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FDA Rules - Energy Drinks vs. Dietary Supplements

Caffeinated Drinks Cited in Reports of 13 Deaths

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RockStar Energy Drinks Cited in FDA Injury Filings

RockStar Energy Drinks Cited in FDA Injury Filings

NY Times
Updated November 28, 2012

Red Bull, Rockstar. 5 Hour Energy, AMP… the list goes on for branded energy drinks. According to Packaged Facts, "energy drinks/shots, sports drinks, and nutrient-enhanced waters, in itself a $15 billion category". I see these products primarily appealing to millennial consumers . Mintel summarizes the current problem at hand: "The biggest challenge energy drinks/shots makers face is to convince various consumer groups that their products are indeed safe to drink if consumed responsibly. But does the "drink responsibly" strategy run the risk of inviting Food and Drug Administration (FDA) intervention?"

The New York Times ran 3 articles on FDA's Adverse Event Reporting on three popular energy drinks and supplements

Adverse Event reports are reports about "adverse health events and product complaints related…" to certain FDA regulated products, including conventional foods, dietary supplements and cosmetics. Foods report voluntarily and dietary supplements are mandatory reports. I started to read the FDA page on Adverse Event Reporting (FAERS) and my head hurts!

So I decided to get some perspective from my expert Richard Perlmutter, M.S. President ofAbington Nutrition Services LLC. He is my go to person on FDA regulations, nutrition facts for foods , how to design a nutrition information label , ingredient statements, etc. I wanted to his clarity here on understanding dietary supplements vs. beverages.

So I posed the following to questions to Richard to helps us understand the beverage/supplement dilema.

Are energy drinks foods or dietary supplements?

Energy drinks have come under recent scrutiny for possibly contributing to injury and death among those who consume them too frequently. The scrutiny is also causing the federal Food and Drug Administration (FDA) some discomfort. That's because the agency allows some of these energy drinks to be classified as food and others as dietary supplements.

Adverse affects that were possibly caused by dietary supplements must be reported to the FDA. However it is not required that adverse affects possibly caused by food be reported.

What is the difference between a beverage and a dietary supplement?

What separates dietary supplement energy drinks from beverage energy drinks is an indefinite murky line. As an example compare a can of Rockstar®, which is a dietary supplement, with a can of AMP®, which is a beverage. They look almost the same. The descriptions on the two cans are also similar. One way that they are dissimilar is that RockStar® has a Supplement Facts panel and AMP® has a Nutrition Facts panel.

In 2009 the FDA authored the Draft Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages on the subject. The report expressed concern with dietary supplements that look like, are displayed adjacent to, and are marketed, as beverages.

What are in these "drinks" that are problematic?

These products often have ingredients, like botanical extracts, that have not been approved for use in beverages. Or they may contain food approved ingredients, but at levels in excess of those typically used in beverages.

The FDA has defined the characteristics of drinks that are dietary supplements, and those that are beverages. But in the marketplace there are many supplements that are passing themselves off as beverages. It is up to the FDA to do a better job communicating and enforcing the rules that separate the two.

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