FDA Warns: Hands Off for Some Sanitizers
The COVID-19 pandemic continues to raise a multitude of legal and practical issues in the midst of a terrible health crisis. The legal issues related to potential legal liability for actions during unprecedented public health crisis will continue to grow. This space has addressed product fraud issues, product immunity issues, immunity issues for reasonable actions taken in a time of incomplete, conflicting, and shifting information, nursing home issues, as well as concerns about whether efforts to prevent or treat the disease may be harmful.
In July, the FDA took steps to alert the public to issues with the now ubiquitous hand sanitizers. On July 2, 2020, the FDA warned of methanol contamination in hand sanitizers citing recent adverse events leading to blindness, hospitalizations and death. FDA made clear that methanol is not to be used as a component of hand sanitizers because of health risks posed by its ingestion or absorption. FDA’s communication went beyond methanol and warned against drinking hand sanitizer (one would think this is obvious, but apparently not), stating that the sanitizer needs to be at least 60 percent ethanol, directing that the labeling must not state that the sanitizer can prevent COVID or provide prolonged protection against it and iterating that the labeling and packaging must not be misleading or potentially attractive to children who may ingest it.
Later, on July 27, the FDA repeated its warning potentially toxic methanol, repeated the risks discussed above, and added neurological and cardiac side effects. It also linked to a list of the potentially dangerous sanitizers that consumers should avoid. The FDA called out a particular manufacturer, and urged a recall of all methanol contaminated product. It further urges consumers to avoid product from any of the manufacturers on the list, even if a particular product is not identified in the list. As I typed this sentence, I looked at the hand sanitizer on my desk that I bought in June; it is on the banned list. I will not be using it any more.
Caution is the watchword for consumers.
Of course, this issue leads to many of the usual risk management and litigation issues–ranging from warning adequacy, contaminated product, causation of the alleged illness, recall and adequacy of recall, retailer liability and/or responsibility to remove product on this list. It is unknown at this point how widespread (or limited) this issue may be.