FDA updates on hand sanitizers safety for use
The U.S. Food and Drug Administration (FDA) has announced that it is providing a new laboratory testing method to assess the quality of finished hand sanitizers. Moreover, the FDA has issued a new press release on August 27th 2020, where it warns consumers about hand sanitizers packaged in food and drink containers. Earlier this month, the FDA expanded hand sanitizer warnings to include 1-propanol contamination.

Date

Liliana Teles

Liliana Teles

Regulatory Affairs Manager

FDA’s TESTING METHOD FOR HAND SANITIZERS

The Food and Drug Administration (FDA) regulates hand sanitizers in the U.S., as they are considered over-the-counter (OTC) drugs. Recently, the FDA warned consumers about methanol contamination in some hand sanitizers (and consequences of its use), publishing a list of hand sanitizers that have tested positive for methanol and advising consumers not to use it. Additionally, the FDA issued updated guidance to provide additional clarification on testing of alcohol used in hand sanitizers manufactured under FDA’s temporary policies. The guidance recommended test methods (USP monograph for ethanol) as well as conducting the testing in a laboratory previously inspected by the FDA and in compliance with current good manufacturing practice (cGMP). The main goal of these guidelines was to help ensure that harmful levels of methanol were not present and that such hand sanitizers are free from contamination. Under the FD&C Act, alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges.

On August 24th 2020, to help ensure that hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities, the FDA provided a laboratory testing method. A Gas Chromatography-Mass Spectromatry (GC-MS) method was developed and validated for the quality assessment of hand sanitizers. This method can be used to test the quantity of alcohol (ethanol and isopropanol) as well as detect impurities (listed in the FDA hand sanitizer guidance).

The United States Pharmacopeia (USP) revision bulletin for alcohol and dehydrated alcohol monographs include testing ethanol for methanol contamination as a quality standard and it will be official from September 1st 2020.

FDA’s UPDATE ON HAND SANITIZERS CONTAMINATION AND PACKAGING

Two days ago, FDA issued a new press release, warning consumers about alcohol-based hand sanitizers that are being packaged in containers that may appear as food or drinks and which, if ingested, may put consumers at risk of serious injury or death.

The FDA has found hand sanitizers packaged in beer cans, children’s food pouches, water bottles, juice bottles and vodka bottles and it has also found that some hand sanitizers contain food flavours (e.g. chocolate or raspberry). One of the reports received by the FDA described a consumer that purchased a bottle thinking it was a drinking water when it actually was a hand sanitizer. This kind of products may result in consumer’s confusion and lead to incidental ingestion of hand sanitizers. Hand sanitizers can be toxic when ingested and there has been increasing reports of adverse effects following hand sanitizer ingestion.

The overall goal of the FDA updates and press releases is to protect health care providers and consumers from using dangerous hand sanitizer products. The increasing people’s awareness to problems associated with hand sanitizers – contamination and misuse – is an essential route to avoid adverse effects and ensure the correct use of such products.

References:

U.S. Food and Drug Administration (FDA) – FDA Updates on Hand Sanitizers Consumers Should not Use. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use

U.S. Food and Drug Administration (FDA) – Direct Injection Gas Chromatography Mass Spectrometry (GC-MS) Method for the Detection of Listed Impurities in Hand Sanitizers. Available at: https://www.fda.gov/media/141501/download

United States Pharmacopeia (USP) – Alcohol Revision Bulletin. Available at: https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/alcohol-rb-notice-20200817.pdf

U.S. Food and Drug Administration (FDA) – FDA New Release – COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers. Available at: https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-warns-consumers-about-hand-sanitizer-packaged-food-and-drink-containers

further
reading

medical devices

BREXIT – Impact on Medical Devices placed in the UK market

From 31 of December 2020, the UK will be regarded as a third country and not a Member State of the European Union. There will be some changes regarding medical devices placed in the UK. The UK’s MHRA has published guidance regarding the regulation of medical devices from 1 January 2021, where it explains what changes and what there is to know about placing a medical device in the Great Britain, Northern Ireland and EU markets.

Read More »
medical devices

Brazil – Class II Medical Devices – New Resolution

A new Resolution of the Collegiate Board of Directors (RDC No. 423/2020) has been published by Brazil’s National Agency of Health Surveillance (ANVISA). This new Resolution announces the elimination of the ‘Cadastro’ pathway regarding the registration of medical devices (Class II) and IVDs, substituting it with a notification registration system.

Read More »
cosmetic products

Butylphenyl Methylpropional to be prohibited in cosmetics placed in the EU market

Butylphenyl Methylpropional, also known as Lilial, is a fragrance ingredient that has been used for years in several cosmetic and non-cosmetic products. Nevertheless, some concerns have been expressed regarding the use of this ingredient and its risk to consumers. According to an amendment to the CLP Regulation (Commission Delegated Regulation No. 2020/1182), Butylphenyl Methylpropional is now classified as toxic to reproduction (Repr. 1B – CMR 1B) and it shall be prohibited in cosmetic products from 1st March 2022.

Read More »
cosmetic products

China Bans Microbeads In Cosmetics

On 16th January 2020, China’s National Development and Reform Commission (NDRC) issued the Notice [2020] No. 80, with the aim of prohibiting the use of microbeads in cosmetics and personal care products. More detailed information was given in the Notice [2020] No. 1146, issued by the NDRC on 10th July 2020.

Read More »
medical devices

EU Medical Devices Regulation – Unique Device Identifier (UDI)

In 2017, two Regulations on medical devices (MDR) and in in vitro diagnostic medical devices (IVDR) entered into force in the European Union (EU), establishing a modernized and more robust EU legislative framework and safeguarding a better public health protection and patient safety. According to the these Regulations, the Unique Device Identifier (UDI) will be mandatory for all medical devices and in vitro medical devices.

Read More »
COVID-19

FDA updates on hand sanitizers safety for use

The U.S. Food and Drug Administration (FDA) has announced that it is providing a new laboratory testing method to assess the quality of finished hand sanitizers. Moreover, the FDA has issued a new press release on August 27th 2020, where it warns consumers about hand sanitizers packaged in food and drink containers. Earlier this month, the FDA expanded hand sanitizer warnings to include 1-propanol contamination.

Read More »
cosmetic products

RAPEX System 2019 Report

Every week, the RAPEX system publishes notifications of urgent measures taken by EU Member-States to prevent, restrict or impose conditions on the marketing of products due to the serious and immediate danger they pose to the health and safety of consumers.

Read More »
cosmetic products

Cosmetic Packaging in European Union

Packaging material is defined as the container (or primary packaging) that is in direct contact with the formulation. According to the European Cosmetic Regulation No. 1223/2009, packaging evaluation is mandatory to guarantee cosmetic product safety. To meet this Regulation requirements, the European Commission issued the Decision 2013/674/EU, establishing guidelines on the practical application of such requirements and identifying information that should be collected on the packaging materials and the potential migration of substances from packaging.

Read More »
cosmetic products

“Anti-pollution” claims in cosmetic products

Nowadays, it is possible to find in the market several cosmetic products with claims like “anti-pollution protection”, “pollution shield”, “against pollution damage” and similar ones. But how can a company test and prove this type of allegations?

Read More »
cosmetic products

UK Product Safety and Metrology EU Exit Regulations

The fact that the United Kingdom (UK) has left the European Union (EU) is not news for anyone. This means that the UK will no longer be considered a Member-State of the EU and will be considered a third country, implying that all the EU rules and regulations will no longer apply.

On July 3rd, the UK government has released the last version of the Product Safety and Metrology EU Exit Regulations, which includes the UK Cosmetic Regulation within Schedule 34.

Read More »
COVID-19

Hand sanitizers contaminated with methanol

The new coronavirus SARS-CoV-2 has led to an increasing demand of hand sanitizers. Nevertheless, not all hand sanitizers made available in the market are safe. The U.S. Food and Drug Administration (FDA) has issued a public warning to consumers and health care providers for possible contamination of hand sanitizers with methanol. The FDA advises the public not to use such hand sanitizers, because methanol is a dangerous and toxic substance.

Read More »
cosmetic products

Acetylated Vetiver Oil as a perfuming agent

Acetylated Vetiver Oil, also called Vetiveryl acetate or Vetiveria Zizanioides Root Extract Acetylated, is a natural complex substance derived from Vetiver Oil. In 2019, the European Commission’s Scientific Committee on Consumer Safety (SCCS) issued an opinion on the safety of Acetylated Vetiver Oil in cosmetic products and considered it safe under specific conditions.

Read More »