This second McGuireWoods alert discussing regulation of hand sanitizer manufacture and distribution addresses new considerations from the Food and Drug Administration (FDA) published in a June 2020 update to its March 2020 hand sanitizer guidance. In this update, FDA concedes to industry that not all alcohol can be easily sourced. Accordingly, FDA lays out additional rules for use of alcohol in hand sanitizer products.
I. FDA Updates Guidance
First, FDA will allow the use of fuel or technical grade alcohol (ethanol) under certain circumstances. Ethanol is readily available as a fuel additive for use either as a straight fuel or blended into the commonly known car fuel E-85 ethanol. It is mostly derived from corn that is not meant for human consumption. As a result, FDA is urging industry, if possible, to use Food Chemical Codex (FCC) or United States Pharmacopeia (USP) as quality standards. Where this is not possible, FDA has stated that it “does not intend” to take action against hand sanitizer that uses fuel or technical grade alcohol provided that the impurity levels are in accordance with the new guidance. FDA cautioned it can modify these policies at any time.
For guidance, FDA stated that there cannot be any gasoline in any sanitizer product. FDA also set very precise PPM levels for impurities in the products, including methanol, benzene, acetaldehyde, acetone, n-propanol, ethyl acetate, sec-butanol, iso-butanol, n-butanol, n-butanol, iso-amyl alcohol, amyly alcohol, and acetal levels. When in doubt about whether an impurity level is permissible, industry participants are asked to submit data to FDA about the chemical in question. The standard rules of the road still apply with the requirements of at least 70 percent active ingredient if using isopropyl alcohol. For all ethyl alcohol, the quality must be high enough in the finished product to allow for an 80 percent v/v concentration within the hand sanitizer.
Two key takeaways are: (1) businesses can use fuel or technical grade alcohol (ethanol), but it must be “pure” by FDA, USP or FCC standards; and (2) if ethanol is used as the base for hand sanitizer, labeling must be updated, as outlined in the guidance.
II. FDA Recalls and Further Warns on Claims
Ingredients matter for FDA, especially when it comes to hand sanitizer made under the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry. For instance, the only permissible ingredients in hand sanitizer are as follows:
In the guidance, FDA specifically noted that ingredients to “improve the smell or taste,” such as adding lavender to a product made under the hand sanitizer guidance, are not permissible. Further ingredients, such as carbomer or treithanolamine, would also be prohibited, as FDA has not listed those as permissible. By far the most impermissible ingredient is methanol, which resulted in two recent recalls of products. In samples of two products on the market, FDA found concentrations of 81 percent and 28 percent methanol in the hand sanitizers. In a recent online publication, FDA clearly stated, “Methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects.” FDA said it will take immediate action for quality violations and claims where products imply or state “prolonged protection” against COVID-19.
III. Litigation Update
As mentioned in McGuireWoods’ March 24, 2020, alert, FDA issued a warning letter to Gojo Industries Inc., the manufacturer and distributor of Purell Healthcare Advanced Hand Sanitizer, and several class action lawsuits were filed against Gojo Industries in New York, Ohio and California regarding claims it had made on its website about the efficacy of its hand sanitizer against specific pathogens like influenza and Ebola. The alert also mentioned another manufacturer of hand sanitizer, Vi-Jon Inc., which makes Germ-X and was the target of a class action filed in California federal court. See Geraldine David et al. v. Vi-Jon Inc., Case No. 3:20-cv-00424 (S.D. Cal.) (3/5/2020). Since the March alert, Target now also faces a class action lawsuit in California for a store-brand hand sanitizer — Taslakian v. Target Corp., No. 2:20-cv-02667 (C.D. Cal.) — and Gojo Industries has settled one of its three pending class action lawsuits. There is a clear trend of class action lawsuits filed across the country against hand sanitizer manufacturers and distributors.
As with any consumer product, a manufacturer, designer or distributor may risk individual and class action lawsuits regarding the product (design or manufacturing defect), product labeling (deceptive/false or failure to warn) and marketing (deceptive/false or failure to warn). To help prevent potential lawsuits, it is vital that companies’ products are well-designed and well-manufactured, and that the product labeling and marketing are accurate, truthful and carefully considered. To the extent a company would like to make any health-related claims on its hand sanitizer products, it should ensure the product strictly complies with all regulatory requirements, given that FDA and class-action lawyers will be closely scrutinizing such claims, and ensure that its product labeling and marketing are accurate and truthful. Types of claims against manufacturers and distributors for product labeling have included the following: