• N95-style masks imported from overseas have fallen short of certification standards.
• Sanitizers have been improperly labeled, riddled with false claims, formulated with suspect ingredients, or otherwise out of compliance with FDA guidelines.
• The disinfectant market is now being exploited in a similar manner. We will reference the handful of examples pictured above throughout this post:
  1. Disinfectant that was falsely labeled as a registered disinfectant.
  2. Unregistered stickers that claim to provide protection against viruses without supporting evidence reviewed by the EPA.
  3. Unregistered disinfectant wipes shipped from Asia without EPA registration.
  4. Unregistered disinfectant that promises long-lasting or residual protection specifically from COVID-19 without supporting evidence reviewed by the EPA. 
  5. Unregistered lanyard that claims to provide 60-day residual protection against the virus without supporting evidence reviewed by the EPA.
  6. Services claiming use of multi-week residual disinfectant without supporting evidence and in direct conflict with statements from the EPA.

EPA Regulation

As explained in a previous post, disinfectants are considered pesticides—further classified as antimicrobial pesticides—because they control bacteria, viruses, mold, and fungi, which are considered pests. As such, they are regulated by the EPA’s Office of Pesticide Programs, and any disinfectant sold or distributed in the United States must be registered with the EPA.

In order to register a product, manufacturers submit:

• Proposed labeling.
• Safety data.
• Efficacy data:
  • In order to be labeled a disinfectant, a product must meet specific testing requirements against certain bacteria.
  • Any virucidal claims, such as efficacy against SARS-CoV-2 (the virus that causes COVID-19), are considered additional claims, and they must also be supported by data and approved by the EPA.

If the EPA is satisfied with the information provided by the manufacturer, registration is granted. While the burden of EPA regulations and registration should pose a larger hurdle to entry into the disinfectant market, the tidal wave of newcomers is both mostly unaware of their violations and too large for the EPA to police. Eventually, these dishonest marketers will receive fines and be ordered to cease and desist, but until then, buyers (and users) must beware.

Illegal Disinfectants

Illegal disinfectants are sold or distributed without a valid EPA registration. This includes products without an EPA registration number listed on the label—such as examples 2 through 5 above—as well as products using a fake EPA registration number—such as example 1 (click here for more information).

To ensure that a disinfectant is legal:

• Don’t buy or use products from suspicious sources.
• Don’t buy or use products that seem unusual in their packaging or labeling.
• Check the label, which must be in English, for:
  • A valid EPA registration number (validity can be confirmed here).
  • A list of active ingredients, as any product registered with the EPA must state them on the label.
  • Hazard and precautionary statements.

Illegal Claims

As stated in the EPA Regulation section above, disinfectants may only make virucidal claims that are supported by data and approved by the EPA. This includes both legally registered and illegally unregistered disinfectants claiming to kill SARS-CoV-2.

As stated in the EPA Regulation section above, disinfectants may only make virucidal claims that are supported by data and approved by the EPA. This includes both legally registered and illegally unregistered disinfectants claiming to kill SARS-CoV-2.

There are also disinfectants approved by the EPA for use against SARS-CoV-2, based not on a demonstrated efficacy against SARS-CoV-2, but on demonstrated efficacy against:

• A pathogen that is harder to kill than SARS-CoV-2 (COVID-19).
• A different human coronavirus similar to SARS-CoV-2 (COVID-19).

To confirm the legitimacy of a disinfectant’s claim that it outright kills SARS-CoV-2 or that it is recommended for use against SARS-CoV-2 due to other kill claims:

• Navigate here and input the EPA registration number found on the label. If there are 3 sets of numbers (separated by hyphens), only input the first 2. 
• If there are no matching records found, the disinfectant’s claims are illegal—as is most evident in examples 4 and 5 above (which claim 99.9% protection against COVID-19 and to "block coronavirus," respectively).
• If there is a matching record found, but the product information does not match the information on your label, it is likely a sub-registration marketed under a different name, which is legal. 
• Note that List N search results also indicate whether a product is proven or simply expected to kill SARS-CoV-2.

Because the EPA has not evaluated the “long-lasting” or “residual” efficacy of disinfectants against viruses, however, NO disinfectant can legally claim effectiveness against viruses . . .

Residual Claims and Treated Articles

There are products that claim 24-hour sanitizing against bacteria only. 

Because the EPA has not evaluated the "long-lasting' or "residual" efficacy of disinfectants against viruses, however, NO disinfectant can legally claim effectiveness against viruses over hours—as in example 4 (24 hours)—days—as in example 5 (60 days)—or weeks—as in example 6 (3–6 weeks), with the exception of 1 recently granted short-term exemption.

In a similar vein, there are antimicrobial pesticides that can be incorporated into plastics, textiles, or other materials to protect the “treated article” from mold or bacteria that would harm it, such as a shower curtain. These pesticides are used more in the manner of preservatives, preventing discoloration, odor, or deterioration, and treated articles may not have any claims associated with public health. In other words, treated articles CANNOT legally claim that they are effective against viruses, such as SARS-CoV-2.

In other words, treated articles CANNOT legally claim that they are effective against viruses, such as SARS-CoV-2.

Our Promise

We would like to take this opportunity to assure our customers that each Betco® disinfectant is registered with the EPA and adheres to their every guideline. Not only can we guarantee our total regulatory compliance, but as demonstrated by our legacy in disinfectants, we can also guarantee their quality and efficacy.

We have prioritized production toward disinfectants that appear on List N and are recommended for use against SARS-CoV-2. We are currently maximizing output of all products effective against the spread of COVID-19, and we continue to take every possible step to ensure the health and safety of our customers.

If you would like to request information about List N disinfectants, please click here to fill out the online form, and a Betco representative will contact you.

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.

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.

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.