Labeled for Your Convenience

Ever wonder what determines the labels on your medication, food, cosmetics, supplements and pharmaceuticals? For many people, it’s just assumed that these things are safe for consumption. Some make that assumption without thoroughly reading them, or better yet, understanding them.  

The Food and Drug Administration, or FDA for short, regulate dietary supplement products under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA): Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. 

That means that the manufacturer is responsible for evaluating the safety and labeling of their products before they go to market. This ensures they meet all the requirements of the Federal Food, Drug, and Cosmetic Act as amended by DSHEA and FDA regulations. FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market.”

FDA’s labeling resources for human prescription drugs are primarily directed to industry staff who develop human prescription drug labeling. Human prescription drug labeling contains a summary of the essential scientific information needed for the safe and effective use of the drug. This includes the Prescribing Information, FDA-approved patient labeling (Medication Guides, Patient Package Inserts, and/or Instructions for Use), and/or carton and container labeling.

In short, it’s required by law that labels on medication and biological products list accurate ingredients, measurements, and directions for a product to legally be sold in the United States. In an article published by medscape.com, it was reported that in June of 2006 the FDA revised a law pertaining to "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," for the sake of managing product risk and minimizing adverse events. Clarity for the consumer was the goal.

In, “What qualifies as a label according to the FDA,” also by Medscape, it states that according to the FDA’s updated legislation, the highlights section is now a half-page summary of information that health care practitioners most commonly refer to and view as most important. A revision to content, format, and order was intended to make the information clearer and more usable. The FDA’s purpose is to ensure consumables, whether that be ingested or applied to our bodies in some fashion, are safe for public use.