FDA Announces National Kick-Off Meeting on FSMA Implementation

By Robert A. Hahn

FDA will hold a “National Kick-Off Meeting on Implementation of the Food Safety Modernization Act (FSMA)” on April 23-24, 2015, in Washington, D.C.

The agency has sent out a save-the-date notice to subscribers to its FSMA webpage, but the notice contains few details.  FDA says that meeting specifics, including registration information, will be made available in March via a Federal Register notice and an announcement on FDA’s FSMA webpage.

We have learned that the public meeting will include opening presentations by the FDA implementation teams for the major pending FSMA rulemakings (including Preventive Controls, Produce Safety, Foreign Supplier Verification Programs, and Intentional Adulteration), as well as breakout sessions during which FDA will seek input from stakeholders.

Despite the use of the word “kick-off” in the meeting title, don’t worry that you somehow missed publication of the FSMA final rules and that FDA is about to “kick-off” implementation.  That is not the case.  FDA has not issued any of the 7 foundational FSMA final rules.  The agency remains under the following court-ordered deadlines for publication of the final rules:

August 30, 2015

  • Preventive Controls for Human Food
  • Preventive Controls for Animal Food

October 31, 2015

  • Produce Safety
  • Foreign Supplier Verification Programs
  • Accreditation of Third Party Auditors

March 31, 2016

  • Sanitary Transportation of Food

May 31, 2016

  • Intentional Adulteration

Although we won’t know the compliance dates until FDA actually publishes the final rules, it is likely that the earliest date that any businesses would need to comply with any of the final rules would be August 2016.  To help you make plans, a rough compliance timeline appears below.

FDA’s decision to hold such a public meeting while it is still drafting the final rules is interesting.  It suggests that the agency is finding certain issues challenging and is willing to present its current thinking and seek feedback before proceeding with the final rules.

Projected Timeline for Compliance with FSMA Final Rules*



  • All businesses (except for small and very small businesses) must comply with Preventive Controls for Human Food rule
  • All businesses (except for small and very small businesses) must comply with Preventive Controls for Animal Food rule



  • Businesses (except small businesses) must comply with Sanitary Transportation of Food rule


  • Importers must comply with FSVP rule (However, if the imported food is subject to the Preventive Controls for Human Food rule or the Preventive Controls for Animal Food rule, the importer must comply with the FSVP rule 6 months after the date that its foreign supplier is required to comply with the relevant preventive controls rule. If the imported food is a raw agricultural commodity (RAC) that is subject to the Produce Safety rule, the importer must comply with the FSVP rule 18 months after the date of publication of the FSVP rule or 6 months after the foreign supplier is required to comply with the Produce Safety rule, whichever is later.  If the imported food is a RAC that is not subject to the Produce Safety rule, the importer must comply with the FSVP rule 18 months after the date of publication of the FSVP rule or 6 months after the effective date of the Produce Safety rule, whichever is later.)


  • Businesses (except small and very small businesses) must comply with Intentional Adulteration rule



  • Small businesses must comply with Preventive Controls for Human Food rule
  • Small businesses must comply with Preventive Controls for Animal Food rule


  • Farms (except for small and very small farms) must comply with Produce Safety rule (However, such farms have an additional two years to comply with the water quality testing, monitoring and recordkeeping provisions of the rule.)



  • Small businesses must comply with Sanitary Transportation of Food rule


  • Small businesses must comply with Intentional Adulteration rule


  • Very small businesses must comply with Preventive Controls for Human Food rule
  • Very small businesses must comply with Preventive Controls for Animal Food rule


  • Small farms must comply with Produce Safety rule (However, small farms have an additional two years to comply with the water quality testing, monitoring and recordkeeping provisions of the rule.)



  • Very small businesses must comply with Intentional Adulteration rule


  • Very small farms must comply with Produce Safety rule (However, very small farms have an additional two years to comply with the water quality testing, monitoring and recordkeeping provisions of the rule.)

*This timeline contains projections or estimates of FSMA compliance dates based on the following assumptions: (1) FDA will publish the final rules on or around the court-ordered deadlines listed above; and (2) the final rules will contain the same compliance dates as the proposed rules.  This timeline may need to be updated as each final rule is issued.

Drug Supply Chain Security Act – What’s Next? A whole lot.

By Tish Eggleston Pahl

The passage of the Drug Supply Chain Security Act (DSCSA) in November 2013 led to a very busy 2014 as FDA and manufacturers, wholesale distributors, and dispensers began the statute’s complex 10-year implementation.  2015 promises to be equally busy.

A Surge Of Activity At Year-End In 2014

2014 closed in a flurry of DSCSA action.  As we reported here, FDA posted a Draft Guidance on Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information (the Standards Draft Guidance) on November 26.  Then, just days later, FDA opened a web portal and issued guidance so that wholesale distributors and third-party logistics providers (3PLs) could begin submitting licensure information (as we discussed here).  Finally, FDA issued a Draft Guidance setting out its interpretation of the extent to which the agency believes the DSCSA displaces and preempts state law.  We took issue with the legal analysis in that preemption Draft Guidance, which you can read about here.

On January 1, 2015, one of the DSCSA’s big milestones arrived.  Among other things, the statute required that, on that date, manufacturers begin sending, and wholesale distributors begin receiving and transmitting, transaction information, histories, and statements for human prescription drug products.  At the end of December, FDA issued a Guidance stating that the agency intended to temporarily exercise enforcement discretion with regard to these product tracing information requirements.  FDA stated that it did not intend to take action against manufacturers, wholesale distributors, and repackagers who do not, prior to May 1, 2015, provide or capture the transaction information, transaction history, and transaction statement required by the DSCSA.

So, What’s Next? 

First is that the agency’s enforcement discretion expires on May 1 and, thereafter, manufacturers, wholesale distributors, and repackagers must be transmitting and receiving the transaction data the DSCSA requires.  Closely thereafter, beginning July 1, dispensers must begin receiving this transaction data – though, given the enforcement discretion FDA provided to manufacturers, wholesale distributors, and repackagers, the agency may be asked to extend enforcement discretion for a period of time to dispensers.

The HHS semi-annual regulatory agenda, the CDER Guidance Agenda, and the DSCSA itself provide clues as to what else is coming in 2015.

By November 27, FDA must issue final regulations setting out national standards for the licensure of wholesale distributors and 3PLs.  According to this entry in HHS’s semi-annual regulatory agenda, FDA hopes to have a proposed rule issued in April.  Meeting these deadlines, however, will be challenging, both for the agency and stakeholders.  This will be a significant rulemaking and the DSCSA’s provisions for establishing national standards for licensure of wholesale distributors and 3PLs are new, a bit vague, and, in some places, appear internally inconsistent.

FDA must issue two guidances within 2 years of enactment on the DSCSA (i.e., by November 27, 2015).  First, the agency must establish by guidance a process for the review and granting of exceptions, waivers, and exemptions from the DSCSA.  Second, the statute also mandates issuance of a guidance on grandfathering – that is, continued distribution – of product that is not affixed with a product identifier by November 27, 2017.

The statute specifically requires that the grandfathering guidance be “finalize[d].”  As this language is not present in the section of the DSCSA mandating guidance on waivers, exemptions, and exceptions, it is reasonable to conclude that the grandfathering guidance will need to be finalized by November 27 and the guidance on waivers, exemptions, and exceptions need only be in draft by that date.  However, the waivers, exemptions, and exception guidance must have an effective date that is not later than 180 days prior to the date on which manufacturers must begin affixing product identifiers to products; as such, that guidance will need to be finalized on or about May 26, 2017.

In addition to what must be issued in 2015, the CDER Guidance Agenda published in January sets out an ambitious list of other DSCSA guidances the agency intends to promulgate.  Notably, FDA appears poised to finalize the current Draft Guidance on Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers.

In the Standards Draft Guidance released in November, the agency stated it intended to issue additional guidance to facilitate the interoperable exchange of product tracing information through standardization of data and documentation practices.  This planned guidance on standardizing data and documentation appears on the 2015 Guidance Agenda.  Numerous questions and requests for clarification have been posed to the agency, and it is possible that FDA will use this guidance to answer some of those queries.

The agency also intends to issue two other guidances:

  • DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs
  • DSCSA: Verification Systems for Prescription Drugs

As manufacturers must begin affixing product identifiers by November 27, 2017, guidance on these subjects, soon, would plainly aid that activity.  What the verification guidance might be is curious – the term is used in several ways in the DSCSA.  Given that it is also addressing product identifier requirements in guidance, this may mean the agency intends to provide guidance on how to determine whether the product identifier affixed to, or imprinted upon, a drug package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager.

2014 was a busy year for DSCSA implementation; 2015 promises to be even busier.

Statement by Senator Bob Dole on Nutrition Report

Contact: Marshall Matz (202) 789-1212; mmatz@ofwlaw.com or Marion Watkins (202) 654-4863; marion.watkins@alston.com

“As co-author with Senator George McGovern of the original 1977 ‘Dietary Goals for the United States’ report, I commend the USDA, HHS and its Dietary Guidelines Advisory Committee for continuing to focus attention on human nutrition.  The Committee’s recently-released report notes the staggering numbers of Americans struggling with obesity and/or preventable chronic diseases.

The science of human nutrition is constantly evolving, making it important to update the U.S. government’s dietary guidelines every five years.

While I agree with much of the report, I believe the Committee exceeded its mandate when it made dietary recommendations based on environmental concerns of “sustainability.”  I urge the Secretary of Agriculture and the Secretary of Health and Human Services to omit those recommendations in issuing their final guidelines.  The science of nutrition can be confusing to the average consumer.  Integrating environmental considerations into dietary recommendations lessens the report’s impact and usefulness.”

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.

Global Child Nutrition Foundation to Honor Secretary Vilsack on April 16th

By Peter B. Matz

Secretary VilsackThe Global Child Nutrition Foundation is proud to announce Secretary of Agriculture Tom Vilsack as the recipient of the 2015 Gene White Lifetime Achievement Award for Child Nutrition.

Please join the Global Child Nutrition Foundation (GCNF) and its partners in honoring Secretary Vilsack for his remarkable achievements in child nutrition at GCNF’s Annual Gala Reception. Now in its 12th year, the Gala has become a signature Washington event with high-caliber honorees and speakers. It will take place on Thursday, April 16, 2015, in Washington, DC, at the Ronald Reagan Building and International Trade Center.

The highlight of the evening will be the presentation of the Gene White Lifetime Achievement Award for Child Nutrition to the Secretary. Over 200 executives from industry and high-level government and NGO officials will come together for the event.

The Gala raises funds for GCNF’s efforts to end child hunger by helping developing countries establish sustainable school feeding programs. At this moment, over 350 million hungry children live in extreme poverty throughout the world. School feeding programs nourish children, provide an incentive for children to go to school, and help lift children, their families and their communities out of poverty.

Global Child Nutrition Foundation’s Annual Gala Reception honoring

U.S. Department of Agriculture Secretary Tom Vilsack

Thursday, April 16 2015


The Ronald Reagan Building and International Trade Center

1300 Pennsylvania Avenue Northwest, Washington, DC 20004

More information at www.gcnf.org

Secretary Tom Vilsack

Throughout his long and distinguished career in public service, Secretary Vilsack has demonstrated his commitment to the nutritional well-being of children at home and abroad. As Governor of Iowa, Vilsack created the Iowa Food Policy Council to advance local food systems, enhance family farm profitability, and combat hunger and malnutrition.  At USDA, Secretary Vilsack is a key Cabinet leader on global food security and served as one of the primary architects of President Obama’s Feed the Future Initiative launched in 2009. Under his leadership, USDA has contributed to improved global food security by focusing on capacity building to improve markets information, food safety systems, basic and applied research and innovations in agricultural productivity.

In 2013, Secretary Vilsack led U.S. efforts on the Global Open Data for Agriculture and Nutrition, which seeks to support global efforts to make agricultural and nutritionally relevant data available, accessible, and usable for unrestricted use worldwide in order to improve consumer health and expand economic opportunities for farmers. Building on those efforts, in 2014, Secretary Vilsack led the launch of U.S. participation in the Global Alliance for Climate-Smart Agriculture, a global effort to share knowledge and practices to address climate change and its impact on agriculture and chart a new path forward towards greater global food security.

Secretary Vilsack continues to be a strong voice for improving the nutritional quality of domestic child nutrition programs and has focused USDA’s McGovern-Dole School Feeding Program on meeting rigorous nutrition and literacy goals. Child nutrition programs in the United States have become global models of excellence under Secretary Vilsack’s leadership and commitment.

FDA Decides Not to Actively Regulate Medical Device Data Systems, Medical Image Storage Devices, Medical Image Communication Devices and Similar Mobile Medical Apps

By Neil F. O’Flaherty

There is good news for certain sectors of the medical device industry.  FDA has decided not to actively regulate medical device data systems (MDDS), medical image storage devices, medical image communication devices and similar mobile medical applications (apps).  In a pre-published Federal Register notice (available here, which should issue in the Federal Register on Monday), FDA announced the availability of two new guidance documents which are intended to put industry on notice of FDA’s policy change.  The guidance documents are currently available on FDA’s website:

  1. “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices,” (MDDS guidance) available here; and
  1. “Mobile Medical Applications,” available here.

Previously, MDDS and medical image storage and communication devices, and similar mobile medical apps, were regulated by FDA as Class 1, 510(k)-exempt devices.  As such, they were subject to FDA’s medical device labeling, medical device reporting, establishment registration, product listing and Quality System Regulation requirements, among others. The policy change greatly decreases the regulatory burden on these types of devices by not requiring manufacturers and other responsible parties for these types of devices to comply with these requirements.

The MDDS guidance provides that FDA does not intend to enforce compliance with the regulatory requirements that apply to MDDS, medical image storage devices and medical image communication devices.  The September 25, 2013 version of the “Mobile Medical Applications” guidance has been updated to be consistent with the MDDS guidance.  In relevant part, the updated  version deletes the example of Mobile Apps that would be regulated as an MDDS and adds that it intends to use enforcement discretion for apps that are “intended to transfer, store, convert format, and display medical device data in its original format from a medical device (as defined by MDDS regulation 21 CFR 880.6310).”  The guidance also provides an example of when a mobile app meets the definition of an MDDS and gives other examples of where FDA will use enforcement discretion.

Although this is good news for industry, FDA has strict definitions of what it considers an MDDS device, a medical Image storage system and a medical image communication system.  Before taking advantage of the decreased regulatory burden in regulatory and business planning (e.g., commercializing new products, modifying treatment of existing products, etc.), firms need to truly make sure that FDA would view their device as falling into one of these categories.  Wrongly relying on your device falling into one of these categories could translate into an FDA compliance action against your company.

For those firms which have a good basis for claiming their product falls into one of these categories, it is important to document why in a written regulatory rationale.  In this way, if FDA or a third-party ever questions your conclusion, you can use the rationale to convince FDA or the party that you are correct or to at least demonstrate your “good faith” deliberations.