food recall presents a serious adverse health consequence or death to humans or animals (SAHCODA), i.e., Class I recalls. The intention is to provide information to consumers to take a closer look at their purchases should they recognize that they shop at a particular location.

There is typically no single source that FDA can access to readily obtain a list of retail consignees of a recalled food product, therefore the decision to list retail consignees requires information obtained from multiple entities throughout a supply chain, including the recalling firm and its intermediate distributors – no small task. In addition, FDA may not be able to fully verify the accuracy or completeness of the information it receives from recalling firms or distributors so its available information may be over and under-inclusive In other words, FDA may not identify every retailer who received recalled product, and might inadvertently identify retailers who, in fact, did not receive the recalled item.

Currently, FDA routinely provides labeling information, product descriptions, lot numbers, and photographs, and if available to FDA – geographic or retail-related distribution information. It also lists all FDA-regulated recalls in the FDA Enforcement Report.

As noted in the Draft Guidance, the release of retailer information is authorized under Section 206 of the 2011 FDA Food Safety Modernization Act, ‘which directs the Agency, in conducting recalls under the section to “consult the policies of the Department of Agriculture regarding providing to the public a list of retail consignees receiving products involved in a Class I recall and shall consider providing such a list to the public,” when FDA considers the release to be appropriate (21 U.S.C. § 350l(g)(2)). The Department of Agriculture (USDA) policy is to make publicly available the names and locations of retail consignees of recalled meat or poultry products that USDA compiles in connection with a recall where there is a reasonable probability that the use of the product could cause serious adverse health consequences or death (Class I recalls). 9 CFR 390.10.’

FDA will consider two specific criteria that may warrant the release of retail consignee information, including when a recalled food is related to a foodborne illness outbreak, and where the information would be most useful to consumers. Examples of such foods are fruits, nuts, vegetables, and rawhide chews sold in bulk bins with no UPC or barcode, raw meat or deli products, or when the food product lacks a lot number, or other identifiers, which consumers can use to readily identify the product as one being recalled.

While there is some understandable concern regarding the publication of consignees and suppliers due to possible disclosure of confidential information, the Agency assures all that it will consider carefully the release of any additional retailer information, weighing risks to consumer health and safety. While FSMA has many facets that aim to proactively improve our food safety, no system is completely fool-proof. In cases where FDA and food manufacturer efforts at preventive controls fail, the additional release, as necessary of retailer information included in a recall will help to ensure the public has a greater awareness of contamination and can avoid the consumption of such products.

Meet New EAS Consultants

Charlotte Peyton has 30 years of industry experience in analytical chemistry working under FDA, EPA and Colorado Marijuana Enforcement Division regulations. She has been a bench chemist, method development chemist and overseen quality management. She has extensive laboratory experience as well as experience with stability programs, cleaning validations, process validations, and SOPs.

Steven Kurtz supports EAS dairy clients with the interpretation of regulations and development of policies to maintain compliance with FDA, USDA and state requirements. He has an in-depth understanding of dairy equipment and processes including NCIMS, 3-A Sanitary Standards.

EAS Consultants Present FSVP Webinar for NCBFAA

EAS Independent Advisor for FSMA, Charles Breen and EAS Independent Consultant, Bryan Armentrout are presenting a webinar focusing on FSVP requirements for the National Customs Brokers and Forwarders Association, NCBFAA.  Titled “Foreign Supplier Verification and How to Protect Your Business”the webinar is open to members and non-members of NCBFAA and will take place November 8, 2018, from 12-1 pm Eastern.

FDA’s recently increased inspections of importers to evaluate their compliance with FSVP requirements is a reflection of FDA’s commitment to making FSVP work. FDA inspections are also revealing that a significant number of importers do not understand what is needed to comply nor how. Customs brokers and freight forwarders, if not importers themselves, can help clients know what FDA is looking for, and who can assist them. Learn actionable steps and protect not just your food, but your business as well.  The cost of registration is $50.00 for members of NCBFAA and for non-members, $75.00.  For more information or to register, visit the NCBFAA registration page.

Four Common Mistakes When Selecting a Rapid Method for Environmental Testing

By Bryan Armentrout

We are now firmly in the era of the Food Safety Modernization Act. It’s no longer theoretical, it’s real world, and FDA is auditing and asking questions about what they are seeing.

I think we can all agree on one thing. The way we looked at environmental pathogen testing in the past is out the window. Gone are the days of testing the same 10 sites every few months for generic Listeria and calling it good. Sometimes, you would get a hit and do an investigation, but that was the extent of the excitement.

You now need a robust program that looks at multiple pathogens and takes them all the way out to speciation. Some companies are even going further and developing a “microbiological map” of their processing areas. The technology is overwhelming, but one factor is still critical, and that’s time.

No one has the time to put all their product on hold while waiting for five days to a week for results. Of course, that assumes that nothing comes back as a presumptive positive. If it does, you can wait a few days longer while logistics breathes down your neck, and customers have empty shelves. What to do?

You need a new program to test for your environmental pathogens. But, how do you choose? Instead of evaluating the ever-changing landscape of tests available, it might be more useful to list four rules you need to follow for your decision-making process. This is an expensive decision, so make the right one as you are going to be living with it for a long time.

You need a fast turnaround, and in most cases, that means you are now considering something that wasn’t even possible in the past -testing samples and releasing in-house. The first step is to get out there and see the amazing new micro testing world that is at your fingertips.

  1. Don’t get sold by a fancy presentation You begin your journey by attending a trade show and marveling at the technology available. You strike up a conversation with a salesperson and after ten minutes, you are convinced that this new whiz-bang machine is the wave of the future. If you place your order today, you can get a huge discount and get one of the few machines that are even available. You can also add in a low monthly payment program. It does everything you want, and more in an hour and costs pennies to operate. It’s amazing, and you are in love. Not so fast, partner. It’s just like when you buy a car. The salesman at the dealership does everything to move you toward a purchase. How? By using your emotions. People buy on emotion and use logic to rationalize their decision after the fact. The thing the salesman wants you to forget is that this is a commodity and another similar model is available just down the street. Remember, any attempt to pressure you into a purchase should be met with a knowing smile. The deal they quote is not a once in a lifetime opportunity, and it will be there once you have time to make a decision in the calm light of rational thought. Be cool, try to find a technical representative of the company to talk with in addition to the sales or marketing staff. Remember it’s a piece of equipment, and one that is equally as good or even better is just around the corner. Add this piece of equipment to your list of possible testing methods and move on down the trade show to the next one.
  2. Not using a validated methodology This goes with the first point. You need a method and technology that are approved for your application. It needs to be benchmarked back to reference methodologies. Has it been used on your product matrix? Peanut butter will likely react very differently to the test than yogurt. Everything on your list needs to clear these hurdles before you even consider it. Don’t accept “the approval will happen in two weeks” line or something similar. You are in control of the validation and benchmarking process and must have a test and equipment that hold up to regulatory scrutiny. Ask the following questions as you look at the candidates:
    1. Has it been validated for my product matrix by one of the following?
      • A recognized independent organization such as AOAC, AFNOR, MicroVal or
      • A US regulatory body (FSIS MLG, FDA BAM or an ISO Method?
    2. Is the method?
      • Fit for the purpose and application
      • Performed under validated conditions by a lab that assures the quality of analytical results These questions come from the USDA Food Safety Inspection Service. They have compiled a list of validated methods that you can use as a starting point. It’s forty-six pages long! Cross off any candidates that didn’t make your list, realizing that FDA utilizes the BAM as their reference for acceptable analytical methods.
  3. Not testing in-house before you buy Never, ever buy a new testing method without trying it out first – for a long period of time. Any reputable company will have a loaner machine you can use. If they balk, cross them off the list and move on. Decide if you can test as a group or one at a time. This is a question of resources and how many people can do what. Don’t use the results for actual product release. Keep that the same as you are doing now. Another good idea is to test at the point of use in the plants. Don’t test at the corporate lab. You lose too many variables that need to be accounted for at the plant. Test it with every permutation you can think of. Analyze enough samples so you can make sure the results are repeatable. Find out the limits of detection for your product. What are the false positive and false negative rates? What is the turnaround time for results? See if your technicians can screw up the test. Make your test as foolproof as you can. Also ask yourself: Can you get test supplies in a reasonable period of time? What is the minimum order quantity? What is the breakpoint for discounts? Are your supplies expiring before you can use them? Are there other uses for this equipment? This list is not inclusive by any stretch; its a starting point. Create the list and stick to it. Don’t change it as you go along as it will bias the results toward the newest test. Be consistent. Remember, you may need to defend the test results in court one day. This is the litmus test for acceptance that you must always keep in mind in the age of FSMA. Send back any that don’t make the cut and cross them off the list.
  4. Not researching the company Great! Your list is down to the top two testing methods. They are both reliable and repeatable, have fast turnaround time, dependability and a decent cost per test. How do you decide now? The test is only as good as the company supporting it. If they are new to the scene, will they be here in five years? Will they come up with a new test and abandon the old one, leaving you with an expensive paperweight? Do they have references you can talk to? Can you talk to references who have had challenges with the test? Are they willing to work with you on price? Can you get other perks such as free service calls? How will they support you and the warranty? Just like the test, you need a huge list of questions to hit them with.

Final Thoughts

Congratulations! This was a big decision, but you made the right one for you. The method and the test you selected are the cornerstones of your new environmental testing program. You are finding out where pathogens hide in your plant and eradicating them. You have a clear record of identification and correction that any auditor will be happy to review. You sleep easy at night knowing that you made the right decision, and you have the ability to defend it if you need to.

Be proud of your work and welcome to the new age of FSMA!

Reference: FSIS List of Foodborne Pathogen Test Kits Validated by independent Organizations

Crozier-Dodson Article on Pathogen Control in Poultry Processing Published in Meating Place

Beth Crozier-Dodson published an article in Meating Place discussing top tips for proactive pathogen control in poultry processing. “One of the most significant aspects of any poultry food safety plan is the implementation of pathogen control measures at each critical control point identified in the processing plant. Those who do this in a proactive manner will be able to reduce the risk of microbial contamination that could prompt a costly recall.”

EAS and FDA Present Webinar on New Dietary Fiber Regulations for IFT

EAS Independent Consultant and labeling expert, James Hoadley, Ph.D. will present a webinar focusing on Declaring Dietary Fiber in Nutrition Information along with Douglas Balentine, Ph.D., Director, Office of Nutrition and Food Labeling, and Sarah Gebauer, Ph.D., Nutritionist at the Center for Food Safety and Applied Nutrition, FDA. The webinar will take place on December 6, 2018, at 9:00 AM – 10:00 AM CT and will be hosted by the Institute for Food Technologists (IFT).

FDA’s release of two Guidance documents in 2018 on labeling of dietary fiber, as well as the prior publication of a scientific review of non-digestible carbohydrates being evaluated for the physiological benefit, have created a need for clarification of these guidance documents to solve industry confusion. Most of the fiber ingredients currently used by industry and declared on labels as fiber have been acknowledged as fiber either by regulation or by enforcement discretion, but what next?  FDA, EAS, and IFT will join forces to discuss the policy on labeling dietary fiber and unravel challenges facing the food industry as it considers the path forward. The webinar is free for IFT members, non-members may register for $20. Join us!

Photos of Old Town Alexandria Put Final Touch on EAS Office Expansion

EAS Headquarters has just undergone a renovation to add additional space to its headquarter offices in the heart of Old Town Alexandria. Included in the buildout is more office space to accommodate expanding staff and the inclusions of a larger conference and training room equipped with state of art audio visual equipment. EAS now has the facility to hold in-house training course and to conduct video training programs and conferences with clients throughout the world. The office is conveniently located across from the King Street Metro Station within minutes of Reagan Airport and downtown Washington.

The corridors are lined with photographs taken of historic Old Town Alexandria by a local award-winning photographer, Carol Jean Stalun. Ms. Stalun was recently invited to the office to view her work and to thank her for her contribution to the appearance of our new headquarters. Her photographs can be viewed at https://www.caroljeanstalun.com/.

We welcome all of you to visit us whenever you are in the area. We would be happy to show off our updated space and to meet you in person.


Being a Third-Eye in a Plant with a Problem – Discussions on Listeria and Salmonella Protection in Food Safety Magazine

Carl Custer wrote about the challenges of Listeria, Salmonella, extraneous materials and worse in an article published in Food Safety Magazine. Carl also shared some of his experiences at problem-solving both while at FSIS and working with clients as a consultant, observing plant practices as “third-eye” in order to solve food safety problems.

Food and Dietary Supplement Labeling and Dietary Supplement GMP Compliance Seminars Coming to Philly

We have just scheduled our spring compliance seminars for Philadelphia, PA. Join us March 12-13 for the Food Labeling Compliance Seminar; March 14-15 for the Dietary Supplement Labeling Compliance Seminar and April 2-3 for the Dietary Supplement GMP Compliance Seminar. These are great opportunities to learn the new details of FDA labeling requirements as well as how to comply with GMP provisions for dietary supplements. Early-bird discounts apply as do multiple employees from the same company. Visit our registration pages to learn more.

Medical Device Regulatory Landscape Discussed in Post AdvaMed MedTech Wrap Up

Senior Director for Pharmaceuticals and Medical Devices, Bryan J. Coleman discussed innovations and the regulatory landscape in an AdvaMed MedTech blog. Bryan shared his thoughts as FDA continues to harmonize and leverage existing regulatory approaches in increasingly more creative ways that allow the industry to grow and flex along with innovation. Still based in sound science and documented evidence, FDA expects sponsor and contract manufacturers to tighten controls over raw materials and component quality equal to internal design and production. Now more than ever companies must plan and prepare for meeting quality requirements and ensure quality measures are weaving design, supporting technologies, supply chain and feedback mechanisms into one cohesive program.