Infection Control & First Aid Blog

FDA approved! EPA registered! What does it all mean?

[fa icon="calendar"] 12/10/20 9:00 AM / by Megan Malke

what does it mean to be FDA approved or EPA registered?

FDA approved! EPA registered!

You've probably come across these declarations within the last few months as the COVID-19 guidelines called for increased hand hygiene and disinfection. Sure, throwing around the FDA (U.S. Food and Drug Administration) or EPA's (U.S. Environmental Protection Agency) weight makes products seem safe and effective, but what is each agency responsible for, and what do their regulations and approvals mean? 

Some marketers have said their products are "FDA approved," but how do you know what the FDA approves? Does "EPA registered" mean the product is effective?

The FDA doesn't approve companies

The FDA does not "approve" health care facilities, laboratories, or manufacturers. However, the FDA does have the authority to inspect regulated facilities to verify they comply with applicable good manufacturing practice regulations. Owners and operators of domestic or foreign food, drug, and most device facilities must register their facilities with the FDA.

What does the FDA approve?

New drugs and certain biologics must be proven safe and effective to the FDA's satisfaction before companies can market them. Manufacturers must also be able to prove they can make the drug product according to federal quality standards.

The FDA does not develop or test products before approving them. Instead, the FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. If the FDA grants approval, it means the agency has determined that the product's benefits outweigh the known risks for the intended use.

Not all FDA regulated products are approved before they go to market, but when approval is not required the FDA still has regulatory authority over these products if there is a safety issue. For OTC drugs there are monographs for different categories that work like a recipe book of what is acceptable. These monographs make it possible for companies to make safe and effective products without FDA pre-approval.
FDA regulated products

FDA regulation of over the counter drugs

A nonprescription, or over-the-counter (OTC) medicine, is one that the FDA has found to be safe and effective for direct consumer use based on the label instructions and warnings. They require a wider margin of safety for OTC medicines than for prescription drugs. FDA requires companies that manufacture drugs to register their manufacturing facilities and list their drug products with the FDA.

Many of Safetec's first aid products are considered OTC products and some of our personal care products are considered cosmetics. These products are subject to FDA regulation of our facilities and products. For example, hand sanitizer, first aid creams, ointments, sprays, and gels are regulated by the FDA.

The EPA

The EPA registers products that kill microorganisms on surfaces as pesticides. Before manufacturers can sell pesticides in the United States, the EPA must evaluate them thoroughly to ensure that they meet federal safety standards to protect human health and the environment. The EPA will grant a "registration" or license that permits a pesticide's distribution, sale, and use only after the company meets the scientific and regulatory requirements.

Surface disinfectants are considered pesticides. Disinfectants kill bacteria, viruses, and fungi. According to the EPA, these are considered pests just as insects, weeds, snails, and slugs are considered pests. Therefore, the EPA classifies disinfectants and sanitizers as pesticides.

Safetec's surface disinfectants are EPA registered in all 50 states, and the EPA approved labels are available on the EPA's website. Furthermore, Safetec's surface disinfectants are registered on the EPA List N. All products on List N have been tested against SARS-CoV-2 (COVID-19) or meet the requirements for the Emerging Viral Pathogen Claim.

EPA Registered products

Conclusion

The EPA  registers products that kill microorganisms on surfaces as pesticides. The FDA regulates products used on humans, such as hand sanitizers and antibacterial soaps. An easy way to remember this is the Environmental Protection Agency regulates products used on the environment around you, such as your workspace, the store, hospital, or even home. The Food and Drug administration mostly regulates products that go in or on your body, the way food and drugs are typically used.

Made in America, for America

As a trusted US infection control and first aid product manufacturer for over 28 years, Safetec strives to keep consumers & workers safe from cross-contamination of infectious disease. The team at Safetec follows exemplary quality control procedures when developing and manufacturing products, and complies strictly with standard FDA, OSHA and EPA guidelines along with Safetec's GMP certification.

A passion for effective, safe, and quality products has guided everything we do at Safetec. We are proud to operate, manufacture, hire, and distribute from the United States.

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Sources:

https://www.epa.gov/ingredients-used-pesticide-products/basic-information-about-pesticide-ingredients

https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved

Topics: EPA, FDA

Megan Malke

Written by Megan Malke

As the Digital Marketing Strategist, Megan works on developing and executing programs to improve Safetec's online engagement and user experience.

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