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FDA - 101 - What Does FDA Approval Mean? (Part Two)

Posted by Jane Akre
Monday, October 06, 2008 3:27 PM EST
Category: Major Medical, Protecting Your Family
Tags: Federal Pre-emption, Preemption, FDA and Prescription Drugs, Dangerous Drugs, Diana Levine, Medical Devices

What does FDA approval mean?

What does FDA approval mean (Part Two) -



IMAGE SOURCE: FDA Web site logo


What does the FDA actually do? And why should we rely on it's assurances of safety?
You'll be hearing more about the weight that FDA approval means in light of ongoing efforts to stop lawsuits against defective drugs or medical devices that are "FDA Approved". A closer look at what the FDA actually regulates, continued from Part One.


Food Additives

FDA field investigators are charged with on-site inspection of food companies, food shipments from abroad. They collect random samples and send them to the lab for analysis.  Compliance officers can recommend legal action and enforcement.

New food additives and color additives are considered food under the law and must be approved for safety after the manufacturer submits information it chooses to verify safety and efficacy.  Food additives that have a long history of use in foods without problems do not require premarket approval.  

Many parents and consumer groups have found that food colorings and additives, presumed to be safe, contribute to behavioral problems in children.


Food for Animals

One hundred million pets do not eat pet food approved by the FDA. The agency does oversee food additives used in pet food. The FDA has the authority to take action against pet food products that are in violation of the law. 

The FDA also oversees drugs and food additives given to poultry, cattle, pigs, horses, dogs and cats.  Critics are concerned about antibiotics added to commercial foods used for animals we eventually consume as a contributor to the evolution of antibiotic resistance.


Color Additives

Colors are added to food, vitamins and food supplements, drugs, cosmetics and some medical devices and are subject to approval by the agency. They can only be used for the application for which they are approved.  



The FDA does not approve cosmetics including makeup, lotions, shampoos, hair dyes, perfumes, face and body cleansers and shaving preparations.   Coal-tar hair dye is not approved, though has been linked to leukemia.  

Colors added to cosmetic products are subject to approval.


Medical Foods

Medical foods are used by people who have special nutrient needs due to a disease or health condition. For example a person with phenylketonuria, a genetic disorder, might need special foods formulated to be free of the amino acid phenylalanine.  A medical food is intended to be used under medical supervision.  The FDA does not approve medical foods.


Infant Formula

The FDA does not approve infant formula before they are marketed. Makers must follow federal nutrient requirements and are required to register with the FDA and provide notification before they market any new formula.


Dietary Supplements

Dietary supplements are no approved by the FDA and do not receive agency review for safety or effectiveness. Their safety is evaluated through adverse event monitoring. Any new dietary ingredient, not introduced into the US before October 15, 1994) must notify the FDA 75 days before monitoring.

In 1994 the Dietary Supplement Health and Education Act (DSHEA) was established to balance consumer access to dietary supplements with FDA regulation.  


Nutrition Facts, Food Labels

The FDA requires that nutrition information appear on most foods including dietary supplements but the agency does not approve any individual food labels.  Labels must include the serving size of food and information about the nutrient content of each serving on the “Nutrition Facts” panel of the food label.   Claims on labels must be truthful and non-misleading.  Claims such as “calcium builds strong bones” are allowed but the FDA does not approve them.


Dietary Supplement Labels

Structure-function claims such as those made for calcium “builds strong bones” explain the role of the food on the human body. 

But structure-function claims made on behalf of a dietary supplement such as “prevents baldness” or “stops coughs” must be submitted to the FDA no later than 30 days after marketing the dietary supplement.  The context of the claim must be included. This is required for dietary supplements, not conventional foods.

Such claims on dietary supplement are required to carry a disclaimer stating that the claim has not been reviewed by the FDA and that the product is not intended to diagnose, treat, cure or prevent any disease.    Conventional foods are not required to carry such a disclaimer.


FDA Logo

The FDA logo cannot be used by any company to suggest the FDA endorses any private or organization, product or service.  # 

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