[Newsletter | August, 2021] – FDA Regulated Products

What is the FDA?

The FDA is the United States Food and Drug Administration, an agency within the Department of Health and Human Services reporting to the President of the United States. It is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. It also ensures public safety associated with the US nation’s food supply, cosmetics, and products that emit radiation. 

What are FDA regulated products?


Except for meat, seafood and poultry products, the following commodities often require FDA approval.

  •       Food from Vietnam to America
  •       Plant and tobacco products
  •       Medicines sent to the US
  •       Biological substances
  •       Cosmetics items
  •       Medical devices and equipment
  •       Radiation-emitting items and radiation-absorbing electronic equipment


What does “FDA approved” mean?

“FDA approved” means that the agency has determined that the “benefits of the product outweigh the known risks for the intended use.” Manufacturers must submit a premarket approval (PMA) application and results of clinical testing in order to get approval.

When deciding to approve a product or drug, the FDA has to weigh the benefits and risks as demonstrated in data produced in scientifically conducted product trials and studies that use production samples of the specific items under consideration. The FDA is usually inclined to approve a product that has a higher risk if the potential benefit is significant – like an artificial heart valve that can save someone’s life.

Benefits of FDA Approval

FDA has a steadfast principle and a long list of guidelines to help a company seek and gain FDA approval. Their main mission has always been to protect the public’s health and safety. When they conduct their approval process, they always look into the safety and efficacy of a product, which can often take a few years. If the product gets FDA approved, that means it has been through rigorous product quality testing and various enhancement processes before being submitted to the FDA for review. 

After acquiring FDA approval, the product now has credibility in the market. This credibility comes with numerous benefits: widespread market impact, higher product demand, company funding opportunities, and so forth. In addition, the process of seeking and acquiring FDA approval also encourages morale and a sense of purpose among the design and marketing teams, leading to broader and deeper insights into both technology and business, while encouraging them to strive for higher quality and innovations for the company products.

How to get FDA approval

FDA Approval of Food, Beverages, and Dietary Supplements

With regards to this branch of products, facilities do not have to obtain any certification or approval before distributing products in the United States. They do need to register with the FDA, but this step does not indicate FDA approval of the facility or its products. 

However, new food additives do require FDA approval. In order to use a new food additive in the products, manufacturers are required to appropriately test the additive and prove its safety to the FDA.

FDA Approval of Drugs Products

Whether or not a new drug product requires FDA approval depends on whether the new drug conforms to an over-the-counter (OTC) monograph. OTC monographs establish conditions under which FDA has predetermined a drug will be safe and effective. Once an OTC monograph is final, drug establishments can market OTC drugs that conform to the monograph without FDA approval. FDA also uses enforcement discretion to allow certain drugs to be marketed without approval if they conform to tentative final monographs.



If a new drug does not comply with a monograph, it will require FDA approval. To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. FDA will then review the data and may approve the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use. Marketing a new drug that does not conform to an OTC monograph without FDA approval is considered as marketing an unapproved new drug, which is a prohibited act under the Food, Drug, and Cosmetic Act (FD&C Act). 

FDA Approval of Medical Devices

FDA places medical devices into one of three risk-based categories: Class I, Class II, and Class III. Class III devices are the highest-risk devices and the only devices that require FDA premarket approval. Manufacturers of Class III devices must demonstrate to the FDA that the device provides reasonable assurance of safety and effectiveness.

Class I and II devices do not require FDA approval. These devices, unless exempt under the FD&C Act, must submit premarket notification (510(k)) to FDA instead. The purpose of a 510(k) is to demonstrate to FDA that the device is substantially equivalent (as safe and effective) to an already legally marketed device. If FDA determines that the device is indeed substantially equivalent to a legally marketed device, the agency clears the product for marketing rather than approving it.

Device establishments must register with FDA and list their devices, but neither registration nor listing indicates FDA approval of the establishment or its devices.

FDA Approval of Cosmetics

FDA does not require approval of cosmetic products and their ingredients (other than color additives) before marketing. Cosmetic companies are not required to register with FDA, but cosmetics do have to be safe for their intended use.

It’s important to be aware that certain claims made in cosmetic labeling can cause FDA to regulate a cosmetic product as a drug. In some cases, this could cause the product to require FDA approval.


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Labeling FDA Approved Products

Manufacturers of drugs and devices that do require FDA approval may include the phrase “FDA Approved” on the product’s labeling, as long as the manufacturer has received a letter from FDA confirming its approval. The FDA logo should not be used on a product’s labeling whether the product is approved or not unless the approval letter authorizes such use. Use of the FDA logo implies that the the FDA has authorized use of their logo as part of their approval, therefore unauthorized use of the logo may violate federal law. Manufacturers who use FDA’s logo on their product labeling when unauthorized may be subject to civil or criminal liability. Further, US Customs will not allow foreign manufactured products to enter the US if they are improperly labeled with the FDA logo. They can, and will, check.

Whether their products require FDA approval or not, food facilities, drug establishments, device establishments, and cosmetic companies must adhere to FDA’s Current Good Manufacturing Practices (cGMPs) and extensive labeling requirements. For those products that do require approval, such as certain drugs and devices, labeling is approved when the product is approved. However, labels are not generally subject to FDA approval.

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