In response to the Coronavirus Disease 2019 (COVID-19) crisis, the U.S. Consumer Product Safety Commission (CPSC) recently issued a series of Home Safe Checklists with guidance on keeping families safe while spending more time at home and indoors. During this time of uncertainty, the CPSC is urging consumers to create safe home spaces for isolation by identifying and handling household “hidden hazards.” Recognizing that isolating with babies, children, and seniors in the home can be especially challenging, the CPSC’s checklists include simple steps for preventing infant suffocation, child drowning, furniture and appliance tip-over, window covering entrapment, and injury from falls or fires. Because consumers are particularly focused on preparing for potential illness and cleaning and disinfecting their homes, the checklists emphasize the importance of preventing accidental poisonings caused by the ingestion of medications, chemicals, and household cleaning products. According to the CPSC, the vast majority of unintended poisonings occur in the home and most often involve blood pressure medications, acetaminophen, bleach, ibuprofen, and laundry packets.
In a short statement regarding its efforts during the COVID-19 crisis, the CPSC explicitly reminded companies of their statutory obligation to continue reporting under Section 15(b) of the Consumer Product Safety Act (CPSA). In addition, the CPSC has continued to enforce child-resistant packing requirements under the Poison Prevention Packaging Act (PPPA) throughout the pendency of the COVID-19 crisis, and since March 1, 2020, has announced at least seven recalls for PPPA violations, including recalls for prescription medication and cleaning products. Recent data suggests that diligent manufacturer compliance with product and packaging requirements is especially important with children home from school and spending more time indoors, increasing their chance of exposure to potentially harmful household products. In March 2020, U.S. poison control centers reported 2,436 exposure cases involving hand sanitizer in children 12 years and younger, compared to 1,605 cases in January and 1,662 in February.[1]
Meanwhile, manufacturers are scrambling to meet the explosive demand for household disinfectant products, including alcohol-based hand sanitizer. While disinfectant manufacturers work to increase production in the face of significant supply chain disruptions and workforce issues, other manufacturers — including cosmetic companies and alcohol distillers — are trying to patch the shortage by retooling production lines to temporarily manufacture hand sanitizer. To help meet the increased demand for alcohol-based hand sanitizer, the federal government has allowed manufacturing firms to begin producing hand sanitizer with limited guidance. The guidance Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) is immediately in effect and outlines that the U.S. Food and Drug Administration (FDA) does not intend to take action against manufacturing firms that register to produce certain alcohol-based hand sanitizers for consumer use during the COVID-19 crisis. The guidance sets forth criteria for the temporary manufacture of hand sanitizer, including a requirement that firms do not add ingredients to improve the smell or taste, due to the risk of accidental ingestion in children. The FDA is also encouraging consumers to report adverse events experienced with the use of hand sanitizers. For further insight on temporary guidelines and enforcement policies issued by the FDA and other federal agencies in response to the critical need for hand sanitizer and other COVID-19 related products, please see Nelson Mullin’s recent alert regarding Concerns for Manufacturers During COVID-19 Pandemic.
While increased consumer demand for disinfectant and sanitizing products (and attendant supply chain and workforce issues) will likely persist in the coming weeks and months, traditional manufacturers should maintain focused efforts on achieving compliance with existing legal and regulatory requirements. Meanwhile, new manufacturers of these products should seek guidance about the applicability of statutory and regulatory requirements and develop and implement strategies for compliance.
