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If you are thinking about opening a food business, there are many regulatory requirements that you will need to meet. Some of these requirements apply to all food businesses, and some are...
If you are producing a food product, there is a good chance it is regulated by FDA. The agency regulates all foods and food ingredients introduced into or offered for sale in interstate...
Guidance and regulatory information on Food and Dietary Supplements; includes guidance for industry as well as manufacturing processes, food facility registration, HACCP, retail food protection...
The name-brand approval process consists of five steps — discovery/concept, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring. The company must test the product on animals before humans to ensure safety.
Do food, medical devices, drugs, and cosmetics need FDA approval? Read our guide on how to get FDA approval for your regulated product.
On January 20, 2026, the Food and Drug Administration's (FDA) new traceability rules will go into effect. But members of the food industry have said the new rules are confusing, and expressed ...
Although the FDA does not have premarket approval of food products, it has the authority to approve certain ingredients before they are used in food or intended to contact food.
The GRAS notification is crucial to getting FDA approval for your food product. This guide explains everything you'll need to get started.
Step 1: Determine the Appropriate FDA Division. The initial step in the FDA label approval process is to identify the correct FDA division for your product. This is crucial as each division, such as food, beverages, dietary supplements, etc., has specific guidelines and standards.
Q4: How Does the FDA Regulate Food Additives and Preservatives? Pre-Market Approval: New food additives must undergo a rigorous pre-market approval process. This includes providing evidence of their safety for the intended use.