FDA Approval

 The U.S. Food and Drug Administration (FDA) plays a vital role in protecting public health by ensuring the safety, effectiveness, and security of drugs, biological products, medical devices, food, and cosmetics. The FDA approval process involves multiple stages designed to verify that these products meet the necessary regulatory standards before they can be marketed and sold in the United States. 

The term “FDA Approved” carries significant weight worldwide, and many manufacturers and marketers promote their products using this phrase on labels, websites, advertisements, and promotional materials. However, this is incorrect in approximately 95% of cases. The FDA does not approve all products sold in the U.S.

While the FDA regulates the distribution of drugs, biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products emitting radiation, most of these products do not require FDA approval or pre-market inspection before entering the U.S. market. 

Partner with RAPS for Accurate Regulatory Insights

Understanding what the FDA approves—and what it doesn’t—is essential for honest marketing and regulatory compliance. At RAPS, we provide expert guidance to help you navigate the complex FDA landscape and avoid common misconceptions, ensuring your product claims are accurate and your business stays compliant.

US FDA Approval for drugs signifies that the product’s benefits outweigh its known and potential risks for the intended patient population. The drug approval process, overseen by the Center for Drug Evaluation and Research (CDER), is rigorous, highly detailed, and time-consuming.

Before a drug can be marketed in the US, it must undergo a comprehensive process including preclinical testing, submission of an Investigational New Drug (IND) Application, multiple phases of clinical trials, New Drug Application (NDA) review, drug labeling compliance, facility inspections, and finally, official FDA approval.

Once approved, the drug manufacturer must complete establishment registration and product listing before distributing the product in the US market.

Currently, RAPS does not provide FDA approval services for generic drugs. However, we offer expert assistance in registration and listing for various other product categories. 

Navigate Drug Compliance with Confidence — Partner with RAPS

The FDA drug approval process is complex, but with RAPS by your side, you gain trusted regulatory support to ensure your products meet all necessary requirements for market entry. Contact us today to learn how we can assist you with registration, listing, and compliance solutions tailored to your product needs.

The US FDA does not require approval for most food products, beverages, or dietary supplements before they are marketed in the United States. However, FDA approval is mandatory for food colors and food additives to ensure safety and compliance.

Currently, RAPS does not provide FDA approval services for food manufacturers. Instead, we offer a comprehensive range of regulatory services to support food, dietary supplement, and nutraceutical manufacturers worldwide, including:

• FDA Food Facility Registration
   
• Food Testing
   
• Food Label Review
   
• GMP Implementation
   
• FDA Pre- and Post-Inspection Support
   

Ensure Food Compliance with RAPS

Navigating FDA regulations for food and supplements can be complex, but with RAPS, you get expert guidance tailored to your needs. From facility registration to label review and inspection support, we help you maintain compliance and build confidence in your products across global markets.