The FDA And The Supplement Industry

If you've ever visited a vitamin or supplement website, you might have seen the following disclaimer:

"These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."

At first glance, it might seem strange to have this notice on a website, but upon deeper inspection, it's actually perfectly normal and required by the FDA in certain instances. 

Why is that? First, let's start with the FDA itself and review what it is! 

The FDA - what is it?

The FDA, or U.S. Food and Drug Administration, is a federal agency that is in charge of regulating products that impact public health such as food, pharmaceutical drugs, medical devices, cosmetics, and even tobacco products. This agency helps ensure that the products that we use every day are safe, but it does not provide approval for every industry it oversees. 

What does the FDA have to do with supplements?

The FDA helps enforce and regulate the dietary supplement industry by defining and enforcing what supplement companies can claim about their products. 

In the interest of public safety, Good Manufacturing Practices (GMPs) have been defined by the FDA enforceable through inspections. 

These GMPs also provide the FDA with the authority to prosecute, seize and remove dangerous products from the marketplace. 

And when reviewing evidence, the FDA determines if a product is Generally Recognized As Safe (GRAS). 

Where did these regulations come from?

Prior to the late 1930s, regulation was largely missing from the food and drug industry - with the exception of one piece of legislation from 1906 prohibiting misbranded and adulterated food and drugs. 

In the early 1900s, deaths from using consumer products were common. Outrage grew until 1937, when an untested medicine killed hundreds. 

Congress had to deal with the problem, and in response, passed the Food, Drug, and Cosmetic Act In 1938. 

The FD&C Act led to foods being treated separately from drugs. While drugs were defined as products for medical purposes with stricter regulation, foods defined as products used for nutritional purposes had fewer restrictions. 

This distinction drawn by the FD&C act is important as it led to vitamins and other supplements being treated as a subset of food products rather than drug products. 

How do drugs and supplements differ? 

The FDA states that drugs are used for treating, preventing, mitigating, diagnosing or curing diseases. They require heavy regulation with clinical trials on human subjects required to show that a pharmaceutical drug is safe and effective for its intended use. It must then be manufactured under controlled conditions and packaged to meet strict labeling standards before being approved by the FDA.

Unlike drugs, the FDA says that supplements are for nutritional purposes only. Since they're not considered drugs, the FDA has different requirements for supplements. In particular, the FDA requires certain manufacturing and labeling practices to be implemented, as well as its own set of guidelines for testing, safety, and efficacy. 

What does this mean when it comes to supplemental claims?

The Dietary Supplement Health and Education Act of 1994 (DSHEA) has mandated that supplement companies do not imply, insinuate, or state that their product diagnoses, treats, cures, or prevents diseases of any kind. 

The disclaimer is mandatory for dietary supplements if they make any claims about affecting the structure and/or function of the human body - and the FDA enforces claims to make sure they are following approved guidelines for dietary supplement allowable claims. 

Are any supplements approved by the FDA?

The FDA does not "approve" supplements because it does not approve food. 

However, certain manufacturing and labeling practices are mandated by the FDA and regularly enforced by inspecting companies to make sure they're meeting regulations. 

If a supplement company does not comply with FDA regulations, the FDA can ban them from selling their product within the U.S. 

 


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