FDA Announces Export Certifications and Fees for Certain Food Products

By Charles Breen, Independent Advisor for FSMA

On August 31, 2018, FDA announced a new voluntary export certification option for certain foods as authorized under FSMA, similar to that available for qualified pharmaceuticals and medical devices. This new export certification program and its associated fees will allow the agency to collect up to $175 for export certifications for food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use. The issuance and collection of these fees begin October 1, 2018, and are in effect for two new types of food certificates, the “Certificate to a Foreign Government” and “Certificate of Exportability.”

Prior to this announcement, CFSAN issued only a “Certificate of Export” for seafood, food additives, and food contact substances and a “Certificate of Free Sale” for foods other than seafood, dietary supplements, infant formula, medical foods, and foods for special dietary use.

Per the FDA’s Constituent Update, the “Certificate to a Foreign Government” will be available for products that meet the applicable requirements of the FD&C Act and will certify that a product (or products) may be marketed in and legally exported from the United States. The “Certificate of Exportability” will be available for export only products and will certify that a product or products meet(s) the requirements of section 801(e)(1) of the FD&C Act and may be legally exported. FDA anticipates that the new certificates will help facilitate exports by assisting industry in fulfilling importing country requirements for certification by FDA of FDA-regulated food products.

Requests for written export certification for FDA regulated products are common from foreign customers or foreign governments. In the case of food products, FDA provides, though does not require, written certification for exports in the form of certificates and lists of eligible exporters for specific products or destinations. Those U.S. companies which export foods are required to follow U.S. laws and regulations as well as those specific to the countries the products are being exported to. It is important to note that laws vary across countries and FDA does not provide any guidance for laws outside of the U.S. that companies must follow.

Most CFSAN export certificates may be obtained by completing an online application through the FDA Unified Registration and Listing Systems (FURLS) Certificate Application Process (CAP). These take several weeks to process with no expedited review option. Some foreign governments require the additional step of verifying the export certificate via apostille or authentication from the U.S. Department of State or, in cases where the certificate was issued after April 2016, a unique Certificate ID, printed in the top left corner of every certificate, may be used to independently verify whether the export certificate was issued by FDA.

EAS offers U.S. import assistance as well as assistance for companies exporting product to foreign countries via the application of a certificate of export as well as obtaining apostille from the U.S. Department of State. Contact us for more information.

Fairman Discusses Tips to Ensure Compliance with Audits in Natural Products Insider

EAS Independent Consultant Heather Fairman discussed Own Label Distributor audits of contract manufacturers as well as steps for ensuring their compliance in the Natural Products Insider. “Own label distributors performing contract supplier and/or contract manufacturer audits often have critical blind spots that may result in products not meeting specifications or their quality and safety expectations,” she says.

Couch Shares Dietary Supplement OLD Responsibilities in AgroFOOD Industry HI Tech

Senior Director Tara Lin Couch, Ph.D. shared Own Label Distributor (OLD) responsibilities in a recent article published in Technoscienze – AgroFOOD Industry HI Tech. Regardless of whether an OLD is domestic or international, the FDA is clear that the OLD is responsible for compliance with the regulatory requirements in 21 CFR 111, she says. “The development of critical OLD processes should include procedures such as qualification of OLD contractors; demonstration that the quality unit is fulfilling obligations of finished product specifications; a complaint system for evaluating all reported consumer concerns for the identification and reporting of Serious Adverse Events (SAEs) to FDA; and change control processes to ensure revisions are tracked and monitored.”

Skolnik Discusses AERs in Natural Products Insider

Norma Skolnik discussed Adverse Events Reporting (AER) requirements for the dietary supplement industry in Natural Products Insider. The requirements as well as the Guidance for Industry: Questions & Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as required by the Dietary Supplement & Nonprescription Drug Consumer Protection Act,” published in 2007 cover SAE reporting for manufacturers and OLDs as well as FDA notification to companies when FDA receives an SAE involving one of their products.

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 will present on Contract Manufacturing scheduled for Saturday, November 10 from 8:30am-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.

Cirotta to Moderate Panel at FDLI Conference Focusing on Tobacco and Nicotine Products

Dean Cirotta will moderate a panel at the upcoming FDLI Tobacco and Nicotine Products Regulation and Policy Conference concerning “The Latest on Product Standards and Other Potential Regulatory Action”. The conference, which takes place October 25-26, 2018 in Washington, D.C., will address issues of effectively regulating the broad spectrum of tobacco and nicotine products both in the U.S. and globally.

Planning for Emergencies – Document, React and Manage all Aspects When the Worst Happens

Dear Readers,

Welcome to the October 2018 edition of the EAS-e-News, a free news publication for industries regulated by FDA. I’d like to invite you to view our latest video discussing EAS services in the infant formula industry. These short videos are a few minutes in length and designed to give you a better understanding of EAS capabilities and expertise of our many talented consultants. You may find all of our capability videos at the bottom of the page under the food tab of the EAS website.

We have a number of new webinars planned for the month of October and early November that we invite you to sign up for. From Preparing for Tobacco TPMPs, to Own Label Distributor Responsibilities and Pharma Data Integrity our complimentary webinars offer the latest regulatory information in a concise one-hour format with time for Q&A.

Independent Consultant, Priya Jambhekar will be speaking at FDLI’s Introduction to Biologics and Biosimilars Law and Regulation on the Regulation of Biological Marketing. This event is being held October 3-4, 2018 in Washington, D.C.. Dean Cirotta will be moderating a panel at the upcoming FDLI Tobacco and Nicotine Products Regulation and Policy Conference which is also being held in Washington, D.C. on October 25-26, 2018. Independent Advisor for OTC Drugs and Labeling, Susan Crane, will be presenting a session as part of the CHPA Academy’s OTC 101 course on OTC drug labeling regulations. This course is being offered in Wilmington, DE October 9-10, 2018.

Our Issue of the Month article is written by Independent Consultant Norma Skolnik and is on the legislation to reform the OTC Drug Monograph System called the OTC Drug Safety, Innovation, and Reform Act. EAS has a strong team of consultants who have in-depth knowledge of the OTC monograph process as well as the Rx to OTC switch. Our FSMA Perspective written by EAS Independent Advisor for FSMA, Charles Breen is on FDA’s new fee-based program Export Certifications for certain food products.

We hope you enjoy this issue of EAS-e-News and we hope that you’ll join us at one of our many webinars and presentations in the coming weeks. It is always a pleasure to meet those who also have a vested interest in ensuring the safety and compliance of FDA Regulated products. We welcome your questions and comments and please feel free to share this newsletter with your colleagues.


Edward A. Steele

EAS Webinar Series Continues with Topics Ranging from Tobacco TPMPs, Own Label Distributors and Pharmaceutical Data Integrity

EAS is offering a number of complementary regulatory webinars this fall. Please join us for these live sessions or view one of our On-Demand webinars found under the Resources tab of our website.

Preparing for Tobacco TPMPs – October 9, 2018, at 1:00 pm Eastern

Join EAS President and COO, Dean Cirotta and Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. for a discussion of expectations for FDA’s in-development Tobacco TPMP Rule and how you can assess your current quality systems in preparation. This webinar is hosted in Cooperation with the Tobacco Merchants Association.

Own Label Distributor Responsibilities – October 11, 2018, at 1:00 pm Eastern

As more and more OTC drug and dietary supplement companies are contracting out manufacturing, packaging, laboratory testing, and distribution services, it is imperative that those in responsible positions for OLDs gain a full understanding of FDA’s requirements for knowing what and how these contracted activities are performed. Learn more about your “OLD” responsibilities and how to document that you are meeting them with EAS Independent Consultant, Bruce Elsner.

Problems with Pharma Data Integrity – October 18, 2018, at 1:00 pm Eastern

FDA takes data Integrity very seriously and their many Warning Letters and Import Alerts to dosage form and Active Pharmaceutical Ingredient (API) manufacturers in the past several years indicate that validation is a consistent problem. Join EAS Independent Consultant Brian Nadel to better understand the Agency’s expectations for data integrity as well as how your company can assess your compliance. Learn critical strategies and processes that each firm should undertake to limit data integrity risk and demonstrate reliable data every time.

Breen Co-Authors Article in Food Quality and Safety Magazine on Responding to Food Safety Emergencies

Independent Advisor for FSMA, Charles Breen has co-authored an article with Stacey Stevens, Senior Vice President of FoodMinds, a food PR firm with which EAS has a collaborative partnership on responding to a food safety emergency. The article, published in Food Quality and Safety magazine discusses the many issues of responding to an emergency and how to focus messaging on that response.

Legislation to Reform the OTC Drug Monograph System: The OTC Drug Safety, Innovation, and Reform Act

By Norma Skolnik, Independent Consultant

With the aim of overhauling the regulation of over-the-counter (OTC) monograph drugs, U.S. Senators Johnny Isakson and Bob Casey recently sponsored bipartisan legislation, the Over-the-Counter Drug Safety, Innovation, and Reform Act of 2018, S.2315. The bill, which has already passed in the House of Representatives, was approved by the Senate Health, Education, Labor, and Pensions committee on April 24, 2018, and was received by the Senate at large on July 17, 2018. A previous bill, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2017, authored by Representative Bob Latta (R-OR) and others, was introduced over a year ago.

As most people know, the current monograph system, which was implemented in 1972, has received much criticism and there have been several prior efforts to revise what’s been called an outdated “broken system”. The current monograph system’s drawbacks include the slow rulemaking process (many OTC drugs are marketed under incomplete monographs), the inability to swiftly and promptly address safety issues, and barriers to innovation (eligibility is largely limited to active ingredients that were marketed before 1972). In addition, FDA has acknowledged that it currently lacks the resources to effectively regulate all OTC monograph products.

The proposed bill is intended to speed up the current slow and time-consuming regulatory procedures by introducing the administrative order process to replace the current rulemaking procedures. It provides options for manufacturers to request administrative orders and for FDA to initiate administrative orders on its own initiative as well as in response to a citizens’ petition.

The S2315 bill would also establish a process for the introduction of new OTC products that are marketed without an approved New Drug Application. This legislation would authorize the agency to grant 2 years of product differentiation and exclusive market protection for certain qualifying OTC drugs, thus delaying the entry of other versions of the same qualifying OTC product.

The bill also includes provisions that would provide FDA with the authority to take rapid action in the event of safety issues with OTC drugs and requires that FDA re-evaluate the OTC cold and cough monograph with respect to children under the age of six and report annually to Congress on the progress of this evaluation. This was prompted by a 2007 internal review that linked the deaths of 54 children younger than 6 years to the use of OTC decongestants and cough medications.

Additionally, the new legislation will help manufacturers who wish to develop innovative products, for example, by adding new ingredients or creating new dosage forms of existing OTC drugs. It should provide a more streamlined regulatory pathway for review of innovations within the OTC Monograph system, accommodating marketplace innovations, such as new uses for ingredients, dosage forms, and other advancements. It should also provide a mechanism to encourage investment in data needed for significant innovations.

Reforming the OTC monograph system should benefit consumers and give FDA the resources that it needs to provide effective oversight of these widely used drug products.

The proposed legislation updates the monograph process by specifically adding a new section to the Federal Food, Drug, and Cosmetic Act (FFD & C) to implement the following:

  • Move away from the cumbersome current monograph finalization process to an “administrative order” procedure. The system for future changes to Monographs would be through the administrative order procedure with an opportunity for development meetings or other consultations, comment on proposed orders, and dispute resolution protections
  • Include by reference existing OTC Review Final Monographs and deem final all existing Tentative Final Monographs by statute
  • Create new pathways to innovation for monograph products, where none currently exits
  • Ensure that the new drug approval pathway and other nonprescription drugs otherwise lawfully marketed are not affected
  • Create a mechanism for faster OTC drug safety label changes;

Importantly, the bill provides FDA with the authority to collect user fees to help cover much of the costs of updating the regulatory system and provide the necessary resources to evaluate and monitor the OTC drug market. It’s hoped that the user fees will provide FDA with the funding and staff required to better oversee OTC drug compliance and build a critical IT/electronic infrastructure. This bill differs from previous versions because of its’ exclusivity provision.

The OTC Drug Safety, Innovation, and Reform Act is now awaiting Senate action. There is a great deal of bipartisan support for this bill, including from the American Academy of Allergy, Asthma & Immunology, the American Dental Association, and the American Academy of Pediatrics, who have urged passage because of the need to overhaul and modify pediatric dosing for OTC drugs, particularly OTC cough and cold drugs. It’s also been supported by the Consumer Healthcare Products Association (CHPA), the leading U.S. trade association representing OTC drug manufacturers and marketers. However, although it has widespread support and appears likely to pass, this is not a “must pass” bill like other existing user fee legislation. When it does pass, this legislation will have an enormous impact on the OTC drug industry in this country.

Issue of the Month Author, Norma Skolnik

This month’s Issue of the Month on Serious Adverse Events Reporting is written by Independent Consultant, Norma Skolnik. Norma has over 35 years of regulatory experience working with the pharmaceutical, OTC drug, and dietary supplement industries. Prior to consulting, she served as Director of Regulatory Affairs for the Americas for Cadbury Adams until her retirement. She also held the positions of Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company.

Drug and Device Corner 2018 September

EAS would like to remind clients, the FDA FY 2019 establishment registration renewal period begins this month. With reference to Drug Establishments, please make sure you are aware of your obligations under the Drug Supply Chain Security Act (DSCSA) during this drug listing certification period. The FDA has released several guidance documents to assist.

In the event you not already seen the Statement from FDA Commissioner Scott Gottlieb, M.D, EAS highly recommends you read this to understand the FDA’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities. The statement includes a link to the FDA’s published internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections.

In addition, FDA recently announced a Special 510(k) Program Pilot, which aims to expand upon the types of changes eligible for the Special 510(k) Program to improve the efficiency of 510(k) review. FDA is working to simplify the review of certain 510(k)s for industry and FDA staff using efficient practices consistent with least burdensome principles. As part of this pilot, certain design or labeling changes that previously were reviewed as a Traditional 510(k) may be eligible to be reviewed through the Special 510(k) pathway instead. The Agency believes that the reliance on design control requirements and previous Agency review of detailed information can reduce review times and still protect the public health. This pilot is part of ongoing efforts to simplify the 510(k) process and help promote timely access to safe, effective, and high-quality medical devices.  EAS offer 510(k) review and submission assistance. Please contact us for more information.

Guidance Document updates on the FDA website:

All centers:

Postapproval Changes to Drug Substances

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank


Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy

Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

Allergic Rhinitis: Developing Drug Products for Treatment

Nonallergic Rhinitis: Developing Drug Products for Treatment

Physiologically Based Pharmacokinetic Analyses — Format and Content

Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development

Technical Specifications—Comparative Clinical Endpoint Bioequivalence Study Analysis Datasets for Abbreviated New Drug Applications

FDA Product-Specific Guidances for Generic Drug Development webpage

FDA in Brief: FDA issues 54 product-specific guidances to promote generic drug access and drug price competition 


Hematologic Malignancy and Oncologic Disease: Considerations for User of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development

Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format


Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing

Recognition and Withdrawal of Voluntary Consensus Standards

510(k) Third Party Review Program

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions