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

“FDA approved!”

Maybe you saw those words on a company’s website, or in a commercial promoting a new product or treatment. Some marketers may say their products are “FDA approved,” but how can you know for sure what the FDA approves?

FDA is responsible for protecting public health by regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.

But not all those products undergo premarket approval — that is, a review of safety and effectiveness by FDA experts and agency approval before a product can be marketed. In some cases, FDA’s enforcement efforts focus on products after they are already for sale. That is determined by Congress in establishing FDA’s authorities. Even when FDA approval is not required before a product is sold, the agency has regulatory authority to act when safety issues arise.

“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?

“NSF Mark!”

NSF certification is your key to making sure that the products you use meet strict standards for public health protection. Choosing a product certified by NSF lets you know the company complies with strict standards and procedures imposed by NSF.

The EPA

What Does FDA approve and Does Not 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 approves new drugs and biologics
  • FDA uses a risk-based, tiered approach for regulating medical devices
  • FDA uses a risk-based approach for human cells and tissues
  • FDA approves food additives in food for people
  • FDA approves color additives used in FDA-regulated products
  • FDA approves animal drugs and approves food additives for use in food for animals

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.

  • FDA doesn’t approve companies
  • FDA doesn’t approve compounded drugs
  • FDA doesn’t approve tobacco products
  • FDA does not approve cosmetics
  • FDA doesn’t approve medical foods
  • FDA doesn’t approve infant formula
  • FDA doesn’t approve dietary supplements
  • FDA doesn’t approve the food label, including the Nutrition Facts panel
  • FDA doesn’t approve structure-function claims on dietary supplements and other foods

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.

Pure C+s surface disinfectants are EPA registered. Furthermore, Pure C+ surface disinfectants are registered and have been tested against SARS-CoV-2 (COVID-19) or meet the requirements.

 

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.

The NSF MARK


What Does the NSF Stamp Mean & Why Is It Important To You?

Around the world, NSF International represents technical excellence in public health and safety, and the NSF mark is a symbol of this expertise.

 

What is NSF?

NSF International is a third-party company that does a complete check of various foodservice equipment and supplies to ensure they meet or exceed NSF’s standards for cleanability, sanitation, and food protection. They test the essential parts that include materials, construction, design, and performance before they are confirmed eligible for the NSF stamp.

 

 

Why is NSF important?

While it is not required that you use NSF disinfectant at your home, office, restaurant, hotel, car etc, it is highly recommended. When you see an NSF stamp on a product you know:

  1. The product was evaluated and reviewed by an impartial third party inspector 
  2. The product labeling claims are true and tested by a trusted third-party
  3. Evidence the company is committed quality, compliance, and safety

 

Health Code Compliance: NSF closely monitors the jurisdictions for the Health Code Department so when you are buying an NSF product, it is sure to pass the test for local, state and federal health codes. Health inspectors can quickly verify compliance of NSF just by seeing the stamp which can help speed up the process. Save yourself the headache of compliance issues and get the products you already know are approved.


Protecting Customers and Operations: The CDC estimates that roughly 48 million people gets sick from a foodborne illness every year, 128,000 are hospitalized, and 3,000 die. Those staggering numbers can be frightening to consumers and commercial kitchens alike. Simple processes like looking for proper equipment and following appropriate food handling guidelines can help reduce the risk. Looking for products with the NSF stamp is a good place to start.

So regardless of if you are applying it for yourself or event, or just your family at home, look for the NSF stamp on your next disinfectant and sanitisation items purchase and keep your customers, family, friends, and investment protected.

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