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Industry News and Press: Regulatory Updates

March 2017 Regulatory Update

Tuesday, April 25, 2017   (0 Comments)
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These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from March 1 through 31, 2017. Please contact Seth Mailhot, Leah Ziemba, or Paulette Morgan for additional information on regulatory issues that may impact upon your business.

The March 2017 Regulatory Update includes the following topics. Click on the link for the complete regulatory update. 
1. Senate committee to vote for new head of FDA, Dr. Scott Gottlieb  The Senate Health, Education, Labor & Pensions (HELP) Committee will vote on Dr. Scott Gottlieb’s nomination to run the FDA Wednesday, April 26th. >>Read more
2. Recalls, warning letters and litigation  FDA’s mandatory food recall gives FDA the authority to order a recall where there is a reasonable probability that the article of food is adulterated or misbranded and a voluntary recall has not been implemented.   As a part of FSMA, each company must have a written recall plan.   In addition to recalls, FDA Warning Letters may also lead to litigation.  >>Read more

3. Other developments of interest  >>Read more
a. Use of the term "healthy” in the labeling comment period is extended
b. Draft Guidance on "Fruit Juice and Vegetables as Color Additives in Food” comment period is extended
c. FDA has again extended the comment period for "Genome Editing in New Plant Varieties Used for Foods”

The Senate Health, Education, Labor & Pensions (HELP) Committee will vote on Dr. Scott Gottlieb’s nomination to run the FDA Wednesday, April 26th. Gottlieb, who served as a deputy commissioner at FDA during the George W. Bush administration, is widely expected to gain approval from the Senate Committee and be confirmed by the full Senate.  The focus of Dr. Gottlieb’s confirmation hearing last month was on pharmaceutical and medical device issues with food-related issues being raised only a few times. As a result, the nominee’s positions regarding the food-related issues under FDA’s umbrella are yet to be known.  

FDA’s mandatory food recall authority went into effect with the enactment of the Food Safety Modernization Act (FSMA) on January 4, 2011. Section 423 of the FD&C Act, as added by Section 206 of FSMA, gives FDA the authority to order a responsible party to recall an article of food where FDA determines that there is a reasonable probability that the article of food (other than infant formula) is adulterated under section 402 of the FD&C Act [21 U.S.C. § 342] or misbranded under section 403(w) of the FD&C Act [21 U.S.C. § 343(w)] and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals. As a part of FSMA, for food with a hazard requiring a preventive control under FSMA, a written recall plan is required for the food.  
21 CFR § 117.139. The written recall plan must include procedures describing the steps to be taken and assign responsibility for those steps for the following: (1) directly notifying the direct consignees of the food being recalled, including how to return or dispose of the food; (2) notifying the public about any hazard presented by the food when appropriate to protect public health; (3) conducting effectiveness checks to verify that the recall is carried out; and (4) appropriately disposing of recalled food, e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.

Before FSMA was enacted, FDA relied on parties to voluntarily recall food products that violated the FD&C Act.  Post-FSMA, FDA still relies on responsible parties to voluntarily recall violated food products; however, FDA’s mandatory recall authority allows the administration to mandate a recall if the responsible party does not initiate one voluntarily. Under FSMA, FDA first provides the responsible party with the opportunity to conduct a voluntary recall and cease distribution of the food in question. The FDA may proceed with a mandatory recall if the voluntary recall is not implemented. In practice, a vast majority of companies elect to initiate a voluntary recall when made aware of science-based evidence that their products are unsafe, or reasonably likely to be unsafe, so FDA has only rarely used its mandatory recall authority.  

Regardless of whether a facility performs a voluntary food recall or FDA uses its authority to initiate a mandatory food recall, the reality is that a recall may result in the filing of private lawsuits.  In addition to many other considerations -- ensuring regulatory compliance with FDA requirements and investigation, taking corrective actions and documentation and timing related to the same, deciding the scope, nature and extent of a food recall, exploring insurance coverage issues, and developing a communications plan, among other considerations -- the threat of litigation requires additional steps, including, but not limited to, preservation of relevant documents and information, identification of company employees with knowledge of recall-related events, assembling a defense team, managing insurance matters and handling public relations.  

In addition to recalls, FDA Warning Letters also may lead to litigation. FDA’s "Regulatory Procedures Manual” notes that it is the administration’s practice to "give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action” and, to do that, FDA issues Warning Letters as a way to "achieve voluntary compliance and to establish prior notice.” FDA is supposed to only issue Warning Letters for violations of "regulatory significance,” which are those violations that may lead to enforcement action if not promptly and adequately corrected.  In practice, Warning Letters provide recipients with an opportunity to understand FDA’s position on a particular issue of non-compliance, correct the issue and then document that the issue has been resolved. If a facility receives a Warning Letter, it is highly recommended that a response be provided to FDA within the requested time frame. If the FDA is able to verify that the corrective actions have been completed, it may issue a Close-Out Letter which confirms that the facility responded with sufficient information to demonstrate that any listed violations have been adequately corrected or that the follow-up inspection shows that implementation of the corrective actions was adequate. Both Warning Letters and any issued Close-Out Letters are publicly available on FDA’s website. Lawsuits have frequently been filed after the issuance of a warning letter.

The importance of consideration of all of the safety, regulatory and legal aspects of recalls and Warning Letters cannot be overemphasized. The appropriate handling of these situations can help increase the safety of the food supply and reduce risk and liability.  


a. The comment period on the use of the term "healthy” in the labeling of food products has been extended to April 26, 2017.

b. FDA reopened the comment period on its Draft Guidance on "Fruit Juice and Vegetables as Color Additives in Food” to May 1, 2017.

c. FDA has again extended the comment period for "Genome Editing in New Plant Varieties Used for Foods” (Center for Food Safety and Applied Nutrition) regarding the use of genome editing techniques to produce new plant varieties that are used for human or animal food, "Genome Editing in New Plant Varieties Used for Foods; request for Comments.” FDA intends to "continue offering consultations for developers of new plant varieties, including those produced using genome editing, in order to help developers ensure that applicable safety and legal questions are resolved prior to market.” The comment period, including on specific questions included in the Notice, extends to June 19, 2017.

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