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 regulated, labeled, and monitored for safety.
But first, let’s clear up one thing…
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
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.
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.
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.