Timeline of FDA Rulings on Hand Sanitizer Ingredients and Fortified Bio Labs’ Predictions
A timeline illustrating why we here at Fortified Bio Labs always use the safest, most effective, and proven methods in our manufacturing process – often going above and beyond what the law requires to keep our consumers, and the businesses who partner with us, safe.
Recent developments in the relaxing and re-tightening of hand sanitizer regulations likely to cause problems for retailers and consumers alike.
Here’s how Fortified Bio Labs has stayed ahead of this problem and will continue to make decisions to the greatest benefit of all our partners.
- In April 2019, the FDA releases ruling on what ingredients – and what grades of those ingredients – are safe for use in human-application hand sanitizers.
Source: FDA Website – FDA issues final rule on safety and effectiveness of consumer hand sanitizers.
- In March 2020, the FDA relaxed these same guidelines to allow for higher production of hand sanitizers amid COVID-19 pandemic.
- Fortified Bio Labs CEO, Marwan Moheyeldien prediction April 1, 2020 regarding relaxed guidelines on hand sanitizer ingredients:
- “Since the FDA eased the rules and regulations for hand sanitizers, we are in the era of the wild wild west.
I believe that the decision to use technical and unrated IPA ethanol that does not meet the USP standard, or no regulation towards the inactive ingredients, is going to prove to be a huge problem.
No one knows what the true outcome of these formulas will be. We have automobile chemical companies using ethanol used in chemical enhancers for automobile fuel systems, being used as hand sanitizer. That is dangerous and reckless.
WE SHALL NOT ENGAGE, in manufacturing hand sanitizers that does not meet FDA, USP and CDC standards. At this time, and until we confirm the supply chain of the quality of the ingredients, we shall only manufacture non-alcohol based hand sanitizers.”
- On April 29, 2020, upon finding satisfactory sourcing agencies, CEO Marwan Moheyeldien released a second statement:
- “Fortified has engaged in the manufacturing of Isopropyl 75% hand sanitizer (USP) and 80% denatured ethanol, all our ingredients meet the USP or Food Chemical Codex (FCC) (also known as ‘food grade’).”
- In May 2020, it was announced that this waiver permitted by the FDA may have backfired, resulting in hand sanitizers containing carcinogenic materials to be released onto an unsuspecting public. The FDA found these new products to contain an ‘unacceptable’ level of carcinogens.
Source: CNN Business – A plan to ease the hand sanitizer shortage could go bust
- On May 3, 2020, CEO Marwan Moheyeldien released the following statement:
- “That is exactly what we were afraid of. Carcinogenic and poisoning is starting to show up. MASSIVE LAWSUITS ARE COMING.”
This situation is an example of why we always operate at the highest, most stringent levels of safety and quality at all times. Even in scenarios where it is not technically required of us, we will always err on the side of tested and proven methods of delivering the best products possible.