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Law360 (April 23, 2020, 5:36 PM EDT) --
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| Carrie Akinaka |
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| Julie Hussey |
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| Thomas Tobin |
Recent examples include some clothing companies making masks and gowns,[1] and certain auto manufacturers reconfiguring production lines to make face shields and ventilators.[2] And with the nation facing a scarce supply of hand sanitizer,[3] many businesses, from local distilleries to multinational fragrance companies, are lending a hand to increase hand sanitizer production.[4]
In March, the U.S. Food and Drug Administration issued formal guidance for temporary manufacturers of hand sanitizer.[5] The guidance allows "entities that are not currently regulated by FDA as drug manufacturers" to prepare and distribute hand sanitizers for public use.
During the period of the declared public health emergency created by COVID-19, the agency announced that it was exercising temporary enforcement discretion to allow new firms to prepare alcohol-based hand sanitizer products. "We are aware of significant supply disruptions for alcohol-based hand sanitizers," FDA Commissioner Stephen Hahn said in a statement accompanying the new guidance.[6] "[T]hese guidances provide flexibility to help meet demand during this outbreak."
Manufacturers should keep several considerations in mind if they want to temporarily repurpose existing manufacturing facilities to enter the hand sanitizer market.
Why Hand Sanitizers Are Important
Hand washing is still recommended. According to the U.S. Centers for Disease Control and Prevention, the best way to prevent the spread of infections and decrease one's chances of getting sick is proper hand washing with soap and water. But when soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer with at least 60% alcohol.[7]
Why the FDA Issued Its Recent Guidance
The agency aims to increase the supply of hand sanitizers. The agency acknowledged that hand sanitizer products were out of stock at many retailers and were difficult for consumers and healthcare professionals to find. The FDA's recent guidance was issued with the express purpose of increasing the available supply of hand sanitizer products to meet the increased demand.
Guidance Targeted to Certain Industries
In addition to guidance for manufacturers of hand sanitizer, the FDA recently issued specific notices to distilleries and other alcohol production firms, which can make the alcohol needed for sanitizing products, and pharmacies, which can compound their own hand sanitizer — all part of the FDA's broader effort to ramp up supply in this time of need.[8]
Importantly, the U.S. Alcohol and Tobacco Tax and Trade Bureau, or TTB, has also authorized companies producing distilled spirits and industrial alcohol to produce alcohol for hand sanitizers in its own recent guidance.[9] Per that agency's guidance, distilled spirits plants may manufacture hand sanitizer products without the TTB's prior approval, as long as the plant complies with FDA guidance.
Defining Hand Sanitizer
Hand sanitizers are drugs.
Hand sanitizers are over-the-counter, or OTC, drugs regulated by the FDA.[10] As such, products manufactured under the new guidance must bear "Drug Facts" labeling provided by the FDA in its guidance.
Hand sanitizers must use a specific formula.
Hand sanitizers manufactured under the new guidance must use only the following United States Pharmacopeia grade ingredients and follow the formulation recommended by the World Health Organization:
- Alcohol (ethanol) (80% volume/volume) in an aqueous solution; or isopropyl alcohol (75% v/v) in an aqueous solution;
- Glycerol (1.45% v/v);
- Hydrogen peroxide (0.125% v/v); and
- Sterile distilled water or boiled cold water.
Hand Sanitizer Manufacturing and Labeling Considerations Under the New Guidance
Manufacturers must register with the FDA.
Manufacturers must register their facility and their products with the FDA Drug Registration and Listing System[11] and will receive an automatic confirmation once the registration is complete. No further communication with the FDA is needed, and production can begin immediately.
The guidance outlines strict production requirements.
The FDA has exacting requirements. For example, manufacturers must use the most accurate method of analysis available to batch-test and verify alcohol levels.
Further, all hand sanitizer must be denatured, according to TTB regulations in 27 C.F.R. Part 20,[12] either during alcohol production or compounding, to prevent adverse effects, including death, from unintentional ingestion, particularly by young children. Manufacturers must also produce the products under sanitary conditions with equipment that is well-maintained and fit for the purpose.
The FDA's enforcement discretion is only temporary.
Per the FDA's guidance, the agency is exercising enforcement discretion only for the period of the public health emergency, as declared by the secretary of the U.S. Department of Health and Human Services.
Marketing cannot be false or misleading.
The FDA also does not allow hand sanitizer brands to make viral claims. While it is acceptable to note that products reduce bacteria, the FDA issued a warning letter in January against a manufacturer that claimed its products were effective at reducing or preventing disease from the Ebola virus, norovirus and influenza.[13]
At least three recently filed class action lawsuits have flowed from similar marketing claims.
Avoid adding ingredients for smell or taste.
The FDA guidance expressly prohibits including other active or inactive ingredients in hand sanitizer products, such as ingredients for smell or taste. This prohibition is to reduce the risk of accidental ingestion and any potential impact on product quality or potency.
Excise taxes on alcohol used to make hand sanitizers are waived for calendar year 2020.
To encourage more manufacturers to produce the much-needed product, the CARES Act, signed on March 27, exempts alcohol used to make hand sanitizer from excise taxes. The exemption lasts through the end of 2020.[14]
There are risks for noncompliance.
The FDA does not intend to take action against companies making hand sanitizers under its guidelines during the public health emergency. However, noncompliance with the guidance documents' instructions puts manufacturers at risk of receiving FDA warning letters or sanctions for the manufacturing of an unauthorized OTC drug.
Analysis and Takeaways
As the nation faces an exigent public health crisis, many manufacturers are stepping up to bolster the short supply of personal and medical products, including alcohol-based hand sanitizers. The recently issued FDA guidance documents provides manufacturers a roadmap to enter the hand sanitizer market.
Hand sanitizers are highly regulated, particularly as the FDA recognizes them as OTC drugs. In the case of hand sanitizers, FDA has temporarily eased its typical rules for the manufacturing of OTC drugs with the express intention to encourage additional manufacturing of hand sanitizers.
Companies looking to repurpose existing production lines to meet the increased need for these products during the public health emergency must register with the agency before production can begin, as well as ensure that they maintain compliance with FDA guidance as manufacturing progresses.
Key takeaways for manufacturers who wish to enter the hand sanitizer market include taking care to ensure the correct composition of hand sanitizer, avoiding added ingredients and using the agency's recommended Drug Facts labeling. Similarly, brands marketing hand sanitizer during the COVID-19 crisis should avoid any false or misleading statements, especially about the product's ability to reduce or prevent viral disease.
FDA and TTB guidance also outlined steps for alcohol producing firms, such as distilleries, regarding the preparation and distribution of alcohol for incorporation into hand sanitizer products for the public's use. FDA guidance generally allows for alcohol-based hand sanitizers incorporating either isopropyl alcohol or ethyl alcohol, but the agency's guidance for alcohol producing firms relates only to ethyl alcohol, given that isopropyl alcohol is manufactured via different chemical processes.[15]
Regardless of the type of manufacturer, companies looking to avail themselves of recent FDA guidance and make alcohol-based hand sanitizers, or supply alcohol for that purpose, should ensure that their production lines are sanitary, their equipment is well-maintained and fit for purpose, and adequate manufacturing records are kept.
Conclusion
Hand sanitizer is hardly the only product facing supply shortages. The FDA has also issued guidance to encourage production of face masks, respirators, gowns and gloves, as well as sterilizers and other disinfecting devices, during this public health emergency.[16]
By following the FDA's recently issued guidance and partnering with legal counsel as necessary, manufacturers intent on making hand sanitizer — or other essential products — can help support public health and reconfigure existing production lines to increase supply of much-needed products.
Carrie Akinaka is an associate at Perkins Coie LLP.
Julie Hussey is a partner at the firm.
Thomas Tobin is an associate at the firm.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
[1] Courtney Reagan, Retailers shift production to make masks, gowns for health-care workers in coronavirus pandemic, CNBC (March 26, 2020), https://www.cnbc.com/2020/03/26/coronavirus-retailers-make-masksgowns-for-healthcare-workers.html.
[2] Linda Chiem, Ford, Fiat, GM To Make Med Supplies To Combat COVID-19, Law360 (March 24, 2020), https://www.law360.com/articles/1256580.
[3] Ganda Suthivarakom, Coronavirus Has Caused a Hand Sanitizer Shortage. What Should You Do?, N.Y. Times (March 11, 2020, updated March 21, 2020), https://www.nytimes.com/2020/03/11/smarter-living/wirecutter/coronavirus-hand-sanitizer.html.
[4] Michael Levenson, Anheuser-Busch and Distilleries Race to Make Hand Sanitizer Amid Coronavirus Pandemic, N.Y. Times (March 19, 2020, updated March 23, 2020), https://www.nytimes.com/2020/03/19/us/distilleries-virus-hand-sanitizer.html; Lindsay Weinberg, Givenchy, Dior Perfumeries Now Manufacturing Hand Sanitizer, Hollywood Reporter (March 16, 2020), https://www.hollywoodreporter.com/news/dior-givenchy-perfumeries-now-manufacturing-hand-sanitizer-1284841.
[5] Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19): Guidance for Industry, U.S. Dep't of Health and Human Servs. and Food and Drug Administration (March 2020, updated March 27, 2020), https://www.fda.gov/media/136289/download.
[6] Coronavirus (COVID-19) Update: FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health, FDA News Release (March 20, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-guidance-production-alcohol-based-hand-sanitizer-help-boost.
[7] Q&A for Consumers: Hand Sanitizers and COVID-19, U.S. Food and Drug Administration (March 26, 2020), https://www.fda.gov/drugs/information-drug-class/qa-consumers-hand-sanitizers-and-covid-19.
[8] Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19): Guidance for Industry, Food and Drug Administration (last updated March 27, 2020), https://www.fda.gov/media/136390/download; Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect: Guidance for Industry, Food and Drug Administration (last updated March 27, 2020), https://www.fda.gov/media/136118/download.
[9] Production of Hand Sanitizer to Address the COVID-19 Pandemic, TTB Newsletter (March 26, 2020), https://www.ttb.gov/public-guidance/ttb-pg-2020-1a.
[10] Q&A for Consumers: Hand Sanitizers and COVID-19, U.S. Food and Drug Administration (March 26, 2020), https://www.fda.gov/drugs/information-drug-class/qa-consumers-hand-sanitizers-and-covid-19.
[11] Drug Registration and Listing System (DRLS and eDRLS), U.S. Food and Drug Administration (Aug. 29, 2019), https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-registration-and-listing-system-drls-and-edrls.
[12] 27 C.F.R. § 20, https://www.law.cornell.edu/cfr/text/27/part-20.
[13] WARNING LETTER: GOJO Industries Inc., U.S. Food and Drug Administration (Jan. 17, 2020), https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gojo-industries-inc-599132-01172020.
[14] CARES Act, H.R. 748, 116th Cong. § 2308 (2020), https://www.congress.gov/bill/116th-congress/house-bill/748/text#toc-H8AE9B1A64F1345A8A836E60C994879B6.
[15] Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19): Guidance for Industry, Food and Drug Administration (last updated March 27, 2020), at 1, https://www.fda.gov/media/136390/download ("This policy does not extend to other types of active ingredients for incorporation into alcohol-based hand sanitizers, such as isopropyl alcohol").
[16] Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff, U.S. Dep't of Health and Human Servs. and Food and Drug Administration (March 2020), https://www.fda.gov/media/136449/download; Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency Guidance: for Industry and Food and Drug Administration Staff, U.S. Dep't of Health and Human Servs. and Food and Drug Administration (March 2020), https://www.fda.gov/media/136540/download; Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff, U.S. Dep't of Health and Human Servs. and Food and Drug Administration (March 2020), https://www.fda.gov/media/136533/download.
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