Is it a drug or a supplement or a beverage?

The FDA has increased its attention and output of warning letters regarding products that claim to belong in one category but truly belong in another. In the press, however, the distinction between these categories constantly gets blurred. Here is a perfect example of the press blurring this distinction, further confusing consumers.

This news story was just released through Nutritional Outlook’s weekly newsletter:

First Functional Drink for Eye Health:

A New York ophthalmologist has created OJO, touted as the first beverage for eye health. The drink features the vitamins and minerals studied in the national Age-Related Eye Disease Study (AREDS) for macular degeneration: vitamins C, E, and beta-carotene, and zinc. The beverage features other eye-health ingredients as well, including lutein, omega-3s, B vitamins, and superfruits.”

Nutritional Outlook article 

Here’s the problem:

1. Beverages aren’t supposed to treat or cure diseases; neither are supplements. The only products that can legally claim to treat and cure disease are drugs. HOWEVER, it’s fine for foods to be associated with reducing the risk  of certain aliments, examples:

Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life. 

 – This claim is from Food Labeling 101 
(No, REALLY, it’s Title 21 of the Code of Federal Regulations Part 101: Food Labeling 
Food Labeling Claims that are allowed, per the Code of Federal Regulations 

There are several different claims permitted for particular nutrients, but there is currently no claim permitted for associating the vitamins and superfruits in this drink with a reduced risk of macular degeneration.

2. This product is based on the findings of the Age-Related Eye Disease Study (AREDS), in which 4,757 participants, ages 55-80 years, with varying levels of age-related macular degeneration (AMD) were given one of four daily oral tablets.

(Well gee, doesn’t that sound like a supplement or a drug?)

The tablets contained either 1) zinc alone; 2) antioxidants alone; 3) a combination of antioxidants and zinc; or 4) a placebo. The good news is that the people who got tablet #3 (antioxidants plus zinc) had a lower risk of developing AMD.
AREDS Study Details 

So instead of taking these oral tablets, you can get the same benefits by drinking this new product, right?   

 The fact that this beverage is supposed to provide the same benefits to eye health as the tablets implies the product is working as a drug; the fact that the beverage is supposed to increase (ahem, supplement) the levels of vitamins and antioxidants that reduce the risk of eye diseases implies the product is a supplement.

3. The product being advertised in this Nutritional Outlook article is advertised as “The Visionary Drink”. The word “drink” and “beverage” both imply this product is a food, and yet a trip to the website features a promising claim with the same fine print as your typical supplement: 

Designed for anyone who wants to help protect and preserve healthy vision.*

*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.

  main site for Ojo Nectar 

Did you notice the way they use the word “protect”? They could get in big trouble for saying the product protects healthy vision, but it’s okay to say the protect is for people who want to protect their vision. Details, details….

The FDA has sent warning letters like this one to companies that sell supplements that look too much like beverages (FDA: “Hey, if you talk about it like it’s a beverage, we’re going to regulate it using beverage rules, even if you call it a supplement.”). Though this drink is posing as a beverage, it’s claims indicate the manufacturers view it as a supplement. These categories are distinct and mutually exclusive.

BOTTOM LINE: The lines between food, drugs and supplements gets fuzzier and fuzzier but becoming more aware of these little tricks and word-plays will help you get a firmer grasp of what you’re putting in your body and why. A product like this one may in fact reduce your risk of age-related eye diseases, but only drugs have to be proven safe and effective before they can be sold to treat disease. Only certain nutrients have enough evidence to support health claims, so knowing what those nutrients and claims are increases your odds of actually improving your health. 

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