The Council for Responsible Nutrition (CRN) submitted a citizen petition to the Food and Drug Administration (FDA) requesting that FDA:

  1. FDA exercise its statutory authority to establish a regulation under which hemp-derived cannabidiol (CBD) may be legally marketed as a dietary ingredient;
  2. Clarify when a hemp-derived substance is subject to the preclusion provisions of 21 USC 321(ff)(3)(B); and
  3. Enforce existing dietary supplement regulations with respect to CBD-containing products being marketed as dietary supplements.

This blog post provides background on the legal provisions FDA views as preventing the lawful marketing of CBD as a dietary supplement and food – known as the “exclusionary clauses” of the Federal Food, Drug, and Cosmetic Act (FFDCA) as well as a summary of CRN’s citizen petition and how the requested actions would alter the regulatory scheme for CBD products.

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The Centers for Disease Control and Prevention (CDC) has issued a guidance document titled Testing Strategy for COVID-19 in High-Density Critical Infrastructure Workplaces after a COVID-19 Case is Identified (the Guidance), which describes different testing strategy options for exposed employees when companies determine testing is needed to help support existing disease control measures. As part of the Guidance, CDC issued a decision tree to assist with determining optional testing strategies. CDC specifically notes that outbreaks of illness among workers in food-producing facilities and surrounding communities have raised “unique questions that identified the need for testing” to supplement existing CDC recommendations. CDC explains the Guidance is intended to supplement and augment existing guidance with the goal of reducing transmission of SARS-COV-2 in the workplace.

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Regulation is a crucial aspect that must be taken into consideration when thinking about creating a new start-up and when entering new markets.

Join GrowingIL’s next webinar on June 24,  2020, where Hogan Lovells partner Gary Jay Kushner will shed light on Agtech regulation in the U.S. and specifically in the fields of biotechnology, plant protection, and seeds.

For more information and to register for the webinar, click here.

The Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) recently released several guidelines for various segments of the food industry to address the COVID-19 pandemic. First, CDC issued Interim Guidance from CDC and the U.S. Department of Labor, Agriculture Workers and Employers (“the Interim Guidance”), which provides recommendations related to COVID-19 transmission considerations for agriculture workers and employers. The Interim Guidance addresses the unique challenges of controlling the spread of COVID-19 given factors such as agriculture work sites, shared worker housing, and shared worker transportation vehicles, which are prevalent in the agriculture sector.

Second, the CDC issued Meat and Poultry Processing Facility Assessment Toolkit (“the CDC Toolkit”) for occupational safety and health professionals and government officials to use in assessing COVID-19 infection prevention and control measures at meat and poultry processing facilities.

Third, FDA released a food safety re-opening checklist, Best Practices for Re-Opening Retail Food Establishments During the COVID-19 Pandemic (“the Checklist”), for previously closed retail food establishments or those that have been open with limited service related to the COVID-19 pandemic.

We summarize these resources here.

The United States Department of Agriculture (USDA) has published a Final Rule codifying internal procedures that must be followed when issuing agency guidance documents. The Final Rule amends USDA’s administrative regulations by adding procedural regulations for the review and issuance of USDA guidance documents. The Final Rule adds a new Subpart Q, “Review and Issuance of Agency Guidance Documents,” to 7 CFR Part 1. The new procedures are in some ways similar to the Food and Drug Administration’s (FDA) “Good Guidance Practices” regulations which for two decades have governed the procedural steps FDA follows when developing guidance documents. Although the Final Rule is positioned as an internal agency procedural requirement not conferring rights on third parties, regulated companies may wish to consider whether the agency properly followed these procedures when commenting on future agency guidance.

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The U.S. Food and Drug Administration (FDA) recently provided an update from FDA Commissioner Stephen Hahn M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas on the forthcoming New Era of Smarter Food Safety Blueprint (Blueprint), which will outline the agency’s strategy to create “a more digital, traceable, and safer food system” over the next decade. In a statement published online, the Agency states the Blueprint will be released “in the coming weeks.” FDA also explains that the Blueprint was days away from being released in March, but was delayed by the shift in focus caused by the COVID-19 pandemic.

Since then, FDA has revised the Blueprint in light of the lessons learned during the pandemic. In the statement, FDA explains that COVID-19 “has accelerated the need” for some measures addressed in the Blueprint.

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On May 27, 2020, the U.S. Food and Drug Administration (FDA) issued new guidance for human food establishments on voluntarily reporting to FDA temporary closures or significantly reduced production due to the COVID-19 public health emergency. The agency’s guidance document is entitled “Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency”
(Guidance). The Guidance details a mechanism by which human food facilities and farms may voluntarily notify FDA of temporary closures and significant reductions in operations, or to request a dialogue with FDA on issues related to continuing or restarting their operations during the COVID-19 pandemic. This Guidance does not apply to restaurant and retail food establishments or to animal food operations. Here we summarize the Guidance.

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On May 22, 2020, the U.S. Food and Drug Administration (FDA) announced two policies to provide temporary flexibility with respect to packaged foods formulation and labeling requirements during the COVID-19 pandemic. The agency’s guidance document is entitled “Temporary Policy Regarding Certain Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines” (“Guidance”). The Guidance details flexibility for manufacturers to make minor formulation changes and flexibility for vending machine operators regarding calorie information for foods sold in vending machines. Like the other guidance documents FDA has issued to provide labeling flexibility during the COVID-19 pandemic, this guidance is effective only for the duration of the public health emergency. We summarize the Guidance in this post.

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On May 19, President Trump issued an Executive Order (EO) authorizing federal agencies to provide regulatory relief to support the economic response to the COVID-19 outbreak. Specifically, the EO allows agencies to rescind, modify, waive, or provide exemptions from regulatory and other requirements that may impede economic recovery, consistent with applicable law and protection of the public health and safety. Since March, federal agencies have responded to the COVID-19 outbreak by taking hundreds of administrative actions, many of which provided flexibility regarding regulatory requirements, in an effort to address the spread of the virus and its impacts. With focus shifting to overcoming the effect the virus has had on the economy, the EO notably requires agencies to review those regulatory standards that they have temporarily rescinded or otherwise modified and determine which, if any, would promote economic recovery if made permanent. The EO also requires agencies to more broadly review current and prospective regulatory priorities and identify those that may inhibit economic recovery. Finally, the EO recommends that agencies provide compliance guidance to businesses and commit to fairness in administrative enforcement and adjudication.

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The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) recently issued a Memorandum of Understanding (MOU) regarding the potential use of the Defense Production Act (DPA) with regard to FDA-regulated food. Importantly, USDA retains its DPA authority for products subject to FDA jurisdiction. The MOU, however, establishes that FDA will be responsible for monitoring the continued functioning of the FDA-regulated food production sector, bringing issues to USDA’s attention should FDA believe that USDA may need to exercise its DPA authorities to address a situation. The MOU is intended to supplement preparedness efforts and directs FDA to take the lead for FDA-regulated industry and monitor the food supply, work with stakeholders to identify and assess potential supply chain disruptions, issue applicable guidance for workers, and educate stakeholders about the potential for use of DPA authority. To the extent FDA identifies disruptions to the supply or other issues, both Agencies will work together to discuss appropriate action, including potentially invoking USDA’s DPA-delegated authorities. The MOU does not actually take any action under the DPA—it does not reflect action by USDA expanding the scope of the President’s invocation of the DPA beyond the meat and poultry sectors, nor does it constitute an order under the DPA.

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