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FAQ: Methanol in Hand Sanitizers

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Aug 03, 2020

Background

Recently, the U.S. Food and Drug Administration (FDA) issued a warning regarding hand sanitizers that are labeled to contain ethanol (also called ethyl alcohol) but have tested positive for unhealthy levels of methanol (or wood alcohol), which can be toxic to users. Contamination levels range from 1% to 80%.

The agency maintains an online list—available here—of hand sanitizers that have tested positive for methanol contamination, as well as hand sanitizers that are purported to have been produced in the same facilities. As of July 29, 2020, all but 1 of the 86 products on the list are made in Mexico, and recalls and import alerts have been implemented for a vast majority.

The ongoing ordeal has spurred many questions from our customers and the general public regarding methanol in hand sanitizers, which we have addressed below. 

Do all hand sanitizers contain methanol?

The FDA regulates the manufacture of hand sanitizers as over-the-counter drugs. Prior to COVID-19, all hand sanitizers sold in the U.S. were required to be made at FDA-registered facilities and formulated with United States Pharmacopeia (USP) Grade ethanol. USP Grade ethanol must be tested for adherence to very strict impurity limits, which are summarized in the table below.

NameAcceptance Criteria
MethanolNMT 0.5, corresponding to 200 μL/L
Acetaldehyde and acetalNMT 10, expressed as acetaldehyde
BenzeneNMT 2 μL/L
Sum of all other impuritiesNMT 300 μL/L

As you can see, USP Grade ethanol can contain methanol, and so too can the hand sanitizers that have been formulated with it. However, it is such a minute amount that it is far below contamination levels and has been deemed acceptable by the FDA.

It is important to note that this is NOT the same as formulating a hand sanitizer with methanol, which is both dangerous and illegal. 

How has methanol in hand sanitizers changed due to COVID-19?

Due to the pandemic and resulting spikes in demand, the FDA has temporarily adjusted their policies to facilitate the production of greater quantities, though certain requirements must still be met.

Among those requirements, which are available in their entirety online here, is an active ingredient of either:

• Ethanol that is not less than 94.9% ethanol by volume* OR
• USP Grade Isopropyl Alcohol

So, under the temporary policy, ethanol no longer has to be USP Grade, but that does not mean that any ethanol can be used. Ethanol may be considered for use in hand sanitizer if:

• It is produced in a facility used for consumable goods and with the same fermentation and distillation processes.
• It is derived from synthetic processes and meets USP Grade or FCC16 (used in food applications) Grade requirements.
• It is produced in facilities normally producing fuel or technical grade ethanol AND:

◦ It is produced using fermentation and distillation processes used for consumable goods, and no other additives or other chemicals have been added.
◦ It meets USP or FCC17 Grade requirements OR the conditions summarized in the table below.
◦ It has been screened for any other potentially harmful impurities (not specified in the USP or FCC requirements) possibly present based on the manufacturing environment.

ImpurityInterim Limit under Temporary Policy
MethanolNMT 630 ppm
BenzeneNMT 2 ppm
AcetaldehydeNMT 50 ppm
Acetal (1,1-diethoxyethane)NMT 50 ppm
Sum of all other impurities*NMT 300 ppm

As you can see in the table above, there is flexibility for certain impurities under the temporary policy, including methanol. While more methanol is acceptable, the interim limit is still vastly lower than the contamination levels found in the banned hand sanitizers, and still no hand sanitizer can be formulated with methanol as an ingredient.

*Lower ethanol content alcohol is acceptable in the temporary policy if it labelled accordingly, and the finished sanitizer meets an 80% ethanol concentration.

**If fuel or technical grade ethanol does not meet these limits because the sum of all other impurities exceeds 300 ppm, it may still be considered for use if individual impurities are identified and meet the interim limits in Table 2 on p. 11 of the entire temporary policy.

What is used in Betco® hand sanitizers?

None of our hand hygiene products are formulated with methanol.

The active ingredient in all Betco® hand sanitizers is USP (U.S. Pharmacopoeia) Grade ethyl alcohol that meets the stringent requirements specified by the FDA.

In fact, Betco is an FDA-registered facility, which means we have proven that we have identified and are effectively preventing potential hazards regarding the hand hygiene solutions being produced in our facility, as well as strictly following cGMP (Current Good Manufacturing Practice) guidelines for their manufacture, fill, and shipment. The FDA even conducts audits of our facility, in which we have never incurred a major violation, thanks to:

• On-staff scientists, who perform rigorous quality testing of raw materials—including ethanol—production and storage equipment, as well as final products.
• A dedicated skin care manufacturing and filling room that prevents cross-contamination and features a closed system.
• A quarantine area, from which skin care products are only released for shipping after having passed testing for contamination.
• Storage of samples from every run 1 year past the expiration date and examination of them for product integrity prior to disposal

The safety and health of our customers is our number one priority, and we take every possible step to ensure it. Hand sanitizers produced at Betco can be used with complete confidence in their ingredients, efficacy, and overall quality.

How were the banned hand sanitizers contaminated?

Although we don’t know for sure, it is safe to assume that if the level of methanol is over 1%, either a contaminated source of ethanol was used (certainly not compliant with FDA recommendations) or methanol—which is cheaper than ethanol—was intentionally added.

How can I avoid hand sanitizers with methanol contamination?

We encourage everyone to regularly check the list maintained by the FDA and to cease use of any hand sanitizer product from the companies or with the names or National Drug Code (NDC) numbers on the list. Do not use a hand sanitizer that:

• Has been tested by the FDA and found to contain methanol.
• Has been made at the same facility as a product that has been found to contain methanol.
• Is labeled to contain methanol.
• Is being recalled by the manufacturer or distributor.
• Is fraudulently marketed as “FDA-approved” (no hand sanitizers are approved by the FDA).

What should I do if I think I have been exposed to contaminated hand sanitizer?

Methanol is toxic when absorbed through the skin or ingested. If you are experiencing symptoms of methanol poisoning—such as nausea, vomiting, dizziness, headaches, weakness, visual disturbances, and loss of consciousness—seek immediate treatment for potential reversal of toxic effects.

How do I dispose of suspect hand sanitizers?

The bottle and remaining sanitizer within should be disposed of in a hazardous waste container. It is important not to flush or pour them down the drain or to mix them with any other liquids.

Do you have other questions regarding methanol in hand sanitizers that were not addressed by this post? Please email us at social@betco.com, so we can add your question and the answer to this list.