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. 

Beverage vs Supplement: What Monster Energy’s switch from supplement to beverage means to the consumer

Next time you pick up an energy drink, take a peek at the label – does it say “Nutrition Facts” or “Supplement Facts”? What difference does one word make? Well, in this case, it’s kind of a big deal.

Monster Energy announces plans to move many of its products from the supplement category to the beverage category. While this may seem like changing one word, this move involves significant changes to how Monster energy drinks are labeled, regulated and monitored for safety.

One of the most common mistakes regarding energy drinks in the news is the claim “the FDA does not regulate energy drinks”. Even the reputable Journal of the American Medical Association made this mistake!

First of all, “energy drink” is a term used to refer to both beverages and supplements, but these are two different categories of products, each with their own set of regulations. Second of all, both beverages and supplements are indeed regulated by the FDA. 

[Henceforth, the term "energy drink" will be used to specifically refer to products in the supplement category, whereas "energy beverage" will be used to refer to products in the food and beverage category]

1) Food/Bev vs Supplement Regulations:

·      Beverages are considered conventional foods; supplements are not food or beverages…or drugs (hence the supplement disclaimers “not intended to treat or cure disease”)

·      Ingredients added to FOOD must be approved food additives OR be classified as Generally Recognized as Safe (GRAS)

o   Example: Ginko biloba is acceptable in supplements, but not permitted in food because it’s not GRAS or covered by any food additive regulation

·      Ingredients added to SUPPLEMENTS must meet these two requirements:

1)   The ingredient must be a dietary ingredient* and

2)   If the ingredient was not sold in the US as a dietary supplement before October 15, 1994 (I’ll explain this date in a second), the manufacturer must file a special report that notifies the FDA of the intention to use this ingredient and must provide scientific evidence of its safety

*A “dietary ingredient” is defined by the Dietary Supplement Health and Education Act (DSHEA) as a vitamin, mineral, herb/botanical, amino acid, metabolite/extract or some other substance intended to boost (or supplement) the level man already consumes.

A blueberry would be a food ingredient

Blueberry extracts would be a dietary ingredient

Why October 15, 1994?

Because that’s when DSHEA was signed into law. Before this time, dietary supplements were subject to the same regulatory requirements as food products. Now, dietary supplements are just “under the umbrella” of food, which is why their safety is monitored by the FDA’s Center for FOOD Safety and Applied Nutrition (CFSAN).

 

2) Food Labels vs Supplement Labels

Food products and supplements are BOTH required to list all the components added to make the final formula

·      Food labels are required to list the ingredients by descending order, meaning the ingredient used the most comes first in the list while the ingredients that make up less than 2% of the total formula go last

o   NOTE: only certain ingredients (Calories, Total Fat, vitamins A and C to name a few) are required to be itemized with the amounts, other ingredients are only required to be mentioned in the list of ingredients

·      Supplements are required to list every ingredient in the formula, either in the “Supplement Facts” panel or in the “Other Ingredients” section

o   NOTE: the supplement label may group “proprietary blends” and list only the total amount of the blend, as long as there are no ingredients added to the supplement that are omitted entirely from the label

Special Circumstances with Caffeine:  caffeine is only required on the food label when it is added, not inherent—this is why dark chocolate does not mention caffeine in the ingredients list, but it is included within the product. When it is added, the word "caffeine" must appear in the ingredients list, but the amount of caffeine is not required to be listed.

If you don't believe me, here is the official FDA statement.

3) Food Safety vs Supplement Safety

·      The FDA limited the amount of caffeine in cola-type drinks to 0.02% (71 mg per 12 oz serving)

·       Neither coffee nor energy drinks are held to this limit (and BOTH have been found to exceed this limit)

·      SUPPLEMENT manufacturers, packers, and distributors are required by the Federal Food, Drug, and Cosmetic Act (the FFDCA) to report any serious adverse events to the FDA

·      FOOD manufacturers, packers, or distributors are NOT required by the FFDCA to report serious adverse events to FDA

By definition, a serious adverse event is a health-related incident that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or medical or surgical intervention to prevent any of the preceding outcomes.  

Want to know more about AERs? See Question #5.

BOTTOM LINE:  
Marketing energy drinks as beverages instead of supplements will theoretically prevent a manufacturer from using questionable ingredients in the product (no unpronounceable plant extracts from different planets allowed). But will this change make the product safer? That remains to be seen. True, the levels of caffeine in the drink may be cut, but only the word caffeine, not the level, is required to be listed on the label. With any supplement, such as a vitamin, reading the directions for how much to consume at once is crucial. However, energy drinks usually look like beverages, and the reports of people experiencing symptoms of caffeine overdose is a clear indication that the directions on the energy drink label are not being followed. With the move to the beverage category, it's still possible for people to consume more servings than they should, just as some people enjoy more than 3 sodas per day.

Remember to read the labels - with caffeinated beverages of any kind, personal responsibility is a key ingredient.

-Green-Eyed Guide

Extra Reading: Beverage Daily Article: Monster Energy switches to beverage