Salmonella in Raw Products – Can FSIS Request a Recall?

By Barbara J. Masters, D.V.M.

I am often asked whether or not the Food Safety and Inspection Service (FSIS) can request a recall for meat or poultry products merely because the products test positive for Salmonella.  The answer to that question today is no.  However, there are times FSIS can request a recall of raw meat and poultry products for Salmonella.  If at any point FSIS determines there is specific product (specific lot, specific product date) in commerce making people sick, it will ask for a voluntary recall of that specific production of product, regardless of whether there is a positive test result.

What is important to understand is that for outbreak recalls, FSIS will use the same thought process regardless of whether the pathogen is considered an adulterant or not.  FSIS would look for the following four factors as part of the outbreak investigation:

  • There are related illnesses (an outbreak) as determined by the DNA analysis of samples from case patients;
  • The evidence supports the conclusion that the likely source of the illnesses was a specific product;
  • The plant produces that specific product; and
  • A specific production of that plant’s product was purchased by, or available to, the case patients at the time and location of the illnesses.

If all of these criteria are met, FSIS will request a recall of the product implicated in the outbreak.  In this circumstance, FSIS is not relying on a positive test result (from the product) to request the product be removed from commerce, rather they are relying on evidence that the specific product has been implicated in causing an outbreak.

In summary, today, FSIS can request an establishment to conduct a voluntary recall for products that test positive for an adulterant (e.g., E. coli O157:H7), but not for product that tests positive for Salmonella.  However, in the case of a foodborne outbreak, FSIS applies the same rules to all pathogens.  If the evidence supports that a specific production of product is the likely source of the illnesses in the outbreak, FSIS will request a voluntary recall (not based on test results of the product).

About Dr. Masters

Mixed in with the attorneys at OFW Law is the former USDA Food Safety Inspection Service’s (FSIS) Administrator, Dr. Barbara Masters.  Dr. Masters is a veterinarian who spent eighteen years with FSIS – the final three years as Acting Administrator and Administrator.  During her rise to the Administrator’s position, Dr. Masters served as the Deputy Assistant Administrator for Office of Field Operations.  While in these key leadership positions at FSIS, Dr. Masters’ primary focus was on the implementation of science-based policies for the protection of public health.

CPSC Enforcement Action Against Michaels Highlights Importance of Proper Reporting

By Elliot Belilos

The U.S. Consumer Product Safety Commission (CPSC) recently filed an action in federal court against Michaels Stores, Inc., seeking civil penalties for allegedly untimely reporting injuries from a vase sold in the stores and, notably, for allegedly falsely reporting the incidents as a retailer rather than as the manufacturer of the product.  According to the Complaint, Michaels misrepresented to the Agency the company’s role in the distribution chain, allowing another company, The Gerson Company (“Gerson”) to report as the manufacturer even though Michaels was the importer of record (and, as a result, the statutory “manufacturer”).

CSPC asserts that Michaels engaged Gerson to contract to have the vase made overseas exclusively for Michaels, but that Michaels was the importer of record, a fact that CPSC alleges Michaels withheld from the Agency in its 15(b) report.  CPSC asserts that Michaels purposefully withheld that information so that Gerson would be the recalling entity, and that the recall would have been more successful had the more well known Michaels been the recalling entity.

This case bears watching as it moves forward.  Certainly companies that are importers of record for products manufactured overseas need to understand that they are deemed to be the manufacturer of those products under the Consumer Product Safety Act (CPSA), and that any report to the CPSC should properly reflect their role in the distribution chain.

Elliot Belilos represents companies on consumer product safety compliance issues, including reporting obligations to the CPSC and corrective actions, up to and including recalls.  Elliot can be reached at

FSIS Poised to Take Action in Response to Increase of Recalls Due to Undeclared Allergens and the Failure to Present Imported Products for Re-inspection

By Brett T. Schwemer

The Food Safety and Inspection Service (FSIS) recently posted on its website a Summary of Recall Cases in Calendar Year 2014.  Comparing this summary with the summaries from 2013 and 2012, a few things immediately stand out.  On a positive side, meat and poultry product recalls for pathogens (Shiga toxin-producing E. coli, Listeria monocytogenes, and Salmonella) and other contaminants collectively decreased in 2014 from years 2012 and 2013.  However, on the negative side, there was a significant increase in recalls in 2014 for undeclared allergens and recalls classified as “other,” which upon closer examination, appear to be largely related to the failure of importers to present imported meat and poultry products to FSIS for re-inspection at the point of entry (otherwise known as a “Failure to Present” (FTP)).  With these trends continuing into 2015, establishments should expect FSIS to respond aggressively.

Undeclared Allergen Recalls

Recalls for undeclared allergens rose from 25 in 2013 to 43 in 2014, a whopping 72 percent increase.  Seven of the recalls in 2014, which occurred at the very end of the year, can be attributed to meat and poultry establishments purchasing cumin that were unknowingly contaminated with peanut protein.  However, the rest appear to be situations where meat or poultry processors failed to properly identify and control incoming ingredients, failed to prevent cross-contamination during processing or failed to ensure that finished products were properly packaged and/or labeled. In short, these recalls were largely preventable.

FSIS has grown frustrated with the continued increase in recalls due to undeclared allergens and has vowed to take action.  Last month, the agency advised the industry that it will be soon be issuing new instructions to inspection program personnel on how to verify that meat and poultry products are correctly labeled.  The new instructions will purportedly contain additional inspection tasks related to label and formula reviews, and provide guidance on what can result in an undeclared allergen in product and what procedures can be adopted in an allergen control plan.  Obviously, if undeclared allergens are found and product has entered commerce, the agency will request a recall.

In anticipation of these new instructions, establishments would be well advised to reassess their current allergen control programs and other procedures to ensure that meat and poultry products are properly labeled with all ingredients listed.  This reassessment should be conducted in light of the FSIS “Compliance Guidelines for Allergens and Ingredients of Public Health Concern: Identification, Prevention and Control and Declaration Through Labeling.”  These guidelines contain certain “best practices” identified by the agency for ensuring that hazards associated with ingredients of public health concern are properly identified, that they are prevented and/or controlled, and that all ingredients are properly declared on product labels.  In addition to these guidelines, establishments should also consider guidance provided by the Food Allergy Research and Resource Program of the University of Nebraska regarding how to develop effective allergen control programs.  Finally, our firm has posted a series of blogs entitled “Steps to Prevent Allergen Recalls – Practice Tips.”

Establishments should also anticipate that, with an increase in inspection tasks related to label review, there will be a heightened risk that inspection personnel will take regulatory control actions for perceived labeling deficiencies that do not arise to a public health concern.  Given that a substantial amount of labels are generically approved these days, many establishments may not be able to point to an FSIS approved label to convince inspection personnel not to take action.  To that extent, it would behoove establishments to get to know officials from the FSIS Labeling and Program Delivery Staff and maintain emergency contact information for these officials in the event that a labeling dispute arises with inspection personnel or there is a need for an emergency temporary label approval.

FTP Recalls

As noted above, 2014 also experienced a dramatic increase in FTP recalls – 6 in 2014 compared to 1 each in 2012 and 2013.  Just two months into 2015, there have already been 7 FTP recalls.

Similar to the recalls for undeclared allergens, it is our understanding that most of the FTP recalls were avoidable.  Pursuant to FSIS regulations, after Customs and Border Protection (CBP) verifies that imported meat and poultry product meets CBP and Animal and Plant Health Inspection Service requirements and releases the shipment, the importer of record is required to have the product presented to FSIS for re-inspection at an official FSIS import inspection establishment.  Unfortunately, in many of the recalls, the importer of record (or broker) failed to ensure that the product was delivered to an official FSIS import inspection establishment for re-inspection or the import inspection establishment inadvertently released the shipment in commerce without the requirement being met.

The increase in FTP recalls, however, is not solely attributable to an increase in mistakes by importers, brokers and import inspection establishments.  Beginning about 7 months ago, FSIS began increasing verification of its import requirements by reviewing data in its Public Health Inspection System (PHIS) twice a week to identify potential FTPs. This increased verification directly correlates to the increase in recalls.

In response, FSIS has indicated that it will continue to, and potentially increase, its review of PHIS data in 2015 to detect FTPs.  If a FTP is detected and product has already entered commerce (i.e., off-loaded at a location other than the official import inspection establishment or other approved located designated on the import inspection application), the agency will likely require the importer of record to conduct a Class I recall of any associated product.   The agency can also withdraw inspection services at the official import inspection establishment until the establishment can provide additional measures to ensure imported product is re-inspected.  Finally, the agency may request CBP to issue a Notice of Redelivery to the importer of record, broker and/or official import establishment demanding that the uninspected product be returned to the custody of CBP. If product is not redelivered to CBP, CBP can initiate action to assess penalties and liquidated damages (additional information regarding FTPs and the actions that FSIS will take in response can be found in the agency’s Prior Notification and Failure to Present: Compliance Guideline for Importing Meat, Poultry and Egg Products to the United States).

Given the increase in verification activities relating to FSIS import requirements and the consequences for failing to meet these requirements, importers of record, brokers and official import inspection establishments would be well advised to work together to implement a system of controls designed to ensure that all imported meat and poultry products are re-inspected at the point of entry.  This should include measures to ensure that the importer of record or designated agent applies for inspection of imported product as far as possible in advance of the anticipated arrival of each consignment, but no later than when entry is filed with CBP, in accordance with FSIS’ prior notification requirement.  It should also include improved means of communication between the respective parties regarding when amenable meat and poultry products may be in a shipment of product and thus require inspection.  Finally, official import inspection establishments should consider implementing more stringent procedures for identifying and controlling imported meat and poultry product that are to be held pending FSIS re-inspection, such as the implementation of new inventory control systems designed to prevent meat and poultry product from being “released” from inventory until re-inspection is complete.  Additional recommendations for adopting an effective hold or retention program can also be found here.

Following the basic recommendations above should go along way towards reducing the number of recalls for undeclared allergens and FTPs each year.  However, if the industry ignores these recommendations and such recalls continue to rise, the industry should fully expect the agency to take additional measures to control what they view as a purely preventable situation.

Medical Devices, Pharmaceuticals and Food Products as Consumer Products – Additional U.S. and Canadian Regulatory Considerations

A Webinar Presented by OFW Law and Davis, LLP

November 12, 2014, 1:00 p.m. EST

During this webinar, attendees will learn about additional regulatory requirements placed on medical devices, pharmaceuticals, and food products as consumer products in the U.S. and Canada. Topics will include, among others:

  • A general understanding of the interplay of obligations at the Federal and state/province levels in the U.S. and Canada
  • Additional labeling and advertisement requirements as consumer products
  • Additional reporting requirements in the U.S. and post-market recordkeeping requirements in Canada
  • Certification requirements under the U.S. Consumer Product Safety Improvement Act
  • The management of crises relating to medical devices, drugs and food products as consumer products in the U.S. and Canada and knowing when, how and why to recall products

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please go to

About the presenters:

Elliot Belilos is of counsel to OFW Law and has more than eighteen years of regulatory and litigation experience representing corporations and associations in consumer product-related matters. Elliot counsels companies on product liability and regulatory compliance issues under the Consumer Product Safety Improvement Act, the Consumer Product Safety Act, the Federal Hazardous Substances Act, the Flammable Fabrics Act, the Poison Prevention Packaging Act, the Federal Food, Drug, and Cosmetic Act, and the Federal Insecticide, Fungicide and Rodenticde Act.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences, Food and Beverage and Intellectual Property Groups. Sara works with clients to get products from idea to market, providing strategic advice on approval and marketing strategies and intellectual property issues. She also works with clients on matters relating to product safety, including Health Canada inspections and enforcement, crisis management and product recalls.

Steps to Prevent Allergen Recalls, Part Two – Another Practice Tip from Ms. Gloom

By Jolyda O. Swaim

In Part One, we discussed using transparencies on the receiving dock as an easy way for personnel to quickly ascertain whether or not the incoming ingredient (at least its ingredient statement) was the same as your specification.  See our earlier blog posting.  In this post, we want to discuss some of the steps a facility may take to ensure that allergens are controlled through product formulation and batching, and finished product labeling.

Formulation and Batching Process

A key in ensuring that your product does not contain an undeclared allergen is to make sure that the “batch sheet” being used at the batching station is correct.  With today’s technology, many companies use computer systems that only permit the most recently-approved batch sheet to be the one available.  There are, however, many facilities still using a hard-copy that was printed off by the Supervisor or designated personnel.  Unfortunately, many times these “hard-copies” find their way into lockers or files where they are “available” the next time that product is run – or three months from now after a formulation change was made.

Many recalls have been the result of an old formulation print-off being used with a new finished product label.  Usually this occurs because someone accidentally used an obsolete batch sheet they had tucked away in a file or in their locker.

Facilities need to ensure that no one maintains copies of batch sheets where one can be inadvertently used.

Personnel should be notified that copies are not to be maintained and all of those “batch sheet hiding places” should be checked for obsolete copies.  Anyone who has spent time dealing with this will know where these places are.  These have included the normal locations – batch employee’s locker – to the not-so-normal – above the suspended ceiling over the batching station.  Make it a point to have a procedure to issue batch sheets as needed and make this easy for those authorized employees needing the batch sheets.  If it is difficult for the employees to get the batch sheet, they will find ways to make it easier – which usually involves making an “unauthorized copy.”

All batch sheets should contain a revision date or formula version number.  When schedules are printed, this information on the formula version should be included.  All responsible personnel should be trained to check that the batch sheet is the correct version listed on the schedule.  This should be a mandated step required to be completed before any actual ingredient batching begins.

Another procedure that will assist in ensuring the proper formulation is used is to have two different employees responsible for staging and batching.  For example, the employee responsible for staging the necessary ingredients uses a batch sheet issued to him and marks this off to ensure the proper ingredients have been staged.  The batching employee then checks off ingredients on his batch sheet.  This provides two (hopefully independent) checks that a batch is being properly formulated and will match its finished product ingredient statement.

Finished Product Labeling

Another reason for undeclared allergens is the use of the wrong finished product label.  While many facilities have this as a CCP, it is still easy to miss a change in an ingredient statement.  I was gloomy when I had an entire shift of beef hotdogs produced using the packaging for a combination beef and pork formula on one of four production lines.  The printing on the beef hot dogs was all in red while the combination product was printed in green.  The QA technician checked the film on all four lines every hour and marked that it was correct on each line – even though the film was green, the product name was wrong, and the formula was different on one line.  Moreover, the two employees on that line packing the hotdog packages into the cases also “looked” at the film.  Remember, people sometimes see what they expect to see, not what is actually there.

One way to prevent a very gloomy day is to train personnel to read the label information out loud during packaging checks.  When you read out loud, you will be concentrating on what you are actually looking at – not what you “expect” to be there.  If the technician had read the product name on the hotdogs out loud, he would have not said the word “beef” on the line in question.  Chances are that the mistake would have been identified at the first check.  This also holds true for ingredient statements or any information that must be reviewed routinely.  Read it out loud to increase your chances of ensuring it is actually correct.

Finally, verification checks should also be done at some frequency to ensure that the batch sheets in use have the latest version number or revision date, and that these also agree with the finished product labeling.  Have a program in place to control formulation changes so that everyone is aware when they will occur.  Control your finished product labeling:  if you receive in “new” film with an updated ingredient statement, literally keep it under “lock and key.”  Do not keep it in regular inventory as there is a good chance it will get used by accident.  Likewise, if you do not use all “old” labeling up before you change your formulation, lock up the remaining inventory.  An employee will need a partial roll of labels and grab that which is the easiest to get.  Make it difficult to grab the “wrong” labels by keeping these (“old” or “new”) out of reach.

About “Ms. Gloom”

In the attorney ranks at OFW Law, there is only one who would raise a hand if all were asked if they had any “hands-on” experience in the operation of a Townsend “Frank-O-Matic” hotdog maker, producing bean sprouts for use in egg rolls or in managing a food facility sanitation crew.  In fact, there are probably no attorneys out there who could raise their hands except Jolyda Swaim.

Prior to law school and OFW Law, Ms. Swaim spent years in the food industry, beginning as a microbiologist and Quality Assurance technician.  In these years, she had direct charge of quality assurance, production, sanitation and consumer affair departments at various companies producing products from pickles, sauerkraut and barbeque sauce, to various meat and poultry products, to frozen entrees, egg rolls and pizza to spices and spice blends.  Her last position at Sara Lee as Director of Food Safety had her auditing its facilities in the United States and Mexico to ensure facilities producing ready-to-eat products were following best practices in sanitation and product handling.

Steps to Prevent Allergen Recalls – A Practice Tip from Ms. Gloom

By Jolyda O. Swaim

Anyone who is remotely involved in the food arena knows that the number one reason for a recall of meat and poultry regulated under USDA’s Food Safety and Inspection Service (FSIS) or all other types of food regulated under the Food and Drug Administration (FDA) is an undeclared allergen.  In fact, a quick review of recalls in Canada shows that undeclared allergens probably result in most of their recalls as well.

So what is happening in food facilities that result in all of these products being manufactured or labeled improperly?  What can be done to control the process and prevent the risk to the consumers who depend on the product label to provide the correct ingredient statement – besides all of the regulatory oversight that will occur at the facility once you have a recall?  There are several procedures that facilities can implement to ensure products are not only produced, but also labeled, correctly.

Many facilities say that they control allergens by having a critical control point (CCP) at packaging to ensure that the finished product is correctly labeled.  For example, someone checks that a hotdog package or package of hotdog buns has the right label on it as part of a CCP at packaging.  The “right” label is determined because the schedule indicates that beef hotdgs were being made or white buns were to be packaged.  The problem with this approach is that while someone can determine that beef hotdogs were made or that a regular white bun was used and the label reflects this fact, the person visually checking the product and label won’t know whether someone used the wrong spice blend in the product.  The person would not know that soy oil was added to the bun instead of a different type of oil because the manufacturer changed sources of oil without notifying the establishment.  While it is important to ensure that the correct label is going on at the end of the line, the real work starts at receiving!

Receiving Ingredients

Anyone who has reviewed ingredient statements for products with numerous ingredients knows how difficult it is to compare two statements which are the virtually the same – except one is missing an ingredient or two, or the statements have the same ingredients but not in the same order of predominance.  Now, try to do this while efficiently unloading 22 pallets of various ingredients from a trailer as is the procedure at many facilities.  Even when there are several personnel involved in the receiving process, this becomes a difficult task.

In reviewing the lessons learned through recalls, many recalls resulted from the ingredient supplier changing the formula of, for example, a spice blend or a complex sauce and neglecting to notify all of their customers beforehand – or the notification occurred but did not reach the receiving dock. This should always be a concern when trying to compare the incoming ingredient label with the ingredient statement in your spec book while keeping up with the unloading of materials.

A tip to prevent a gloomy day: if you receive multi-component ingredients, you can make it easy for your employees at receiving to quickly identify whether or not the incoming item has the same ingredient statement as that approved – and which is used on the respective finished product label: use transparencies.


If you are old enough, you may remember that before we had computers and Power Point presentations, we had transparencies.  These were clear plastic sheets we could run through the copier and print our presentations or pictures on to, which we then displayed onto a screen with an overhead projector.  These clear plastic sheets can still be run though the copier and printed with “life size” copies of your suppliers’ ingredients statements.

Get an actual ingredient label from all of your incoming ingredients which you have verified as correct.  Take each of these and make a “transparency.”  Provide these to your incoming receiving personnel.  These transparencies can then be used by these personnel to quickly place over the respective incoming ingredients statement to determine whether or not there has been a change.  If the label on the transparency perfectly “matches up,” then there has been no change and product is good to receive.  If it does not match up, something has changed and the receiver can take appropriate next steps.

The use of transparencies will greatly speed up the process of ensuring ingredients received are correct with much greater accuracy than trying to actually compare two statements side-by-side.  Transparencies will not “catch” an issue where the supplier formulated a product incorrectly; they will, however, prevent those issues where the formulation and label were changed and the facility was not made aware of the change – an issue which has accounted for numerous allergen recalls.

My next blog will address some steps to take to try to ensure you are formulating, batching, and labeling your products correctly.

About “Ms. Gloom”

In the attorney ranks at OFW Law, there is only one who would raise a hand if all were asked if they had any “hands-on” experience in the operation of a Townsend “Frank-O-Matic” hotdog maker, producing bean sprouts for use in egg rolls or in managing a food facility sanitation crew.  In fact, there are probably no attorneys out there who could raise their hands except Jolyda Swaim.

Prior to law school and OFW Law, Ms. Swaim spent years in the food industry, beginning as a microbiologist and Quality Assurance technician.  In these years, she had direct charge of quality assurance, production, sanitation and consumer affair departments at various companies producing products from pickles, sauerkraut and barbeque sauce, to various meat and poultry products, to frozen entrees, egg rolls and pizza to spices and spice blends.  Her last position at Sara Lee as Director of Food Safety had her auditing its facilities in the United States and Mexico to ensure facilities producing ready-to-eat products were following best practices in sanitation and product handling.

CPSC Proposes to Make Voluntary Recalls and Compliance Programs Legally Binding

By Elliot Belilos

On November 13, 2013, the U.S. Consumer Product Safety Commission (CPSC) issued a proposed interpretive rule concerning corrective action plans for “voluntary” recalls that may impact future voluntary consumer product recalls in two significant ways.   First, CPSC proposes to make voluntary recall agreements that companies negotiate with CPSC legally binding.  Second, CPSC proposes to permit the staff to require ongoing compliance programs as a component of such agreements.

Legally Binding Voluntary Recalls: Under the current regulation (16 C.F.R. § 1115.20(a)), voluntary corrective action plans – which identify the remedial actions a company intends to take, up to and including a product recall – have no legally binding effect.  The proposed rule would make such corrective action plans binding, allowing the CPSC to go to federal court to enforce the terms of the agreement.

Compliance Programs: The proposed rule would also allow staff to insist that voluntary recall agreements require companies maintain ongoing compliance programs, defining the terms of such compliance programs such as levels and frequency of internal and third-party testing.  The proposed rule provides examples of circumstances that might warrant a compliance program, as well as examples of requirements that may be included in a compliance program. The proposed rule also sets forth enforcement measures CPSC may take to remedy violations, including seeking injunctive relief, specific performance, and sanctions.

Since the proposal was issued, there has been considerable debate in the product safety community as to (1) whether the CPSC has the authority to issue this rule as proposed, and (2)  whether the proposal, if implemented, would create a deterrence for companies to come forward and propose a voluntary recall and/or slow down the recall process.

Comments on the proposed rule may be submitted to CPSC by February 4, 2014.

For more information on how this proposal may impact your company, please contact me at 202-518-6358 or

The Phone Call that Comes Too Late

By Brett T. Schwemer

At least once a month, our USDA or FDA practice group receives that phone call…the phone call that comes from an existing or prospective food client at that point in time (and no sooner) when the proverbial “slop is about to hit the fan.”

In our experience, most food companies do a good job recognizing that they need regulatory or legal assistance. They just don’t always recognize it soon enough. While the old adage, “better late then never,” holds true when it comes to seeking regulatory or legal advice, the effectiveness of legal counsels’ or regulatory experts’ efforts in terms of the likelihood of a favorable outcome often hinges on how early these experts become involved.

There are many examples of when food companies have hurt themselves by waiting too long to seek regulatory or legal assistance.  Take, for example, a potential recall situation.  In many instances, companies do not seek assistance from legal counsel or other regulatory experts until just moments before an FDA or FSIS Recall Committee asks for a conference call with the company to discuss the matter.  At this point in time, the agency has likely already made up its mind that there is a need for a recall and has decided on the Recall Classification.  Convincing FSIS or FDA to accept a lesser action (like a market withdrawal) or lower classification (Class II or Class III recall instead of a Class I) at this point is often futile, particularly when there has not been adequate time for legal counsel or other experts to learn all the facts and prepare.  Engaging assistance early in the process, when a potential problem or contamination event is discovered and legal or regulatory experts can discuss the merits of a market withdrawal or a particular recall classification with the agency, will increase the chance of a favorable outcome.

Another re-occurring “late” call is from meat or poultry companies waiting until they receive a Notice of Alleged Violation from FSIS before they seek legal assistance.  A FSIS Notice of Alleged Violation is a letter that alleges violations of the Inspection Acts and threatens referral to a U.S. Attorney’s Office for criminal prosecution.  These letters are typically issued months, and sometimes years, after the alleged unlawful conduct occurred and after the agency has completed its investigation.  If a company waits until the issuance of a Notice of Alleged Violation to hire legal counsel, it will be difficult for counsel to gather the appropriate facts to defend the action, due to factors such as employee turnover at the company, faded recollections, and/or lost or destroyed records.  Even more importantly, by waiting to obtain legal counsel, the company has already missed the most crucial time that legal counsel is needed, i.e., during the process that FSIS collects records, interviews employees, and takes employee statements.  Once this evidence is provided, it is too late to argue that the records or statements were protected by company privileges, were taken out of context, or did not adequately portray the situation at hand.  For this reason, it is critical that companies seek legal counsel immediately after they become aware that there are allegations that could lead to criminal prosecution (e.g., allegations regarding shipment of adulterated or misbranded product, inhumane treatment of animals, fraud, etc.).

Finally, one of our most common late calls…the dreaded FSIS or FDA suspension action after numerous repetitive noncompliances.  In most cases, agencies make companies aware that they are on thin ice well before taking suspension actions.  If a company has been put on notice that its corrective actions are not preventing noncompliances from reoccurring, it may be time to seek outside experts to provide a fresh look at the situation.  In many instances, these experts can provide experience gained from representing clients in similar situations to recommend more effective corrective/preventive actions that a company may not have considered.  In some situations, these experts may also assist a company in appealing alleged noncompliances that are not based in fact or law, helping to ensure that potential enforcement actions are not based on faulty grounds.  In either case, seeking assistance early can help minimize the chance that the government agency will feel the need to take such a drastic action as shutting down an establishment.

Judging whether to seek outside assistance is not always an easy task.  Obviously, the ability to handle an issue in-house, the likelihood of adverse action/results and cost of services provided are factors to be considered. However, when it becomes likely that legal or regulatory counsel is needed, it is imperative that it is sought in a timely manner. Knowing when to seek legal or regulatory assistance could be the difference between a recall or market withdrawal, a criminal prosecution or a letter of warning, and a plant suspension or no action at all.

Dealing With FDA Warning Letters

By Casper E. Uldriks

The FDA issues Warning Letters to provide firms notice that unless they achieve voluntary correction of the violations noted in the letter, the agency is prepared to initiate an enforcement action without further notice.  Enforcement actions may include, for example, the seizure of goods, injunction and/or prosecution.  Other administrative actions may be taken, such as the automatic detention of foreign products presented for entry into the U.S. or issuing a mandatory recall order.  The FDA expects a response to a Warning Letter within 15 working days of the firm’s receipt of the letter.  It can be a challenge for some firms to meet this deadline.

Who really issues the Warning Letter?

For certain types of violations, such as manufacturing regulations, a Warning Letter may be issued by the FDA District Office in which the recipient is located. If the firm is located in Cambridge, Massachusetts, then the New England District Office would issue the Warning Letter to the firm.  If the firm is located in Houston, Texas, then the Dallas District Office would issue the Warning Letter to the firm. For certain other types of violations, such as for a product that lacks premarket approval or for not complying with advertising and promotion requirements, the FDA Center with jurisdiction over the product would issue the Warning Letter.  If a drug was involved, the Warning Letter would be issued by the Center for Drug Evaluation and Research. If a medical device is involved, then the Warning Letter would be issued by the Center for Devices and Radiological Health. A response to the Warning Letter should be sent to the point of contact identified in the letter for further communication.

Basic practical factors

Regardless of the particular issues raised in the Warning Letter, there are practical steps that can be taken to facilitate the response process.  The response should be well reasoned, address how each immediate problem will be resolved and how such violations will be prevented in the future. Each response should provide sufficient and concrete detail so the FDA can objectively determine whether or not the proposed corrective action is adequate.  Documentation provided in the initial and subsequent responses should be cross-referenced to the Warning Letter and, where appropriate, any related FDA Form 483 observations.  This will help to ensure that the FDA and you are “on the same page” when you are discussing a particular issue during a meeting or a telephone conversation with the Agency.  The purpose is to avoid confusion at this stage of the interactive process.

Meeting deadlines

Developing a meaningful response is usually a daunting task.  The content and tone of the FDA’s Warning Letter can instill a sense of alarm. Meeting the 15-day deadline makes it difficult to provide a well-reasoned and realistic response. The initial promise and plan of correction in the response may indicate that the firm is headed down a constructive successful path or traveling in a misguided direction.  In addition to the regulatory issues, the response should provide a detailed corrective action plan with a prompt, but reasonably achievable, timeline. In some cases implementing adequate corrections is bound by certain time frames.  The nature of the correction or corrective action often takes longer than the 15-day time frame allows.  For example, sterilization validation necessarily requires weeks to accomplish. If the 15 day response states that required sterilization validation has been completed, the FDA has prima facie evidence that the firm fails to understand how to meet its regulatory obligations.  A request by the firm for additional time to make corrections without providing FDA a reasonable basis for the request can work to a firm’s disadvantage in the process. In all probability, the FDA’s view of an unsupported request would not merit any special accommodations from the agency. In any case, timeframes proposed in the firm’s response should reflect the shortest time possible to provide the best possible result given the nature and risk of the issue at hand.

Promise of correction

Making a promise and keeping a promise will create the foundation for the FDA’s follow-up action.  A response deemed “adequate” by the FDA will in all likelihood prompt a follow-up inspection to verify whether or not the firm has fulfilled its promises.  If the same or similar types of violations continue, then the FDA will collect evidence of a firm’s failure.  Likewise, the firm will struggle with a loss of credibility and foster an expectation that the firm is not able to achieve compliance. Consequently, the FDA is motivated to act promptly.  A firm’s ability to negotiate with FDA may be adversely affected if the firm is suffering a credibility crisis with the Agency.

The FDA will expect rigorous adherence to the corrective action plan and sufficient evidence to demonstrate the plan is or will be effective.  In that regard, unrealistic or empty promises work to characterize the firm as a chronic bad actor that presents a significant risk to the public health and safety. The firm’s discussions during or after the inspection and the adequacy of the Warning Letter response may lead the FDA to the conclusion that, “They don’t get it.”  Salvaging one’s image becomes an uphill effort.  What you promise and what you actually accomplish should coincide.

USDA-FSIS’ “Test and Hold” Policy

By Jolyda O. Swaim

On February 8, 2013, the United States Department of Agriculture’s Food Safety and Inspection Service’s (FSIS) policy on “Test and Hold” will go into effect.  This policy requires “official establishments and importers of record to maintain control of product tested for adulterants by FSIS and not allow such products to enter commerce until negative results are received.”  The Federal Register publication outlining FSIS’ final policy may be viewed here.

In the past, while FSIS had encouraged establishments to hold product pending receipt of FSIS test results for adulterants, it had not required companies to hold product under their control until FSIS negative results were received.  Many establishments did not follow this guidance and subsequently had to initiate recalls of product shipped in commerce due to positive results.  FSIS adopted its new policy to prevent future recalls due to a company’s unwillingness or inability to hold product pending test results.

It is important to note, however, that FSIS’ new policy only applies to FSIS testing for adulterants and not to establishment testing for adulterants.  However, FSIS continues to advise all establishments to hold product pending their own testing for adulterants.

The FSIS has identified the following adulterants as covered by the policy:  (1) Salmonella, Listeria monocytogenes, E. coli O157:H7 and Non-O157:H7 STEC on ready-to-eat products, (2) E. coli O157:H7 and the six (6) Non-O157 STEC on raw non-intact beef products or products intended for such use, (3) Listeria monocytogenes on food contact surfaces or ready-to-eat products, (4) residues of veterinary drugs or carbadox in livestock and (5) economic adulterants.  If FSIS tests product for one of these adulterants, FSIS would expect the establishment to have documentation and support that the product is controlled pending the results.

However, this does not mean the establishment cannot move the product to another location pending the test results.  The establishment would have to show the product is still within its control as a result of measures such as company seals or “other adequate controls.”  The establishment would also have to demonstrate that it has not yet completed its pre-shipment review of the product represented by the test results, as FSIS will deem this to mean that the product is in commerce and no longer held.

If product is shipped pending FSIS adulterant testing without adequate controls, FSIS would take the position that the establishment shipped uninspected and possibly adulterated product and would likely take enforcement actions, including suspension of inspection or issuance of a Notice of Intended Enforcement – besides requesting a recall of the affected product.  So, come February 8th, it is important that establishments have written procedures and documentation in place to ensure that any product sampled by FSIS for an adulterant is held and that the pre-shipment reviews for these products are not completed until negative FSIS results are obtained.