FDA De-Listing of Synthetic Flavors

Steve Armstrong

Q: FDA’s recent announcement delisting seven synthetic flavors caused a flurry of conversation and some confusion within the flavor and extract world. Would you clarify?

Armstrong: Thank you for the question and the opportunity to clear up confusion on FDA’s October 8, 2018 Constituent Update on the removal or delisting of seven synthetic flavors from the list of approved food additives. FDA was clearly reluctant to take this action, but it did so because several activist groups had petitioned for the delisting and then went to court to force FDA to take the action.

FDA made clear in its announcement in the Federal Register that it was only de-listing the synthetic form of these substances, which are labeled as “artificial flavors.” This means that a flavor manufacturer need only remove these synthetic substances from its flavor portfolio. These include synthetically-derived benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone, and pyridine. In addition, the FDA also is amending the food additive regulations to no longer provide for benzophenone’s use as a plasticizer in rubber articles intended for repeated use in contact with food.

In the Federal Register notice published on October 9, 2018 the agency said its revocation of the approvals “does not affect the legal status of foods containing natural counterparts or non-synthetic flavoring substances extracted from food.” FDA noted that each of the seven synthetic substances has a natural counterpart in food or in natural substances used to flavor foods. For example, they say, “benzophenone is present in grapes, ethyl acrylate is present in pineapple, eugenyl methyl ether (methyl eugenol) is present in basil, myrcene is present in citrus fruit, pulegone is present in peppermint, and pyridine is present in coffee.”

According to the Federal Register notice and the communication on FDA’s website, companies may continue to use the seven flavors provided they are only made from the natural extracts and are labeled as “natural flavors.” Companies using these synthetic flavors have 24 months from the publication of the rule in the Federal Register to identify suitable replacement ingredients and reformulate their food products.

This is an unusual situation and one precipitated by the Delaney Clause, an antiquated section of the Food, Drug, and Cosmetic Act. That section of the law prohibits FDA from approving a food additive if, after appropriate testing, it is found that the additive induces cancer in humans or animals. The clause is absolute. It does not provide FDA any leeway for applying a scientific risk assessment, even in situations where, as in the present case, the usage levels of an additive are low and inherently self-limiting, meaning exposures well below any area where they could possibly present any cancer risk. However, the petitioners had submitted data showing high levels of these synthetic substances did induce cancer in lab animals.

So, even though FDA had no concerns about either the synthetic or natural versions of these seven flavors, which had been used for decades, with no concerns about their safety as presently used in foods, the Delaney Clause required that the agency, as a legal matter, take the action requested by the petitioners. Six of the seven were delisted in response to these citizen petitions; the seventh (Styrene) was delisted because it is no longer in use. The agency clearly did not like having to take his step, but the Delaney Clause gave it no choice. The decision to de-list, it said, was required as a legal matter, not a scientific one. It’s possible that this action may signal an effort by the flavor and extract industry to modify the Delaney Clause.

2019 Produce Compliance Dates for FSMA

January 28, 2019, marks the compliance date for four categories of produce growers:

  • Sprouts from Very Small Farms (with certain exemptions), 
  • Sprouts from Very Small Farms eligible for a qualified exemption to comply with other requirements in 112.6 and 112.7, 
  • Other small farms, (except those with certain water requirements), and 
  • Small Farms eligible for a qualified exemption to comply with other requirements in 112.6 and 112.7

must come into compliance.

FSMA’s Final Rule on Produce Safety, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, and FDA’s helpful Small Entity Compliance Guide concerning determination of business size (based on annual monetary value of the food farms sell directly to qualified end users) are two important resources for farms growing and harvesting produce for consumption without further processing.

Recent foodborne illness outbreaks from romaine lettuce illustrate why it is prudent to take a fresh look at some specific areas where the introduction and harboring of pathogens can wreak havoc and cause devastating public health and economic consequences.

FDA’s recently announced that the list of possible growing areas identified as the source of the E. coli outbreak in romaine lettuce has been narrowed to three California counties, and one farm in particular. However, FDA concedes that this does not explain all of the illnesses. As of December 13, 2018, traceback information from five restaurants in four states have identified 11 different distributors, nine different growers, and eight different farms as potential sources of the contaminated lettuce, so it is likely that the outbreak cannot be explained by a single farm, grower, harvester, or distributor. FDA continues to investigate.

It’s also not only E. coli causing produce industry woes. Listeria monocytogenes prompted recent recalls of pre-packaged salad products and asparagus, as did a summer outbreak of Cyclospora in melons and lettuce. 

Why are these events continuing to happen? FSMA’s many requirements were designed to prevent just such occurrences. Are growers not complying with the regulations because they are too difficult to understand, or too difficult to follow? Or are these outbreaks examples of Murphy’s law, that no matter the risk mitigation strategy, if something can go wrong, it will?

The answer, in my view, is yes to all three – and I’ll add that sometimes downstream consequences are not fully understood until it is too late. 

Take for instance, this past summer’s E. coli outbreak in romaine lettuce. The fact that after so many months FDA still cannot pinpoint the exact source of the outbreak suggests these companies and areas under investigation appear (at least on the surface) to be largely in compliance. As of this writing, Whole Genome Sequencing testing has identified only one result where an agricultural water reservoir sediment contains the same E. coli O157:H7 strand implicated in the outbreak. However, the agency says it isn’t clear how the water became contaminated and that additional illnesses demonstrate that this reservoir cannot be the only cause of such a widespread outbreak. 

As compliance dates for various sized produce and sprout farms arrive, FDA will continue to transition from an educational to a regulatory approach for FSMA and supplier enforcement. Prudent companies will take a step back and review their supplier, manufacturing, agricultural and transportation protocols to ensure that all conceivable entry points for microbiological, chemical and physical hazards are controlled, and, when problems do occur, quickly testing entry points to identify and reduce impacts.

Just because something hasn’t yet happened at your facility doesn’t mean it won’t, and don’t assume that just because something happens at one of your suppliers or distributors, that your company won’t see negative repercussions. Food safety is everyone’s business.

EAS stands ready to help you with all aspects of FSMA compliance. Contact us or more information end-users and we invite you to view our many industry information sheets to learn more about our services with regards to foods, FSMA and other FDA requirements for all product areas.

Meet New Consultants

Timothy Morck, Ph.D.

Timothy Morck provides expertise in nutrition-related research, product development, regulatory and public policy and global scientific affairs. Dr. Morck’s career includes clinical nutrition practice, research, and medical school faculty appointments, scientific association management, entrepreneurial personalized nutrition start-ups, and executive and senior management positions at several global food, nutrition and pharmaceutical companies including The Dannon Company, Mead Johnson Nutritionals, Abbott Nutrition, Nestle Health Science and Nestle Corporate Affairs. The interplay between the legal, scientific, and regulatory framework surrounding medical foods has been a particularly sharp focus for him. He received a B.S. in animal science from Penn State University, followed by MS and Ph.D. degrees in nutrition (biochemistry & physiology minors) from Cornell University.

Paula Trumbo, Ph.D.

Paula Trumbo works with clients on food and dietary supplement labeling, claims, and other nutrition related issues for compliance with FDA regulations. Prior to consulting, she led FDA’s Nutrition Science Review Team responsible for the pre-market review of the scientific evidence for food labeling, including health claims, meeting the definition of dietary fiber, and amendments to the Nutrition and Supplement Fact label. She was the US delegate to the Codex Committee on Nutrition and Foods for Special Dietary Uses. Prior to joining the FDA, Dr. Trumbo served as Study Director for a number of study panels at the Institute of Medicine’s Food and Nutrition Board and was Associate Professor of nutrition at Purdue University. Dr. Trumbo has a PhD in biochemistry with minor in nutrition.

Farm Bill Solves “Added Sugar” Problem for Single Ingredient Products

The recently signed Farm Bill answers a number of questions, particularly for those manufacturers of single ingredient foods, jars of honey and maple syrup specifically, who objected to the requirement in FDA’s 2016 Final Rule of adding a declaration of daily value (DV) for added sugars as misleading.  Single ingredient products no longer require an added sugar declaration on the label.

FDA Technical Amendments for Nutrition and Supplement Facts Panels Released

FDA released a technical amendment correcting or further explaining minor errors and omissions in the May 27, 2016, Final Rules for Food Labeling: Revisions of the Nutrition and Supplement Facts Labels and Food Labeling: Serving Sizes of Foods that Can Reasonably be Consumed at One-Eating Occasion. These latest technical corrections are considered administerial in nature. Should you have any questions on these or other labeling issues please contact us for assistance.

Issue of the Month – Tamika Cathey

Tamika Cathey consults with an international client base on regulations pertaining to safety and quality of pharmaceuticals and dietary supplements. She evaluates client compliance readiness by conducting audits, risk assessments and mock FDA/GMP investigations and works to design improvement programs based on findings. Tamika has a B.S. in Biology from Greensboro College in North Carolina. Prior to consulting she held positions such as Associate Director, Regulatory Affairs for Charles River Laboratories, and Consumer Safety Officer at FDA’s Atlanta District. She is a certified auditor with the Natural Products Association and holdsFDA Level II certifications for the Clinical Bioresearch Monitoring Auditor and Drug Auditor Program.

Dietary Supplement Specifications Development – Still Challenging the Industry Ten Years Later

Tamika Cathey

Specifications Development, as defined in FDA’s Good Manufacturing Practices for dietary supplements (21 CFR §111) have posed one of the biggest challenges to industry since the inception of the requirements in June 2007. Specifically, 21 CFR §111.70 requires manufacturers to develop specifications for each component used in the manufacturing process and the finish product, including raw material components, in-process controls, packaging/labeling materials, and finished products. To be compliant with 21 CFR §111, each specification must ensure the quality of the material or product by addressing its identity, purity, strength or concentration, physical composition and lack of potential contaminants or ensuring that potential contaminants are present at acceptably safe levels. However, manufacturers continue to struggle with understanding specifications development and compliance. This is evidenced by the many Warning Letters and Form 483s issued by the FDA in the past ten years.

Certainly, the intent of specification requirements is well understood, at least conceptually by industry. The main purpose for requiring adequate specifications is to prevent product(s) adulteration and ensure that the finish product meets at least 100% of all nutrient claims declared on the Supplement Fact Panel (SFP) throughout its best by date or expiration date per 21 CFR §101.9 under the Nutritional Labeling and Education Act (NLEA). Once a specification is set, the specification must be verified using scientifically sound and justified testing analysis and/or visual examination analysis such as organoleptic, macroscopic, microscopic, chemical, or microbial. Recognized test methods can be obtained from compendial sources like USP monographs, AOAC, FCC, or NF and used a starting point in determining an appropriate method. Multiple tests and examinations are usually deployed to ensure specifications are met per 21 CFR §111.75 and 21 CFR §111.320. All of this ensures consistent reproducibility and reliability of a finished product that is either being manufactured or packaged.

A look at recent warning letters illustrates this lack of understanding with findings such as: 

  • A lack of or incomplete identity component specifications (e.g. dietary ingredients, excipients or process aids, coating materials etc.) for each component per 21 CFR §111.70(b)(1) and 21 CFR §111.70(b)(2).
  • Lack of or incomplete specification(s) for in-process controls in manufacturing process per 21 CFR §111.70(a).
  • Lack of or incomplete product specifications for finish products per 21 CFR §111.70(e) to include package/labeled products (e.g. 21 CFR §111.70 (d) & (f) & (g)).

Briefly, specifications are a set of defined parameters benchmarked against associated acceptance criteria providing characteristics and quality of a finish dietary supplement. The expectation is that when specifications are established, they will be written, managed in a controlled system with revision histories that are tracked, monitored, reviewed and approved by the Quality Department. This means materials and products being used from other sources will be unequivocally identified, the microbiological purity and other purity requirements will be assessed to determine strength and concentration of a dietary ingredient. The physical composition will be evaluated, and any potential contaminants will be identified.

When developing specifications, it is a good idea to begin as early as possible by identifying critical quality attributes of finish product(s) and the manufacturing process as a whole. These quality attributes are to be identified with acceptable ranges determined in order to assess the attribute. Scientifically sound/valid test methods and examinations are tools used to conduct the assessment. Each specification developed should address sections of identity, purity, strength, composition, and contaminants to meet regulatory requirements outlined in 21 CFR §111.

Dietary supplement manufacturers must consider component specifications, including dietary ingredients, as defined in 201(ff) of the FD&C Act and label claimed on SFP, and non-dietary ingredients such as excipients, capsules, and coating materials.

In addition, in-process specifications must be established for any point, step, or stage of manufacturing and packaging processes. Simply put, these specifications focus on verifying material composition thorough a series of physical tests and examinations such as in-process checks and metal detection. These specification requirements can be met by developing a comprehensive Master Manufacturing Record (MMR) as required in 21 CFR 111.210.

Packaging and labeling specifications for components including container closure systems and materials that may come in contact with finish product including desiccants, cotton, pouches, lids, outer cartons, labels, and inserts should include approved/qualified supplier information, name and description of item, and physical attributes such as material type, size, dimensions, and color. Physical attributes and item descriptions can be obtained from a reliable C of A. Keep in mind that packing specifications must be developed for every packing configuration used for finish products. Set process and control specifications within the MMR and set a requirement that visual examination for each batch will be performed.

Finally, finished product specifications (FP) establish the identity, purity, strength, composition, and limits of contaminates for each finished batch of dietary supplement. In short, the finish product specification details testing requirements for a finished batch. All dietary ingredients listed on the SFP must be identified on the FP specification and additional requirements of minimum and maximum acceptance criteria.

It is expected that the claimed SFP ingredients meet at least 100 percent of the label claim in order to meet the requirements NLEA detailed in 21 CFR 101.9. Release specifications may be set at a higher percentage to account for any needed overage amounts formulated into the product to ensure the 100-percent requirement is met throughout the product expiration date or best buy date.

In closing, specifications development can be established based upon acceptable ranges and values set forth by industry, academia, and scientific data/results from published journals, and/or product history in manufacturing. Refer to NLEA mandatory and voluntary labeling disclosure set forth by FDA 21 CFR 109 (j). Accredited laboratories and American Herbal Product Association can provide guidance for building the appropriate specification to include test method. Reference any sources used to determine appropriate specification. If further assistance is needed, manufacturers can also work closely with the qualified supplier(s), an accredited 3rd party laboratory, and/or qualified consultants to help with specification development.

Government Shut Down Impacts FDA and Industry Operations

Dear Readers,

Edward A. Steele

Welcome to the January 2019 edition of EASeNews! We hope this year, as with each year, brings a renewed commitment to safety and innovation in the advancement of your product lines and business.

As the Government Shut Down continues, FDA recently announced that agency operations will continue to the extent permitted by law, maintaining core functions that address imminent threats to the safety of human life as well as activities funded by carryover user fee funds. FDA will continue to respond to emergencies – such as monitoring for and quickly responding to outbreaks related to foodborne illness and the flu; support high-risk food and medical product recalls when products endanger consumers and patients and pursue civil and criminal investigations as appropriate and continue screening food and medical products that are imported to the U.S.. Mission critical surveillance for significant safety concerns with medical devices and other medical products will also continue.  During this period of lapsed funding, however, FDA does not have legal authority to accept user fees assessed for FY 2019 until an FY 2019 appropriation or Continuing Resolution for the FDA is enacted. This includes regulatory submissions for FY 2019 that require a fee payment and that are submitted during the lapse period.

At EAS we are also committed to ensuring our message of compliance reaches the industry. Most recently, our initiative to create video shorts discussing industry challenges and EAS capabilities is well underway! I am pleased to announce the release of Senior Director of Pharmaceuticals and Medical Devices, Bryan Coleman’s discussion of the importance of good preparation for FDA’s GxP audits as well as our auditing services; and Senior Director of Food Consulting Services, Allen Sayler’s discussion of challenges for the dairy industry, particularly in light of the many oversight organizations, as well as EAS’ dairy capabilities. In December we also released our first Hot Topic Report, a short video with Bryan Coleman discussing CDRH increased numbers of medical device inspections and what that means for the industry. We plan to release new hot topic videos to coincide with important FDA announcements. Watch your inbox for these pertinent updates impacting to your industry.

For those who work in Dietary Supplements I am pleased to announce a new training effort aimed at employees and management who are looking to complete their annual GMP compliance refresher training. EAS will host a series of four one-day GMP Refreshers around the country and we invite you to consider outsourcing your quality department’s training to our experts! Join us at one of our upcoming events taught by our internationally recognized compliance experts and gain a greater understanding of your requirements under FDA’s 21 CFR 111.

For those looking for a deeper dive into GMPs we remind you of our two-day full GMP Compliance seminar, which will take place April 2-3, 2019 in Philadelphia, PA. Earlybird rates will expire on February 2, 2019.

In addition, our Food Labeling and Dietary Supplement Labeling Compliance seminars will also take place in Philadelphia, March 12-13 and March 14-15 respectively. More information is found on our EAS website.

Our Issue of the Month article, written by Independent Consultant Tamika Cathey who works in dietary supplement GMP compliance (and who is our trainer for the August 13 Refresher training in Andover, MA), discusses specifications development – which continues to challenge the manufacturing industry. Our Ask the Expert is written by Steve Armstrong, Independent Advisor for Food Law and Regulation, and discusses FDA’s decision to delist seven synthetic flavors and how that decision impacts those firms still using them. Finally, our FSMA perspective, written by Independent Advisor for FSMA, Charles Breen, reminds all firms, (and specifically those working in produce and sprouts as new compliance dates for these industries arrive at the end of January), that food safety is a diligent and on-going process of review, redevelopment (as needed) and execution of pertinent practices to keep consumers safe.

As always, thank for reading our updates and for your interest in EAS. Feel free to share this newsletter with your colleagues and let me know if you have questions.

Sincerely,

Ed

Tamika Cathey

Tamika Cathey

Tamika Cathey provides regulatory compliance services pertaining to safety and quality of pharmaceuticals and dietary supplements. She evaluates client compliance readiness, executes mock GMP/FDA audits, performs risk assessments and gap analyses per FDA regulations and creates improvement programs based on findings. Cathey consulted with EAS from 2012-2016 and we are very pleased that she is again able to offer her expertise to our clients.

Dietary Supplement GMP Refresher Training 2019 NY

Dietary Supplement GMP Refresher Training

November 12, 2019

Plainview, NY

The Good Manufacturing Practices (GMP) dictated in FDA’s 21 CFR 111 require that "Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the person's assigned functions". In order to maintain compliance with this requirement, most companies require that employees attend an annual GMP refresher training. Training programs ensure a deeper understanding of how to perform specific job responsibilities in a GMP compliant manner.

EAS Consulting Group, leaders in FDA regulatory is pleased to offer a new one-day refresher training to help firms meet their training requirements in an in-person personalized setting, providing an opportunity to learn directly from our GMP experts and ask specific questions regarding their GMP issues or situations.

Dates and Location

November 12, 2019

Hilton Garden Inn Melville
1575 Round Swamp Road
Plainview, New York 11803

Registration

$300

Register

Discounts

Group Rate, two or more from the same firm – 10% per person (GROUP10)
Federal/State Government Employees – 10% per person (GOV10)

Registrants with Promotion codes - Limit one Promotion code per transaction

Includes:

  • Participant’s Manual with presentation slides
  • Pocket Guide: 21 CFR Part 111
  • Lunch

Instructor

Heather Fairman, Independent Consultant

Who Should Attend?

  • Individuals involved in the manufacturing, labeling, packaging, storing and distribution of dietary supplements. In addition, members of the management, regulatory affairs, and quality control/assurance teams would benefit from this training.
  • Attorneys and others interested in learning about the requirements of the dietary supplement GMPs and how they should be applied.

Minimum Registration Policy

  • Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel within 45 days of the training and refund the registration fee in full.

Cancellation Policy

  • Cancellations received before 46 days prior to the training event will result in a $95 processing fee. No refunds will be given for cancellations received after that date. Substitutions will be allowed as long as notice is given to EAS in advance.

For More Information

Dietary Supplement GMP Refresher Training 2019 MA

Dietary Supplement GMP Refresher Training

August 13, 2019

Andover, MA

The Good Manufacturing Practices (GMP) dictated in FDA’s 21 CFR 111 require that "Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the person's assigned functions". In order to maintain compliance with this requirement, most companies require that employees attend an annual GMP refresher training. Training programs ensure a deeper understanding of how to perform specific job responsibilities in a GMP compliant manner.

EAS Consulting Group, leaders in FDA regulatory is pleased to offer a new one-day refresher training to help firms meet their training requirements in an in-person personalized setting, providing an opportunity to learn directly from our GMP experts and ask specific questions regarding their GMP issues or situations.

Dates and Location

August 13, 2019

Courtyard by Marriott Boston Andover
200 Rivers Edge Drive
Medford, MA 02155

Registration

$300

Register

Discounts

Group Rate, two or more from the same firm – 10% per person (GROUP10)
Federal/State Government Employees – 10% per person (GOV10)

Registrants with Promotion codes - Limit one Promotion code per transaction

Includes:

  • Participant’s Manual with presentation slides
  • Pocket Guide: 21 CFR Part 111
  • Lunch

Instructor

Tamika Cathey, Independent Consultant

Who Should Attend?

  • Individuals involved in the manufacturing, labeling, packaging, storing and distribution of dietary supplements. In addition, members of the management, regulatory affairs, and quality control/assurance teams would benefit from this training.
  • Attorneys and others interested in learning about the requirements of the dietary supplement GMPs and how they should be applied.

Minimum Registration Policy

  • Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel within 45 days of the training and refund the registration fee in full.

Cancellation Policy

  • Cancellations received before 46 days prior to the training event will result in a $95 processing fee. No refunds will be given for cancellations received after that date. Substitutions will be allowed as long as notice is given to EAS in advance.

For More Information

Heather Neves Duncan Fairman

Heather Neves Duncan Fairman

Ms. Fairman brings nearly 30 years of experience in QA/QC and regulatory compliance from her leadership roles in FDA regulated industries. She was formerly director of Corporate QA and regulatory compliance and the chief safety officer at Natural Organics, Inc., a New York based dietary supplement manufacturer. She has vast experience in establishing, reviewing and executing thorough SOPs, and in handling FDA audits, issues and responses.

Dietary Supplement GMP Refresher Training 2019 TX

Dietary Supplement GMP Refresher Training

May 7, 2019

Denton, TX

The Good Manufacturing Practices (GMP) dictated in FDA’s 21 CFR 111 require that "Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the person's assigned functions". In order to maintain compliance with this requirement, most companies require that employees attend an annual GMP refresher training. Training programs ensure a deeper understanding of how to perform specific job responsibilities in a GMP compliant manner.

EAS Consulting Group, leaders in FDA regulatory is pleased to offer a new one-day refresher training to help firms meet their training requirements in an in-person personalized setting, providing an opportunity to learn directly from our GMP experts and ask specific questions regarding their GMP issues or situations.

Dates and Location

May 7, 2019

Hilton Garden Inn
3110 Colorado Boulevard
Denton, Texas 76210

Registration

$300

Register

Discounts

Group Rate, two or more from the same firm – 10% per person (GROUP10)
Federal/State Government Employees – 10% per person (GOV10)

Registrants with Promotion codes - Limit one Promotion code per transaction

Includes:

  • Participant’s Manual with presentation slides
  • Pocket Guide: 21 CFR Part 111
  • Lunch

Instructor

Robert Fish, Independent Advisor for Quality and Compliance

Robert FishMr. Fish joined EAS Consulting Group, LLC in November 2006 after ten years consulting for FDA regulated industries. He spent 33 years with Food and Drug Administration (FDA), the last 6 years of that service as Director, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Prior to that position, Mr. Fish was Director of Compliance at the Nashville District Office and was also a Supervisory Investigator at the Nashville District Office. Mr. Fish began his career as an investigator in the Minneapolis District Office in 1962 and subsequently served as an Investigator at the Grand Rapids Residence Post and the Detroit District Office. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceutical, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert, speaking at international events on FDA inspections and GMPs.

Who Should Attend?

  • Individuals involved in the manufacturing, labeling, packaging, storing and distribution of dietary supplements. In addition, members of the management, regulatory affairs, and quality control/assurance teams would benefit from this training.
  • Attorneys and others interested in learning about the requirements of the dietary supplement GMPs and how they should be applied.

Minimum Registration Policy

  • Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel within 45 days of the training and refund the registration fee in full.

Cancellation Policy

  • Cancellations received before 46 days prior to the training event will result in a $95 processing fee. No refunds will be given for cancellations received after that date. Substitutions will be allowed as long as notice is given to EAS in advance.

For More Information

Dietary Supplement GMP Refresher Training 2019 CA

Dietary Supplement GMP Refresher Training

May 14, 2019

Riverside, CA

The Good Manufacturing Practices (GMP) dictated in FDA’s 21 CFR 111 require that "Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the person's assigned functions". In order to maintain compliance with this requirement, most companies require that employees attend an annual GMP refresher training. Training programs ensure a deeper understanding of how to perform specific job responsibilities in a GMP compliant manner.

EAS Consulting Group, leaders in FDA regulatory is pleased to offer a new one-day refresher training to help firms meet their training requirements in an in-person personalized setting, providing an opportunity to learn directly from our GMP experts and ask specific questions regarding their GMP issues or situations.

Dates and Location

May 14, 2019

Courtyard by Marriott Riverside UCR / Moreno Valley Area
1510 University Ave
Riverside, CA 92507

Registration

$300

Register

Discounts

Group Rate, two or more from the same firm – 10% per person (GROUP10)
Federal/State Government Employees – 10% per person (GOV10)

Registrants with Promotion codes - Limit one Promotion code per transaction

Includes:

  • Participant’s Manual with presentation slides
  • Pocket Guide: 21 CFR Part 111
  • Lunch

Instructor

Timothy Stewart, Ph.D., Independent Advisor for Dietary Supplements

Tim Stewart Ph.D.Tim Stewart is a Ph.D. chemist who advises clients on FTC, AG and FDA regulatory compliance issues such as Customs and Border Patrol, Import Alerts, State and Federal observations/violations, Consent Decrees, California Proposition 65 requirements, and vendor qualifications.  Prior to consulting, he worked at Paragon Laboratories as a Quality Control Manager and researcher at both Harvard Medical School and the University of Southern California.

Who Should Attend?

  • Individuals involved in the manufacturing, labeling, packaging, storing and distribution of dietary supplements. In addition, members of the management, regulatory affairs, and quality control/assurance teams would benefit from this training.
  • Attorneys and others interested in learning about the requirements of the dietary supplement GMPs and how they should be applied.

Minimum Registration Policy

  • Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel within 45 days of the training and refund the registration fee in full.

Cancellation Policy

  • Cancellations received before 46 days prior to the training event will result in a $95 processing fee. No refunds will be given for cancellations received after that date. Substitutions will be allowed as long as notice is given to EAS in advance.

For More Information

FDA’s CDRH Increasing Medical Device Inspections

FDA’s CDRH announced an increasing number of inspections of medical device manufacturers for a targeted risk-based approach for improved compliance in their recent Medical Device Enforcement and Quality Report. Since 2007, the FDA has increased its annual number of device inspections by 46 percent and has increased annual inspections of foreign firms by 243 percent. Will your firm be ready when FDA knocks on your door? Learn more from Bryan J. Coleman, EAS Senior Director for Pharmaceutical and Medical Devices in this Hot Topic report.

 

EAS’s 2018 Year in Review and Expectations for 2019 – Evolving FSMA, Anticipation for TPMPs

As we reflect on 2018, we are again honored that so many look to EAS as their regulatory solution to a complicated world of FDA requirements. FDA’s continued focus on safety as well as the industry’s embrace of regulations that often challenge their old methods of doing business can only mean continued improvements and communications in the name of public health. In 2018, the Food Safety Modernization Act (FSMA) again dominated the news as numerous compliance dates arrived. We received questions from all over the world, particularly on issues pertaining to the Foreign Supplier Verification Program (FSVP). As of June 1, 2018, FDA had completed 256 inspections of foreign firms resulting in the issuance of 483s. Based on that, one of the primary concerns our callers have is understanding what constitutes an FSVP in FDA’s eyes and whether their documentation or documentation they were in the process of preparing, would qualify as compliant. Questions on what is a Qualified Individual and how EAS can assist in that regard with foreign suppliers are also a concern.

Our Independent Advisor for FSMA, Charles Breen, stayed busy preparing updates on FSMA compliance as part of our EAS-e-News monthly column “FSMA Perspective” and he, as well as all of our consultants who work in Foods, collaborated on numerous webinars and articles helping the industry to gain a greater understanding of FDA expectations. We even conducted our first webinar in Spanish presented by Gustavo Gonzalez, Ph.D., “FSVP – What Does it Mean for Your Business?” which is available on-demand free of charge on the EAS website. More recently, Charles presented a webinar on FSVP for the National Customs Brokers and Forwarders Association of America.

It wasn’t just FSMA that got industry’s attention. New labeling regulations for food and dietary supplements have kept food and supplement manufacturers busy. From sugars to fibers to new requirements of what and how to include nutritional information, our Food Labeling and Dietary Supplement Labeling seminars have been very well attended. (Our spring series is scheduled for Philadelphia and hyperlinks here point to registration information should you be interested in joining us). In addition, EAS published articles on the subject and is pleased to be in the final preparation stages for a webinar on December 6th where James Hoadley, Ph.D. one of our expert labeling consultants and trainers will discuss the new dietary fiber regulations with two members of FDA’s CFSAN for the Institute for Food Technologists. These labeling issues are requiring firms to rethink how products are not only labeled but marketed and our Product Development and Labeling team is enjoying the challenge of helping firms navigate new requirements as they find solutions that meet both business and FDA expectations.

The dietary supplement industry continues to be challenged by GMPs dictated in 21 CFR 111 as evidenced by 2018 statistics indicating the top observations issued are still Specifications and Testing, Master Manufacturing Records and Batch Production Records, Quality Unit Responsibilities, and Complaints; the same as they have been since 2010 when the 21 CFR 111 regulations applied to all sizes of dietary supplement firms. Following is a graph prepared by the Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., which summarizes the posted FDA statistics through 2017 and clearly illustrates this never-ending trend. If there is one bright spot, it is that the percentage of firms getting an Official Action Indicated (OAI) or Voluntary Action Indicated (VAI) is down to 54%. It has been significantly higher in previous years.

TOP FDA Observations: 2010 - 2017

RankCitationDescriptionNumber of Times Cited
201020112012201320142015201620172010-2017
121 CFR 111.75Testing541112262871881441952161421
221 CFR 111.70Specifications321041762342041542142511369
321 CFR 111.205MMRs28539411782678794622
421 CFR 111.255BPRs1852749371717287538
521 CFR 111.103QU Operations1843476647455576397
621 CFR 111.553Product Complaints1534427036283163319
721 CFR 111.453Holding & Distribrution618294732273046235
Total Observations631132819642211154912941625184212444

In medical devices, FDA’s decision to expand the use of the De Novo submission pathway was welcomed by industry. De Novo applications are appropriate in cases where it appears that the device meets the statutory standards for classification into Class I or Class II under section 513(a)(1) of the FD&C Act, and when the sponsor has determined that the device does not fall within any existing classification regulation. EAS authored an article for MedTech Intelligence on the subject.

EAS expanded its services into the area of cannabis GMPs in 2018. This newly evolving industry, regulated by some states as a food, others a dietary supplement and in some cases as a pharmaceutical, is challenged in many regards with how to set up, validate and verify a quality system. Quality is one of EAS’ many strong capabilities and our team of consultants is rising to the challenge of assisting this newer industry. Tara Couch presented a webinar “Quality Systems for the Cannabis Industry” and for the first time, we incorporated cannabis applicability into our two-day dietary supplement GMP seminar for a special presentation. We were also frequent contributors to the Cannabis Industry Journal including Gabe Miller who authored an article on Food Safety in the cannabis industry and Celia Schebella who discussed designing cannabis edibles in the state of California.

As we look ahead to 2019 there are a few notable things on the horizon that EAS consultants are watching for:

On the Tobacco front, the Center for Tobacco Products’ director Mitch Zeller, announced at the annual Tobacco Merchants Association (TMA) meeting that the agency is actively working on developing its own set of GMP protocols for the tobacco industry, called Tobacco Product Manufacturing Practices (TPMPs). In an effort to help tobacco firms begin forward thinking in these terms, EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. and President and COO, Dean Cirotta presented a webinar in partnership with TMA (now available on-demand) on how to prepare for these TPMPs based on the long-standing GMPs for the dietary supplement industry.

In addition, OTC Monograph reforms have been underway for some time and it is anticipated that 2019 will bring these new requirements to light. Independent Consultant Norma Skolnik prepared an article for EAS-e-News on expectations earlier in the year and EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, will present a five-part webinar series on the subject starting January 16. She’ll discuss why these reforms are necessary, are being undertaken now, and how OTC drug companies can expect those changes to impact their labels.

In the Dairy world, FDA has fast-tracked a review of how the words “milk” and “cheese” are used in dairy substitutes. The Dairy industry is also anticipating enforcement of the new Appendix T of the PMO which will implement FSMA-like requirements aimed at preventive measures to improve safety. More information on both of these as they unfold.

On the home office front, the EAS staff was very pleased when the extensive expansion and renovation of our office space was complete, and we think it looks great! This new area enables EAS training hosted in the DC area to move in-house and offers enhanced meeting capabilities, both in-person and remote. If you are in the D.C. area, we invite you to come by! In addition, we completed a major redesign of our website, found at easconsultinggroup.com. We hope you’ll agree that this new digital space is not only improved in appearance but provides easier access to not only information about EAS services and seminars, but also regulatory information prepared by our independent consultants and distributed through a variety of professional trade journals and organizations.

We also welcomed 24 new consultants, re-welcomed three consultants who returned to EAS after a stint in the industry and brought on a new office manager, Jodi Burns. EAS is only as strong as our professional network of skilled and knowledgeable consultants, directors and support staff. We feel we have some of the best in the business!

If it seems like EAS consultants have a wide-reach of educational support, you are right. All told EAS presented 13 two-day public seminars, will have conducted 19 webinars by the end of 2018; published 40 articles, and spoke or moderated at 25 industry events such as IFT, Food Safety Consortium, Supplyside West and a variety of FDLI-hosted events. We also exhibited at important trade shows such as IFT, Supplyside West, Food Defense Conference, IAFP and others.

One trade show event, nearest and dearest to our hearts was the 2018 AdvaMed MedTech Intelligence conference in Philadelphia where Ryan Steele, granddaughter of Chairman and CEO of Ed Steele, and daughter of CFO Brett Steele, was an invited speaker on the main stage sharing her story as just one many who has been positively impacted by the innovation of science and technology, in Ryan’s case with the implantation of a vertical expandable prosthetic titanium rib, which is the only FDA approved device to treat thoracic insufficiency syndrome.

It is stories such as hers that brings home why we all do what we do, designing products that fill a need and a niche and do so safely and effectively. While FDA regulations may feel cumbersome at times, it is those instances, where important decisions with critical outcomes are in front of us, that we can all appreciate FDA’s diligent focus on ensuring only compliant products are available to the US consumer. Here at EAS, we support firms working in all FDA regulated commodities to do just that and we take great pride in our ability to meet their needs.

Thank you for journeying with us in 2018 and we look forward to a peaceful and prosperous 2019. Have a very happy holiday and New Year!

Drug and Device Corner 2018 December

Guidance Document updates on the FDA website:

All centers:

  • Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for IndustryOn December 3, 2018, the U.S. Food and Drug Administration (FDA) published the guidance for industry entitled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.” The final guidance provides recommendations to industry on Post-complete response letter (CRL) meetings between the FDA and abbreviated new drug application (ANDA) applicants to clarify deficiencies identified in a CRL to an ANDA submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act.

CDER:

CDER & CBER:

CDRH & CBER:

CBER:

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

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

Join Tim on December 18, 2018, at 1:00 pm Eastern for his discussion on Overcoming Seafood Fraud in a complimentary webinar hosted by EAS. Reserve your seat today!

Essential Quality Systems for Own Label Distributors Discussed in Natural Products Insider

Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., has written an article for Natural Products Insider on the intersection of OLD and Quality Systems. “The development and implementation of essential own label distributor quality systems and programs will go a long way to ensure GMP compliance in a contract manufacturer partnership,” she says.

In addition, for those who missed or would like to review the very informative webinar presented by Bruce Elsner, also on OLD responsibilities, it is now available on-demand on the EAS website along with many other complimentary webinars covering a wide range of regulatory topics.

Appendix T Storm is Hitting the Grade A Dairy Industry

Senior Director for Food Consulting Services, Allen Sayler, published an article in Dairy Foods Magazine on FDA’s PMO (Produce Milk Ordinance) new Appendix T, which mirrors FSMA in many ways in that it requires preventive controls for those hazards not already covered in the PMO. This new requirement may well be the dairy industry’s most significant new regulatory challenge for 2019. “One of the major challenges many firms face is the establishment of acceptable written food safety programs and maintenance of required records that demonstrate compliance with Appendix T. The failure of a Grade “A” dairy plant to meet any of these requirements will result in either loss of its Grade “A” designation or a request for the state to remove its Grade “A” designation.”

New Report on the Sources of Foodborne Illnesses Highlights Urgency of FSMA Compliance

The Interagency Food Safety Analytics Collaboration (IFSAC) report, “Foodborne illness source attribution estimates for 2016 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States”, highlights why FSMA is so important a tool in driving the food industry to do more to prevent foodborne outbreaks. Each year in the U.S., an estimated 9 million people get sick, 56,000 are hospitalized, and 1,300 die of foodborne disease caused by known pathogens. IFSAC identified four priority pathogens, Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter that together cause 1.9 million foodborne illnesses each year. In addition to their frequency, these pathogens are also well-known for the severity of the illnesses they can cause, and the fact that targeted interventions can significantly reduce their incidence.

The IFSAC statistical analysis showed 1,255 outbreaks between the years 1998 and 2016 (3,553 in raw data) in which a confirmed or suspected food or foods could be assigned to a single food category: 762 caused or suspected to be caused by Salmonella, 235 by E. coli O157, 37 by Listeria, and 221 by Campylobacter. Using outbreak data, the report estimates:

  • Salmonella: Illnesses came from a wide variety of foods, of which more than 75% of illnesses were attributed to seven food categories: Seeded Vegetables (such as tomatoes), Chicken, Pork, Fruits, Other Produce (such as nuts), Eggs, and Beef.
  • E. coli O157: Nearly 75% of illnesses were linked to Vegetable Row Crops and Beef.
  • Listeria monocytogenes: Illnesses were most often linked to Dairy products and Fruits.
  • Campylobacter: Over 80% of non-Dairy foodborne illnesses were attributed to Chicken, Other Seafood (such as shellfish), Turkey, Other Meat/Poultry (such as lamb or duck), and Vegetable Row Crops, with the majority of illnesses most often linked to Chicken.

Since FSMA’s passage in January 2011, FDA has worked hard to educate stakeholders on the many new food safety requirements covering all foods (with limited exceptions) under FDA’s purview. The message of the newly released IFSAC report strongly suggests that manufacturers and processors of implicated food categories should take special care. If not FDA coming to look, it will be FSIS to check on food safety measures and controls.

For example, the Produce Safety Rule and more recent Guidance for Industry establish science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. Specific requirements include agricultural water (pending further research), biological soil amendments, worker hygiene, building and equipment requirements. Growing sprouts is given special attention because of the inherent risk.

After the largest E. coli O157 outbreak in a decade, the Agency confirmed in early November that three samples of irrigation canal water were found to be contaminated with the H7 strain that sickened so many and killed five. Shortly before this announcement, the Agency released a Draft Guidance for Industry on minimizing food safety hazards for cut produce that discusses how to comply with new Good Manufacturing Practices as well as hazard analysis and risk-based preventive controls.

You may have also want to read EAS Senior Director for Food Consulting Services, Allen Sayler’s recent article in Dairy Foods Magazine on how FDA’s enforcement of Appendix T in the 2017 Pasteurized Milk Ordinance is focusing on FSMA-like requirements. I expect this to be a game changer for the Dairy industry.

Reports such as IFSAC’s find that the majority of severe foodborne illnesses can be mitigated through better controls, and more diligent efforts at safety. We can only be encouraged as FSMA compliance dates tick forward and we learn more of the “whats” and “hows” of preventive controls and better implementation methods. Unfortunately, we also learn much from cases where preventive controls did not work. When that happens, all of the industry should take note, assess their own procedures and make adjustments as needed so that we can collectively continue to create a safer food supply.