FDA Responds to Failures in Recall Process

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By FoodReady

Caliente! Hot Topic!

Have you heard? FDA is going to initiate recalls and announce recalls to consumers. Technically, the FDA initiating a recall is not new, because FDA gained the authority to initiate a recall in 2011 with the signing of the Food Safety Modernization Act (FSMA). FDA has produced three new guidance documents on public notification of a recall. The last of the three, Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C, Guidance for Industry and FDA Staff February 2019, was recently published.

What is the Purpose of the February 2019 Guidance?

FDA is communicating to the industry and providing recommendations for its own staff for when they will initiate a recall and publish a public warning of a recalled food. FDA has seen, in rare cases, where there is no cooperation from the recall firm or there is slow announcing of a recall. FDA calculated the average time for a firm to announce a recall is four days; it is implied that four days is too long for hazardous food to be in commerce. The FDA intends to work cooperatively with the recall firm. The FDA must first provide the responsible party with an opportunity to voluntarily cease distribution and recall the article of food. FDA gives the first opportunity for initiating and announcing a recall to the Owner, Operator, or Agent-in-charge. Infant formula recalls are mandated separately, but all food, ingredients, and chewing gum are otherwise covered by the guidance.

It’s not all bad news!

For the fiscal year 2018, there were 7420 recalls and 831 classified as a high risk. Since 2012, the 2018 numbers are the lowest number of recalls. What happened after 2012? February 2013 was the start of FDA uploading whole genome sequences to GenomeTrakr and the transition away from PulseNet which uses the method of pulsed-field gel electrophoresis. The greater sensitivity of whole-genome sequencing has led to more recalls.

Timeline: April 2016

Given a head’s up on a pending report from the Office of the Inspector General (OIG), FDA created a team of senior leaders with oversight of recalls; the team meets at least weekly. Named Strategic Coordinated Oversight of Recall Execution (SCORE), SCORE expediated the process for suspending the registration of two facilities as of December 2017.

This is where the E. coli hits the fan.

The Food and Drug Administration’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply, December 2017. The 2017 report published by the OIG found FDA failures in food recall practices. The OIG made a series of recommendations on how the agency might improve its management of recalls.

Timeline: January 2018

FDA draft guidance [the January 2018 draft guidance is no longer available] on FDA’s policy and notification of recalled products and posting recalls to the FDA Enforcement Reports was published to assist the food industry in working with FDA through a recall.

What products are covered?

Food, drug, or device intended for human or animal use; cosmetic and biologic intended for human use; tobacco product; and any item subject to quarantine regulation. Radiation emitting electronic products are not covered.

Timeline: April 2018

I wanted to know when and how FDA used its new authority under the Food Safety Modernization Act (FSMA) in 2011. Last year I wrote what I learned in a blog post, which included 3 cases:

  1. Sunland peanut butter sold finished products containing Salmonella.
  2. Kasel dog treats recalled after Salmonella found.
  3. Triangle Pharmanaturals’ kratom dietary supplements contain Salmonella.
 

One of my favorite sentences from the Kasel recall notification is as follows:

“If you do not voluntarily cease distribution and conduct a recall in the time and manner described in this section, FDA may, by order, require you to immediately cease distribution of the affected pet treats.”

Timeline: September 2018

FDA Draft Guidance, Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls Guidance for Industry and FDA Staff September 2018, was the first of three guidance documents published by the FDA. If known, FDA will notify the public of stores where recalled food was sold. Retail consignees include grocery stores, pet food stores, convenience stores, but not restaurants or distributors.

Timeline: November 2018

In this FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market November 2018, two examples were given for when FDA has notified the public of a recall:

  • FDA Investigated Multistate Outbreak of Vibrio parahaemolyticus Linked to Fresh Crab Meat Imported from Venezuela September 2018

     

  • FDA Alerts the Public Regarding Recalled Vegetable Products, October 2018 McCain’s Ready-to-cook and ready-to-eat (RTE)

While I appreciate the explanation, the following sentence stopped me in my tracks: We’ve already acted on these draft guidances.

I had previously heard that FDA was acting on a different unpublished draft guidance document, but here I saw it in print. It is not clear if the FDA is working from the published draft guidance shared with the food industry or from unpublished, draft guidance documents.

The second guidance document was published: Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff, November 2018. The Q & A addresses three questions.

  • When will the FDA publicize retail consignee lists?

    FDA will determine the likelihood of serious adverse health consequences or death of humans or animals (SAHCODHA) resulting in the food being adulterated and in most cases a class I recall. Some class II recalls or unclassified recalls will be publicized. I was very interested to see examples of what the FDA considers high-risk foods:

    1. Listeria monocytogenes -smoked salmon, pumpkin seeds
    2. Salmonella in ready-to-eat food-peanut butter, alfalfa sprouts, deli products
    3. Certain undeclared allergens in food
    4. E. coli O157:H7 in leafy greens
    5. Botulinum toxin- e.g. under processed canned chili
    6. Choking hazard in baby food, and
    7. Misbranded food with missing or incorrect food allergen labeling

For notification by FDA and in most cases, the retail packaging will make recalled food difficult to identify, and the food will be likely to still be in homes or stores. For example in the spring 2018 Romaine lettuce recall, much of the Romaine was beyond its shelf life and was not expected to be available in stores or homes by the time the recall was announced. From the Q & A guidance: There may be situations where both criteria are not met and FDA notifies the public. The FDA is not required to contact the firm before issuing a public warning or allow its review of the proposed statement. FDA may supplement or correct [the] warning.

  • What information will the FDA provide?
    When FDA notifies the public of a recall, they wish to have information that helps the consumer identify the product. Such information includes the name of the food, lot or code dates, product description, photographs, geographic information, retail-related information, e.g. by naming the retail store chain and potentially store-specific information such as city and state. FDA will describe the risks and information about similar food that is not affected by the recall. FDA will state that the information may be under or over-inclusive.
  • How will the FDA publicize this information?
    FDA Public Warnings will come as a press release posted on the FDA website, alerts, and public notices by email, web, or social media. Public notification of a recall is published in the weekly FDA Enforcement Report.
 

Timeline: February 2019

The FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls February 2019, and FDA Guidance, Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C, Guidance for Industry and FDA Staff February 2019, detail the FDA’s current thinking on when FDA will notify consumers of a recall. Companies that do not cooperate with the FDA for a recall or communicate a recall slowly to the public may experience the FDA announcing a recall.
FoodReady can help you meet the requirement of the rule and be prepared for a potential recall. The FoodReady website has free resources, and the folks at FoodReady are here to help! Contact us.

References:

1. Food Safety Modernization Act (FSMA) January 2011
2. FDA Rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food September 2015
3. Office of the Inspector General (OIG) Report, The Food and Drug Administration’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply December 2017
4. FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D. on efforts to support more efficient and effective food recalls December 2017
5. FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy steps for strengthening public warning and notification of recalls January 2018
6. FDA Draft Guidance, Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls Guidance for Industry and FDA Staff September 2018
7. FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market November 2018
8. FDA Guidance, Questions, and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff November 2018
9. FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls February 2019
10. FDA Guidance, Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C, Guidance for Industry and FDA Staff February 2019
11. 21 CFR Part 7 FDA Enforcement Policy, Subpart C–Recalls (Including Product Corrections)–Guidance on Policy, Procedures, and Industry Responsibilities