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 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.
By William (Bill) Scopa
The US Customs and Border 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.
The FDA requires firms that manufacture foods, pharmaceuticals and medical devices to register their facilities on an annual or biennial basis, depending on the product category. Keep in mind, FDA assesses a Medical Device establishment registration user fee annually. Drug products and medical device products must also be listed with the FDA.
Any changes or updates to a facility’s information, such as address, contact information, or designated U.S. Agent, should the location be based outside of the U.S., must be reported in a timely manner. Changes to a drug listing must also be updated as soon as possible. The agency dictates these changes be reported, at the very least, the June or December following such a change.
FDA uses facility registration and product listing information as part of their compliance reviews for cross referencing product listings and forms at U.S. ports of entry. Discrepancies can cause products to be considered misbranded and / or potentially lead to the detaining of goods. Additionally, FDA may at any time make announced or unannounced inspections at registered facilities, so it is imperative that all information uploaded into the FDA system is done with care and accuracy.
EAS offers registration and listing services to our clients, as well as appointment as the U.S. Agent for foreign clients. Our comprehensive services enable your firm to outsource these important, yet cumbersome, administrative tasks to our experts. EAS helps you to keep track of compliance deadlines, applicable user fees and acts as a conduit of information between your firm and the FDA.
For more information, we invite you to view our website and Video Shorts which offer quick snapshots of many of EAS’s services. For more information on our registration and listing services specifically, you may wish to view the “Registrations and Listing Services” video found in the third row. For a more detailed look at many FDA compliance requirements we invite you to view our On-Demand regulatory webinars which offer regulatory information on a variety of topics. More information on U.S. Agent requirements can be found here.
Contact EAS with any questions on registration and listings or to engage EAS as your U.S. Agent. The process is simple, and the benefits can be endless.
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 review more on infant formula regulatory challenges in our recent webinar, now available on-demand.
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 and will be joined by EAS Independent Advisor for Label and Claims, Betty Campbell. 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 and Betty in Alexandria, VA on November 6 (register early as seating is limited) or attend the training remotely. More information can be found here.
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.
The FDA recently issued a warning letter to a company for inaccurate information in one of their drug listings. Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act and 21 CFR Part 207) outlines the requirements for registration and listing of drug products. EAS would like to remind our clients of the importance of ensuring not only that your drug listings are current, but also correct with regard to both product and label information. Failure to fulfill your listing obligations renders your product misbranded. If you have questions or would like further information, please contact EAS.
The Office of Global Policy and Strategy (OGPS) has launched its own Twitter account, https://twitter.com/FDA_Global. The FDA invites all to follow their new Twitter handle for day-to-day information on FDA’s global regulatory work, foreign offices and international arrangements. Have questions? Contact: FDA_Global@fda.hhs.gov.
Guidance Document updates on the FDA website
This guidance addresses how to comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603, hereafter the “combination product PMSR final rule,” “final rule,” or “rule”).
Federal Register Generic Drug User Fee Rates for Fiscal Year 2020
The FDA has published the FY2020 GDUFA fee rates.
07-22-2019 FDA is announcing the withdrawal of the draft guidance for industry Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information, issued in December 2016.
This guidance provides recommendations for clinical trials designed to establish clinical effectiveness and safety for hormonal drug products intended to prevent pregnancy.
This guidance describes the process that allows for the revision of compendial standards that are harmonized with the approved quality and labeling requirements for a drug product application.
This guidance describes the Food and Drug Administration’s (FDA’s) Inactive Ingredient Database (IID) and provides recommendations for how to use the IID in the development of drug products.
This guidance describes the Food and Drug Administration’s policy concerning the conditions under which the Agency does not generally intend to take regulatory action against a licensed pharmacist in a State-licensed pharmacy or Federal facility or a licensed physician using the bulk drug substance oxitriptan to compound oral drug products for patients with tetrahydrobiopterin (BH4) deficiency.
This Guideline is intended to provide internationally harmonised guidance on when it would be appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented.
This guidance describes the Food and Drug Administration’s (FDA’s) current recommendations regarding the overall development program to establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer.
The purpose of this technical specifications document is to provide the current thinking of FDA’s Division of Antiviral Products (the Division) in regard to the submission of next generation nucleotide sequence analysis procedures and data in support of resistance assessments for the development of antiviral drug products.
CDER & CBER
This guidance is intended to assist sponsors of new drug applications (NDAs) and biologics license applications (BLAs) in the application of population pharmacokinetic (population PK) analysis.
This guidance provides information on how the FDA defines the types of changes to approved risk evaluation and mitigation strategies (REMS), how application holders should submit changes to an approved REMS, and how the FDA will process submissions from application holders for changes to REMS.
This guidance is intended to assist applicants in writing the DRUG ABUSE AND DEPENDENCE section of labeling, as described in the regulations for the content and format of labeling for human prescription drug and biological products.
This guidance provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drug and biological products and drug-device or biologic-device combination products submitted under a new drug application (NDA) or a biologics license application (BLA).
The purpose of this guidance is to assist sponsors with the development of drugs for treatment or prevention of the serious cutaneous manifestations of the heterogeneous group of disorders collectively known as epidermolysis bullosa (EB).
This guidance has two purposes: 1) to make it clear that an effect on symptoms or physical function, without a favorable effect on survival or risk of hospitalization, can be a basis for approving drugs to treat heart failure; and 2) to provide recommendations to sponsors on the need to assess mortality effects of drugs under development to treat heart failure.
This guideline is intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples.
This guidance describes how sponsors and applicants must organize the content that they submit to the Agency electronically for all submission types under section 745A(a) of the FD&C Act.
This document provides guidance on important information about a live case presentation that should be provided as part of an original IDE application or a supplement to an IDE application when requesting inclusion of a live case presentation during a clinical investigation.
This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH or the Center) employees.
This guidance document provides the Center for Devices and Radiological Health of key provisions set forth in section 517A of the Federal Food, Drug, and Cosmetic Act, as those provisions pertain to requests for appeals of significant decisions under 21 CFR 10.75, as well as for the timeframes and procedures of regulatory decisions and actions taken by CDRH under 21 CFR 800.75.
In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, this guidance document describes the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new premarket notification (510(k)).
This draft guidance document, when finalized, will provide recommendations for (1) complying with the clinical testing special control under 21 CFR 876.4340(b)(8) for premarket notifications (510(k)s) for high intensity ultrasound systems for prostate tissue ablation, and (2) collecting clinical data to support marketing submissions for new types of prostatic tissue ablation devices.
This guidance document provides recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems.
The purpose of this guidance is to provide NADA sponsors of Type A medicated articles with FDA’s current thinking on the recommended content and format of Blue Bird labels.
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.
EAS Independent Consultants and Toxicologists, Robin Guy and Robert Kapp will present 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 Robin and Bob on August 22 at 1 pm eastern for an informative discussion on GRAS and how you can increase your chances for a successful submission the first time. Register today!
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.
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 November 6 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.
We also invite you to join us August 22 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 for working with FDA’s OFAS during their review. For more information, and to register click here.
Lastly, we welcome Rebecca Harter to the EAS team of independent consultants. Rebecca has a unique skillset with her background in sensory experience including blending for optimal texture development and quality, flavor development and 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.