In response to the COVID-19 pandemic, the demand for hand sanitizer has increased exponentially. Manufacturers of much-needed hand sanitizers face a maze of regulatory rules and restrictions in every country in which their products will be sold. For example, the U.S. Food and Drug Administration has monitored hand sanitizers entering the market, and the agency has regularly updated its list of recalled hand sanitizer products, including many that have been sold at national retailers. In an infographic overview, Shook consumer products attorneys guide the producers of hand sanitizers and retailers through what they need to know to successfully make, label and sell their products in the U.S., U.K., Canada and Mexico. Learn the relevant details and questions to ask about each country’s requirements; guidance on product ingredients, product testing, labeling, promotion and distribution of hand sanitizers; and direct actions to take to ensure products get safely to market in full…
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The U.S. Food and Drug Administration (FDA) has entered a new phase of enforcement for the Foreign Supplier Verification Program (FSVP) regulation, the legally required due diligence program to review and approve foreign suppliers of imported food. In May 2020, FDA placed two companies on Import Alert 99-41, which is essentially an import ban where an importer cannot import the food until they implement an appropriate FSVP to FDA’s satisfaction. This is not the first time FDA placed a company on Import Alert 99-41. However, the previous import alert listing concerned a company that imported food associated with a recall and foodborne illnesses. In this instance, there is no indication that the food caused any food illnesses or was otherwise non-compliant; rather, it appears that the only issue was the importers failed to comply with the FSVP requirement. This inherently changes the tenor of an FSVP inspection because they now…
By Shook Associate Matt Williams California often serves as an incubator for litigation that thereafter sweeps across the country. This phenomenon may hold true for newly minted COVID-19-based price-gouging lawsuits. Indeed, California has quickly become the epicenter of price-gouging enforcement and class action litigation. Food producers, distributors, retailers and online marketplaces such as Amazon have become the targets of price-gouging actions. Importantly, there is currently no federal price-gouging law, meaning that companies must navigate 50 different state laws. California’s price-gouging statute provides that “consumer food items or goods” cannot be sold for 10% more than the price advertised immediately before a declared state of emergency. The statute provides an exception for price increases if the seller can prove it was “directly attributable” to costs imposed by up-chain suppliers or increases in labor and material costs during the emergency. Violations are prosecuted by the California Attorney General and local district attorneys,…
Shook Partner Katie Gates Calderon and Associate Elizabeth Fessler have authored “Best Practices for Food and Beverage Pricing Right Now” for Law360, which discusses how food and beverage companies may face regulatory actions and reputational damage if they are perceived to have raised their prices too much during the COVID-19 pandemic. “With increased demand and potentially increasing production costs due to supply chain disruptions, many in the food and beverage industry may be wondering how to deal with the economic pressures without running afoul of price-gouging statutes,” Fessler and Gates Calderon write. Many states have different laws governing price-gouging, and those laws often differ on what an acceptable price differential may be. Understanding which state laws apply and documenting all aspects of the reasoning for any price increase are key, they explain, concluding, “If you are contacted about pricing issues, it may be best to contact outside counsel before providing…
By Shook Of Counsel John Johnson The U.S. Food and Drug Administration’s (FDA) regulatory requirements for food companies, including manufacturers and importers, remain largely unchanged during the COVID-19 outbreak. However, COVID-19 is disrupting plant operations and supply-chains, which companies must be mindful of as they continue to function within the regulatory requirements: Food safety remains FDA’s top priority. The agency is continuing to work with companies to implement food recalls, and FDA will conduct mission critical, for-cause inspections when necessary. Monitor email inboxes for a message from an FDA investigator indicating that the agency is requesting records to conduct a remote inspection. FDA has indicated that these remote inspections will start for food importers to determine their compliance with the Foreign Supplier Verification Program (FSVP). Current Good Manufacturing Practices (cGMPs), Food Safety Plans, Hazard Analysis Critical Control Points (HACCP) Plans and FSVP must continue to be implemented. In doing so,…
By Partner Lindsey Heinz and Associate Zac Parker The U.S. Food and Drug Administration (FDA) sent warning letters to Jimmy John’s Franchise, LLC and its supplier Sprouts Unlimited Inc. regarding food safety practices after the agency traced an outbreak of E. coli to Jimmy John’s produce, which had previously caused outbreaks of foodborne illnesses. In the letter to Jimmy John’s, FDA focused on the company's prior sales of adulterated products, its misrepresentations to FDA regarding the sourcing of its sprouts, and the need for Jimmy John’s to demonstrate “long-term, sustainable corrections” that would prevent these outbreaks in the future. It comes as no surprise that letters like these make headlines and risk hurting a food supplier’s reputation. In light of these warning letters and the concerns raised by potential outbreaks of the new coronavirus COVID-19, food manufacturers must be vigilant about supply chain management, whether at the growing, transporting, processing or…
More than half of in-house counsel surveyed in a new white paper by Shook, Hardy & Bacon plan to increase legal spending in the next two years to accommodate the evolving cannabis market, with a significant growth in litigation threats anticipated over the next decade. Read the results of the white paper >> “Articles and comments from industry players (and its detractors) often invoke images from the wild, wild West, and that might be a fair assessment in that the legal landscape for these products remains unclear,” stated Shook Partner Katie Gates Calderon, co-chair of the firm's new Cannabis Law Practice. Shook, Hardy & Bacon’s Cannabis Law Practice has released a report in partnership with ALM Media, exploring the impact of the global cannabis economy on the food and beverage, health and wellness, and consumer goods industries. The results of this in-house counsel survey show that legal departments outside the…
On May 31, 2019, the U.S. Food and Drug Administration (FDA) held a widely anticipated public hearing with stakeholders on cannabis and cannabis-derived compounds to gain insights on product safety and a potential regulatory framework for products containing such substances. The hearing focused on cannabidiol (CBD)—a popular but controversial compound that has been added to products ranging from tinctures and lotions to sodas and ice cream. Interest in the product was spurred by the passage of the 2018 Farm Bill, which removed hemp (cannabis plants with less than 0.3% THC content) from the Controlled Substances Act. The Farm Bill also complicated FDA’s role in regulating CBD because although the substance was de-scheduled by Congress, the Agency still regulates it as a drug—meaning that any consumer product with CBD is technically a misbranded drug in violation of FDA rules. While the Agency has taken limited actions against companies using CBD as…
In-house and outside counsel joined representatives from the U.S. Food and Drug Administration (FDA), Department of Agriculture (USDA) and Federal Trade Commission (FTC) in Chicago for the American Conference Institute’s Food Law Conference on April 9-11, 2019. The conference covered a number of key topics, including the impact of Food Safety Modernization Act (FSMA) implementation, changes to California's Safe Drinking Water and Toxic Enforcement Act (Prop. 65) and emerging issues such as hemp and cannabis ingredients, blockchain and 3D-printed foods. Shook Partner Lindsey Heinz presented with Matt Dornauer, general counsel for Phusion Projects, LLC, on how to navigate the unique challenges of marketing and advertising through social media. Heinz and Dornauer discussed a wide array of issues, including what food and beverage companies can glean from FDA social media guidance in the pharma space, how to draft a comprehensive social media policy and overarching best practices to ensure that companies…
The U.S. Food and Drug Administration (FDA) has announced that it will take a number of steps to advance its consideration for the potential regulatory framework for cannabis and cannabidiol (CBD) products. Specifically, this includes a public hearing, an agency working group, question-and-answer updates and the possibility of enforcement actions. A public hearing on May 31, 2019, aims to obtain “scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” Electronic or written comments will be accepted until July 2, 2019. FDA is seeking comments, data and information related to (i) what levels of cannabis cause safety concerns; (ii) how the mode of delivery (e.g., ingestion, absorption, inhalation) affects the safety of, and exposure to, cannabis; (iii) how cannabis interacts with other substances; and (iv) standardized definitions for cannabis-related ingredients, supply chain quality control, effective marketing and labeling of…
