Many hand sanitizers for bulk or retail purchase carry the FDA-approved branding on their packaging. But why is that, and what does the FDA actually do to approve these products? How can we protect ourselves from dangerous imitators and inferior products? Today we look to answer these questions and many more, so join us as we unpack the importance of FDA approval for wholesale hand sanitizer and retail choices.


What is FDA approval?

The Food and Drug Administration (FDA) is a US-based regulatory organization that ensures compliance with its regulations. These regulations cover everything from the content of individual foods to packaging requirements and prescription drug appeal.

According to Wikipedia, the FDA was established in 1927 as a way to prevent imitators and false actors from selling dangerous products. Before that, it was the Bureau of Chemistry. If you’ve ever heard the term “snake oil salesperson,” then you know exactly why the FDA needs to exist. However, when it comes to bulk hand sanitizer in Malaysia (a relatively recent innovation), it is worth looking at how inferior products in this category can be harmful to human health.

Essentially, there are several forms of alcohol. Ethyl or isopropyl alcohol are examples of alcohols, as are ethanol and methanol. Ethanol is the active ingredient in FDA-approved hand sanitizers and is used to cleanse, sanitize and clean our hands. Methanol, on the other hand, is a poisonous substance that can leach into our skin and cause damage to our internal organs.

As you can see, the difference between the two products is substantial, and the importance of the FDA should be apparent. Currently, the FDA maintains and updates a list of suppliers whose hand sanitizer products have been found to contain methanol. But how does the FDA test products before they come to market?

Afro woman applying hand sanitizer,during Covid-19

How does the FDA approve products?

The FDA performs a variety of tests specific to the product type they are investigating. In the case of hand sanitizer, they are checking the form of alcohol present in the product. Additionally, as this public service announcement states, they measure and observe the amount of alcohol in hand sanitizing products.

For products with less than 60% of the active ingredient, the FDA will not approve them. This is because they are not effective in sanitization or “subpotent.”


How can we ensure the products we buy are FDA-approved?

There are several methods of ensuring that you purchase FDA-approved products. The best indication will be from the manufacturer themselves, who is likely to note their bulk hand sanitizer is FDA-approved.

You can also visit the FDA’s health fraud scams page. This is a great resource for current FDA investigations, historical records and much more. The FDA also maintains a consumer updates page, which covers information on a broad range of products, including medical equipment, food and cosmetics.

The FDA also warns that you should check the product label if you cannot verify the manufacturer’s legitimacy through a website or the Food and Drug Administration. Though they admit, irresponsible sellers are unlikely to list methanol or other dangerous substances on their products. If they do, it is a good way to ensure you are not purchasing an inferior or potentially dangerous product. Remember to inform your children and teens about the potential dangers of unapproved hand sanitizer, and keep all forms of alcohol away from pets.