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Registrar Corp

World's Leading FDA Compliance Experts

How to Get FDA Approval

Jul 21, 2023

Learning how to get FDA approval —or if you need it— depends on the type of product you’re marketing in the U.S. FDA does not require all types of products to be approved. In some cases, only certain ingredients need to be approved. 

Read on to learn which regulated industries and products require FDA approval and how to obtain it when necessary.

FDA Approval of Food, Beverages, and Dietary Supplements

FDA does not approve any food, beverages, or dietary supplements. Food facilities don’t need any type of certification or approval before distributing products in the United States.   

Most food facilities must register with FDA and remain compliant with the Food Safety Modernization act (FSMA), but being registered and staying in compliance does not indicate the facility or its products are FDA approved. FDA Food Facility Registration serves two main purposes:  

First, it provides the agency with the necessary contact information for routine and emergency communication. Second, it informs FDA about a facility’s products and activities. This allows FDA to set an inspection schedule based on potential food safety risks.  

One of the few exceptions to FDA approval for food, beverage, and dietary supplement product is food additives. New food additives do require FDA approval. If a manufacturer wishes to use a new food additive in their product, they will need to put the additive through appropriate testing and prove its safety to FDA.  

Another potential exception is dietary supplements that claim to treat, diagnose, prevent, or cure diseases. If a company markets a dietary supplement under any of these claims, it may be subject to drug regulations and could require FDA approval if it does not meet certain requirements (See FDA Approval of Drug Products). 

FDA Approval of Drug 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 pre-determined 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 being FDA approved. 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, however, 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).  

Though FDA approves new drugs, the agency does not approve compounded drugs. Drug establishments must register with FDA and list their products, but neither registration nor listing indicates FDA approval of the establishment or its products. 

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 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 and list their devices with FDA. But as with food, beverage, dietary supplements, and drug products neither registration nor listing indicates FDA approval of the establishment or its devices

FDA Approval of Cosmetics

 

FDA doesn’t require cosmetic products or their ingredients to be approved before they go to market. The one exception is color additives (see FDA Approval of Color Additives). 

Before 2022, cosmetic companies didn’t need to register with FDA. They only needed their products to be considered safe for their intended use. But since the recent Modernization of Cosmetic Regulations Act (MoCRA) was passed on December 29, 2022, FDA now has greater oversight over the cosmetics industry. As a part of this new oversight, cosmetics companies must now register with FDA.   

Again, registration with FDA does not equal approval. FDA registration of a cosmetics facility only gives FDA insight into the facility and the products it markets in the U.S.  

Similar to dietary supplements, there is a potential exception for FDA approving of cosmetic products. Certain claims made in cosmetic labeling can cause FDA to regulate a cosmetic product as a drug. And in some cases, this could cause the product to require FDA approval (See FDA Approval of Drug Products). 

FDA’s Approval of Color Additives

 

Approval is required for color additives used in food, drugs, cosmetics, and some medical devices. Certain high-risk colors also require FDA color batch certification of every individual batch. Color additives may only be used in compliance with their approved uses, specifications, and restrictions.  

Products that contain unapproved color additives are considered to be adulterated under the FD&C Act. Adulterated products may not be distributed in interstate commerce in the U.S. Cosmetic products with color additive violations may also be detained at U.S. ports of entry.

 

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. This is as long as the manufacturer has received a letter from FDA confirming its approval.   

You should never use the FDA logo on a product’s labeling, even if it has been approved. That could imply that the product is endorsed by FDA, therefore unauthorized use of the logo may violate federal law. Manufacturers who use FDA’s logo on their product labeling may be subject to civil or criminal liability.  

Approval aside, food facilities, drug establishments, device establishments, and cosmetic companies still have to comply with FDA’s Current Good Manufacturing Practices (CGMPs) and labeling requirements. For 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.  

You may be wondering how FDA enforces its requirements when so many products don’t require premarket approval. FDA regulates products by conducting routine facility inspections and randomized shipment inspections at the U.S. border. 

 

Work Towards FDA Approval With Registrar Corp 

 

Registrar Corp helps food and beverage, drug, medical device, and cosmetic companies comply with U.S. FDA regulations.  

We can work with you to register your company with FDA, list your products with FDA, and review product labels for FDA compliance. Our team of regulatory specialists can also help submit color additives to FDA for color batch certification.  

Still have questions about FDA approval or want to learn more about Registrar Corp?  

Call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day. 

Author


Registrar Corp

World's Leading FDA Compliance Experts

Registrar Corp thrives on the collective expertise of over 200 professionals, including former FDA officials and experienced industry specialists. Our team of regulatory specialists is our greatest asset, offering deep insights into the latest and longstanding FDA regulations. With our simple, straightforward, and actionable articles, you can navigate the complex regulatory landscape with ease.

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