The FDA’s role in regulating nutritional supplements explained

Resources related to this video

Overview of dietary supplements and the FDA's role in regulating this group of foods.
http://www.fda.gov/Food/DietarySupplements/

Describe the methods, equipment, facilities, and controls for producing processed food.
http://www.fda.gov/food/guidanceregulation/cgmp/

Read the full transcript below.

Hello, I’m Dr. David Katz, Chief Medical Advisor to Adaptive Health, makers of Instaflex Advanced.

In many of the other videos you’ll find here I’ll be talking about specific products like Instaflex Advanced, but today I wanted to address another frequent question… and that relates to FDA oversight of a company like Adaptive Health and products like Instaflex Advanced.

The FDA regulates dietary supplements, drugs and food—but it does it in different ways. The standards really need to be different. Drug companies can make billions of dollars on a patented drug and can afford to spend the nearly billion dollars it takes to do a whole batch of relevant studies to show that a drug is effective at treating a particular condition.

It’s rarely justified to spend a billion dollars on research to bring a supplement to market because supplements are rarely protected to the same degree as a patented drug. So instead, a lesser standard is used. There absolutely does need to be good scientific evidence before bringing supplements to market.

And what the FDA requires is all the information on the vile be accurate, that the company identify itself, that a consumer be able to identify the source of a product, and in general dietary supplements need to specify what they’re for.

And that’s an interesting distinction with drugs. Drugs treat medical problems and conditions; supplements do not. What they do is support healthy function. So for instance, a product like Instaflex Advanced supports healthy joint function. It’s not claimed to treat any specific condition. And that’s an important distinction. Once something becomes a treatment for a condition, it does have to satisfy the requirements for a drug because it’s acting like one.

Another important consideration about FDA oversight of supplements is good manufacturing practices, and the FDA established strict regulatory language about good manufacturing practices in 2007. And the reputable companies that market supplements and combinations of supplements and products in this space, honor all of those standards.

And they require that all of the labeling be completely accurate with regard to composition, and dose, and sourcing. And the best companies in this space exceed the standards that the FDA imposes.

The FDA of course lacks the person power to inspect every supplement makers and that’s why there is some stuff on the market that does not fully represent the claims on the vile. That’s a problem we all have to be careful. All the more reason to become familiar with sources that you can trust. And I can tell you personally that the makers of Instaflex Advanced reliably exceed the GMP standards set forth by the FDA.

So the two relevant acts that relate to the oversight of nutrient supplements are DSHEA, the Dietary Supplement Health and Education Act—that goes back to the mid-1990s—and good manufacturing practices.

Instaflex Advanced, and other products made by Adaptive Health, are designed to comply with all of these regulatory standards by the FDA and to exceed them.

For more information, we’ll provide relevant links on the site to direct you to some of the source material.