As new companies every where are popping up to make hand sanitizer, remember not all are following the FDA regulated formulas. Some companies are even using toxic chemicals!
In March of this year, the FDA provided a temporary ruling, allowing entities not currently regulated by the agency, to produce alcohol-based hand sanitizers for consumers and hand rub for healthcare personnel, for the duration of the public health emergency – as long as they remain within the guidelines of the FDA’s policy, with no deviation.
According to the FDA’s temporary ruling, all components of the formulation are required to meet a specific grade and purity for the finished product to meet efficacy specifications:
Ethanol Not less than 94.9% Ethanol by Volume
Meets USP or FCC Grade Requirements
Must be screened for any potentially harmful impurities
Must be denatured
Isopropyl Alcohol USP Grade
Glycerin (glycerol) USP or FCC Grade
Hydrogen Peroxide USP or Technical Grade
Water Purified USP Grade
However, in addition to efficacy, safety concerns were also considered. To prevent human consumption of the finished product, the ethyl alcohol used must be denatured. In addition, label warnings, reminding the user to keep the product out of the reach of children must be present in order to prevent poisoning by ingestion. Unfortunately, too many reports have been reported where children and young adults consuming the “undenatured” hand sanitizer have died.
To meet the demand, over 1,500 manufacturers registered with the FDA to produce the alcohol-based hand sanitizers and hand rubs for BOTH retail and hospital use, while other companies started producing the raw materials required to make the products meet the defined specifications. Businesses such as producers, distilleries and perfume makers ramped up their ethyl alcohol production to meet the new demands set by the hand sanitizer manufacturers. Prior to the COVID-19 outbreak, the global market for hand sanitizers was estimated to be $1.35 billion. However, with the demand increasing due to the virus, it is predicted to reach $1.87 billion this year.[i] Some of this product is being manufactured by entities who have never worked under the stringent guidelines of the FDA, and as a result, the FDA has begun to cite, fine, and force some manufacturers out of the market in an effort to remain diligent.
Hydromer’s hand sanitizer solutions are registered with the FDA, ensuring that you are buying quality effective solutions. Want to learn more about our sanitizer formulations? Click HERE.
[i] Fortune Business Insights (May 19, 2020). Impact of COVID-19 on Hand Sanitizer Market to Reach USD 1.87 Billion by 2020. Available online: https://www.globenewswire.com/news-release/2020/05/11/2030895/0/en/Impact-of-COVID-19-on-Hand-Sanitizer-Market-to-Reach-USD-1-87-Billion-by-2020