FDA has announced that inspections to cover FSMA Foreign Supplier Verification Program (FSVP) for Human and Animal Food will be made by requesting an importer’s FSVP records be sent to the Agency electronically (or through other prompt means) instead of an in-person inspection by an Investigator. The Agency is making remote FSVP records inspections during the COVID-19 pandemic to protect both its own staff and that of importers. FDA has determined that most routine onsite inspections are temporarily impractical to conduct at this time.
EAS assists clients with all aspects of FSMA compliance including records audits and development of Good Documentation Practices. Should your firm need assistance pending a request from FDA, or if you would like to proactively insure records are in order contact Allen Sayler, Senior Director of Food Consulting Services.
The temporary shift to remote FSVP inspections will remain in effect until further notice. For more information on FDA’s decision to request FSVP documentation electronically, read the Agency’s Constituent Update here.
Since COVID-19 was first identified, the FDA regulated
industries have been trying to navigate the unique impacts that it has had on
the health of our nation, our economy, as well as the global supply chain. We
are all learning how to work in new ways as we strive to stop the spread of
this virus and protect our families, employees, neighbors and communities.
While the FDA has temporarily amended or suspended certain provisions
and is implementing enforcement discretion, the agency is clear that it fully
expects firms to continue to operate in a compliant manner to ensure the ongoing
safety of the products it regulates.
This has left many firms challenged with how to continue
operations given reduced workforces, possible limitations in supply chains and
of course, social distancing.
To that end, EAS is announcing a webinar series covering
various aspects of compliance in the era of COVID-19. In this issue of EASeNews
you’ll see just the start of our e-learning initiatives, including:
We are in the process of scheduling additional webinars and
look forward to providing you with the most up to date regulatory information and
guidance available. You may also wish to refer to the EAS website, where we
have added a new column on our homepage with summaries of various FDA related COVID-19
Please let us know how EAS can support you and know that we
remain committed to providing you with the most comprehensive regulatory
support available, both now and in the future.
FDA has filed a motion with the United States District Court for the District of Maryland requesting a 120-day extension of the premarket application deadline (currently set for May 12, 2020) for many e-cigarettes, cigars and other tobacco products.
The extension is sought solely because of the coronavirus outbreak and the challenges posed during these extraordinary circumstances. If granted, the 120-day extension would move the deadline to Sept. 9, 2020. However, until a court decision is made, the May 12, 2020 deadline remains in effect.
EAS Consulting Group is closely monitoring these and other FDA initiatives. Please contact us with any questions or if we can be of assistance in the preparation and filing of your PMTAs.
If the court grants this extension, FDA intends to revise its January 2020 enforcement priorities guidance to be consistent with the new deadline, including continued enforcement discretion for a period of up to one year from the date an application was submitted (up to Sept. 9, 2021 if the 120-day extension is granted) or unless a negative action is taken by FDA during that time.
Given the unprecedented challenges that we are all facing, I want you to know that our thoughts and prayers go out to you, your families and employees. We are all learning how to work in new but effective ways, while protecting our neighbors and communities. With the increasing urgency and uncertainty of COVID-19, we at EAS are first and foremost committed to the safety of our employees, consultants, and clients. Please be assured that we are doing everything in our power to minimize the exposure and spread of this virus.
To that end, EAS has made workplace adjustments that allow us to protect the health of our personnel, while continuing to provide the reliable expertise and consulting services you have come to expect. EAS is fully operational and all EAS staff members are working from home with the same tools and capabilities as they have in our offices. Therefore, you may continue to reach us, as you always have, through our EAS phone numbers and email addresses.
Our team continues to closely monitor the unfolding COVID-19 information from the FDA and USDA to ensure all new requirements related to the virus are well understood and provided to our clients in a timely manner.
Though we have temporarily cancelled all non-critical business travel, we remain available to assist you remotely with all your ongoing regulatory consulting needs. Whether it is providing desk audits, SOP reviews, training, labeling review and development, submission support or simply augmenting or supporting your internal regulatory and quality teams, we are committed and available to you and your employees during this crisis.
Thank you for your understanding as we work together during these challenging times. We are honored that you have placed your trust in EAS, and our entire team is committed to ensuring you have access to the resources and expertise needed to meet your ongoing regulatory and compliance requirements.
As Coretta Scott King said, “The greatness of a community is most accurately measured by the compassionate actions of its members.” I think this is important to remember, because only together can we successfully navigate these challenging times.
EAS highly values our professional relationship with our clients and given that it is difficult to predict the impact of the COVID-19 virus we want to take this opportunity to let you know of the risk reduction measures we have taken to protect our staff, consultants and you.
All foreign travel is suspended
Domestic travel is limited to business-critical trips.
We are asking clients to reschedule on-site visits for later in the spring or early summer.
We are proactively monitoring employee health
We are limiting in-person meetings between staff, consultants and clients.
We are utilizing recommended sanitizing and cleaning procedures.
However, during this period of uncertainty, I want you to be assured that EAS remains available to provide you with remote (via teleconference or videoconference) consulting services, such as:
Document writing and review
Thank you for your understanding during these unprecedented times. Please know that EAS will continue to support you and your regulatory consulting needs and provide you with all our available resources as your trusted FDA consulting partner.
If you have any questions or require assistance please do not hesitate to contact me or our staff.
I hope this finds all of you and all of your family well. As your trusted FDA regulatory partner, EAS Consulting Group strives to keep your company informed of current activities at the Agency that may impact your business. Given the Coronavirus Disease 2019 (COVID-19) outbreak, the FDA has been working hard to fulfill its responsibility of protecting the public health and ensuring the safety of our nation’s food supply.
In accordance to the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, dietary supplement manufacturers, packers, or distributors must submit all complaints with the accusation of a Serious Adverse Event (SAE) to the FDA via the electronic MedWatch Form 3500A available on the FDA website within 15 business days of receipt of the complaint.
The guidance discusses the FDA’s intended approach to enforcement of SAE reporting requirements for medical products and dietary supplements during a pandemic, acknowledging that both industry and FDA workforces may be reduced because of high employee absenteeism and other limited resources. During this pandemic, as much compliance and continuity with company complaint processes and SAE reporting requirements should be maintained as possible, with those related to product safety taking highest priority. However, if necessary SAEs can be “stored” and reported to the FDA within the six (6) months after the restoration of normal activities. It is important that the declaration of the pandemic issued by the World Health Organization (March 11th, 2020 for COVID-19) and the situation of high absenteeism or other factors that is/are preventing normal SAE requirements be well documented.
After the pandemic is resolved and a pre-pandemic state has been restored, it is expected that firms will resume fulfilling all reporting requirements on time as well as submit reports that were stored because of pandemic-related high employee absenteeism.
Please let me know if EAS Consulting Group can be of any assistance during this time.
FDA has announced an immediate partial stop work order to state contracted entities for activities such as compliance checks and vape shop inspections in light of the COVID-19 outbreak and in keeping with the White House Coronavirus Task Force and cross-government guidance.
While this stoppage does not apply to those carrying out non-portable activities, such as certain lab activities or the monitoring of imported products, FDA has indicated it will continue to adjust its approach to a number of activities, including facility inspections for all FDA-regulated products such as food, animal feed, drugs, biological products, devices and tobacco.
According to Mitch Zeller, CTP Director at FDA, while inspections will cease immediately, administrative work can continue for two weeks, and the entire situation will be reevaluated over the coming four weeks.
Though inspections are being temporarily halted, it goes without saying that all FDA regulated industries must remain vigilant in ensuring compliance requirements continue to be met. Now is not the time to lose our focus on the safety and legality of our products.
If EAS can be of assistance with any questions related to your current compliance status or how to strengthen operations to better meet FDA expectations, please do not hesitate to contact me.
On March 20, 2020 FDA issued a new guidance on the manufacture of alcohol-based hand sanitizers. This guidance indicates that the FDA is going to use enforcement discretion and allow non-traditional drug firms to make alcohol-based hand sanitizers provided they can meet the following minimum requirements:
The hand sanitizer must be made from alcohol (USP or FCC grade) and be formulated in accordance with the designated 80% denatured alcohol-aqueous v/v solution for ethanol or 75% v/v/ for isopropyl alcohol solution.
Other ingredients in the overall formulation beyond the alcohol API) are limited to: Glycerol (1.45% v/v), Hydrogen Peroxide (0.125% v/v) and the balance is composed of sterile distilled water or boiled cold water [to be used to QS to volume].
No other active ingredients can be added, used or substituted.
A batch record for the production of each batch needs to be generated and maintained in enough detail to determine that it was formulated properly, traces raw materials by lot number and captures weights/volume measures and any calculations.
The manufacturing facility and equipment need to be sanitary, maintained and fit for the intended use.
Finished product testing needs to be conducted using a method appropriate to determine the alcohol content of each batch prior to release.
The FDA approved hand sanitizer label and drug facts panel is used (as referenced in the FDA Guidance – Appendix A, B, C, D).
The manufacturing facility must register with FDA CDER and drug list the hand sanitizer products in the DRLS (Drug Registration and Listing System).
There must be a means of receiving and accepting adverse event reports (AER) for reporting under the FDA’s MedWatch process. (Often these AERs come in initially as a general product complaint so a means of performing assessment a triage of complaints is likely a necessary tool as well.)
Please note that this guidance and the exceptions outlined will only remain in effect as long as the Department of Health and Human Services emergency declaration (of 31 January 2020) remains in effect.
For more information on GMP requirements for OTCs and an overview of FDA enforcement actions I encourage you to view this complimentary on-demand webinar.
Please let me know if you need any assistance or help with registration, listing or setting up for the limited GMP requirements to meet the intent of this guidance.
EAS Memo on FDA Hand Sanitizer Manufacturing Guidnace for COVID-19 Response.
Given the current COVID-19 outbreak that has resulted in numerous travel bans and restrictions all over the world, it is important to note FDA’s temporary enforcement suspension of FSVP supplier verification on-site audit requirements for receiving facilities and importers under FSMA, provided other supplier verification methods are used instead.
My colleague Allen Sayler and I recently co-wrote an article on FSVP requirements published in Food Safety Magazine that discusses the FSMA rule for importing dietary supplements.
When the 1994 Dietary Supplement Health and Education Act (DSHEA) created a legal class of foods, called “dietary supplements,” it carved out many unique regulatory requirements and exemptions. Since the passing of the Food Safety Modernization Act (FSMA) in 2011, dietary supplement firms have the added confusing task of identifying which FSMA rules apply, and what impact, if any, this has to their current dietary supplement quality system designed to meet 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as well as all other applicable statutory requirements. This can be even more challenging when a firm imports dietary supplements or ingredients.
There are seven major rules that have been issued by the FDA to support the enforcement of FSMA:
Current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk-Based Preventative Controls for Human and Animal Food (HARPC)
Foreign Supplier Verification Program (FSVP) Rule
Intentional Adulteration Rule
Product Safety Rule (Fruits and Vegetables)
Sanitary Transportation Rule
Standard for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Voluntary Accredited Third-Party Certification Program
The cGMP and HARPC requirements for foods are dictated in 21 CFR 117, but firms that are in compliance with dietary supplement cGMPs in 21 CFR 111 are exempt from Subparts C – HARPC and Subpart G – Supply Chain Program of 21 CFR 117. In addition, since both 21 CFR 111 and 21 CFR 117 define the cGMP requirements for the sourcing, manufacturing, packaging, holding and distribution of foods, a dietary supplement firm that is in compliance with 21 CFR 111 will already have a quality system in place to address the 21 CFR 117 requirements as well. It is also very important to note that 21 CFR 111 has very rigorous and specific quality and testing requirements for raw materials, in-process materials, packaging components and labels, and finished products; detailed requirements for manufacturing, packaging, and labeling operations; and extensive responsibilities that must be conducted by a Quality Unit.
Whenever a dietary supplement product or ingredient (raw material) is imported from a foreign supplier, the FSMA Foreign Supplier Verification Program (FSVP) rule applies, and many of the raw materials used for the manufacture of dietary supplements are sourced from foreign suppliers. This is NOT covered under 21 CFR 111. However, a Supplier Qualification Program consistent with 21 CFR 111.75(a)(2)(ii) that incorporates the requirements for FSVP is the optimal way to ensure compliance with this FSMA requirement. This Supplier Qualification Program should be a multi-step process which includes the use of a Supplier Qualification Questionnaire, often referred to as the “Paper” or “Documentation” audit; an on-site facility audit of the supplier; and confirmation testing to ensure that the material meets the quality requirements for identity, purity, strength, composition, and the lack of potential contaminants as dictated on the Raw Material Specification. The extent of testing necessary is dependent on the type of material being qualified as well as the responses on the questionnaire and results of the on-site audit. Periodic requalification of the supplier is also required and is based upon a number of factors such as the frequency of material quality issues.
I hope this information is beneficial, as everyone works to ensure continued compliance to all of the FDA regulatory requirements for dietary supplement finished products while also taking all appropriate and necessary precautions for the health and wellbeing of every employee, the community, the nation, and the World.
If you missed FDA’s briefing to food stakeholders on how the COVID-19 Pandemic is affecting the food industry, here are top-line takeaways on immediate impacts to your business. Additionally, attached is a more detailed summary of the meeting.
Should you need any assistance or have any questions on steps your company should take in response to the FDA recommendations, please don’t hesitate to contact
Routine foreign inspections were postponed earlier this month and only “mission-critical” inspections will be conducted as deemed necessary.
Now routine domestic inspections will also be postponed and only “mission-critical” inspections will be conducted as necessary in cases where there is Class I Recall, a foodborne outbreak, or COVID-19 related situation.
Ensuring a continuous supply of safe food is a critical factor for the US and the FDA and Department of Homeland Security are working together to ensure that is the case. Food facilities involved in this supply, are therefore not subject to the quarantine and shelter in place orders and any issues with this should be addressed to the latter and FEMA.