Cosmetics & The Law

On April 15, 2020, the FDA updated and issued as”final” the three guidance documents it had prepared to promote the availability of hand sanitizers during the COVID-19 crisis, found at:

(1) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-temporary-compounding-certain-alcohol-based-hand-sanitizer-products-during-public-health;

(2) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during; and

(3) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-manufacture-alcohol-incorporation-alcohol-based-hand-sanitizer-products-during.

None of the three updates to the guidances retract the FDA’s initial advisory announcements that for the duration of the COVID-19 it would not pursue actions against the designated compounders, companies, and alcohol manufacturers for the production of hand sanitizers, provided the resulting products conform to specifications set forth in the guidances.  However, the updated guidance documents do provide additional information in the form of clarifications and elaborations of the specific technical requirements for products that will conform with the guidances.  For instance, the updated final guidance to potential manufacturers now includes a further specification of the grade of isopropyl alcohol (USP or FCC) that may be used, and includes a list of recommended formulas for the denaturing of alcohol to be used in complying hand sanitizers.

Unfortunately, the FDA did not issue any documents summarizing or highlighting changes from the prior versions of the guidances, which it no longer makes available. Consequently, those who are considering entering the hand sanitizer market based on the prior guidances are advised to review the specifications in the updated final guidances to confirm that they still are preparing products that will come within the temporary safe harbor from enforcement actions the FDA is offering.