Getting Your Medical Device Into the U.S. Market

If you are a manufacturer whose medical device is either a Class I, or a 510(k) exempt device Class II device, consider yourself and your company lucky that you do not have to try to “thread the needle” of the litigious and arduous process known as 510(k) clearance. Getting a device ready for 510(k) submission is usually time-consuming, costly, and full of challenges.

All 510(k)’s are based on the concept of substantial equivalence (SE) to a legally marketed (predicate) device. If you are the maker of a Class II medical device or an IVD and want to launch it in the U.S. market, you must submit a 510(k) to the FDA. For Class III devices, a premarket approval (PMA) submission is needed.

510(k)’s have unique content and format requirements – they are not identical to a European Technical File – and the FDA’s recent changes to 510(k) requirements make the submission process more rigid than ever.

Class II devices are designed to perform as indicated without harming patients or users, but they require a greater level of safety and effectiveness assurance than do Class I devices. Examples include powered wheelchairs, infusion pumps, surgical drapes, surgical needles, suture material, and acupuncture needles.

Class III medical devices do not have enough information to ensure safety and effectiveness through the general or special controls used for Class I or Class II devices. These higher-risk devices need premarket approval (PMA), which includes a scientific review, to ensure their safety and effectiveness. Examples include replacement heart valves, silicone gel-filled breast implants, and implanted cerebral stimulators.

Here are some practical tips for a 510(k) filing:

  • Establish a “Regulatory plan” as early in the process as possible. The regulatory plan should include a list of all the deliverables required. The plan needs to be owned by all the applicable team members not just the person issuing the plan.
  • Don’t be surprised or disheartened that questions will arise despite your best efforts. The FDA is swamped with 510(k) reviews and any deficiency that they can find in your submission allows them to go to the next submission to keep the commitment that the FDA will review all submissions in a timely manner. “Put yourself in the FDA examiner’s shoes”.
  • Don’t try to blind the FDA examiner with excessive or extraneous information in the hope that they will bypass the information for the sake of time. In my experience, the FDA examiners read every document and every page!

The FDA sends back most 510(k)’s during the first review cycle to request more information – in recent years this has applied to more than 70% of 510(k) submissions!

Also, many medical device companies are compiling and submitting 510(k)’s to the FDA for review without establishing a Quality Management System and without documenting Design Controls and without documenting Risk Management which can bode trouble for the submission as well as FDA inspection time.

You might want to consider using a competent consultant or at least asking an objective party to review the submission for completeness before sending it to the FDA. This will minimize the risk of delay and rejections.

FDA Allows Co-Manufacturers More Time to Comply With Supply-Chain Program Requirements

In a nod to one of the more complex aspects of current food manufacturing and FSMA compliance, FDA recently published guidance that it will exercise enforcement discretion for two years over supply-chain requirements for domestic co-manufacturers of human and animal foods, and also under the Foreign Supplier Verification Program (FSVP).

The agency defines “co-manufacturing” as a contractual arrangement whereby a brand owner arranges for a co-manufacturer to manufacture or process food on its behalf. The enforcement delay will give brand owners time to develop new supplier contracts allowing them to share information on ingredient suppliers, such as audits, with their co-manufacturers.

In co-manufacturing, a supply-chain program can be implemented by the brand owner, the co-manufacturer, or both. The agency said it will not take enforcement action against a co-manufacturer that is out of compliance if supplier approval and verification activities are divided between the brand owner and the co-manufacturer.

Co-manufacturers subject to FSMA preventive control requirements and that manufacture or process a raw material or other ingredient received from a supplier are defined as “receiving facilities” under 21 CFR Parts 117 and 507. Receiving facilities that find a hazard in a raw material or ingredients requiring an applied control are required to approve their suppliers for those raw materials or ingredients. But the supply-chain provisions allow an entity other than the receiving facility — such as the brand owner — to conduct supplier verification activities, provided the receiving facility documents its review and assessment of the other entity’s documentation.

When contract prevents a co-manufacturer from being able to review a brand owner’s documentation of supplier verification activities, the co-manufacturer would not be able to verify suppliers based on a review of the brand owner’s documentation. In this situation, the co-manufacturer would need to conduct its own supplier verification activities that might otherwise not be required. The net result would be unnecessary costs to both the co-manufacturer and supplier. If the brand-owner’s supplier approval process is adequate, the co-manufacturers verification activities would not add any greater assurance of safe human or animal food.

In its Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food, the agency said it will not take enforcement action if:

  • A brand owner conducts supplier approval activities;
  • The co-manufacturer describes these activities in its food safety plan; and
  • The co-manufacturer conducts any necessary supplier approval activities not conducted by the brand owner.

Similarly, the agency will not take enforcement action if:

  • A brand owner determines and/or conducts supplier verification activities for its co-manufacturer;
  • The co-manufacturer describes these activities in its food safety plan; and
  • The co-manufacturer conducts any necessary supplier verification activities not conducted by the brand owner — for example, sampling and testing of the raw material or other ingredient.

The agency said it was exercising enforcement discretion “because the guidance represents a less burdensome policy consistent with the public health,” and is immediately in effect. Implicit in all FDA guidance is that the agency has the authority to take an enforcement action under other regulations should it become necessary to protect public health.

Brand owners and co-manufacturers have until November 6, 2019 to be in compliance with supply chain and FSVP requirements.

Our Year in Review

As 2017 draws to a close, it is appropriate to reflect on a year full of change, important milestones and growth not only at FDA but also here at EAS Consulting Group. Both organizations saw new staffing and new initiatives. With the inauguration of President Trump, FDA saw a changing political dynamic with new enforcement policies, and guidance documents; and on the EAS front, new staffing, partnerships and initiatives were aimed at helping the industry conduct efficient, safe and compliant business in order to meet FDA requirements.

Here are some highlights from 2017 which we think best demonstrate the commitment of both FDA and EAS to better the greater good.

On the FDA front:

Most significantly for FDA, Scott Gottlieb was confirmed as the new Commissioner. Under his guidance a number of initiatives are underway in all regulated industries, with some specific highlights in pharma, medical device and food mentioned here.

In the area of pharmaceuticals, the compliance date for Drug Master File electronic submissions was extended until May 5, 2018, giving a bit more time for the industry to get a handle on this complicated process. EAS, which has long assisted pharma manufacturers in technical review of stability data and assembling applications and reports added the additional service of electronic filing preparation and submission over two years ago in anticipation of FDA’s move to this requirement. Those firms who have not already updated their processes to e-CTDs, as they are commonly called, should be fully engaged in doing so now.

The Class II Medical Device industry had a reprieve in July when FDA published a sizable list of class II medical device products that no longer require premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), to provide reasonable assurance of safety and effectiveness, subject to certain limitations. Medical device 510(k) filings are a laborious process with many confusing elements. Readers may wish to refer to our August 2017 EAS-e-News issue of the month article, where Independent Consultant Joe Ouellette, discussed some ways to simplify the process. If your company requires 510(k) filling assistance, EAS has many medical device experts who can help with these requirements.

The U.S. Agent verification for medical device facilities process saw a change in October whereby U.S. Agents must now confirm with FDA their consent to act in that role. EAS provides U.S. agent services to countless foreign clients. This is not only an FDA requirement, EAS prides itself on providing comprehensive services in this area with open and free flowing communication between the client and FDA as well as answering questions on various FDA matters which can be confusing. In EAS, foreign firms have a dedicated liaison with the agency.

On the Food Safety Modernization Act front, new enforcement requirement deadlines continued to move forward. May 30 was the deadline for food importers to notify FDA whether their products are subject to FSVP regulations. Our Independent Advisor for FSMA, Charles Breen, writes a monthly column on the latest requirements for EAS-e-News, called FSMA Perspective and we have offered numerous webinars on the various requirements, free replaysof which can be found on our website. You may also be interested in our handy digital FSMA Pocket Guide, downloadable and searchable for easy reference on the go.

A significant change for food manufacturers was a 1.5-year extension of compliance dates for new requirements for updated nutrition information on food labels, including dietary supplements. Public comments were requested through November 1, 2017 on various considerations such as the definition of a single-serving container; a dual-column labeling for certain containers; reference amounts customarily consumed (RACCs); and amending the label serving size for breath mints. Even with this extension, EAS saw record numbers at our recently held Food Labeling Compliance Seminar and continues to provide in-house trainings on the subject as well – an indication that the industry at-large is preparing for compliance in advance of FDA’s deadlines.

On the EAS front:

EAS has seen fantastic growth in the past year. With new regulations and requirements set forth by the agency, novel technologies and products requiring the design and review of stability studies, toxicology, data review and statistical analysis prior to highly technical application submissions, FDA regulated industries have sought our support in meeting these requirements. Through outsourcing expertise to firms such as ours, companies are able to enhance their technical capabilities in a cost effective manner.

To meet these demands, EAS gained two new director level positions, welcoming Allen Sayler as Senior Director, Food and Cosmetics Consulting Services in January. His addition to EAS senior management greatly increased our competencies into the dairy industries. Tara Lin Couch, Ph.D., became Senior Director Dietary Supplement and Tobacco Services in August. Tara’s expertise in the dietary supplement industry has been well known to our clients since 2012 when she first joined EAS as an Independent Consultant. She was appointed to the position of Independent Advisor for Dietary Supplements in 2015. Timothy Stewart, Ph.D. accepted the role of Independent Advisor for Dietary Supplements in October. EAS also added 33 new Independent Consultants, accomplished experts in their fields who have hit the ground running in support of our clients and training initiatives.

We also expanded our partnerships through a relationship with Almater Food Technologists based in Italy. This unique collaboration will enhance the ability of EAS clients who seek assistance in exporting foods into the EU as well as Almater’s clients who seek additional assistance with FDA compliance.

Our Product Development and Labeling Strategic Services initiative, started in 2016, saw huge growth as companies continue to seek advice on how to position their products and guidance on the proper use of various claims such as “healthy”, “natural” and GMO labeling. The success in this area has led to the creation of additional specialized teams of independent consultants who can address client needs requiring multiple areas of expertise.

EAS greatly increased our training capabilities in 2017. Our Food Labeling Compliance seminar was awarded 16 CEUs by the prestigious Commission on Dietetic Registration, lending further credence to the quality of our long running program, and providing an additional service to those participants who seek continuing education credits. We are proud that a number of our Independent Consultants are Lead Instructors for Preventive Controls for Human Foods (PCHF) under the Illinois Institute of Food Technology’s Food Safety Preventive Controls Alliance, and for the Foreign Supplier Verification Program (FSVP) under the International Food Protection Training Institute. EAS also became a training center for the Safe Quality Foods (SQF) 8.0 and Quality courses under the Safe Quality Foods Institute. Finally, Allen Sayler’s popular Dairy Processing 101 three-day seminar has become a new fixture in the EAS training center.

Finally, EAS was honored to be invited presenters at over 30 trade organization conferences and tradeshows and webinars for outside organizations. From the Institute of Food Technologists (IFT), Food Drug Law Institute (FDLI) Consumer Healthcare Products Association (CHPA), National Customs Brokers and Forwarders Association of American (NCBFAA) and the Safe Quality Foods (SQF) our Independent Consultants and home office staff are well recognized and sought-after experts in their areas.

As we look towards 2018 we are anticipating more movement by FDA in areas such as tobacco as the agency seeks input on its new initiative of pursuing lower nicotine levels in cigarettes to non-addictive levels and create more predictability in tobacco regulation. EAS is one of very few consulting firms to offer comprehensive services to the tobacco industry and we take an active role in the trade organization the Tobacco Manufacturers Association.

As always, EAS stands at the forefront of tracking industry regulations and applying those requirements in a practical and meaningful way for clients. We take great pride in our expertise and ability to provide quality regulatory assistance. We welcome your inquiries as to how EAS may help your business and above all wish you a happy and prosperous 2018.

FDA Issues Guidance on Facilities Exempt from CGMP and Preventive Controls

One of the first steps for assessing a facility’s compliance status under the rules implementing the Food Safety Modernization Act is to consider whether the facility is required to comply or if it may qualify for an exemption, however narrow it may be.

As a simple rule of thumb, if a food establishment is required to register with the agency, it is required to comply with FMSA rules. But some registered facilities may qualify for exemptions from some requirements. The FDA released draft guidance last month on exemptions for “solely engaged” facilities from the current good manufacturing practice (CGMP) and preventive controls requirements in 21 CFR Part 117 or Part 507.

For example, an establishment that exclusively holds raw agricultural commodities (RACs) — other than fruits and vegetables — for human and animal food use, hulls or shells nuts, and does not engage in any other activities covered by the CGMP requirements in Parts 117 and 507 is exempt from the CGMP requirements.

Similarly, if all activities performed by a facility are exempt under one or more preventive controls exemptions, the facility is not subject to the Part 117 and/or Part 507 preventive controls requirements. But if any part of a facility is engaged in an activity subject to the CGMP or preventive controls requirements, the entire facility is then subject to CGMPs, the preventive control requirements, or both, the agency said.

A facility that stores unexposed, packaged human and animal food that does not require time/temperature control, stores grain RACs intended for further processing and distribution, and does not engage in any additional activities covered by the preventive controls requirements is exempt from the preventive controls requirements. However, a facility that stores unexposed packaged human food that does not require time/temperature control but also cuts vegetables – that is, manufactures/processes food – is not “solely engaged” in activities exempt from the preventive controls requirements, so it must comply with the preventive controls requirements in Part 117.

The agency also issued final guidance in October on Current Good Manufacturing Practice Requirements for Food for Animals. The guidance emphasizes the “flexible” nature of the CGMP requirements, and says there may be significant differences in how CGMPs are implemented in facilities where undesirable microorganisms are a food safety concern for the type of animal food produced compared to facilities producing an animal food for animals that are not as likely to be affected by undesirable microorganisms.

This means animal food companies must implement appropriate CGMPs for their unique facility, the type of animal food, and the animal(s) for which they are producing.

There are a number of FSMA initiatives coming out of FDA, the requirements of which can be confusing, particularly in the case of those companies which are authorized an exemption. Greater details on exemptions can be found on FDA’s website. Those companies wishing to discuss their particular circumstances may wish to contact a consulting firm such as EAS to learn more about which rules of FSMA apply.

A Look at the Regulation of OTC Sunscreen Formulations

The process of developing and testing a sunscreen is not unusually difficult but it does require close attention to the regulations and coordination with the testing laboratory preparing the efficacy data.

Sunscreens may be part of a cosmetic line and those that are intended to provide protection from incidental sun exposure during the normal day’s activities are often called “cosmetic sunscreens”. On the other hand, sunscreens intended to provide protection from prolonged sun exposure activities such as beach, pool, or other activities where sun exposure is high and resistance to water or perspiration is required. These products are often called “active or sport” formulations. The formulation requirements for each class are slightly different but the underlying regulations for the products are the same.

In the United States, sunscreens and several other categories of functional products are regulated under the over-the-counter (OTC) drug regulations of the Food and Drug Administration (21 CFR 352). These regulations define the allowable active ingredients (termed UV filters) and their maximum use concentrations, the performance testing required to establish the efficacy of the product (SPF, Broad Spectrum coverage, and water resistance), and labeling of the product.

An important concept of the OTC program is that the active ingredients used in the formulation will be considered safe provided that the regulations are followed. Therefore, the individual new formulation does not require approval from FDA. The specific OTC drug regulations for sunscreens are unique to the United States, but many of the same principles apply in many markets. In the European Union, sunscreens are regulated as cosmetics (for labeling) but certain restrictions for active ingredients and testing apply.

In all major markets, the active ingredients that can be used as UV filters are prescribed by positive lists (that is, only ingredients on the specific list for that market may be used). The maximum concentration of each active ingredient is also indicated. These lists for both specific ingredients and maximum concentrations are not the same across markets. Thus, a product prepared for one market may well not be acceptable in another. For example, the United States has a shorter list of approved UV filters than does the EU and so many EU products are excluded from the U.S. market.

A functional sunscreen formulation is not simply the sum of its active ingredients. If it were, efficacy testing would be rather easy. The remaining ingredients, termed inactive ingredients under the regulation, are essential not only for the aesthetics of the product but for its efficacy as well. To function effectively, the formulation must hold the UV filters in a film on the surface of the skin. The film holds the UV filters to form a “tortuous path” through which the UV light must pass. The filters scatter and absorb the UV light attenuating exposure to the skin below. Since the surface of the skin is not flat, the formulation must form a film that can cover the skin peaks and valley to block the UV light.

While the formation of a surface film is required for function, it can impact product esthetics. Cosmetic sunscreens, such as facial moisturizers, are intended for incidental UV exposure with limited water or perspiration exposure. These products may be successful with less robust film former. Active or sport formulation require considerable water resistance (once they have dried on the skin) and so need more robust, less water-soluble film formers.

In summary, to ensure regulatory compliance of OTC sunscreen formulations, it’s important to closely follow the regulatory and testing requirements.

FDA Proposes Four-Year Compliance Delay for Produce Rule’s Water Standard

FDA issued a proposed rule September 13, 2017, that would extend the compliance dates for agricultural water requirements in the Produce Safety Rule, giving the agency four years to reconsider the water standards to ensure that they are feasible.

FDA Commissioner Scott Gottlieb hinted at a possible “course correction” in relation to the water standards, in a presentation last month at the National Association of State Departments of Agriculture annual meeting in New Orleans.

The agency has gotten the message from stakeholders that the microbial quality standards for agricultural water are “too complicated, and in some cases too costly, to be effectively implemented,” he said.

Under the proposed rule, the earliest non-sprout compliance date for the water standards won’t be until January 2022.

In another announcement, Gottlieb said the planned 2018 produce inspections by states under agency-funded cooperative agreements will not begin until spring 2019. He urged the states to use the 2018 cooperative agreement funding for On-Farm Readiness Reviews — voluntary farm visits by a team of state officials, cooperative extension agents, and FDA produce experts, to give farmers an assessment of their “readiness” to meet the new requirements.

NASDA and FDA have already pilot-tested On-Farm Readiness Reviews in six states, and they are planning to roll out the program nationally this fall.

A NASDA-FDA working group formed to work on plans for training state and federal inspectors recently piloted a regulator training course. The agency has four regulator training courses planned for 2018, Gottlieb said. “We’re committed to offering more training courses before the start of inspections to ensure we train inspectors to meet these needs,” he said.

The agency is also growing its Produce Safety Network of FDA produce safety experts located across the country.

FDA is still working on “a rather large guidance document” on the Produce Safety Rule and Gottlieb said he is aware there is “some frustration that this guidance has not come out yet.” He said the agency now expects to publish the draft guidance early next year.

Gottlieb also noted concerns raised regarding the use of traditional Form 483 reports to document regulatory issues during produce inspections. The agency is “planning to explore additional ways of communicating our concerns about what we observe during produce inspections,” he said.

In response to requests from stakeholders, the agency also has listed eight additional water testing methodsas equivalent to the method incorporated by reference (Method 1603) in the Produce Safety Rule and it and intends to add other methods to the list as they are identified, he said.

Finding the correct balance between food safety and real-world irrigation practices when growing produce, domestic and foreign, has presented FDA with significant regulatory challenges. The extension in the dates for compliance with agricultural water requirements gives the agency more time to accomplish internal produce rule preparations, and allows produce growers more time to adjust irrigation practices if they prove to be needed.

U.S. Dairy Industry Challenge – How Many Food Safety Plans Are Enough?

The U.S. dairy processing industry is facing a significant challenge as it moves toward compliance with the FDA Food Safety Modernization Act (FSMA). This is best captured by a conversation I had with a corporate quality assurance vice president about six months ago. When asked how many written food safety programs each of the dairy plants in his company had, the reply was, “Because of the current regulations, private certification systems, customer expectations and our own corporate food safety requirements, the number ranges between three and five per plant.

I asked how they could manage this number of different food safety programs, which one(s) the plant employees were trained on and how they kept the records required for each written food safety program separated and organized. While he may have had a solution, he did not provide an answer to my question. The challenge is exactly that; with so many demands on dairy plants today to operate in a multi-jurisdictional government world, a multiple customer world and competing, private food safety standards, can one written food safety program meet the requirements for all these different parties?

For many U.S. dairy processing plants, because of industry consolidation, their compliance enforcement deadline for the FSMA “Preventive Controls for Human Foods (PCHF)” regulation was September 2016. The regulation mandates a written food safety program that requires a risk-based hazard analysis incorporating “preventive controls” and development of a supply chain management program. Also, this regulation mandates radiological hazards be considered. The preventive controls program is to be supported by compliance with updated Good Manufacturing Practices (GMPs) found in 21 CFR 117, Subpart B. We will call this “Written Food Safety Plan #1”.

Starting in 2008, many larger dairy companies rebuilt their written food safety programs to comply with the requirements found in one of the Global Food Safety Initiative’s (GFSI’s) recognized third-party food safety certification schemes such as Safe Quality Foods (SQF), the British Retail Consortium (BRC), FSSC 22000 and the International Featured Standard (IFS). While the four GFSI schemes have differences, they all require a written food safety program that utilizes prerequisite programs to support the written HACCP Plan. The hazard analysis part of the HACCP Plan is supposed to incorporate “risk” into the decision-making process but does not require any recognition of potential radiological hazards. The GFSI schemes utilize specific prerequisite programs instead of GMPs to receive their certification. We can designate this as “Written Food Safety Plan #2”.

In May 2017, the U.S.-based National Conference on Interstate Milk Shipments (NCIMS) adopted the most significant changes for Grade “A” dairy plants since the early 1990s. These changes are likely to be accepted by the FDA in October 2017 and enforced in all “Grade A” dairy plants by October 2018. The new requirements will require a FSMA “Preventive Controls-like” written food safety program that will be evaluated by trained FDA Regional Milk Specialists once every three years, in addition to the routine GMP-like state inspections required once every three months. These NCIMS changes are similar, but not the same as required in the FSMA Preventive Controls regulation, with the FDA GMP requirements being somewhat superseded by the NCIMS Pasteurized Milk Ordinance (PMO) dairy plant operational requirements. In addition, the Preventive Control supply chain management requirements were modified to recognize the NCIMS strict requirements for utilizing only raw milk from Grade “A” licensed or permitted dairy farms and dairy ingredients from Grade “A” dairy plants. We recognize this as “Written Food Safety Plan #3”.

Finally, many large dairy companies have mandated policies and procedures on the content and details for a dairy plant’s written food safety plan. These mandated policies and procedures are “enforced” via corporate-based or private auditing companies hired to conduct plant-by-plant assessments. We can call this “Written Food Safety Plan #4”.

The problems related to multiple and possibly competing written food safety programs in dairy plants are significant. First, most dairy plants are challenged, like any food processing plant, with managing one written food safety plan. So how does a plant maintain and implement multiple written food safety programs? Second, how does plant management decide on the instructions and training for the plant staff that are responsible for delivering a safe finished product, based on multiple written food safety plans? Third, most plants are resource-challenged to support one written food safety plan, so where do the resources come from to maintain, implement and train staff on multiple written food safety plans?

A “revolutionary” process is required for a dairy plant with up to four different food safety programs to consolidate into one which contains the key requirements in one written food safety plan. This consolidated plan needs to use hybridization techniques to achieve a “Best in Class” food safety program. Such hybridization in nature many times produces much stronger off-spring with unique and new abilities to meet the challenges of the real world. This is the expectation for the “hybridized”, consolidated written food safety plan that will replace the multiples.

In conclusion, dairy plants need to conduct a hybridization exercise to move toward one “Best in Class” written food safety program that meets or exceeds government, private certification, customer and internal corporate requirements.

With more than 150 independent consultants, EAS has the expertise to assist any dairy plant or company in developing a “Best in Class” hybridized written food safety program. For more information, please contact Allen Sayler, EAS Senior Director of Food and Cosmetic Consulting Services at 571-447-5509 or via email at asayler@easconsultinggroup.com.

FDA Issues New Food Defense Guide, Food Safety Software

FDA released two useful tools last month to advise and assist companies in complying with new FSMA rules.

The agency issued a Small Entity Compliance Guide(SECG) to help small food businesses comply with the FSMA final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration.

“We encourage you to comply with the [intentional adulteration] rule as soon as possible,” the agency said. The mandatory compliance dates depend on the size of the business. Businesses that do not qualify for exemptions must comply by July 26, 2019. Small businesses – with fewer than 500 full time equivalent employees — have until July 27, 2020 to comply. Very small businesses are exempt from the rule, except for a documentation requirement which has a compliance date of July 26, 2021. A very small business is defined as a business (including any subsidiaries and affiliates) averaging less than $10 million, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food, plus the market value of human food manufactured, processed, packed, or held without sales.

The intentional adulteration rule requires a written food defense plan that must include:

  • A vulnerability assessment to identify significant vulnerabilities and actionable process steps, and associated explanations;
  • Mitigation strategies and associated explanations;
  • Procedures for food defense monitoring;
  • Procedures for food defense corrective actions; and
  • Procedures for food defense verification.

The rule applies to all food facilities, foreign or domestic, that are required to register because they manufacture, process, pack, or hold human food for consumption in the U.S.

Although this new FDA guidance is for small entities, it includes useful advice for any size of business thinking about ways to minimize the risk of intentional adulteration — such as how to prepare a food defense plan, the required contents, who must sign the document, what ongoing records are required, who is qualified to create the plan, where and for how long records must be held, and so on. Perhaps equally useful is the guide reflects current FDA thinking, and offers some reason for confidence that following the guidance will probably be acceptable to FDA.

As a FSMA consultant, I should note that the qualified individual who creates the food defense plan may be, but is not required to be, an employee of the facility.

The agency also unveiled a new software program called the Food Safety Plan Builderto help owners and operators develop food safety plans. The program was modeled after the Food Defense Plan Builder, created to help food facilities create food defense plans.

The new tool asks a series of questions to help identify potential hazards and the preventive controls needed to address the hazards. The FSP Builder, much like the SECG for Mitigation Strategies, is current agency thinking. Using the tool correctly to design a facility specific FSP should satisfy FDA, at least initially, that a good faith effort is being made by a regulated firm to follow food good manufacturing practices, and identify hazards in need of controls(s). It may also help firms distinguish between safety hazards that FDA will review, and quality characteristics unrelated to food safety that are present in many operating SOPs.

The agency won’t have access to any documents developed using the software, Jenny Scott, senior advisor in FDA’s Office of Food Safety, emphasized in an agency blog. However, during an inspection, FDA will review the FSP.

Tips for Auditing a Contract Laboratory

Contract laboratories provide an extremely valuable and necessary service to the dietary supplement industry. The own-label distributor or manufacturer rarely has an in-house laboratory equipped with the appropriate scientific expertise to conduct all the testing required in 21 CFR 111, Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.However, a contract laboratory must be thoroughly scrutinized by the own-label distributor or manufacturer to ensure the laboratory complies with the applicable subparts of 21 CFR 111.

All personnel must possess the education, training, or experience needed to perform their job function in accordance with 21 CFR 111.12(c). Responsibilities and activities for each job function should be described in a formal job description. A comparison of the job description to on-the-job training provided in a personal training record as well as a resume or biography of several selected individuals should be examined during the audit to verify compliance with the regulatory requirements, but also ensure the laboratory has the scientific expertise to competently perform the desired tests.

The laboratory facility used to perform testing must be adequate per 21 CFR 111.310 and in accordance with 21 CFR 111.27, all equipment must be of appropriate design, construction, and workmanship to enable them to be suitable for their intended use. The latter is generally accomplished using an equipment qualification program. Documentation supporting the qualification of several different types of equipment should be reviewed during the audit. Part of the review must include an assessment of any software or electronic operations being performed by the instrumentation.

All electronic equipment and records must comply with the requirements dictated in 21 CFR 11, Electronic Records, Electronic Signatures. Equipment must then be calibrated and maintained at a frequency dictated by the manufacturer to maintain accuracy and precision and these activities must be documented in equipment log books as governed by 21 CFR 111.35(b)(3).

All laboratory controlled processes, including written procedures for test methods, must be developed and implemented in the laboratory as required by 21 CFR 111.325. There must be evidence that these test methods are being conducted, as written, by laboratory personnel and that this is documented at the time of performance. The documentation must be thorough and detailed and include the performance of each step of the method. Test methods employed must be scientifically valid as required by 21 CFR 111.75(h)(1) and 111.320(b).

The FDA described a scientifically valid test method as one that is accurate, precise, specific for its intended purpose, and consistently does what it is intended to do (rugged). Documentation that a method meets these criteria is accomplished from method validation studies for the sample matrix via experimentation, peer-reviewed literature, or compendial sources. Several examples of such documentation should be reviewed by the auditor.

Other critical laboratory controlled processes to examine during a contract laboratory audit include those for out of specification (OOS) investigations, deviations, and corrective and preventative actions. These situations are inevitable and a strong quality system must be in place for handling them.

There are many important aspects to choosing a contract laboratory, from assessing testing and record-keeping to confirming it is equipped and suitable for its intended use. A pre-audit of a contract laboratory helps to ensure that their procedures match those required by FDA as well as your own internal requirements. This up-front work will go a long way towards finding the right partnership to enable distributors and manufacturers to market safe products.

FDA Funds States’ Efforts to Implement FSMA Produce Rule

FDA awarded almost $31 million in funding last month to help states implement FSMA produce safety programs — on top of the almost $22 million the agency awarded last fall for that purpose. The year-two funding underscores the importance of state partnerships as the agency moves forward with prevention-based oversight of U.S. food safety.

Commissioner Scott Gottlieb said the agency’s partnerships with states are especially critical for fresh fruits and vegetables. Transformation of the U.S. food safety system “can’t happen without the support of state partners who are helping food producers and growers understand and achieve the new requirements promulgated at Congress’ direction,” he said, in announcingthe new funding.

The states applied for funding under two tracks – one covering infrastructure, education, technical assistance, and inventory, and the other also including inspection, compliance and enforcement activities. The level of funding was based on the number of farms growing covered produce within the jurisdiction. So, for example, California ($1.9 million), Pennsylvania ($1.3 million) and Washington state ($1.3 million) were among the top recipients of the 43 total states to receive funds.

Using the new funding, states will, among other activities:

  • Establish a process to develop and maintain a produce farm inventory.
  • Formulate a multi-year plan to implement a produce safety system.
  • Develop a performance measurement system, plan, and/or process to measure progress towards the goals of the cooperative agreement.
  • Evaluate legislative or regulatory authority for produce safety.
  • Provide education, outreach, and technical assistance, prioritizing farming operations covered by the rule.
  • Implement a compliance program for applicable produce safety regulations at the state level.

The funding will help awardees provide education, outreach and technical assistance, Gottlieb said. The agency will also continue its own outreach. “We want to hear from farmers and other food producers to understand what challenges remain and how the FDA can best support their efforts to enhance produce safety,” Gottlieb said.

The agency also recently announced plans to extend the compliance dates for agricultural water standards under the produce rule, and it is considering simplifying those standards.

There are no certainties for future funding, but broad support from states will be a major influence on upcoming appropriations.

Changes in What Constitutes ‘Dietary Fiber’ for Nutrition Facts Labeling May be in the Works

One of the more controversial aspects of the FDA’s final rule on revising the Nutrition Facts Panel (NFP), 81 Fed. Reg. 33742(May 27, 2016), changes the definition of “Dietary Fiber” as it is disclosed on the NFP.

The new rule requires that only certain naturally occurring dietary fibers such as those found in fruits, vegetables and whole grains, and added isolated or synthetic fibers that FDA has determined have a physiological effect that is beneficial to human health, can be declared on the NFP under “Dietary Fiber.” Previously, fibers in foods could be labeled as dietary fiber without necessarily providing evidence of beneficial physiological effects.

Under the final NFP rule, a fiber ingredient that is “intrinsic and intact in plants” automatically meets FDA’s new dietary fiber definition. In addition to fiber that is naturally occurring in foods, the final regulation identifies seven isolated or synthetic non-digestible carbohydrates that, when added to foods, can be declared as “Dietary Fiber.” They are: [beta]-glucan soluble fiber (as described in 21 CFR 101.81(c)(2)(ii)(A)), psyllium husk (as described in 21 CFR 101.81(c)(2)(ii)(A)(6)), cellulose, guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose.

But other fibers that are “isolated” or “synthetic,” must gain FDA approval and show they have a beneficial physiological effect before they can be counted as “Dietary Fiber” on the NFP. Under the final rule, food manufacturers can submit petitions to FDA for approval of additional sources of “Dietary Fiber” with physiological benefits and many have done so already.

FDA reacted by publishing a request for scientific data, information and comments to help it determine whether certain fibers should be added to the definition of “dietary fiber” published as part of the NFP final rule.

The request for information, along with an accompanying draft guidance, is intended to help industry understand how FDA reviews the scientific evidence to determine whether other fibers beyond the seven identified in the final rule should be added to the regulations. It also provided an opportunity to add to or comment on FDA’s review of the science with respect to whether any of the 26 additional specific types of fiber provide a physiological effect that is beneficial to human health and thus should be included in the fiber definition. The comment period closed on February 13, 2017.

Some segments of the food industry remained unsatisfied. On April 7, 2017, the American Bakers Association (ABA) filed a petition urging the agency to revoke its new definition of “Dietary Fiber” for Nutrition Facts labeling purposes. Whether the ABA’s request will receive serious consideration remains to be seen.

On June 13, 2017, FDA’s Office of Nutrition and Food Labeling announced that it intends to extend the compliance date for the new Nutrition Facts rules. ABA praised the move. But how long the compliance date will be extended and whether FDA also will reconsider certain aspects of the regulation are unknown. FDA Commissioner Scott Gottlieb stated before a Senate Appropriations Sub-Committee hearing on June 20, 2017, “We are not reopening the regulation…We are just using this time to develop additional guidance documents.”

Whether industry dissatisfaction with FDA’s final regulation on the disclosure requirements for “Dietary Fiber” on the Nutrition Facts label will lead to a wholesale change in the agency’s approach, or merely the addition of a few more substances to its list qualifying as having beneficial physiological effects, remains to be seen. But some changes can be expected.

FDA Unveils Accredited Third-Party Certification Site

In one more step toward improved oversight of imported foods, FDA unveiled a new section of the FDA Industry Systems (FIS) websiteon June 21, 2017, to allow organizations – including foreign governments and agencies or private third-parties – to apply for recognition as third-party accreditation bodies under the FSMA voluntary Accredited Third-Party Certification program.

The accredited bodies will accredit third-party auditors, who can then conduct food safety audits of foreign food entities and issue certifications that qualify them for the Voluntary Qualified Importer Program (VQIP). Under VQIP, U.S. importers can use the certifications by foreign entities to secure expedited entry of food shipments.

The accreditation bodies will monitor the performance of the third-party auditors and submit reports to FDA. Third-party auditors accredited under the program must conduct unannounced facility audits, notify FDA of any serious public health risk, and must ensure that their agents are competent and objective.

The VQIP allows for two kinds of audits, regulatory and consultative, but only a regulatory audit can be used for certification. For regulatory audits, the auditor must submit an audit report to the FDA within 45 days of the audit.

Under fee-based VQIP, FDA may grant recognition to an accreditation body for up to five years.

Water Standards Delay

In another significant move last month, FDA announced that it plans to extend the compliance dates for agricultural water standards under the FSMA Produce Safety Rule, except in the case of sprouts. The agency is considering simplifying the standards, which have proved to be some of the most challenging to develop in the entire FSMA rulemaking process.

The agency said it remains committed to protecting public health while implementing rules that are “workable.” FDA said it will extend the compliance dates “using appropriate procedures at a later time.” It has not decided how long the extension will be. So, at least for now, that’s an indefinite delay.

Process Labeling – Pathway to Transparency?

A thirty-year old federal court opinion that is well known to students of food and drug law holds that in the absence of a detailed, Congressionally mandated definition, courts and regulators should follow the common understanding of “food” as an article that delivers “taste, aroma and nutrition.” In the 21st century, however, food not only nourishes and satisfies, it also frequently makes a statement — about how it was made, where it came from and how the earth and its inhabitants were treated along the way.

Foods with these sorts of claims – called “Process Labeling” — are everywhere. Even on a casual trip to the supermarket, it’s hard to miss the increasing use of labels claiming that a food is “certified organic,” “shade-grown,” “free-range,” or “rain forest certified,” to name but a few. Process labeling is oftentimes also about what was notdone to a food. For example, “Non-GMO” indicates that the food used no ingredients made from genetically modified organisms, or “GMOs,” shorthand for the agricultural bioengineering methods that have helped farmers grow corn, soybeans and other cash crops.

Consumer Appeal

Food marketers today, as one of them recently told me, need to appeal to consumers’ desire to know about the “genealogy” of a food. Of course, this interest is relatively new but growing exponentially and to a very real extent can be attributed to the fact that food in the United States is by and large safe, plentiful and relatively inexpensive. Two authors who have studied communication in modern agriculture explained the phenomenon this way:

As top concerns for consumers are already largely being met, there is a freedom that was not historically available to delve deeper into food issues, to ponder how food was grown and raised and to think about these matters while waiting to check out. Consumers are not wrong for doing this; it is a fundamental right of the consumer to question.

The Communication Scarcity in Agriculture, J. Eise, W. Hode (New York, N.Y. 2017) at p. 46.

Consumer concerns over the impact of modern food production on health and the environment have helped drive the popularity of Process Labeling. The Council for Agricultural Science and Technology, a nonprofit scientific organization, recently assembled a cross-functional panel of experts to assess the phenomenon and make policy recommendations. The panel concluded:

Under appropriate government oversight, these ‘process labels’ can effectively bridge the information gap between producers and consumers, satisfy consumer demand for broader and more stringent quality assurance and ultimately create value for both producers and consumers.

The mounting popularity of Process Labeling is readily apparent. In the U.S., consumer purchases of organic products have reached record levels, amounting to over $43 billion last year, and up 11% over the previous year. The demand for environmental or “eco” labeling is robust, with more than 460 different labels relating to 25 industry sectors now in use in nearly 200 countries. Food companies are embracing Process Labeling in the name of “transparency,” with many committing to provide more information – via labeling – about how food is produced.

Execution Challenges

While Process Labeling has great appeal and potential utility, execution can be difficult for three reasons.

First, such labels require a “process” clearly defined by a standard fixed either by the government or a well-established, independent agency. The standards for organic farming set by the National Organic Program are the leading example of such a third-party standard.[1] USDA’s systems of grading meat, poultry, butter and eggs, and requiring Country of Origin Labeling (“COOL”) are other examples of clearly defined process standards. Sellers, buyers, trade groups and industry associations have also established quality standards and guidelines against which Process Labeling claims can be assessed.[2] However, it is hard, if not impossible, to find widely accepted, well-established definitions for some of the most popular process claims such as “cage-free,” “grass-fed,” “free range,” “naturally raised,” and many others.

Second, even with a defined standard, substantiating Process Labeling claims can be challenging, especially for large-scale operations with far-flung suppliers. Adequate substantiation requires supply chains operating under strict control, with rigorous oversight and continuous monitoring. The food producer must maintain strong and transparent supplier relationships and check in frequently to assure that the operation is running as agreed and without errors or gaps. Independent verification is helpful, and producers can obtain that kind of help from the USDA’s Agricultural Marketing Service, which provides a wide variety of independent verification services through its Process Verified Program (“PVP”), a voluntary, user-fee-funded program. The PVP uses highly trained auditors to conduct inspections, review processes and documentation and thereby assure that a producer is adhering to the standards supporting the process claim.

Third, Process Labeling can send inferential messages about health or well being that can be highly misleading without prominent disclaimers or other disclosures. The Federal Food, Drug, and Cosmetic Act (“FFDCA”) provides that a food is misbranded if its labeling is “false or misleading in any particular.” The FFDCA has long been interpreted as holding a producer strictly accountable for the claims made in labeling. This includes accountability for omissions, as the FFDCA empowers FDA to find a label misleading if it fails to reveal facts that are “material” in light of the representations that are made for the product.

GMOs are a case in point. A recent consumer survey concluded that an overwhelming majority of consumers worldwide think non-GMO foods are healthier than foods made with GMOs. However, FDA has found no scientific basis to require labeling because GMO foods are safe and not materially different from non-GMO foods. Now consider whether the following claims should appear right alongside each other on a food’s principal display panel:

Healthy / Non-GMO

Is this lawful? Or does the implication that non-GMO foods are healthier violate the FFDCA by failing to disclose the scientific consensus that GMOs are safe and that avoiding them does not brings a health benefit? Information necessary to avoid misleading consumers should be provided at the point where the claim is made. In this case, the label should have noted the FDA’s position on the same panel, or at least on an adjoining one.

Conclusion

Process Labeling can inform consumers about the origins of their food and the methods by which it was produced, and in doing so promote a sense of interconnectedness and a better understanding of agriculture. However, such labeling requires clearly defined standards and significant investments in supply chain oversight and monitoring. Process Labeling claims can mislead consumers about benefits where none exist.

The CAST panel, while seeing the upside of Process Labeling, recommended strict regulation. Labelers should explain the scientific significance of the process (“GMO corn for reduced pesticide use”) and disclose when there is no benefit (“rBST-free / No significance difference has been shown in milk from non-rBST cows”). Such standards of care can certainly help unlock the potential of Process Labeling to educate consumers and help them feel just a bit closer to their world and the ways in which their food is made.

First FSVP Compliance Deadline Arrives

In a significant FSMA milestone, May 30, 2017 was the initial deadline for U.S. food importers to implement a foreign supplier verification program (FSVP).

Beginning May 30, the U.S. Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system is requiring filers to enter at least one additional code for their food shipments, noted Sharon Mayl, Senior Advisor for Policy in the Office of Foods and Veterinary Medicine, in an interview posted on the agency’s website just days ahead of the deadline.

Importers covered by the deadline should enter the code “FSV” to indicate that the entry is subject to the FSVP regulation. When it sees that code, ACE will ask for the importer’s name, email address, and unique facility identifier (UFI) – and FDA has formally recognized the Data Universal Numbering System (DUNS) for this purpose.

If a food is exempt or not yet subject to the FSVP, the filer should enter “FSX,” to indicate that the food is exempt from FSVP or that compliance with FSVP is not yet required — or “RNE,” to indicate that the food is exempt because it will be used for research or evaluation.

For a limited time, Mayl said, importers can enter “UNK” – indicating unknown — for the DUNS number if they don’t have one. But this option is temporary and they will need to get a DUNS number to come into full compliance. Importers without DUNS numbers should use this link to obtain a free DUNS number: fdadunslookup.com.

FSVP verification by importers should be based on an evaluation of the risk of the food and the supplier’s performance, so verification could include a review of the supplier’s food safety records, sampling and testing, as well as onsite auditing.

FSVP compliance dates are based on the size of the foreign supplier and the regulations that apply to the supplier. Importers generally must comply six months after their foreign supplier must be in compliance with the FSMA preventive controls or produce safety rules.

For companies unsure of whether they are covered by the FSVP, the agency has created a useful chart titled Am I Subject to FSVP?

EAS Offers U.S. Agent Services for Foreign Companies

The FDA’s regulatory requirement for foreign firms to have a U.S. Agent can be confusing, to say the least. There are very specific requirements for foreign firms to have a U.S. Agent, and failure to have a competent and responsive U.S. Agent can cause significant compliance issues, delays in applications and submissions and can even impact the importation of their product into the United States. The information below is provided to offer clarity to these requirements and help firms understand this area of the FDA’s governing requirements.

For FDA purposes (as defined in section 201(e) of the Federal Food, Drug, and Cosmetic Act), a U.S. Agent means a person who is physically residing or maintaining a place of business in the United States. A U.S. agent cannot be in the form of a mailbox, answering machine or service, or another place where an individual acting as the foreign facility’s agent is not physically present. U.S. Agent is not the same as a shipper’s U.S. Agent for CBP (Customs and Border Patrol).

What does a U.S. Agent do? Your appointed U.S. Agent will become your firm’s first point of contact with the FDA. They will facilitate communications between your company and the FDA in the area of applications, site inspections, regulatory notifications and resolution of formal compliance concerns (FDA 483s and Warning Letters).

This is particularly beneficial when time zones put your normal operating hours out of synch with the FDA’s routine working schedule. For all human and animal drug application holders and sponsors (DMF, VMF, NDA, BLA, ANDA and NADA, etc.) the U.S. Agent can work to assist and coordinate the migration to electronic submission filing submitting your Amendments, Supplements, Annual Reports, LoAs, etc. via the FDA ESG system.

The FDA eCTD requirements for submissions to CDER and CBER went into effect May 5, 2017, for NDAs, ANDAs and BLAs and will go into effect May 5, 2018, for DMFs and INDs. Submissions of 10 GB or smaller MUST be sent via the FDA ESG. After these dates, only submissions greater than 10 GB will be accepted via physical electronic media.

Who is required to have a U.S. Agent? All foreign establishments and firms who wish to ship their products into the U.S., firms who have an active regulatory submission or are required to be registered with the FDA are expected to have an appointed U.S. Agent. This includes any drug product applications (INDs, NDA, ANDAs, BLAs, NADAs, DMFs, VMFs, etc.) whether pending or approved, the distribution of drug substances, intermediates and finished dosage forms into the U.S. for either commercial or research and development purposes.

A U.S. Agent must be identified for every single foreign facility registration. This includes food facilities (21 CFR 1.232 (d)) under which dietary supplement facilities fall (21 CFR 1.227), drug establishments (21 CFR 207.40 (c)) and medical device facilities (21 CRF 1.232 (d)). A U.S. Agent appointment is required for all ANDAs (21 CFR 314.95(7)) and NDAs (21 CFR 314.52(7)) as well as foreign color manufacturers (21 CFR 80.21(d)). It is highly recommended, although not necessary, to have a U.S. Agent appointed to your DMFs. While INDs do not require a U.S. Agent, it is certainly beneficial to have one.

When is a U.S. Agent required? The U.S. Agent must be appointed before any registration, application or communications with the FDA can begin. As a foreign firm, at the time of registration and listing, you will be asked to provide the name and contact information for your U.S. Agent. Likewise, at the time of submission of any application to CDER, CBER, CDRH, an appointment letter must accompany each specific submission and be on file with the FDA to facilitate any communications.

EAS Consulting Group offers the full breadth of U.S. Agent services to clients around the globe and we are prepared to assist you with meeting the regulatory requirements in this area. Let us know how we can help you.

FDA Combines Old and New Inspection Tools for Imported Foods

The Food and Drug Administration is using a combination of old and new tools to improve the safety of imports and a quick look at the numbers explains why.

We’ve seen the familiar statistics: Almost 50 percent of fresh fruit, 20 percent of fresh vegetables, and 80 percent of seafood is imported. The U.S. imports from more than 200 countries and from about 125,000 firms, so a risk-based approach to inspection is really the only kind of oversight that makes sense.

FDA’s Don Prater, in his new role as acting assistant commissioner for food safety – which makes him the agency’s new point person for FSMA – discussed this in an FDA Constituent Alert last month.

FDA activities related to imported foods are undergoing big changes, largely due to FSMA, he said.

Overseas inspections are very resource intensive because of the need for coordination with national and local authorities, visa requirements, logistical arrangements, language (need for interpreters), and other challenges, he said. So the agency will keep focusing on facilities that pose the highest risk.

The agency currently uses the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system to electronically screen all regulated shipments imported or offered for import into the U.S. In addition, it is now using data analytics to get a deeper understanding of the global inventory of regulated entities, he said. This will help the agency target its resources.

Traditional inspection will continue, Prater said, so facility inspections and examination at the port of entry will continue to be important tools. The challenge is integrating the old and new tools. The agency currently has several FSMA implementation groups working on this issue.

One challenge involves using information from third parties for oversight activities. A big question is how the agency can use this information in planning its work, he said.

Integrating open source material, such as new reports and social media, has great potential, but is challenging to evaluate and confirm. FDA historically has been very conservative in using unofficial and unconfirmed information to direct its focus. Data analytics may offer some degree of confidence as FDA gains experience.

The agency has recognized just three countries as providing the same level of public health protection – New Zealand, Canada and, just last month, Australia. It is still too early to know when and what will be a recognizable difference in FDA surveillance activities compared to those prior to recognition.

The Food Processing Industry’s Newest Challenge: Safe Quality Food’s Edition 8.0

The Safe Quality Food Institute (SQFI) is coming close to releasing its long-anticipated Edition 8.0. While many things could change during the final review and “sign-off” by the SQFI Technical Advisory Committee and SQFI staff, it is likely that the new SQF Edition 8.0 will have the following formatting and content changes. Some of these changes make the new Edition 8.0 more closely aligned with the FDA’s Preventive Controls for Human Foods (PCHF) regulation.

SQFI has indicated that Edition 8.0 will be enforced by SQF certification bodies six months after the implementation date (expected April 1, 2017). If SQFI meets its final publication schedule, all SQF-certifications after October 1, 2017 will have to have incorporated all Edition 8.0 changes.

Formatting Changes:

  1. Edition 8 has divided the food safety requirements in Edition 8 into specific food sectors as follows:
    • SQF Food Safety Fundamentals (applies to all food processors)
    • SQF Food Safety Code for Primary Production
    • SQF Food Safety Code for Manufacturing
    • SQF Food Safety Code for Storage & Distribution
    • SQF Food Safety Code for Food Packaging
    • The SQF Retail/Wholesale Grocery Code
    • The SQF Quality Code (Formerly Level 3)
  2. All food quality requirements have been incorporated into a separate “SQF Quality Code” and all previous food safety items have been relocated into the specific “SQF Food Safety Codes”.

Specific Operational or Substantive Changes:

  1. Levels #1, #2 and #3 have been eliminated.
  2. A food processor may forgo the unannounced certification audit once during each three (3) year cycle and voluntarily choose to move to annual unannounced recertification audits. Locations with annual unannounced recertification audits shall be recognized on the SQFI Certificate as an “SQFI Select Facility.”
  3. All products produced, stored or processed on site shall be included on the site’s certificate, unless exempted. The site must demonstrate that exemptions that are either site or product specific as part of the scope of certification do not put certificated product at food safety risk.
  4. The requirements for a food processor’s “Environmental Monitoring” have been expanded, similar to the FDA FSMA “Preventive Controls for Human Foods (PCHF)” requirements:
  5. SQFI and the certification body must be notified by the food processor in writing within 24 hours of becoming aware of a food safety problem that requires public notification. SQFI can be notified at foodsafetycrisis@sqfi.com.
  6. The site and the certification body shall agree on the audit scope before the certification audit begins. The agreed upon audit scope cannot be changed once the audit has commenced.
  7. The certification body must advise the supplier (food processor) of the name of the SQF food safety auditor at the time that the SQF audit is scheduled.
  8. In instances where a food processing plant has some operational written procedures or records kept or managed by the corporate office, the SQF audit may need to be conducted at the corporate office location as well as at the food processing plant location.
  9. The definition of “critical nonconformity” has been slightly expanded to include the failure to meet food safety regulations such as state, USDA or FDA regulatory actions.
  10. The section on “Food Defense” is now titled “Food Defense and Food Fraud”.
  11. Significant new requirements on allergen management have been added, consistent with the FDA FSMA “PCHF”.
  12. If a food processor chooses to not implement any Module 11 GMP-like requirements, the reason for not implementing must be submitted in writing to the certification body prior to the audit.
  13. Water requirements have been strengthened. Water stored on-site must be routinely monitored and water used as an ingredient in processing or for equipment cleaning and sanitizing must be treated, with water microbiological samples be taken annually.
  14. Lighting in food processing and handling areas and at inspection stations shall be at an average illuminance of 200 lux, or as required by applicable regulations.
  15. A current list of all chemicals used in the food processing plant is now a requirement.
  16. All ventilation equipment and devices in product storage and handling areas shall be adequately cleaned to prevent unsanitary conditions.
  17. There are significant new written and operational requirements related to maintenance of the processing facility and processing equipment.

For more insight on the new SQFI Edition 8.0, contact Allen Sayler, EAS Senior Director of Food & Cosmetic Consulting Services at 571-48-5509 or asayler@easconsultinggroup.com.

EAS Consulting Group is a licensed SQFI Training Center and has scheduled SQF Edition 8.0 training sessions. EAS can also provide on-site SQF-based assessments by SQF-registered consultants.

A Good Time for Stakeholder Comment on FSMA Guidance

FDA has published and continues to prepare more draft guidances. As they become available, it’s important for companies to know how and what FDA expects to see during inspections. Now is the time to study the relevant draft documents and submit comments on agency expectations that will impose a high financial burden. In a very real sense, FDA relies on the regulated industry to help the agency understand the real-world implications of its policies as it begins enforcing the new FSMA rules.

The agency has said it will strive to achieve a balance between its public health mission and easing regulatory burdens, and the new administration is committed to continuing that approach.

A case in point is the water quality standards in the produce safety rule. In response to comments from stakeholders, the agency issued a March 20, 2017 notice acknowledging that parts of the FSMA produce rule setting numerical criteria for pre-harvest microbial water quality may be too complex to translate, understand, and implement. The agency is considering ways to simplify the water standards in a fashion that protects public health across the great diversity of circumstance for growing food.

Another issue with many moving parts and implications for industry is the use of third-party audits. The FDA has invited comments on its guidance on the Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards. There is no deadline for comment on this guidance.

The VQIP guidance document, FDA’s Voluntary Qualified Importer Program, is closely tied to Third-Party certification and it too needs advice and input from affected industry.

Another key FSMA document, FDA’s Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods, is open for public comment through July 17, 2017.

Remember that even finalized guidance just represents the FDA’s “current thinking” on a topic and is not binding. Companies can “use an alternative approach if it satisfies the requirements of the applicable statutes and regulations,” the agency says. FDA suggests you contact its Technical Assistance Network (TAN) to discuss any alternative approaches. Although (necessarily) slow to answer policy questions, the TAN’s goal is to be an authoritative source for scientific and technical answers.

Understanding the Drug-Cosmetic Conundrum When Marketing Your Products

Products marketed as cosmetics can easily find themselves the target of FDA compliance action based on improper claims and statements.

FDA is charged with enforcing the laws and regulations that ensure the safety and labeling of products, including cosmetics, that account for 20 – 25 % of all U.S. consumer spending.

Cosmetics were first regulated under the 1938 Federal Food, Drug and Cosmetic Act (FFDCA). They are defined as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles…”.

By comparison, drugs are defined as articles (1) intended to treat or prevent disease or (2) that affect the structure or function of the body. Cosmetics are products that provide mostly superficial effects that do not include “nutrition” as with foods or that “treat or prevent disease or affect the structure or function of the body” as with drugs. Because of the narrow definition and generally low safety risk for cosmetics, they can be marketed, with the exception of color additives, without pre-approval by FDA.

As with all products regulated by FDA, cosmetics must be safe and properly labeled. A cosmetic is considered unsafe (adulterated) if (among other things) “it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual…”. Also, cosmetics must be labeled in accordance with the applicable laws which include the FFDCA and the Fair Packaging and Labeling Act (FPLA).

Under this regulatory framework, a product can be classified as both a drug and a cosmetic. Product classification depends on the intended use which is determined based on claims made for marketing the product and whether or not the statements fit the definition for cosmetics and/or drugs. Because of the difference in the regulatory schemes for cosmetics and drugs, FDA has sought over the years to make sure that a marketed product stays within the established boundaries that apply. For example, a cosmetic may not make claims that the product will treat and prevent a disease or alter the structure or function of the body.

So how does one tell what claims pose a risk that a product will be classified as a drug and subject to FDA compliance action? This is a complicated question and there are no quick, easy answers. Product classification does not necessarily depend on the presence of a single word or phrase and FDA will typically make a determination based on all product statements and representations or “claims” taken together. FDA’s Warning Letters provide the most readily available source of information on claims.

Let’s look at what types of claims are problematic based on recent warning letters. Many problem claims relate to a structure or function of the body (skin) which is appropriate for a drug rather than a cosmetic.

A warning letter dated October 18, 2016, based on an establishment inspection and a website review, noted:

  • The product label said, “It stimulates cell-cell interaction, assists in the formation of collagen, and increases skin elasticity…”
  • The website included the claims “Stimulates cell-cell interactions, and accelerates cell renewal” and “Helps to preserve cellular energy, assists the formulation of collagen and strengthens in structural proteins”
  • The product insert included the claims “[I]nduces signal transduction…reconstructs protein structure…acts as a topical Botox…”, “[S]timulates cell respiration and increases cell turnover.”, “[A] biosafe alternative to Botox, it relaxes muscle contraction…” and “Increase Microcirculation”.

A warning letter dated September 20, 2016, based on a website review, cited the following claims:

  • “Lemon, a powerhouse of vitamin C…with its antibacterial properties, and boosts collagen production…It also lightens age spots…”
  • “By increasing blood flow…”
  • “Organic shea butter is a powerhouse… has natural anti-inflammatory properties that can take the sting out of insect bites.”

A warning letter dated April 14, 2016, based on a website review, noted:

  • The product website included the claim – “Removes Wrinkles Instantly”
  • Product Ingredient Claims – “Tests using a 0.5% concentration of the culture have shown a clear reduction of uneven pigmentation and obvious lightening if the skin.”
  • “A super anti-oxidant …eliminates age spots, contains protection from ultraviolet A and B and boosts collagen synthesis.”

As you can see from these examples, products marketed as cosmetics can attract FDA compliance action based on improper claims and statements. The FDA issued more than 29 warning letters to cosmetic firms in 2016.

EAS labeling experts are available to assist with the regulatory compliance of claims for cosmetic products.

FDA Urges Industry Groups to Develop FSMA Guidance

The Food and Drug Administration is encouraging industry groups and trade associations to develop their own guidance to help their members comply with new requirements under the Food Safety Modernization Act.

FDA laid out steps for developing guidance in a January 31 constituent update and said the agency would help by providing technical advice and by checking for any potential conflicts with federal regulations.

FDA would prefer the scope of the industry guidance be kept broad to increase its usefulness for any future FDA guidance. The agency is especially interested in guidance on topics not covered by existing or planned FDA guidances.

The recommended steps are:

  • Define the scope of the guidance – produce grown in a greenhouse, for example – and decide how much of the process will be included, whether just a single process or the entire supply chain, and whether the guidance is for regional, national or international use;
  • Establish a work group of experts from industry and academia – and invite both state and federal government;
  • Develop draft guidance;
  • Finalize the document and circulate it to stakeholders for comment – including state and federal regulators.

The agency said it may place links to final industry guidance on its website.

FSMA extended FDA’s authority to include produce all the way to the farm level. The agency issued a final rule on Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption on November 27, 2015. That rule went into effect on January 26, 2016, with staggered enforcement dates depending mostly on size. Certain sprout growers were required to comply by January 2017 – because sprouts are considered to pose a higher food safety risk.

In January, the agency issued draft guidance for compliance of sprout operations with the produce safety rule. But there is plenty of room for additional guidance for other products.

FDA has said it will rely heavily on partnerships during the implementation phase of FSMA. Realistically, it has no other option. The call for industry-developed guidance is part of this strategy and it will certainly help both the agency to leverage its limited resources, and for industry groups to share best practices for safer food.

Using Temporary Marketing Permits for Food Products

FDA food standards of identity are regulations that establish the names and define the basic nature of certain foods. Food standards prescribe, among other things, what ingredients are required or optional and may describe the manufacturing process when that process has a bearing on the identity of the food. If a food is labeled with the name that is included in a food standard of identity, it must comply with that food standard. If it does not meet the standard, it is a non-compliant food product.

So, how can you market foods that have food standards of identity if you want to use a new ingredient or new technology not included in the food standard? You have to either ask FDA to revise the food standard regulation or you must use a different name. However, if you want to use the name specified in the food standard regulation, you can still market a product that deviates from the food standard if you obtain a temporary marketing permit (TMP). A TMP is permission to market a food under a standardized name that deviates from that food standard of identity.

FDA recognized that prior to revising a food standard, market testing is needed to assess the feasibility of making the change and to test for consumer acceptance of the food. Therefore, it established procedures for TMPs that allow manufacturers to market test their products before a standard of identity is revised.

Manufacturers may request a TMP under regulations in 21 CFR 130.17. This regulation requires manufacturers to submit certain information with their application, including information about the applicant, a description of the deviation from the food standard, a statement on how the deviation is advantageous, and proposed labels for the food.

FDA will evaluate the information provided in the TMP application to see if any new ingredient is safe and determine whether the manufacturer has given a rational basis for the deviation from the standard. If FDA grants the TMP, it publishes a notice in the Federal Register granting the TMP for 15 months. The TMP will expire in 15 months from the date the product first enters interstate commerce, but can be extended by application to FDA. When applying for an extended TMP, the applicant must simultaneously submit a petition to revise the food standard regulation. If FDA grants the extension, it publishes a notice in the Federal Register and invites other interested parties to market the product. This extended TMP is in effect until FDA makes a ruling on the petition to amend the food standard.

It is important to note that FDA thoroughly reviews the TMP to determine if there is a rational basis for the deviation and that consumers are not misled by the name or label. FDA also reviews the labels for compliance and needs to accept the labels prior to granting the TMP. Receiving a TMP is an important step in revising food standards to address innovation. EAS consultants are available to assist manufacturers in applying for a TMP.

FDA’s Revised Draft Guidance on Listeria Controls

FDA released updated draft guidance on preventive controls for Listeria monocytogenes in ready-to-eat foods last month, adopting the “seek and destroy” approach used by USDA’s Food Safety and Inspection Service.

Facilities that produce ready-to-eat foods that are regulated by both FDA and USDA will benefit from a uniform federal approach, the agency says.

As every food facility manager knows, the persistence of Lm in processing facilities – in hard-to-reach locations such as drains and ducts – presents a serious challenge for food safety personnel. The hardy pathogen can find its way onto food contact surfaces and can then contaminate the food products. To make matters worse, it survives refrigeration temperatures, so the only effective preventive measure is to keep Lm away from ready-to-eat foods.

The updated guidance includes recommended procedures for environmental sampling and schedules for routine cleaning and sanitizing. Generally, the agency recommends that food contact surfaces should be cleaned and sanitized at least once every 24 hours. But the schedule for any surface needs to be based on the characteristics of the products and processes, the agency says.

If you clean and sanitize less frequently than every 24 hours, you should validate the frequency of your cleaning and sanitizing by microbial testing and not allow the reduced frequency to impact the microbiological condition of the production equipment, it says. And if the results of environmental monitoring or product testing indicate a problem, you should consider increasing the frequency of cleaning and sanitizing as part of an overall corrective action procedure.

The updated guidance suggests that non-food-contact surfaces such as drains, floors, waste containers, cleaning tools — and any surfaces that have a greater potential to become a source of Lm contamination – should be cleaned and sanitized every day. This would include surfaces likely to be touched by personnel who touch the food products or food contact surfaces, or areas where there could be a build-up of moisture or product residues.

Other non-food-contact surfaces such as condensate drip pans, overhead piping, ceilings and walls, coolers, and HVAC systems should be cleaned and sanitized weekly or monthly, the agency says. Motor housings and external surfaces of enclosed processing systems should be cleaned and sanitized weekly. Freezers containing exposed ready-to-eat foods and the interiors of ice makers should be cleaned and sanitized semi-annually, the guidance recommends.

I believe that effective implementation of this Lm draft guidance in RTE facilities would go a long way to address one of the toughest food safety challenges. And the careful documentation of all these activities would show FDA inspectors the facilities are implementing all the necessary preventive measures.

Recent Developments in EU Food Regulation

As part of a new series in EAS-E-News on services provided through EAS partnerships, Italy-based food technology and consulting firm Almater shares the following insights on regulatory developments in the EU in the area of foods, including so-called novel foods.

The European Union has significantly revised its legal and regulatory framework for novel foods in recent years, as well as its requirements for labeling, presentation and advertising of food.

The EU updated its 1997 regulation on novel foods with the adoption of a new novel food regulation (No 2283/2015) on November 25, 2015. The regulation, a centralized authorization procedure for novel foods at EU level, offered new provisions on nano-ingredients and on “insect-food,” and a simplified authorization procedure for “traditional products” from third countries. It also clarified requirements for food produced from cloned animals.

Under EU law, a “novel food” means any food that was not used for human consumption to a significant degree within the Union before May 15, 1997. Genetically modified foods fall within a different regulatory framework, as do food additives, enzymes, flavorings and extraction solvents. Some food categories may fall within the scope of the novel food regulation, requiring a prior-authorization to access the EU market. These include: food with a new or intentionally modified molecular structure (for instances a patented synthetic polymer); food from microorganisms, fungi or algae (such as extracts obtained from a mycelium cultivated in a submerged fermentation), food from plants or their parts, or from animals or their parts (for instances lipid extract from a specie of krill), food from cell culture or tissue culture (upcoming cultured meat, for example).

The novel food regulation also includes food consisting of engineered nanomaterials, food consisting of, isolated from or produced from material of mineral origin and food resulting from a new production process.

From January 1, 2018, the EU marketing authorization procedure will be centralized at the European Commission, which will evaluate novel food applications taking into account the European Food Safety Authority’s risk assessment and “other legitimate factors.” The current individual licensing authorizations will be replaced by generic permissions.

The novel food regulation allows applicants protection – for a limited time – for new scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the EU list. The regulation also includes a simplified authorization procedure for traditional foods from third countries that have historically proved safe for food use.

The novel food regulation includes a better definition and ad hoc provisions on nano-ingredients. As the term “engineered nanomaterials” is currently defined in Regulation (EU) No 1169/2011, nano-ingredients are considered novel foods under EU law. The Commission is called upon to reformulate this definition to reflect scientific and technological change and internationally agreed definitions. EFSA and EU Member State risk assessors are working to enforce scientific and regulatory framework on nanoscience and nanotechnologies in the food and feed chain. The novel foods regulation provides a clear opening for the use of whole insects and their parts in foods, if they pass an EFSA risk assessment.

Regulation (EU) No 2283/2015 entered into effect on January 11, 2016 and will become fully applicable from January 1, 2018, except for certain provisions.

EU regulatory framework on food information

The EU’s regulation on the provision of food information to consumers (No 1169/2011), which went into effect in December 2014, will be fully applicable from December 2016 for nutrition declarations on prepacked food.

A cornerstone of food labeling in the EU market, this regulation requires new mandatory information on allergens and nutrition. In addition, it includes new requirements for specific products such as nano-ingredients, refined oils/fats of vegetable or animal, de-frozen foods or formed fish/meat etc.

The regulation also broadens the role of the European Commission.

Third-Party Certification Will be Critical for Import Safety

The Food and Drug Administration released an amended final rule last month establishing user fees so the agency can administer the FSMA program for accreditation of third-party certification bodies to conduct food safety audits.

The fees apply to accreditation bodies seeking FDA recognition as well as to third-party certification bodies that seek direct accreditation from FDA. In addition to application fees, the agency will also seek annual user fees and renewal fees.

Third-party certification is an important component of FSMA’s preventive approach. The landmark food safety legislation gave FDA the authority to require risk-based import certification of food. And importers can use facility certifications to qualify for other programs such as the Voluntary Qualified Importer Program (VQIP), which offers expedited review of import entries of food.

In a separate December 14 notice, FDA issued a fee schedule for fiscal year 2017, effective from January 13 through September 30, 2017. The hourly fee for review work by FDA staff will be $204 excluding travel costs — or $285 per hour if travel is involved, the agency says.

The estimated application fee, including travel, for an accreditation body seeking direct accreditation from FDA in FY 2017 will be $35,100. The agency estimates it will take 60 “person-hours” to review an accreditation body’s application, 48 person-hours for an onsite performance evaluation of the applicant, and 45 person-hours to prepare a written report documenting the onsite assessment.

In its justification of the fees, the agency offered some insights into its typical costs for overseas travel. In fiscal year 2015, for example, FDA’s Office of Regulatory Affairs spent more than $2.5 million on 269 foreign inspection trips for programs related to the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. The average cost was $9,373 per foreign inspection trip and the trips averaged 3 weeks or 120 paid hours.

Because this user fee program is just getting under way, renewals and annual fees will not be collected in 2017, but the agency has set the following estimated fees for planning purposes:

  • Annual fee for a recognized accreditation body — $1,579.
  • Annual fee for an accredited certification body — $1,974.
  • Annual fee for a certification body directly-accredited by FDA — $20,208.
  • Renewal application fee for a recognized accreditation body — $18,855.
  • Renewal application fee for a certification body directly-accredited by FDA — $26,460.

FDA says there will be no exemptions or reduced fees for participation in the program by small businesses or entities or for public-sector entities. It notes that the cost to the agency for performing the application review and monitoring “will not vary greatly regardless of the entity’s size or public versus private status.”

I believe the third-party certification program provides FDA a way to extend its reach and leverage its resources to improve the safety of food imported into the United States. And although fee-based programs are unpopular among the regulated community, they do allow the agency to reliably fund programs that are scalable and sustainable.