FDA Proposing to Change the 510(k) Submission Process for Medical Devices

Each month, EAS selects one question sent in by readers to be answered by one of our experts. This month’s question is answered by George Yanulis D.Eng., an expert in medical device safety and the 510(k) process.

Question: Why is FDA proposing to change the 510(k) submission process for medical devices?

Yanulis: The rapid technological advances in the medical device arena have been dramatic. A 510(k), otherwise known as a Premarket Notification, is the mechanism by which device manufacturers notify FDA of their intent to market a medical device at least 90 days in advance of doing so. By reviewing the data in a 510(k), FDA is able to determine whether the device is equivalent to a device already placed into one of the three classification categories, Class I (General Controls requiring the least amount of regulatory control because they present minimal harm to users), Class II, (General Controls with Special Controls that must comply with specific labeling requirements, mandatory performance standards and postmarket surveillance) or Class III, (those devices requiring a PMA due to insufficient information to assure the safety and effectiveness solely through general or special controls. As a consultant, Class III medical devices have been my primary focus, particularly in the ICD and cardiac pacemaker device areas.

On November 26, 2018, then FDA Commissioner Scott Gottlieb announced changes to the process for approving medical devices for the U.S. market aimed at dramatically revamping the popular 510(k) clearance pathway which enables approvals based on predicates. FDA recognizes its current approach has the potential to limit advancing technological innovation and FDA is now looking to limit the age of predicates to ten years in order to avoid using outdated technologies as older predicates are less relevant to today’s requirements of interconnectivity and complexity.

FDA is proposing an approval outside of the 510(k) process if the comparable device being used is older than a decade, a change that would significantly disrupt the current process through which the vast majority, (80%) of devices are approved. FDA proposes creating a new alternative 510(k) pathway that will focus on objective safety and performance criteria. While devices more than 10 years old are not believed to be unsafe, nor would those devices need to be removed from the market, the change will encourage use of more modern predicates and as such encourage competition to adopt modern technologies and features while improving overall standards and improving outcomes.

As an expert who has collaborated directly with the FDA and particularly with CDRH, I welcome these changes. My expectation is that all devices will continue to be safe and effective, and substantially equivalent as dictated in the 510(k).

You may find some of the below FDA resources to be helpful, and please contact EAS with specific questions regarding your 510(k) filing.

https://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/

https://www.fda.gov/downloads/Training/CDRHLearn/UCM421766.pdf

2019 April Ask the Expert

Each month, EAS answers one question sent in by our readers. This month’s Ask the Expert is answered by Independent Consultant and former head of the NOAA Seafood Inspection Program and Division Director in FDA’s Office of Seafood, Timothy Hansen. Tim has extensive experience in seafood regulatory affairs, certification, and advises the seafood industry on science and technological matters. If you would like to ask a question of one of our experts, click here.

Question: As a seafood importer how can I protect myself from fraudulent suppliers?

Hansen: The seafood industry is mostly comprised of smart, hardworking, honest professionals that take regulatory compliance seriously, and a few unscrupulous operators who aim to misrepresent their products for financial gain or enhanced competitive advantage. It would be wise for all firms and particularly importers of seafood to be aware of some of the more common fraudulent practices so that you can protect your firm, your customers and ward off FDA enforcement action by perpetuating fraud to your customers. Some types of fraudulent activities to be aware of:

Species substitution, usually representing a lower cost but similar species as a higher cost or higher quality species such as Chum Salmon for Coho Salmon. When this occurs, not only is the fish fraudulent but so too is the labeling including PDP, weight declaration and nutritional information.

In other cases, suppliers may provide a fraudulent shipment weight due to overglazing of ice, overbreading that exceeds USDC, NIST or AOAC standards, or even what is called “rat packing” where the superior product is on top, hiding the inferior product underneath.

According to the NOAA Fisheries Seafood Inspection Program, as of 2014 around 30% of seafood in the U.S. is considered fraudulent. This can be attributed to intentional fraud where the seafood operator is looking to gain an unearned profit, “best” the competition, or they commit fraud due to pressures stemming from the inability to fill customer orders. In other cases, unintentional fraud may also be committed, attributed to honest mistakes such as the misinterpretation of regulations or miscommunications and messaging errors due to poor process controls which lead to unknowingly receiving and accepting a fraudulent product from a supplier.

There are a number of ways the seafood industry can protect themselves, the most obvious of which is to develop relationships with reputable suppliers and to regularly inspect incoming shipments. In addition, if your firm does not already have fully developed product specifications guidelines consider creating these as part of your business operations plan. You will also want to have a Quality plan in addition to your HACCP plan and enhance your labeling controls beyond the minimum HACCP requirements. Consider also utilizing process control techniques such as statistical weight control charts and Quality Assurance software.

Protocols for all Quality, HACCP and other SOPs must be developed by a competent person, either within your organization or created by an outside entity, such as EAS, with expertise specific to the seafood industry. Ensuring compliant process control techniques can significantly increase your company’s integrity, leading to a satisfied customer, and reduce your risk of regulatory action.

EAS has a team of experts with career histories in FDA inspections and the seafood industry. If we can help your company to create or improve your compliance programs, please give us a call. We invite you to view our many industry services facts sheets on the EAS website, or more specifically that which pertains to our seafood services.

How Do Legal Teams Find and Identify Good Expert Witnesses?

Each month EAS answers one question sent in by a reader. This month’s question on how to choose an expert witness for FDA legal proceedings is answered by Independent Consultant, Ronald J. Levine. Ron has had a successful career history as a litigator at one of the top New York law firms and is available to EAS clients for assistance with compliance questions and risk assessments. We were interested in hearing Ron’s thoughts since EAS provides consultants who can become a part of a legal team, by writing expert opinions, participating in depositions or being called to the stand as an expert witness. You can view EAS’ Expert Witness Services Sheet to learn more. If you would like to ask a question of our independent consultants, please contact us.

How Do Legal Teams Find and Identify Good Expert Witnesses?

Thank you for an excellent question. As a litigator who has retained many expert witnesses during my 40- year career as a lawyer, I have found that finding the right expert for a case can make all the difference in the world.

In almost any investigation or litigation involving regulated products, an expert can help explain your position to the fact-finder and render opinions which an average person would not have the knowledge or experience to offer. The FDA expert’s ability to offer a deep understanding of complex regulations and production protocols, such as Good Manufacturing Practices (GMP); and assistance with developing strategy in responding to the FDA; can make the expert a valuable extension of the legal team.

Where are the Legal Teams Looking?

Once the legal team has identified the subject area and credentials of the expert required for the task, they will begin the search.

The team may well begin with publications, articles and websites in the practice area and will be most interested in the positions the expert has taken in the past on the topic at issue – to see whether the opinion aligns with the legal team’s stance.

Experts who have testified previously, with names appearing in published court opinions, may be found by attorneys who are researching the legal authority in the area. Also, legal teams may send out queries via bar groups and industry associations.

How can I find a “Good” Expert?

There are at least three qualities of a “good” expert witness.

First and foremost, experts should be able to articulate what makes them an expert. Expertise could be based upon academic and professional credentials​ and on the job experience. In some cases, experience as an academic provides extra credibility, particularly those who have published in peer-reviewed journals.

Secondly, a “good” expert is one who is able to articulate his or her opinions in a manner which lay people will understand and accept. The expert will not be addressing peers who talk the same language. They will be trying to convince a jury, who may have limited educational credentials​ and no experience in the field. Legal teams will also be looking for experts who are poised and make others feel comfortable. They are going to avoid those who arrogant or not willing to listen.

Finally, legal teams are looking for experts who are able to handle themselves under intense cross-examination. They need to be able to listen to questions. The expert must be on the alert for trick questions, and know how to answer questions posed by experienced trial lawyers. Legal teams want to work with a seasoned expert who are familiar with the courtroom.

What Does the 2018 Farm Bill Say About Sugar, Honey, and Agave?

Each month EAS Independent Consultants answer one question sent in by our readers. This month’s question is answered by James Hoadley, Ph.D., an expert in food and supplement labeling and content claims and long-time instructor for our popular Food and Dietary Supplement Labeling Compliance Seminar. Prior to consulting Jim was the Senior Regulatory Scientist, Nutrition at FDA’s CFSAN Office of Nutritional Products, Labeling and Dietary Supplements.

If you’d like to ask a question of our experts, contact us here. To learn more information on our Food and Dietary Supplement Labeling Seminars please visit our webpage.

Question: I am a smaller company that produces maple syrup and honey sold in jars. Does the 2018 Farm Bill mean I no longer have to comply with the 2016 FDA Nutrition Facts requirements for these two single-source products?

Hoadley: One of the NUTRITION FACTS changes introduced in the FDA’s 2016 revisions to nutrition labeling regulations was a new line in the Nutrition Facts for Includes __ g added sugar. When a food contains sugars, but not added sugars, then the “Includes X g added sugars” line may be omitted from the Nutrition Facts and replaced by a “Not a significant source of added sugars” footnote. The term added sugar includes both sugars that are added during the processing of foods, and sugars packaged as such; e.g., a bag of sugar or a bottle of honey would need to declare its entire sugar content as added sugar. Including the single ingredient sources of sugar as added sugar was unpopular and confusing. FDA’s rationale was that when you purchase a bag of sugar, you are going to use it to add to food, so its use is as added sugar. In the past year FDA attempted to make the added sugar declaration more palatable for producers of products like honey and maple syrup by allowing for an enforcement discretion option of footnoting the added sugars declaration with a statement such as “†All these sugars are naturally occurring in honey.” The footnote option was not enough to sugar-coat the “Includes X g added sugars” requirement in some segments of the food industry. Though your product no longer has to declare added sugar, it still needs to comply with all other requirements for Nutrition Facts. 

2018 Farm Bill. SEC. 12516. LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS.
The food labeling requirements under section 403(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar, honey, agave, or syrup, including maple syrup, that is packaged and offered for sale as a single-ingredient food bear the declaration “Includes X g Added Sugars.”.

Congress joined in the party by placing an ‘added sugars’ section in the miscellaneous provisions of the 2018 Farm Bill. The 2018 Farm Bill has decreed that FDA shall not require any single-ingredient sugar, honey, agave, or syrup product to bear the “Includes X g added sugars” declaration in its Nutrition Facts. The Farm Bill is an omnibus bill that directs agriculture and nutrition policies; it gets renewed at 5-year intervals. The 2018 Farm Bill covers the years 2019-2023. Provisions of the 2018 Farm Bill go into effect January 1, 2019.

FDA De-Listing of Synthetic Flavors

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.

Laser Products and 510(k) Requirements

Each month EAS’ Ask the Expert answers questions sent in by readers on a variety of FDA regulatory topics. This month’s question on FDA’s regulation of lasers and 510(k) applications is answered by Jerry Dennis. Jerry is a former member of CDRH where he was responsible for radiation safety standards for laser products, (21 CFR 1040). He also developed regulatory policies and guided CDRH in report review criteria and regulatory policy pursuant to the Radiation Control Act and its regulation on radiation physics and biological effects. Prior to CDRH, he was a manager of high energy laser products for Hadron, Inc. If you would like to ask a question of our experts, click here.

Question: Is the FDA laser standard and product report in addition to the requirement for premarket notification (510k) or premarket approval?

Answer: Yes! And, FDA has additional regulatory requirements not only for laser products that are medical devices but also for other medical devices that generate radiation of any kind, in addition to requirements for certain other kinds of electronic products that generate radiation.

The FDA Center for Devices and Radiological Health (CDRH) has promulgated radiation safety performance standards for the following kinds of medical devices: diagnostic x-ray systems and their major components; radiographic equipment; fluoroscopic equipment; CT equipment; medical laser products; sunlamps and UV lamps for tanning; and ultrasonic therapy products. Additionally, there are such standards for television receivers, cold-cathode gas discharge tubes, microwave ovens, laser products other than medical laser products, and high-intensity mercury vapor lamps (for general illumination).

Manufacturers and/or US importers of products subject to such standards are required by regulation to certify their products’ compliance with the applicable standards, to submit product reports that describe their products and their manner of compliance with the standards and annual reports and to maintain distribution records. Additional portions of the regulations cover notifications and corrections. General requirements under these regulations require reporting of radiation defects or of accidental radiation occurrences for all products that generate radiation whether or not there is an FDA standard. The FDA electronic product radiation safety regulations are in 21 CFR 1000 through 1050. The only exception is that mandatory reporting under part 803 supersedes the reporting of accidental radiation occurrences for electronic products that are also medical devices.

If your company produces a radiation emitting product, contact EAS for assistance with product development and testing protocols, filing reports to FDA and appropriate packaging and insert labeling.

How to Prioritize Planning for Food Safety Emergencies

Charles BreenThis month’s Ask the Expert is on how to prioritize planning for food safety emergencies, particularly in light of the challenges of not only the emergency itself but recovering from it with your company’s reputation intact. It is answered by Charles Breen, EAS Independent Advisor for FSMA and Stacey Stevens, a Senior Vice President at FoodMinds, a division of Padilla. FoodMinds is EAS’ newest cooperative partner, and together our services help our clients working in the food industry to tackle regulatory and public relations challenges.

Question: As part of FSMA I am working to develop our company’s food safety contingency plans. How do I prioritize and plan for the first steps we need to take – investigations, recall communications and managing our public relations?

Answer: Great question and one worthy for all companies to consider, especially, as you point out on the regulatory side, FSMA mandates include both a hazard analysis risk assessment and if hazards in need of control exist, a recall plan. In addition, every company strives to mitigate harm to its reputation in the face of public scrutiny. So, how does one go about developing a comprehensive plan and assigning tasks on both sides of the coin? First, on the safety front:

In the interest of public safety, whenever a food safety issue has been reported, whether by FDA, another food safety authority or the public, unless you can unequivocally rule out your product as the culprit, initiate a recall. While the FDA and other food safety authorities could be wrong, they very rarely are. This will help to limit further harm, particularly in the case of Class 1 recalls which have a high likelihood of injury or death. Make sure management, as well as legal representatives, are informed of the decision to recall.

Next, per regulation, file a Reportable Food Registry report on FDA’s website. This must be completed within 24 hours of learning of the problem. It’s OK to have incomplete information to start, you must update the file as more information becomes available.

Keep good records and implement your Trace Back and Trace Forward action plan – match ingredients and sources with bills of lading so that you can attempt to identify the source of the problem. Establish the last documented evidence before the problem arose, the time the problem became known, and documentation that it was controlled. You’ll also need to identify recipients of the product and alert them directly. If those recipients cannot be accurately identified, the recall will grow exponentially larger, more expensive, and harder to manage.

Next, on the communications front, remember to take control of the messaging and communicate early and often. The public will want to know what you are doing to protect them now and how you will do things differently in the future. Be empathetic, forthcoming, and express an understanding of the seriousness of the situation. Don’t forget social and on-line media, websites and microsites – post brief updates in real time to keep everyone informed from line employees to key stakeholders and consumers.

In many cases, companies involved in a food safety emergency will enlist the assistance of qualified and experienced third-party consultants to help them through the crucial regulatory and safety steps as well as strategic public relations messaging.

What Exactly is an FSVP?

Ask the Expert offers a chance for our readers to submit questions to EAS regarding areas of regulatory confusion. This month’s question is answered by Allen Sayler, Senior Director of Food Consulting Services. If you’d like to submit a question, please use the “contact us” link on our website.

Question: FDA is cracking down on enforcement of the Foreign Supplier Verification Program (FSVP) through inspections of US-based FSVP importers with almost 200 FDA 483s issued stating “failure to develop an FSVP” which allows FDA to designate the imported food as “adulterated” and demand it be removed from the US marketplace. FDA has budgeted over 2000 foreign inspections/investigations during the coming year so “failure to develop an FSVP” is likely to become more common, forcing FDA’s hand to strengthen its regulatory enforcement. The question is, “When will FDA remove the “soft glove”, training and educational approach and move toward active enforcement of the FSVP regulation?” The second related question is, “How does the FSVP Importer know if their FSVP meets FDA expectation?”

Answer: Interesting questions and one thing I have learned during my long regulatory career is that one can never accurately predict when FDA will publish a new regulation, direct their field investigators to intensify their regulatory effort or ramp-up compliance enforcement. In trying to determine the general time period when FDA may start to take more aggressive regulatory action against US-based FSVP Importers, it is important to look at “signs”. One sign is the recent statistics indicating as of mid-June 2018, the number of FSVP-focused inspections the Agency has conducted is nearly equal to the total number for all of the calendar year 2017. In more detail, well over half of the number of FSVP inspections so far have resulted in the issuance of Form 483s, noting that the FSVP Importer has failed to develop an FSVP program including a written hazard analysis plan, an effective and written supplier management program and the correct foreign supplier documentation available for FDA review at the US-based FSVP Importer’s office. Another sign is when the Agency believes it has fully trained most or all of those field investigators so they are equipped to conduct the on-site FSVP investigations. It appears this has been completed or is near completion for the FSVP regulation. Additionally, foodborne illness outbreaks are a key sign, and over the past year, the incidence of foodborne illness from imported foods does not appear to have increased significantly so this “sign” does not appear to be pushing FDA to strengthen FSVP enforcement, although one serious foodborne illness outbreak attributed to imported foods will immediately change this “sign”. All of these together, indicate that the Agency is preparing for more aggressive FSVP enforcement which will likely mean those importers with inadequate or missing FSVP programs will have their products blocked from import. If one had to guess, we anticipate this stronger FSVP enforcement of FDA to start sometime in late 2018 to early 2019 for human foods.

How can firms ensure that they have a developed FSVP that meet’s FDA’s expectations? As Sharon Mayl, Senior Advisor for Policy in the Office of Foods and Veterinary Medicine at FDA, said in an interview, “FSVP inspections are based on the review of records, rather than observations of food production. In addition to an onsite visit, FSVP inspections may include a documentation review of materials sent to FDA upon request. The investigator will review these materials for deficiencies.

One way to address this is to contract for the services of a qualified consultant to perform the FSVP Qualified Individual responsibilities. This would also solve the second question for US-based FSVP Importers, “How does the FSVP Importer know if their FSVP meets FDA expectation?” The other way is to hire a Qualified Individual that as the credentials identified in the FSVP regulations. Either way, you need a knowledgeable, well trained “Qualified Individual.” EAS has a number of food safety experts available to serve as the Qualified Individual, should you decide to contract out this important responsibility.

OTC Monograph System Gets an Update

This month’s Ask the Expert is answered by EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane. Susan specializes in quality and regulatory compliance for over-the-counter (OTC) and dietary supplement products. She has a thorough knowledge of federal regulations pertaining to the marketing, labeling, and distribution of OTC drugs and dietary supplements.

Each month EAS chooses one question sent in by a reader of EAS-e-News. To submit your question, use the Contact Us link on our website.

Q: Why is FDA updating the OTC monograph system?

Crane: The current OTC monograph system has been in use since the 1970’s and has proven to be a lengthy and cumbersome rule-making process for finalizing, or making changes to the monographs. Several monographs have been in the “Tentative Final” stage for 40 years, while hundreds of active ingredients still lack FDA determination as to their safety and effectiveness. The FDA simply lacks the resources to manage the system as it currently exists.

To address the problem, the FDA, in consultation with other stakeholders, worked with Congress to draft legislation. The resulting Over-the-Counter Drug Safety, Innovation, and Reform Act is currently moving through the legislative process with bipartisan support so is expected to pass and be signed into law, hopefully before the mid-term elections in November.

The reforms include, but are not limited to:

  • replacing the current rule-making process with a more efficient “administrative order” process
  • providing FDA with funding through a new user fee program
  • providing mechanisms to allow FDA to more quickly address safety issues that arise
  • encouraging innovation by offering exclusivity to manufacturers for new active ingredients or conditions for use

EAS is monitoring the legislation and will provide details as they become available.

Why is Codex Alimentarius Important to Me?

This month’s Ask the Expert is answered by Senior Director for Food Consulting Services, Allen Sayler, who recently returned from the 50th session of the Codex Committee on Food Additives held in Xiamen, China where 53 countries and 32 food industry observer organizations participated. Mr. Sayler has been an active food industry representative attending various Codex Committee meetings since 1997. Each month EAS experts tackle one question sent in by readers. To ask your question, please use our Contact Us form on the website.

Question: As a small, medium or large food manufacturer, why are Codex food standards important to me? I don’t export outside of the US and I don’t use imported materials in my production.

Sayler: The adoption of Codex food standards is intended to result in a similar change to individual country food standards, so they are similar or identical to Codex standards. This will affect all US food manufacturers, even those that do not export foods to other countries.

While Codex Alimentarius standards are voluntary, all participating governments (approximately 190) have agreed that as Codex adopts food standards, member countries should start changing their food standards to reflect these internationally-recognized Codex standards. If a country like the US does not start the process of changing its food standards to be similar to the Codex standards, and another Codex member country challenges this, the dispute is resolved using the World Trade Organization’s “Dispute Settlement Body”. The loser has to either change its food standards, pay the winner a fee comparable to the lost income from not having access to the loser’s markets or agreed that some of the loser’s food exports will be blocked by the winning country(s). While US government adoption of Codex food standards has been slow, over time, it is likely that US food standards will be changed.

Background Information: The Codex Alimentarius Commission, (meaning “Food Code” in Latin), is a United Nations-supported organization that develops food standards, guidelines, and operational principles in order to protect consumer health and facilitate international trade. These documents range from food quality and safety requirements, pesticide, and vet. drug residues, food additives, food hygiene, food contaminants, labeling as well as new food standards for fruits and vegetables, seafood, dairy products, etc. All Codex documents are intended to be scientifically-based in order to protect the health of those consuming the food. Specific country and regional standards, preferences and non-scientific requirements are not intended to override applicable Codex standards.

Using the recent Codex Committee on Food Additive meeting in China as an example, over 500 new food additive provisions were adopted while another 200 were blocked from adoption or removed from the Codex General Standard for Food Additives (GSFA). In addition, all food additives in the various Codex food standards are being methodically moved into the GSFA, which means some of importance to the food manufacturing industry may be dropped or maximum use level changed. Differences in each country’s food additive regulations are one of the primary reasons for blocking food imports.

There are many examples where Codex standards have been adopted as the national standard of food safety and policy, and even more examples where exporting countries have found that adoption of Codex standards to be a key to success due to its reference in bilateral and plurilateral trade agreements. Countries that wish to adopt Codex standards as their own national standard may receive support in doing so. The important work of the Codex Commission has created a greater worldwide awareness of food safety, quality, and consumer protection issues.

Last month you may have taken the opportunity to read the article written by Bruce Silverglade in EAS-e-News on the US Codex office’s move within the USDA and new opportunities that may provide food companies. Answers to more specific questions on the US Codex Alimentarius Commission or FAO Codex can be addressed to asayler@eassconsultinggroup.com.

How can implementing a GMP system for regulatory compliance also streamline business at a cannabis facility?

This month’s Ask the Expert is answered by Independent Consultant, Kathy Knutson, Ph.D. Kathy is a lead instructor for Preventive Controls for Human Food (PCHF); Preventive Controls Qualified Individual (PCQI) and trained in the prevention of Intentional Adulteration (IA). Each month EAS experts tackle one question sent in by readers. To ask your question, click here.

QuestionHow can implementing a GMP system for regulatory compliance also streamline business at a cannabis facility?

Knutson:I am a food microbiologist with expertise in food safety. I work with the food industry in writing Hazard Analysis and Critical Control Point (HACCP) and food safety plans. I find myself using the same food safety knowledge from the food industry, in the cannabis-infused edibles industry. It makes sense because it is all just food that must be manufactured and be safe for human consumption. Unlike the food industry, currently, there is no federal legislation for the cannabis industry. At the federal level, cannabis is illegal.

Manufacturers of cannabis-infused edibles are legally found in states where legislation has been passed at the state level for either medical or recreational cannabis. It could be argued that edibles sold by way of prescription for medical use need to have a higher level of rigor in food safety than an edible for recreational use. In some states, the manufacturers are inspected like a restaurant. There is the talk of HACCP, but many states are just not there yet. The cannabis industry would do well to learn lessons from the food industry on HACCP from the late 1950s and preventive controls from 2011. Good Manufacturing Practices (GMPs) must be instituted, before making the leap to HACCP or preventive controls. GMPs are the foundation of HACCP and preventive controls. Without GMPs, there is no food safety.

Manufacturers of cannabis-infused edibles can find GMPs in 21 CFR 117 Part B. This is the Preventive Controls for Human Food rule where much of the food industry lives. A quick search for information on GMPs leaves one overwhelmed. There are university extension specialists, HACCP organizations and private businesses which offer GMP training. As a valued partner of EAS Consulting Group, the many experts are here to show you the path to food safety. Like a start-up company in the food industry, manufacturers of cannabis-infused edibles would be wise to start with GMPs. Once the foundation is solid, the manufacturer can build food safety.

Adverse Events, Serious or Not?

This month’s Ask the Expert question on Serious Adverse Events Reporting is answered 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.

QuestionShould you report an Adverse Event if you’re not sure whether or not it’s really “serious”?

AnswerIf in doubt, you should always report an adverse event for any prescription drug, OTC drug or dietary supplement. FDA’s definition of “Serious Adverse Event” per 21 CFR 310.305(b) covers “any adverse experience that results in any of the following outcomes: Death, a life-threatening adverse experience, hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.”However, Emergency Room treatment is also often considered to be a serious event and usually reported to the FDA. Furthermore, if a consumer believes an event to be serious, it must be investigated and most likely reported. Many companies are reluctant to report because they’re afraid that submission of a Serious Adverse Event report via the required MedWatch (3500A) form is an admission that your product caused the adverse event but this is not the case.

Does Our Company Offer Enough Training?

EAS is pleased to introduce a new column in our EAS-e-News called Ask the Expert. Each month our expert consultants and Senior Directors will answer one question sent in by readers (edited if applicable to remove identifying information). If you’d like to submit a question, please use the “contact us” link on our website.

This month’s Ask the Expert question is on training requirements in a manufacturing facility is answered by EAS Independent Consultant, Karen Dixon.

Karen has a strong focus on the development and implementation of FDA readiness programs including processes, compliance considerations, and integration within all levels of an organization. Her unique combination of expertise in operations, training systems, finance, product quality, Quality Management Systems, regulatory affairs, and ISO-9001-2015 makes her a valuable asset to EAS clients. She has held positions such as Manager, Quality Management System at Altria and Philip Morris USA and is a Certified Quality Auditor (CQA) with the American Society for Quality.

QuestionHow can I ensure our company offers effective training for all levels of employees at our manufacturing facility?

DixonIn an FDA regulated manufacturing environment, the importance of a solid training program is critical to meeting your quality system requirements. Most manufacturing companies are faced with ‘doing more with less’ and often training is a burden. There are several solutions that can address training efficiencies and enhance the overall knowledge base of your employees. After all, your employees are your most important asset.

First, no training program should be one-size fits all program. Your procedure/process should be designed for flexibility in training delivery while ensuring you meet critical requirements. Developing a level or class system within your training SOP will aid the manufacturing process when there are competing opportunities. For example, a level 1 could be defined as the employees’ immediate job function and the work instructions associated with it. Level 2 would be your ‘read to understand’ material, and/or quality procedures designed for understanding. Level 3 training could be those materials and/or courses developed to enhance employees’ capability, i.e. business writing classes. This categorization would allow the firm to focus priority. Training an employee in their immediate process in order to produce a quality product is more pressing than a continuing education class for example.

For your infrastructure, implement a training procedure with these requirements clearly defined.

  • Type of training (Level 1, 2, 3)
  • Platform (i.e., computer-based, classroom, on-the-job or read-to-understand)
  • Trainer (i.e., buddy system, subject matter expert, certified trainer)
  • Record keeping requirement (roster, training assessment)

It is important to remember that the FDA Inspector will want to see evidence that an employee has been provided the appropriate training for the tasks they are performing; therefore, good documentation is imperative. There are a number of training options, of course. One is a “canned” Learning Management Systems (LMS). Another is attending public courses to meet your training requirements. Depending on the topic, some public courses have been vetted and certified to offer continuing education units (such as EAS Consulting Group’s Food Labeling Compliance Seminar), others, though not providing specific CEUs meet the training requirements required by FDA, (such as EAS’ Dietary Supplement Good Manufacturing Practices Seminar). Still, a third option is to bring outside trainers into your facility to provide a customized approach to your specific business and training needs. Customized programs offer an opportunity to bring in experts familiar with your type of business as well as the federal, state and industry regulations with which you must comply so that those in-house programs developed to meet your needs exactly.

Steps to Achieving Effective Manufacturing Training

No matter the type of learning environment, online, public or in-house, there are some basic steps needed to achieve optimum adult learning:

Here are a few points to consider about each step:

Design: During this phase of development, you should focus on the need for the training or conducting a ‘needs analysis’. Considering the business goals or metrics behind the topic of the training. Create clear learning objectives to uncover topics that are influencing the training.

Develop: Points to consider under development: 1) stay true to the plan developed during the Design phase, don’t drift into another topic or focus area, 2) Gather credible sources of information for the training. Use facts, input from Subject Matter Experts, and guidance from seasoned employees.

Deliver: Consider your audience through a leaner-centric approach. Delivering learner-centric material means you are delivering to adult learners who learn very differently than adolescents. Clients should consider investing in a full-time training developer who has been trained in adult learning principles. Most clients already have an employee or employees dedicated to training, even as part of a job. There are many inexpensive courses available that would enhance their ability on understanding adult learning. Investing in a two to the three-day course would bring a return on investment quickly.

Evaluate / Continuous Improvement: Your training program will never be complete. Continuously evaluating the health of your program through metrics is important. Whether it is a simple measure of percent complete trained, evaluation of non-conforming product incidents, or waste percentages there is always a way to measure the health of your training program. Revisit your initial training material and improve as needed.

To learn more about training design and developing a flexible training program, contact EAS Consulting Group. Our independent consultants can provide a perspective your company needs to ensure processes and procedures are accurately in place to support full compliance with current and future FDA requirements while also providing counsel on how your infrastructure can work for you in meeting production goals.

Ask the Expert February 2018

EAS is pleased to introduce a new column in our EAS-e-News called Ask the Expert. Each month our expert consultants and Senior Directors will answer one question sent in by readers (edited if applicable to remove identifying information). If you’d like to submit a question, please use the “contact us” link on our website.

Tara Lin Couch Ph.D.This month’s question answered by Tara Lin Couch, Ph.D., Senior Director for Dietary Supplement and Tobacco Services and the topic is whether there is a crossover between ISO certifications and GMPs in the laboratory.

Question: If a contract Laboratory is ISO certified, can we bypass an onsite audit if we incorporate this statement in our SOPs?

Couch: Absolutely not, ISO certification does not equal GMP compliance. I have seen many labs that are ISO certified and have terrible GMP compliance. Remember, ISO 17025 is not looking at the whole lab, it is looking at a specific test method or operation. It will dictate that the lab can run a particular test, Vitamin C for example, or operate a balance, but does not look at the entire laboratory quality systems. There are certain things that are covered in GMPs that are not covered in ISO, OOS (Out of Specifications) investigations would be one of those. OOS investigations should be conducted in accordance with the FDA, Center for Drug Evaluation and Research (CDER), Guidance for Industry: Out of Specification (OOS) Test Results for Pharmaceutical Production, issued in October of 2006. In this guidance, the FDA states that an investigation must be thorough, timely, unbiased, well-documented, and scientifically sound to be meaningful. There is a quality manual requirement in ISO 17025 that touches on investigations, but it is not near the level of detail that you would find in a GMP environment.

Ask the Expert 2018 January

EAS is pleased to introduce a new column in our EAS-e-News called Ask the Expert. Each month our expert consultants will answer one question sent in by readers. If you’d like to submit a question, please use the Contact Us link on our website.

Allen SaylerToday’s question is answered by Allen Sayler, EAS’ Senior Director for Food Consulting Services and pertains to testing of Listeria species or monocytogenes. This question was asked at our recent webinar focusing on Listeria and the full list of questions asked by webinar participants as well as their responses are provided here.

QuestionIs it recommended to test for Listeria species or monocytogenes for all four environmental monitoring zones as well as a finished product for RTE foods?

SaylerIt is not practical or financially possible to establish a finished product testing protocol for RTE foods that is statistically valid. Therefore, a limited finished product testing program that describes taking at least one sample for each day’s production or for each production lot would provide an adequate finished product testing program. It is our opinion that for those processing environments that are associated with moist conditions or the use of water for cleaning the floors, outside of processing equipment, etc.; an environmental monitoring program should be based on detecting Listeria species, with swabbing concentrated on Zone 3 (floors, walls, door knobs, floor drains). Zone 2 should only be included if there are a positive Zone 3 swab and a vectoring strategy implemented to identify the true source. For relatively dry processing environments, it is recommended that Salmonella be the choice for detection of environmental contamination. It is strongly recommended that ATP swabbing is utilized on clean and dry FCS (Zone #1). A calibrated ATP system can provide results within 1 minute and allow the sanitation crew to reclean and re-swab the FCS to ensure it has been effectively cleaned. This approach is “preventive” versus environmental swabbing and testing of Zone #1, which can take up to 48 hours to get results as well as a similar delay it obtaining results for finished product testing for the presence of L. mono. or Salmonella. Microbial testing of Zone #1 and the finished product is “reactive”, not preventive.

Ask the Expert January 2018

EAS Webinar on FDA Draft Guidance: “Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry” October 31, 2017

EAS received an overwhelming response to our recent webinar on controlling Listeria monocytogenes in ready-to-eat foods. As a service to the industry, we thought it would be helpful to provide some of the questions generated by webinar participants answered by EAS Senior Director for Food Consulting Services, Allen Sayler. Please understand that these responses do not constitute consulting advice. Should you have questions or require clarification based on your own company’s situation, please reach out to Allen at asayler@easconsultinggroup.com.

Webinar Participant Questions & Answers:

  1. Can comprehensive, high sample rate finished product testing be used in place of FCS swabs? Answer: Unless the finished product testing protocol is statistically valid, it is strongly recommended that ATP swabbing is utilized on clean and dry FCS. A calibrated ATP system can provide results within 1 minute and allow the sanitation crew to reclean and re-swab the FCS to ensure it has been effectively cleaned. This approach is “preventive” versus a finished product sampling plan which is “reactive”.
  2. What do you recommend for a processing plant that produces RTE foods but during processing, there is no exposure to the environment, prior to packaging? Such as our products are in an enclosed system from Raw Material tank to Mixing tanks and to Finished Good tank. Is 21 CFR 117.130 (c)(1)(ii) fully applied?Answer: 21 CFR 117.130 (c) (1)(ii) states the following:“The hazard evaluation required by paragraph (c)(1)(i) of this section must include an evaluation of environmental pathogens whenever a ready-to-eat food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.” We are of the opinion that all food processing plants, regardless of whether the product is protected from the environment prior to packaging, need some type of environmental monitoring program.
  3. Is there guidance on what “exposed to the environment” means? What about products that are processed in closed system post killing step, then packaged? Answer: The phrase “exposed to the environment” needs to be taken intuitively. However, based on the answer to #2 above, it is not necessary to “dial-in” term “exposed to the environment” as we are of the opinion every food processing plant should have an environmental monitoring program.
  4. Is the recommendation to test Listeria species or monocytogenes for all four zones and finished product testing for RTE foods? Answer: It is not practical or financially possible to establish a finished product testing protocol for RTE foods that is statistically valid. Therefore, a limited finished product testing program that describes taking at least one sample for each days’ production or for each production lot would provide an adequate finished product testing program. It is our opinion that for those processing environments that are associated with moist conditions or the use of water for cleaning the floors, outside of processing equipment, etc.; an environmental monitoring program should be based on detecting Listeria species, with swabbing concentrated on Zone 3 (floors, walls, door knobs, floor drains). Zone 2 should only be included if there is a positive Zone 3 swab and there is need to use vectoring to identify the true source. For relatively dry processing environments, it is recommended that Salmonella be the choice for detection of environmental contamination. It is strongly recommended that ATP swabbing is utilized on clean and dry FCS (Zone #1). A calibrated ATP system can provide results within 1 minute and allow the sanitation crew to reclean and re-swab the FCS to ensure it has been effectively cleaned. This approach is “preventive” versus a finished product sampling plan which is “reactive”.
  5. Is there a good number of vector sponges to take when finding a Listeria hit? Answer: The simple answer is enough to identify the true source of any positive environmental swab, particularly if the positive was found in a floor drain or on a floor source. Some industry “vectoring” plans take swabs at pre-set distances from the source in quadrants. An example might be 5 feet intervals at 0°, 90°, 180°, and 270°. These samples will provide information on the best direction to continue to gather environmental swabs to identify the true source of the environmental contamination.
  6. When an FCS is tested for Listeria, is the recommendation still that all finished product be placed on hold until a negative test result is confirmed? (For all finished product from the production run in progress when FCS testing was performed). Answer: While there is no requirement by FDA, it is common industry practice that whenever any FCS is tested for Listeria(species or monocytogenes), finished products that contain anything that came into contact with the tested FCS be put on hold until such time as the results of the swabbing are known. If such product were to be released to customers or consumers and the FCS swabbing came back positive for Listeria, then an immediate Class I recall with a public press release would be the likely outcome. Utilizing ATP swabbing technology is a much more effective way to routinely detect and correct unclean FCS.
  7. What would you recommend that facilities producing RTE products with a short shelf life (produce, packaged salad kits, etc.) approach Zone 1 testing?Answer: See the answers to #1, #4 & #6. It is our opinion that there should be no direct environmental swabbing of Zone 1 for Listeria or any other human pathogen. ATP technologies work much better and provide an almost immediate feedback so the unclean FCS can be recleaned and sanitized prior to any contact with food ingredients, food packaging or the food itself.
  8. Do these new guidelines apply to frozen vegetables? Answer: In Section III of the draft Guidance document, any process (freezing) needs to be validated to determine whether there is a listeristatic or listericidal effect that will demonstrate that the food is not adulterated. While frozen vegetables originate from fresh produce covered by the FDA FSMA Produce Safety regulation, microbiologically, the Listeria bacteria is not killed by freezing but does not reproduce (listeristatic). Once frozen vegetables contaminated with Listeria is thawed, Listeria starts to grow and become a human health threat so yes, the FDA draft Guidance would also apply to frozen vegetables. On page 32 of the draft guidance, it states the following, “Many foods are stored in a frozen state – e.g., to extend shelf life before retail sale or as a product available to consumers in the frozen state. L. monocytogenes does not grow at temperatures below freezing (Ref. 12 and Ref. 13). Therefore, freezing is a particularly effective temperature control measure to prevent growth during storage. Freezing will not eliminate L. monocytogenes from foods and cannot be relied upon as a control measure for the elimination or reduction of Listeria monocytogenes.”
  9. How does FDA define finding Listeria spp or L. mono. “on occasion?” In other words, what is “too high” a rate of detection. Answer: We are not aware of any FDA-based numerical definition of finding Listeria “on occasion”, or what is “too high” a rate of detection of Listeria in environmental swabs. Of much more importance to FDA and to customers and consumers in general, is the corrective action follow-up and root cause analysis conducted to identify the true cause of the positive Listeria swab and adjust manufacturing operations to eliminate the real source of the contamination.
  10. What is the FDA expectation of Listeria levels in a plant? Answer: We are not aware of any FDA-based numerical expectation of what might be an “acceptable” number of Listeria swabs being positive versus negative. What is of more importance is the frequency of re-occurrence and response to positive samples. If the same swabbing location was positive for Listeria every other month for 6 months, then that indicates a failure to identify the true root cause. We are aware of an unpublished and non-scientific practice where more than 3 positive in 100 samples, regardless of location, may indicate a more thorough corrective action effort is needed. It is very important that all environmental monitoring results be incorporated into some type of trend analysis to determine if patterns of positive results exist that need additional attention.
  11. How does the FDA Draft Lm Guidance relate to the FDA Food Code and application in the retail grocery environment? Answer: All FDA guidance documents represent FDA’s current thinking on a topic. Many times, this guidance is intended to clarify the section of an FDA law or regulation. The draft guidance specifically states that it is not intended to be applicable to retail food operations. The Retail Food Code (applicable to grocery stores and restaurants) is utilized by FDA to provide the requirements for retail food operations. It is essentially a Public Health Code or model, not an FDA law or regulation, intended for adoption by states, counties and local governments. Modification of the Retail Food Code must be done through submittal of proposals to the Conference on Food Protection, which meets approximately once every two (2) years to consider new proposals.
  12. What is the FDA perspective on the risk associated with finding L. monocytogenes in the environment in raw vs. RTE areas? Answer: We are of the opinion that FDA is utilizing a positive environmental swab result for L. monocytogenes in “raw” areas of the processing facility as evidence that this source could find its way into the RTE areas of the processing operations. They are very likely to intensify their efforts to identify L. monocytogenes in RTE areas. If none is found, FDA is likely at a minimum to note the positive L. monocytogenes result in their Form FDA 483 observations.
  13. Is FDA focusing in finding Listeria in raw areas, while using Whole Genome Sequencing, even if processing facilities have implemented adequate raw-RTE separation and controls? Answer: FDA is utilizing pulsed-field gel electrophoresis (PFGE), multiple locus variable number tandem repeat analysis (MLVA), and whole genome sequencing (WGS) as the main tools for the PulseNet’s fingerprinting of food pathogens. It is our understanding that all positive environmental swabs that detect a foodborne human pathogen are analyzed using PFGE at a minimum, regardless of the location of the swabbing.
  14. Does the guidance doc require zone 1 sampling 3-4 hours into production? Or is that for zone 2 and 3? If it is zone 1, what kind of swabbing is required? Listeria spp? or L. mono.? Answer: An FDA Guidance document cannot “require” anything, but as stated in the answer to #11 above, it is the Agency’s most current views. FDA field investigators are not authorized to enforce any FDA Guidance documents but can use the information in such document as a benchmark to measure whether the industry is taking reasonable precautions to ensure their food is safe. On page 37 of the draft guidance, there is a reference to taking environmental samples 3 – 4 hours after the start of production. On page 36 of the draft guidance, it states, “We recommend that even the smallest processors collect samples from at least 5 sites of FCS and 5 sites of non-FCS on each production line for RTE foods. We recommend that larger processors determine the appropriate number of sampling sites based on the size of the plant.”It is our opinion based on answers to previous questions, that any environmental swabbing is conducted primarily on Zones 3 for the detection of Listeria species. This is not the recommendations from FDA found in the draft Guidance document, which states on page 37,
    • Collect environmental samples from specific FCSs on the production lines at least once every week when the plant is in operation; and
    • Test each FCS in the plant at least once each month.
  15. Does the recommendation to test Zone 1 for Listeria apply to high-risk foods only? Do you expect Zone 1 to be tested in low moisture/Aw food plants? Answer: Based on the current statements in the draft Guidance, FDA appears to be making no differentiation between low-risk, medium-risk and high-risk foods regarding the recommendation to gather environmental swabs for FCS (Zone 1).
  16. What is more powerful? Testing finished product based on ICMSF N=20 or more samples or zone 1 testing (but not test finished products)?Answer: A Zone 1 (FCS) positive test for L. monocytogenes should be considered the same as a positive finished product test. It is our opinion that the preferred testing program for RTE food manufacturers focuses on environmental testing as a means to implement preventive controls rather than finished product testing, which is a reactive approach. Sampling should consist of:
    • A credible number of environmental swabs taken primarily in Zone 3, and
    • Effective corrective actions including additional environmental samples and vectoring for any positive environmental samples, and
    • Utilization of ATP swabbing at every production start-up on a representative number of FCS and immediate recleaning if the calibrated ATP result is “positive”, and
    • Accumulating a set of retailed finished product samples (one from each production lot) and storing these to the end of the shelf life of the finished product, and
    • Test a minimum number of finished product samples (one per production run or production day) for foodborne pathogens, which for most foods would be L. monocytogenes and for dry foods, Salmonella.