4.3 What Does the FDA Do For Us?

The FDA ensures ....

foods are safe, pure, wholesome that drugs and therapeutic devices are safe and effective that cosmetics are harmless and that all these products are correctly labeled and packaged.

what is pre-approved inspection?

inspection after a company has made an application to the FDA to market a new product

what is "for-cause" inspection?

investigates a specific problem that has come to the attention of the FDA

What does the FDA inspect?

manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. Those inspected include: - vaccine and drug manufacturers - blood banks - food processing facilities - dairy farms - animal feed processors - compounding pharmacies - facilities that conduct studies in people (clinical trials) - laboratories that conduct studies in animals or microorganisms when these studies are used to apply for FDA approval of a medical product foreign manufacturing and processing sites for FDA-regulated products that are sold in the United States - imported regulated products at the border

How can you report problems to the FDA?

to the FDA online, via phone, or via mail. For emergencies: Call 9-1-1 immediately.

What role does the FDA play in dietary supplements?

FDA regulates both finished dietary supplement products and dietary ingredients FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.

what does the FDA do?

Protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective Protecting the public from electronic product radiation Assuring cosmetics and dietary supplements are safe and properly labeled Regulating tobacco products Advancing the public health by helping to speed product innovations

When and why was the FDA formed?

agency began with the passage of the 1906 Pure Food and Drugs Act.

What is the Food and Drug Administration (FDA)?

one of the nation's oldest and most respected consumer protection agencies an agency of the United States Department of Health and Human Services whose principal purpose is to enforce the Federal Food, Drug and Cosmetic Act.

what is a clinical trial?

product is testing in a human data population