Independent Consultant and infant formula expert, Robbie Burns, Ph.D., published an article in Natural Products Insider on regulatory considerations for the development of infant formula for sale in the U.S. In addition to this article you may wish to view the video and review more on infant formula regulatory challenges in our recent webinar, now available on-demand.
EAS Independent Advisor for FSMA, Charles Breen and Consultant Kathy Knutson, Ph.D. will co-present a webinar on Food Defense on September 12, 2019 at 1pm eastern. Food Defense is increasingly a worry for firms as our global business climate opens opportunities for intentional harm both domestically and overseas. The ability of food manufacturers to identify and mitigate the impact of intentional attacks that compromise food safety is not only required as part of the Food Safety Modernization Act (FSMA) it makes good business sense to protect consumer health and brand reputation. Join Charles and Kathy for this complimentary webinar by registering here. [add hyperlink]
EAS Independent Consultant and Toxicologist, Tom Jonaitis will be joined by Independent Advisor for Color Additive Safety, Robert Martin, Senior Director for Food Consulting Services, Allen Sayler, and Director of Labeling and Cosmetics, Cathryn Sacra for a discussion on the challenges and pitfalls of successful GRAS submissions. GRAS, or Generally Recognized as Safe, is a designation granted by FDA for food ingredients. It can take years of safety studies and thorough documentation before a GRAS designation is warranted so understanding the requirements is essential for streamlining the process.
Join Tom, Robert, Allen and Cathryn on August 29 at 1pm eastern for an informative discussion on GRAS and how you can increase your chances for a successful submission the first time. Register today! [add hyperlink when ready]
EAS Independent Consultant and General Counsel with Herrick Feinstein LLP, Ronald J. Levine, will present a one-day intensive seminar on understanding the requirements and expectations of becoming a strong expert witness. With more and more matters finding their way to the courts, in many cases the expert witness reports and testimony can provide the key pieces of information to make or break a case. Ron will share his expertise and help participants hone their skills on developing reports and testimony as well as how to build their resume. Join Ron in Alexandria, VA on November 6 (register early as seating is limited) or attend the training remotely. More information can be found here.
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, the 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.
Each month EAS answers one question sent in by readers of EASeNews. This month’s question on the risk-base of high-risk foods is answered by EAS Independent Advisor for FSMA, Charles Breen.
Question: How do you determine the Risk-Base of High-Risk Foods?
Breen: With the passage of the Food Safety and Modernization Act in 2011, Congress told FDA to identify high risk foods. FDA had (and continues) to understand the term “high risk” to mean foods that may present hazards, which, if not controlled, are likely to cause illnesses or injury when consumed.
FDA has given high risk food firms priority for inspectional purposes but has never clearly defined what is or is not “high risk.” Many high-risk food facilities are covered by specific rules, such as juice and seafood HACCP, or special programs, such as Domestic and Imported Cheese and Cheese Products, and agency support to States for the Pasteurized Milk Ordinance and Interstate Milk Shippers list.
So, what are High-risk foods? As defined in the Food Safety Modernization Act (FSMA) section 204(d)(2)(A), these include:
- Those in which there is a known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, while taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention (CDC);
- Food with a high likelihood of potential risk for microbiological or chemical contamination or that would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food;
- The point in the manufacturing process of the food where contamination is most likely to occur;
- The likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;
- Foods that result in a likelihood of foodborne illness should it be contaminated, and
- The likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.
In the absence of defined formulas, each of these criteria could be applied qualitatively and to varying degrees to assign high risk or not high risk to facilities. In FDA’s view, this was useful to efficiently respond to new risk-based information. Likewise, it allows for less FDA attention to known high risk foods such as fluid milk that have long history of safe production. But it does not comply with the mandate in section 204(d)(2)(A) of FSMA.
Prior to the Court order to finally publish a list of high-risk firms, inspections could be tailored to meet goals within appropriated and often unpredictable resources. For example, if the goal is to inspect X % of the high-risk inventory in one fiscal year, and resources are cut, the number of facilities classed as high risk could be tweaked to still allow FDA to meet the goal. (Management cliché: Never set a milestone you don’t know you can reach.)
There are negatives to this approach. A few that come to mind include the fact that a facility can never be certain whether or not it is on the high-risk list. The lack of flexibility is frustrating for agency critics and oversight committees due to an inability to hold FDA accountable on a clearly defined, fixed level of accomplishment. Lastly and importantly, it does not comply with FSMA.
FDA recently was mandated to take specific and determined action in creating designation criteria for these high-risk categories and submitting documentation to the Office of the Federal Register for publication. Deadlines include:
- Designation of the list of high-risk foods required by FSMA Section 204(d)(2)(A) by September 8, 2020
- Publication of Proposed Rule for recordkeeping requirements for the designated high-risk foods as required by FSMA Section 204(d)(1) by September 8, 2020, with final rule publication no later than November 7, 2022
- Publication of the list of high-risk foods on the FDA website is required by FSMA Section 204(d)(2)(B) Upon publication of the Final rule in the Federal Register.
Agency critics hope that having a defined list will mean FDA’s attention to high risk foods will drive down the number of illnesses and deaths caused by pathogens. I am less sure there will be a cause and effect relationship between a list and declining harm to consumers.
While there is considerable overlap between factors in the old way FDA used, and the new way FSMA prescribes, the basic assumption has changed. It’s no longer “as many high-risk foods as the budget allows” and is now “every high-risk food no less than every three years.” It will make it more difficult to obfuscate budget shortfalls as easily as was the case before FSMA.
Rebecca Harter assists EAS clients with a variety of food safety, labeling and sensory product development challenges in both human and animal food industries. She is well versed in both FDA and USDA regulations pertaining to including shelf life analysis, product matching, flavor development, thickeners (Hydrocolloids and Starches), managing ingredient density variation in dry blending, freeze-thaw stability, colorants, and spice-extractive conversions. Prior to consulting, Rebecca was the Director of Regulatory, New Products, and Quality at PetAg, Inc.
William (Bill) Scopa has over 30 years at Customs and Border Protection (CBP) at both ports of entry and Headquarters. During his 15 years at the ports, he processed import and export clearance of cargo and passengers. At Headquarters, as a Branch Chief, he led the development of policies and procedures addressing such areas as, intellectual property rights, anti-dumping and countervailing duties, and revenue collections. He spent several years leading CBP’s trade enforcement efforts in targeting evasion such as misclassification and undervaluation. His last position was CBP’s liaison to other government agencies to develop CBP import processing of imports for EPA, FDA, and DEA.
By William (Bill) Scopa
The US Customs and Board Protection (CBP) has varied enforcement responsibilities, including detecting drug smuggling, weapons of mass destruction, and Immigration. Typically, these concerns are not what will cause the importer delays in their cargo shipments. The more common delays, ones where consultants such as EAS with expertise in CBP operations can assist, are due to CBP’s other mission, assigned to it from its inception in 1789 – trade and revenue. Under this mission, CBP has programs such as Antidumping and Countervailing Duties; Import Safety, Intellectual Property Rights; Revenue; Textiles; Trade Agreements; and country of origin marking. All of these have risk to them, and any inconsistencies in paperwork, descriptions, value; and tariff classification are likely to cause delays. It is up to you and/or your Customs broker to be knowledgeable of all requirements.
As an importer, it is your personal responsibility to take “reasonable care” to ensure that you are compliant. As a consultant, we can review or even generate documents based on your data that keeps your company in compliance with the many varied and complex entities that oversee the legality and safety of product entry into the U.S. Generally, “reasonable care” means that you have put in place the proper compliance procedures. CBP has put out excellent informed compliance documents, even one on taking “reasonable care”. Click for CBP Compliance Documents.
Before you import, a few fundamental questions need to be answered. Did you consult these documents? CBP also has a system, Customs Rulings Online Search System (CROSS), where importers request rulings on classification and other matters, and CBP publicizes its response. Click for CROSS. If your facts and circumstance are the same, the ruling can assist you to make the proper entry, or help should your shipment be detained at the border. Understanding how to assess the similarity of products within CROSS is key to compliance.
One important point is to ensure that your broker is knowledgeable about your products, understands program codes associated and has verified that data. Many products can be regulated by other federal agencies, and you and your broker need to know those requirements. Generally, the importer remains liable, even for a broker error. Are you sure that your broker knows which FDA program code to submit? Mistakes will likely cause delays. CBP’s Automated Commercial Environment (ACE) verifies data as well as provides FDA and other agencies visibility into your entries. Are you sure that your broker is provided all the necessary information by you or the manufacturer to submit a proper entry?
CBP also provides programs to help importers increase the level of trust with CBP. Being trusted means benefits such as fewer exams and expedited releases. Did you know that at the land border the delay could be with the trucking company or driver? CBP offers a program for low risk commodities named The Free and Secure Trade (FAST) program Click for FAST This program allows expedited processing for commercial carriers who have completed background checks and fulfill certain eligibility requirements. To be eligible, you must also be a part of CBPs Customs-Trade Partnership Against Terrorism (C-TPAT) program. C-TPAT is available to all qualified importers, and other entities. The issues with both concern supply chain security. The CTPAT benefits are:
- Reduced number of CBP examinations,
- Moving your imported product entries to the front of the inspection line,
- Possible exemption from Stratified Exams,
- Shorter wait times at the border,
- Assignment of a Supply Chain Security Specialist to the company, and
- Access to the Free and Secure Trade (FAST) Lanes at the land borders.
Besides securing the supply chain, CBP offers programs to assist with trade compliance. One is account management through CBP’s Centers of Excellence and Expertise (CEE). CBP has 10 CEES, and each focuses on certain parts of the tariff. For example, there is the Agriculture and Prepared Products CEE in Miami. There is also the Pharmaceutical, Health and Chemicals CEE in New York. Consultants such as EAS can help address any questions or confusion with these CBP CEEs.
Finally, CBP has an Importer and Self-assessment (ISA) Program CBP ISA Program. Show CBP that you can monitor your own compliance with proper controls, and you can be removed from CBP’s regulatory audit pool, and should CBP find noncompliance, there is an opportunity to avoid penalties by filing a [Prior Disclosure](https://www.cbp.gov/sites/default/files/assets/documents/2017-Oct/Prior Disclosure FINAL.pdf). Generally, an importer can file a prior disclosure and avoid penalties when it finds its own mistakes and informs CBP. One way to proactively keep your business on top of irregularities is to have a qualified consultant perform a desk audit of documentation and filings to ensure data is in order. A more in-depth audit of SOPs and facilities could be warranted in instances where significant discrepancies are found.
Let’s discuss a little bit about the different programs that can cause delays.
Antidumping and Countervailing Duties (ADCVD). There are 483 different ADCVD orders issued, these orders affect a wide range of products from grocery plastic bags; to pencils, and seafood products. The orders are assessed, not only against specific countries, but against different exporters and manufactures, and each exporter or manufacturer can be assessed different rates of duty. In the agricultural arena, duty rates can be high 2 or 3 hundred percent. CBP enforces these orders. Did you check the ITC and Commerce websites or have your consultant check to see if your product is covered? ITC ADCVD Orders Did you or your consultant check CBP web site for ADCVD messages which describe the products covered? CBP ADCVD messages Submitting a tariff classification covered by one of these ADCVD orders without the proper entry type will likely have your cargo stopped.
Import safety. Did you know there are 47 government agencies that have access to all or parts of the import entry data? Fifteen of them actually require that importers provide import data attached to the CBP entry. Products can overlap different agency regulation; especially with FDA; for example, drugs with DEA, food products with APHIS, wildlife with FWS, seafood with NMFS, and tobacco and alcohol with TTB. CBP is the border agency and CBP officers and import specialist will assist the other agencies in enforcement.
Revenue (value, classification, description) All of your imports require proper Harmonized Tariff classification, valued correctly and described accurately. An ambiguous or too general description on the entry or manifest cargo description increase the risk for further review
Trade Agreements There are trade agreements with 20 countries that CBP enforces. Free-trade-agreements all have their own document requirements. Delays can occur, for instance, by not having the proper country of origin certificates.
Country of Origin No matter what type of examination CBP does, if a product is found not to be properly marked with the country of origin, the importer can be forced to mark the goods before release. Please see the Marking Requirements for more information.
Preparing and maintaining the required documentation, applications and oversight of suppliers and transporters of your imported FDA regulated products can be a challenging and confusing process if you try to “go it alone”. It is crucial for the smooth flow of your products through US Customs, that all requirements are addresses properly. One way to do so is to work with a consultant such as EAS Consulting Group to conduct an assessment of your current CBP program for imports, review documentation prior to filing with CBP or to just have a periodic consultant with your import team and that of EAS’ import team. Doing so increases the confidence that your shipments will arrive on-time and in a salable condition. EAS’ CBP Team is managed by Senior Director Allen Sayler. For more information on services or to discuss you specific CBP questions send Allen an email here.
Welcome to the August issue of EASeNews, the free newsletter for industries regulated by FDA. We had numerous questions after the brief mention of FDA’s new requirements for identifying and communicating information on high-risk foods. Our Independent Advisor for FSMA, Charles Breen is shedding light on the subject in this month’s Ask the Expert when he answers our most frequently received question – How is the risk-base of a high-risk food determined?
Bill Scopa, who was formerly with Customs and Border Patrol, has provided a very interesting article on CPB and steps firms importing products into the U.S. marketplace should take to ensure expeditious entry. As you know, EAS Consulting Group is frequently called upon to assist firms which have detained products for any number of reasons. EAS acts as a U.S. Agent for foreign firms and can assist you with import requirements per FDA and USDA regulations. Contact us to learn more about these services.
Registration for our Expert Witness seminar is underway. Expert Witnesses are relied upon for their opinion reports and testimony as cases are adjudicated through arbitration, mediation and trials. Our Independent Consultant, Ron Levine, who is also General Counsel at Herrick Feinstein will conduct a one-day seminar to help those interested or already acting as an Expert Witness to improve their skills and positioning as an expert when called upon to act in this capacity. Learn more and register here. [hyperlink]
We also invite you to join us August 29 for a complimentary webinar on GRAS submissions. This will cover pertinent information that must be included in a GRAS submission, as well as pitfalls firms face when preparing the dossier. Additionally, there will be a discussion on the process once submitted and expectations in working FDA’s OFAS during their review. For more information, and to register click here. [hyperlink]
Lastly, we welcome Rebecca Harter to the EAS team of independent consultants. Rebecca has a unique skillset with her experience with her background in sensory experience including blending for optimal texture development and quality, flavor development/modification and mouthfeel development, product stability.
Thank you for your interest in EAS and as always please feel free to contact me with any questions and to share this newsletter with your colleagues.
August 29, 2019 at 1pm eastern
Tom Jonaitis, EAS Independent Consultant
Cathryn Sacra, Director for Labeling and Cosmetic Consulting Services
Allen Sayler, EAS Senior Director of Food Consulting Services
Before a substance can be legally added to food in the U.S., with rare exceptions, it must be either an approved food additive or determined to be generally recognized as safe (GRAS) for use in food.
Developing a food ingredient so that it is ready for GRAS submission can be a time consuming and costly process. Understanding the major components of a GRAS submission, the details of the required sections, and factors FDA considers when reviewing GRAS submissions are imperative to a successful submission and the receipt of subsequent “No Questions” response from FDA.
Join EAS Consulting Group, leaders in FDA regulatory consulting services on August 29, 2019 for a review of GRAS notification requirements, strategies to strengthen preparations and communications with FDA and avoiding GRAS dossier compilation and submission pitfalls. EAS has prepared numerous GRAS notifications, helping clients to gain a new foothold in the marketplace.
This webinar could be one of the most valuable hours of time invested all year.
About the Presenters
Canadian-based Tom Jonaitis works with clients in the food, dietary supplement, consumer product and related industries, providing comprehensive toxicology and regulatory consulting guidance and support. He is an expert in regulatory evaluations including scientific literature hazard reviews and summaries, as well as creating pre-market quality and safety dossiers for novel food and dietary supplement ingredients applications to government agencies – FDA, Health Canada and Australia’s TGA, FSANZ. Tom reviews and evaluates the results of in vitro and in vivo toxicological studies and has additional expertise in pesticide/agricultural chemical regulations, workplace hazard classifications, and spray foam human health risk assessments.
Cathryn Sacra has served in multiple roles since joining EAS in 2008. She provides clients with service and support, from initial project inquiries through project completion as well as manages the food, dietary supplement, and cosmetics labeling teams.
Allen Sayler has expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, bakery products, food additives, botanical products and food packaging as well as GSFI Third-Party Certification programs such as Safe Quality Foods. Allen has spent more than 35 years as a food processing and regulatory expert, with half of the time serving the industry and the other have as a state and federal government employee.
November 6, 2019 from 9:00 AM – 5:00 PM
Presented by Ronald Levine, EAS Consulting Group Independent Consultant and General Counsel with Herrick, Feinstein, LLP
As highly regulated industries are subject to more claims and litigations, and with growing agency challenges to ingredients, processes and branding, the target company’s regulatory compliance is often a key issue in presenting a successful defense. An expert witness’ opinion, report and testimony will play an essential role in mounting the response.
For attorneys, choosing a knowledgeable and experienced expert witness is of paramount importance. Unlike attorneys who are schooled in the world of litigation, experts often come from academia, the government and industry, and are not familiar with the unique skills required to be an effective witness.
Join EAS Consulting Group’s Independent Consultant and General Counsel at Herrick Feinstein LLP, Ronald J. Levine, for a one-day seminar on the role, expectations and skills for being an effective expert witness. Serving as an expert can be a part-time or full-time career. Whether you are just starting as an expert, or are looking to improve your skills, this seminar is meant to help to arm you for the important role you will be playing. We will also be discussing how to craft your resume and promote yourself with an aim of increasing opportunities to serve as an expert.
Additional seminar topics include:
- Understanding the discovery process and the role of the expert
- The engagement process of becoming an expert
- How experts are utilized in investigations, trials, and arbitrations
- Projecting expertise as part of written reports and oral testimony
- The business of being an expert witness
Two options for attendance
1700 Diagonal Road, Suite 750
Alexandria, VA 22314
(register early, seating is limited)
$695 (early-bird – register before September 1, 2019)
$795 (September 2)
$695 (early-bird – register before September 1, 2019)
$795 (September 2)
About the Presenter:
Ron Levine has 40 years of experience advising consumer products companies in complex commercial matters. In addition to providing consulting services for EAS, he serves as the General Counsel of Herrick, Feinstein LLP, a law firm with offices in New York and Newark, NJ. He has practiced with Herrick since 1984, where he was a partner from 1985-2018. He served as Chair of the firm’s Litigation Department for 15 years.
A pragmatic advisor who helps clients anticipate, minimize and resolve the financial and reputational damage arising from claims and potential claims, Ron specializes in crisis management, for food and beverage manufacturers, and advises on class action litigations and investigations, including serving as an expert witness, related to labeling, the Food Safety Modernization Act (FSMA), advertising claims, product recalls, FDA regulations and other concerns.
The EAS Expert Witness team is greatly enhanced with the addition of Ron. By strategically matching the regulatory purview of the case at hand with our former high-level FDA and industry executives, EAS offers in-depth analysis of FDA and other Federal and state laws as well as standard industry best practices. Ron, along with Steve Armstrong, EAS Independent Advisor for Food Law and Regulation and former Chief Counsel for Campbell Soup Company and Bruce Silverglade, an EAS Independent Consultant and a Principal with the law firm Olsson Frank and Weeda Terman Matz, PC, lead the EAS Expert Witness team of consultants providing detailed and critical services to firms in all FDA commodity areas.
July 24, 2019 at 7:00 PM IST, 9:30 AM EDT
Presenter: Sophia Lily, EAS Independent Consultant
Foreign companies exporting FDA regulated products to the United States can at any time expect an FDA announcement of facility inspection. Looking at the complete safety package from record keeping and retention, to specifications and testing to employee training, FDA ensures foreign firms operate with the same safety standards required of companies operating within the U.S.
A look at trends of inspection findings of foreign manufacturers provides insight into industry challenges concerns garnering FDA’s increased focus.
Learn more about how FDA conducts foreign facility inspections as well as recent inspection trends. Understanding how gaps may be addressed before FDA knocks on your door will lead to a safer consumer product as well as a smoother inspection process.
Join EAS independent consultant Sophia Lily on July 24 at 7:00 PM IST and 9:30 AM EDT for this complimentary webinar. Reserve your seat today!
About the Presenter
Sophia Lily has over 25 years of experience in the regulated pharmaceutical, nutraceutical and food industry Quality Control, Quality Assurance. Based in India, she is experienced in handling inspections, validations, vendor audits and training. She routinely works with, including training, personnel in a range of GMP topics including Data Integrity. With expertise including GMP compliance, gap analysis and remediation and development of roadmaps to compliance, she has successfully implemented effective quality management systems for many companies both small and large.
Ron Levine, EAS Independent Consultant and General Counsel of Herrick, Feinstein LLP will lead EAS’ newest training initiative with a comprehensive look at how to be an effective and sought-after Expert Witness.
Ron Levine has over 40 years of experience advising consumer products companies in complex commercial matters. He offers a wealth of services to EAS clients including
- Litigation research including relevant records and subpoena requests
- Research on outcomes of litigations involving similar claims
- Due diligence assessments including claim history of a target company, risk management policies and procedures
- Preparing for FDA inspections from the perspective of record production and management
- Preparing and editing reports to federal agencies and other entities
Ron’s latest projects include helping Expert Witnesses strengthen their understanding of the role, expectations and skills required for being an effective expert witness. With topics including
- Understanding the discovery process and the role of the expert
- The engagement process of becoming an expert
- How experts are utilized in investigations, trials, and arbitrations
- Projecting expertise as part of written reports and oral testimony
- The business of being an expert witness
Ron is a pragmatic advisor who helps clients anticipate, minimize and resolve the financial and reputational damage arising from claims and potential claims, Ron specializes in crisis management, for food and beverage manufacturers, where he advises on class action litigations and investigations, including labeling, FSMA, advertising claims, product recalls, FDA regulations, new technologies such as 3-D printing and block chain and many others.
Additionally, Ron has developed EAS’s newest seminar on how to become and strengthen skills as an expert witness. This seminar, in Alexandria, VA and offered remotely will be November 6m 2019. For more details see EAS in Action.
EAS Independent Consultants presented two webinars in June. Understanding the Food Fraud Puzzle, which was co-presented by EAS consultant Mehrdad Tajkarimi, Ph.D. and Leann Chuboff of SQFI and GMPs for OTCs with Bryan Coleman are both ready for viewing on the EAS on-demand webinars page of the EAS website.
Independent Consultant Bruce Elsner discussed considerations of Own Label Distributors for the assurance of GMP compliance and certificates of analysis in Natural Products Insider. Dietary supplement companies that contract out some or all their operations often fail to consider how little they know about the operations of those providing the contracted services and thus may be taking significant risks, he says.
The requirement to comply with FSMA is well understood for food manufacturers, and there are no exceptions for warehousing facilities. FDA inspections of facilities that receive, store and distribute human or animal food can occur at any time and firms must be prepared for such an inspection 24 hours a day. Jerry Heaps discusses ways warehousing facilities can and should stay on top of FSMA requirements in Food Safety Strategies.
Independent Consultant, Sophia Lily, is expert of pharmaceuticals who is based in India will present a webinar on how to prepare for FDA facility inspections, including a look at recent FDA observations and trends. Understanding how gaps may be addressed before FDA knocks on your door will lead to a safer consumer product as well as a smoother inspection process. Join Sophia Lily on July 24 at — eastern and — Indian Standard Time. This webinar is conveniently timed for our overseas audiences. Register today!
EAS will bring its popular Dairy Processing 101 seminar to the Process Expo in Chicago, October 8-11, 2019. This full day event covering an overview of the US dairy industry will include the impact of dairy farm practices on the quality and composition of raw milk; how raw milk and dairy product prices are established; an appreciation of government requirements for dairy plants including FSMA’S PCHF regulation; exposure to milk chemistry and microbiology (including dairy cultures); an in-depth overview of dairy processing technologies related to milk beverages, cheese, yogurt, ice cream, as well as hands-on practical knowledge of dairy laboratory testing systems and capabilities. Registrations are being taken by Process Expo.
As highly regulated industries are subject to more claims and litigations, and with growing agency challenges to ingredients, processes and branding, the target company’s regulatory compliance is often a key issue in presenting a successful defense. An expert witness’ opinion, report and testimony will play an essential role in mounting the response. Join EAS Consulting Group’s Independent Consultant and General Counsel at Herrick Feinstein LLP, Ronald J. Levine, for a one-day seminar on the role, expectations and skills for being an effective expert witness. Serving as an expert can be a part-time or full-time career. Whether you are just starting as an expert, or are looking to improve your skills, this seminar is meant to help to arm you for the important role you will be playing. We will also be discussing how to craft your resume and promote yourself with an aim of increasing opportunities to serve as an expert. [Add hyperlink when ready]
EAS’ next Dietary Supplement GMP Refresher Training takes place August 13, 2019 in Andover, MA. Taught by Independent Consultant Tamika Cathey, this one-day intensive training is designed and priced so that firms can outsource their GMP training requirements to EAS. Conveniently located around the country, following the August training in Massachusetts, the fall GMP Refresher training will take place in Long Island November 12, 2019. Visit the EAS website for more information on the August 13 GMP Refresher training in Andover and the November 12 GMP Refresher training in Long Island.
EAS Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D. will present a workshop on cGMPs for dietary supplements along with attorney Marc Ullman of Rivken Radler, LLP at the upcoming American Herbal Products Association Hemp-CBD Supplement Congress in Denver, August 14-15, 2019. This event, focused on the challenges and opportunities of marketing hemp and CBD in dietary supplement products, will provide critical information for companies navigating the rapidly evolving legal, regulatory and financial landscapes to manufacture and market dietary supplement products with hemp or hemp-derived ingredients like CBD. For more information and to register visit the AHPA webpage.
By Susan Glenn
Each month EAS experts answer one question sent in by readers. This month’s answer regarding USDA labeling is provided by Susan Glenn. Susan is an expert in matters pertaining to USDA and FDA regulations of the food industry with a particular focus on labeling, product standards and requirements. To ask your question of our experts, contact us.
Question: How does USDA labeling differ from FDA food labeling?
Glenn: Though both food products, USDA labeling is uniquely different from FDA labeling. While covering the full scope of regulations would require more time than can be answered simply here, (EAS does offer an in-house one-day USDA labeling compliance seminar), here are some brief facts to help you understand the differences.
USDA does not require an allergen statement at the end of the ingredient statement.
USDA requires all ingredients be listed by their common and usual name. Adding the allergen statement is voluntary but, if used, must follow all of the requirements of the Food Allergen Labeling and Consumer Protection Act (FALCPA).
USDA does not require the type size of the ingredient statement and address line to be 1/16”. 9 CFR 317.2(b) states “Any word, statement, or other information required by this part to appear on the label must be prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.” For poultry, the reference is 9 CFR 318.116.
The New Nutrition Facts Panel formats for FDA are not required for USDA. On January 19, 2017 USDA published a proposed rule to revise the nutrition facts panel format and certain reference amounts customarily consumed (RACC) to be consistent with FDA nutrition facts panel formats and certain RACC changes. By the end of July 2017, USDA announced the purposed rule was placed on the inactive list of rules and could be re-introduced “at a later time.” Meat and Poultry companies have the option to use the new FDA formats but must adhere to all of the FDA regulations pertaining to the formats and RACCS.
There are many additional differences between USDA and FDA regulated products, with labeling a big concern and one which can be confusing if the nuances between USDA and FDA labeling and not well understood. For more information on USDA labeling contact EAS.
As part of the FDA’s ongoing efforts in their goal of more ANDA approvals in order to increase access to high-quality lower cost generic drugs, the agency began on 18 June 2019 to publish additional data in the existing Paragraph IV Patent Certifications list. The FDA hopes to assist ANDA applicants in their business decisions to pursue generic drug development. The list will now include, on a prospective basis, the following information:
- Number of potential first applicants
- 180-day decision status
- Date of first “first applicant” approval
- Date of first commercial marketing
- Expiration date of last qualifying patent
For further information, please see the FDA’s Patent Certifications and Suitability Petitions website.
The FDA has posted a website regarding products containing cannabis or cannabis-derived compounds, and particularly cannabidiol (CBD), articulating their current position and 4 specific points they are working to learn more about. The webpage includes a link to a public docket the FDA is using to gather information and data. The docket is available for comment until 16 July 2019. The agency has consistently stated, however, that it believes that CBD is not a legal ingredient in a food or a dietary supplement because it has been investigated as a Investigational New Drug (IND) and has been approved for use in the drug Epidiolex.
Effective 17 June 2019, the FDA is making pre-assigned ANDA number requests available via the CDER NextGen Portal.
Guidance Document updates on the FDA website
- Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework
The purpose of this guidance is to describe the benefit-risk assessment framework that the Agency uses in evaluating whether applications for opioid analgesic drugs meet the standard for approval under section 505 of the Federal Food, Drug, and Cosmetic Act.
- Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment
This guidance describes the Food and Drug Administration’s (FDA’s) current recommendations regarding the important components of a drug development program for compensated NASH cirrhosis.
CDER & CBER
- ANDA Submissions — Content and Format of Abbreviated New Drug Applications
This guidance details the information that should be provided in each section of the common technical document (CTD) format for human pharmaceutical product applications and identifies supporting guidance documents and recommendations issued by FDA to assist applicants in preparing their ANDA submission.
- Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
This guidance recommends approaches that sponsors of clinical trials to support a new drug application or a biologics license application can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations in their clinical trials.
- Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs
This guidance pertains to submissions made to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER).
- Formal Dispute Resolution: Sponsor Appeals Above the Division Level
This guidance describes the formal dispute resolution (FDR) procedures for sponsors that wish to appeal4 a scientific and/or medical issue to the office or center level and provides a structured process for resolving disputes.
- Mouse Embryo Assay for Assisted Reproduction Technology Devices
FDA is issuing this draft guidance to outline draft recommendations on conducting the mouse embryo assay (MEA) to support premarket submissions and lot release of assisted reproduction technology (ART) devices.
CDRH & CBER
- Testing for Biotin Interference in In Vitro Diagnostic Devices
This guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing be performed, and how the results of the testing should be communicated to end-users, including clinical laboratories and clinicians.
- Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507
The purpose of this guidance is to help industry subject to Title 21 of the Code of Federal Regulations (21 CFR) part 117 (part 117) or 21 CFR part 507 (part 507) determine the number of employees for purposes of the “small business” definition under parts 117 and 507.
- CPG Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI)
This guidance document represents the Agency’s current thinking on animal products containing ethylenediamine dihydroiodide (EDDI) or feeds containing unapproved new drugs under the provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
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.
Ramakrishnan Narasimhan (aka ‘Rama’) is a versatile, knowledgeable and competent professional with over 35 years of management experience in the manufacturing sectors pertaining to food, pharmaceutical and dietary supplement industries. He has wide ranging experience in designing, developing, guiding and auditing customized and standard product safety and quality system standards. His ‘think outside the box’ approach to solving complicated technical issues and problems enables novel solutions for clients. He is a frequent invited speaker in the area of product safety (food, pharmaceutical and dietary supplements) in international and domestic conferences.
Angel Suarez is a former Supervisor Consumer Safety Officer with the Food & Drug Administration. In this role he had responsibility of import enforcement in areas of seafood and Low-Acid Canned Food (LACF) as well as foreign inspections, warning letters, detentions, import alerts, import bulletins, and sample collections. He is the co-author of numerous publications including portions of the National Shellfish Sanitation Program’s Shellfish Equipment Construction Guide and the National Shellfish Sanitation Program’s Guide for the Control of Molluscan Shellfish Annotated Manual. In addition, he has developed training courses including FDA Certified Better Process Control School, Inspection and Sampling of Abnormal Food Metal Containers and the FDA Shellfish Officer Standardization Course. Angel has a B.S. with a major in Biology and minor in Chemistry and Physics from the Inter American University.
Robert Kapp, Ph.D. has over 30 years’ experience as a toxicologist involved with the management, development, and safety of new and existing products in a broad spectrum of industries including preclinical program study design, study reports, occupational and industrial toxicology and evaluating clinical and product safety data. Dr. Kapp assists EAS clients with writing critical position papers, GRAS notifications, 510(k) submissions, US EPA Premarketing Notifications, toxicology profiles, Safety Data Sheets and labels in the US and in global markets. Prior to consulting Dr. Kapp worked as Director, Toxicology Laboratory at Exxon Biomedical Sciences, Inc. He has a Ph.D. in toxicology from George Washington University.
By Robert Kapp, Ph.D.
Safety Data Sheets (SDSs) (formerly known as Material Data Sheets (MSDSs) contain basic information about a chemical or product needed to insure the safety and health of the user at all stages of its manufacture, storage, use, and disposal.
Interestingly, SDSs have a long and involved history, extending back into time – ultimately resulting in the present-day format. There are records indicating that MSDS-like documents were used 4000 years ago to describe pharmaceutical use in Egypt. A thousand year later, the Greeks recorded not only their own observations, but also some of their early experimental work on similar documents. Skipping ahead another millennium, chemical data sheets were continuously being developed by chemists at avante garde chemical companies as a way of transmitting various data to fellow chemists: melting/freezing/flash points, viscosity, density. As the industry became more enlightened in the last 100 years or so, the chemists began adding additional items, such as reactions and fire hazards. While health/safety and toxicological data had been developing over the past few 1000 years, it was only recently included on these data sheets as the next logical step in an all-inclusive document.
The US Federal Government got involved in the mid-1960s and developed its original Form LSB-00S-4 to meet the needs of maritime workers, added safety and hazard information for the first time to a chemical safety sheet. It was published and became law on August 23, 1968 in 33 FR 12008 as amendments to 29 CFR parts 1501, 1502 and 1503. Over the ensuing few years, there was pressure on Congress to extend benefits of the Longshoreman’s Act, plus additional safety and health coverages, to all of the nation’s industrial workers. With the passage of Public Law 91-596, on December 29, 1970, OSHA was established within the Department of Labor.
Initially, the formatting for these MSDS’s was fluid and varied considerably from company to company and from country to country. The EU standardized the format into what is now the 16-section document. Nevertheless, the quality, type of information and specifics of the MSDSs remained chaotic and in the minds of regulators, need some consistency. There was an effort to coordinate these vastly different documents by the US Government: The Hazard Communication Standard (HCS) (29 CFR 1910.1200(g)), was revised in 2012, requiring that the chemical manufacturer, distributor, or importer provide Safety Data Sheets (SDSs) (formerly MSDSs or Material Safety Data Sheets) for each hazardous chemical to downstream users to communicate information on these hazards.
The information contained in the SDS is largely the same as the familiar MSDS, except now the SDSs are required to be presented in a consistent user-friendly, 16-section format. When one creates an SDS, he/she must be aware that the proper labeling and warnings are included for the area (country) the product will be sold – the place that regulates the product.
Sections 1 through 8 contain general information about the chemical, identification, hazards, composition, safe handling practices, and emergency control measures (e.g., firefighting). This information should be helpful to those that need to get the information quickly. Sections 9 through 11 and 16 contain other technical and scientific information, such as physical and chemical properties, stability and reactivity information, toxicological information, exposure control information, and other information including the date of preparation or last revision. The SDS must also state that no applicable information was found when the preparer does not find relevant information for any required element.
The basic toxicological information is placed methodically in Section 11. While the specific format is not set, the acute data is a generally good place to start. Toxicological data such as the oral and dermal LD50s (Dose at which 50% of the animals exposed would be expected to succumb – this is a calculated formulaic number from a limited number of animals) as well as the inhalation LC50s (Concentration of a chemical at which 50% of the animals exposed would be expected to succumb). Basic information on skin, mucous membrane, respiratory and eye irritation as well as any repeated dose information would also be inserted in this section. Any cancer listings from IARC, EPA, NTP, ACGIH, NIOSH or OSHA would be included here. Any repeated dose studies that generate the no observed adverse effect level (NOAEL) should be briefly included here. Some companies insist on a toxicological profile of the chemical in this section, while others put minimal information.
There are other sections which will depend upon the toxicology section. For instance, Section 3 is the Hazard Identification and usually deals with the safe handling of the material by the user. This also includes things other than toxicity (e.g. flammability, vapor, etc.) but it is the application of the toxicological data to direct how the user must handle the product. If there are serious issues in handling the product, this has to be pointed out here. Sometimes potential health effects are detailed in this section. If this is global/EU, then those warning pictograms go in this section.
Section 4 is first aid. There are stock phrases that go in here based upon the toxicological profile of the material. Section 5 is Fire Fighting measures and can also relate back to the toxicology section if there’s some serious chemical reactions with the product.
Section 12 is ecological information. This is very important for EU. They put more emphasis on this than we have historically here in the US. The EU regulators want to know the potential ecotoxicity to fish, daphnia, algae and if the product biodegrades and/or bio-accumulates which can produce long-term harm to the environment.
The relevant regulatory information including exemptions, what agency takes precedence, rules to follow in the country that product is in, Toxic Substances Control Act (TSCA) – 1976 Public Law 94-469) listing, etc., should be in Section 15.
To summarize, many companies put a considerable amount of information on their SDSs while others – not so much. As a rule of thumb, the data should be as complete as possible with what is at hand with toxicological statements evaluated by a certified toxicologist. One should never speculate or overstate the effect of the product. As in all things scientific – be truthful and accurate.
Welcome to the July edition of EAS-e-News, the free newsletter for industries regulated by FDA. FDA took an important step this month when it agreed to settle a lawsuit filed by the Center for Science and commit to defining a designated list of “high-risk” foods as well as a proposed rule for high-risk food record keeping requirements by September 8, 2020. Additionally, the final rule will be established no later than November 7, 2022. Originally, Congress mandated that FDA designate high-risk foods by January 2012 and propose recordkeeping requirements for facilities that handle those foods by January 2013, so this renewed effort is welcomed as an important protection against food-borne illnesses which sickens countless annually.
I am pleased to say that EAS is an invited training partner for two upcoming events. First, Tara Lin Couch, Ph.D., Senior Director for Dietary Supplements and Tobacco Services will present a workshop on dietary supplement GMPs along with long-time training partner Marc Ullman, Of Counsel at Rivkin Radler, at the upcoming AHPA Hemp-CBD Congress taking place in Denver, August 14-15, 2019. Additionally, EAS will bring its popular Dairy Processing 101 seminar to the Process Expo in Chicago, October 8-11, 2019. More information on both of these seminars can be found in the EAS in Action section of this issue.
Additionally, EAS is announcing a new training seminar that we are very excited about. Coming on November 6, 2019, EAS Independent Consultant and General Counsel at Herrick Feinstein, Ronald Levine, will instruct a full-day event in Alexandria, VA on how to become, and strengthen skills, in the important service of providing Expert Witness services for FDA litigation, arbitration and mediation matters. EAS has over 30 consultants who serve in the capacity of Expert Witness. This important and critical component, as part of a comprehensive legal team, has become a critical factor in the demonstration of compliance expectations.
We invite you to join EAS at the International Association of Food Protection Annual Meeting, July 21-24, 2019 in Louisville, KY. EAS will be exhibiting at booth #319 and additionally independent consultant PC Vasavada will be speaking as part of an esteemed panel, along with Senior Director Allen Sayler, on FSMA compliance and FDA enforcement. You may wish to also view our recent webinar, Understanding the Food Fraud Puzzle, available on-demand on the EAS website.
I am pleased to welcome two new independent consultants, Rama Narasimhan and Angel Suarez. I am always impressed with the caliber of independent consultants who choose to work with EAS for the benefit of our clients. I invite you to learn more about both in the Who’s Who section of this issue.
I hope you enjoy this issue and please feel free to share with friends and colleagues who may also have interest.