Hand Sanitizers, COVID19 and FDA Regulatory Actions – Recent Developments

Wow! What a different world we are in than just a month ago.  As consumers lives have been shifted by the sudden emergence of the threat of the COVID-19 virus, the FDA has acted quickly to show that it is not asleep at the wheel, and that it will act both to increase the availability of products consumers need to protect themselves, and to protect consumers from products intended to exploit the crisis. Cosmetic manufacturers need to keep aware of these developments.

First, the FDA’s has opened a small window for the development of product for which there is substantial consumer demand: hand sanitizers. At the same time, the FDA has made clear it will act quickly and aggressively against any misleading claims about the efficacy of products as treatment for COVID-19.

On March 13, 2020, the FDA issued (without prior public comment) a guidance indicating that it would not pursue actions against certain designated categories of entities for the compounding of hand sanitizers, providing the resulting products met formula requirements specified in the guidance:

[w]e understand that some consumers are currently experiencing difficulties accessing alcohol-based hand sanitizers containing at least 60 percent alcohol.

The guidance specifies that the sole entities to which it applies are “pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities.”   “Registered outsourcing facilities,” includes entities registered with the FDA under Section 503B of the Food, Drug and Cosmetics Act for the compounding of drugs.

Although the guidance does not change the status of the rulemaking of consumer antiseptics as it stood as of April 2019, it opens the doors to State-licensed pharmacies and registered outsourcing facilities to begin compounding the highly sought after healthcare setting antiseptics and consumer hand rubs.

In contrast to its action to increase the availability of hand sanitizers, on March 9, 2020, the FDA also issued a press release announcing that it had issued warning letters to seven companies for fraudulently marketing products as COVID-19 treatments. The press release quoted FDA Commissioner Stephen Hahn asserting:

[t]he FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health. We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one.

The products targeted in the warning letter were items marketed to be ingested –teas, essential oils, tinctures and colloidal silver –not topically applied products such as skin creams or cleansers. Nevertheless, the announcement and warning letter are clear indications that the FDA will carefully review any product including a reference to COVID-19 in its marketing and likely take action if any improper efficacy claims are utilized.

What immediately comes to mind is a January 2020 warning letter the FDA issued in a similar vein to Gojo Industries, makers of Purell hand sanitizer, instructing the company to stop marketing the product as effective in preventing Ebola, the flu and more. Some of the challenged statements included:

    • “Kills more than 99.99% of most common germs that may cause illness in a healthcare setting, including MRSA & VRE”
    • “GOJO Blog What You Need to Know About Candida auris in the Healthcare Setting”:
    • “To help prevent transmission, …. PURELL® Advanced Gel, Foam, and Ultra-Nourishing Foam Hand Sanitizer products demonstrated effectiveness against a drug resistant clinical strain of Candida auris in lab testing.”
    • “PURELL® Products Help Eliminate MRSA & VRE . . . 100% MRSA & VRE Reduction[] . . . A recent outcome study shows that providing the right products, in a customized solution, along with educational resources for athletes and staff can reduce MRSA and VRE by 100%[]”

Notably, the above claims were found primarily in the company’s social media marketing, not on the labels.

Take aways…Manufacturers uncertain if they fit within the entities the FDA has provided clearance to manufacture hand sanitizer should discuss the issue with counsel. Similarly, any manufacturer considering marketing products with any reference to COVID-19 or any other medical condition should also have counsel review those claims and understand that it is not only label and packaging claims that can get a company in hot water with the FDA.

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