The term "FDA approved" is often used in the food industry, but what does it mean? This article will explain the significance of FDA approval, its impact on food safety, and how it relates to your role.
What is the FDA?
The FDA (Food and Drug Administration) is a federal agency within the United States Department of Health and Human Services. Its mission is to protect public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation. The FDA also plays a significant role in the nation's counterterrorism capability by ensuring the security of the food supply and fostering the development of medical products to respond to public health threats.
FDA Approval for Food Products
When a product is "FDA approved," it means the FDA has decided that its benefits are greater than its risks for its intended use. For food products, this means checking that the product meets safety standards and doesn't harm public health. FDA approval involves a thorough process that includes testing, reviewing how the product is made, and confirming it follows labeling rules.
Nine steps for getting your food product approved by the FDA
Here are the main steps to get FDA approval for food products:
Product Classification and Pre-Submission: Check if the product needs FDA approval and find out what is required. Sometimes, you might need to talk to the FDA before you submit new food additives.
Ingredient Evaluation: Make sure all ingredients are safe and approved. This often involves the GRAS (Generally Recognized as Safe) notification process for new ingredients.
Labeling Compliance: Ensure all product labels meet FDA rules, including nutrition facts, ingredient lists, and health claims.
Facility Registration: Register your manufacturing facility with the FDA. This is required for all facilities that produce, process, package, or store food for consumption in the U.S.
Good Manufacturing Practices (GMPs): Follow GMPs to ensure products are made consistently and meet quality standards. This involves detailed documentation and quality control checks.
Food Safety Plan: Create and implement a food safety plan as required by the Food Safety Modernization Act (FSMA). This includes identifying hazards and preventive controls.
Inspection Readiness: Be prepared for FDA inspections by keeping detailed records and complying with all regulations. Inspections can happen regularly or in response to specific issues.
Post-Market Surveillance: After the product is on the market, monitor its safety and compliance. Report any problems to the FDA. This may involve routine product testing.
Corrective Actions: If any issues are found, take immediate steps to fix them. This could include recalling products, changing the formula, or updating labels and marketing.
FDA's Role in Food Safety
The FDA is responsible for enforcing food safety regulations to protect consumers. These regulations cover various areas, including food production, processing, distribution, and retail. The FDA sets standards to prevent foodborne illnesses, which can be caused by various pathogens such as bacteria, viruses, and parasites, as well as harmful chemicals and toxins. These standards include temperature control, sanitation, and labeling.
History and Evolution of the FDA
The FDA (Food and Drug Administration) started in the late 1800s and early 1900s. It officially began in 1906 with the Pure Food and Drugs Act. This law was made to stop the making, selling, or transporting of bad or mislabeled foods, drugs, medicines, and alcohol.
Over time, the FDA took on more responsibilities. Now, the FDA oversees not only food and drugs but also medical devices, blood products, vaccines, cosmetics, and animal products. You can learn more about the FDA's history here.
The Food Safety Modernization Act (FSMA)
The Food Safety Modernization Act (FSMA), signed into law in 2011, strengthened the FDA’s role in keeping food safe. FSMA focuses on preventing food safety problems before they happen. It gives the FDA new powers to enforce food safety rules, respond to issues quickly, and verify that imported foods meet the same standards as domestic foods. FSMA also works with state and local authorities to create a national food safety system.
Good Manufacturing Practices (GMPs)
Good Manufacturing Practices (GMPs) are rules the FDA enforces to confirm products are made and controlled to high-quality standards. GMPs cover everything in production, from starting materials and equipment to staff training and hygiene. For food, GMPs ensure facility cleanliness, proper storage and handling of ingredients, and checking processes to ensure safety and quality.
FDA's Role in Food Recalls
When a food product is found to be unsafe or contaminated, the FDA helps remove it from the market. This is called a food recall. Recalls are a part of the FDA's job to protect public health. The FDA can order a mandatory recall if there’s a high chance the product could cause serious health problems or death. Most recalls are voluntary and started by the company.
After a recall, the FDA makes sure the product is taken off the market and that consumers know about the recall. The FDA also helps the company find and fix the problem to prevent it from happening again.
Conclusion
Knowing what "FDA approved" means is necessary for Quality Managers working in the US market. The FDA certifies that food in the United States is safe and clean. They set and enforce food safety rules, handle food recalls, and use regulations like the FSMA and GMPs to protect public health. Staying updated on FDA rules and seeing that your products follow them can help keep your food products safe and high quality.
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About the Author: Robert Jakobson
Robert Jakobson has worked in the manufacturing industry since 2010. With over a decade of experience in B2B marketing, he specializes in helping companies improve their operations with software and hardware solutions. His deep knowledge of the industry and passion for technology make him a trusted expert. Robert’s experience ranges from product development to marketing, giving him valuable insights into how businesses can use tools like the Inspectle Food Safety Inspection software to stay compliant and improve their processes.