As most regulatory professionals well know, there is much that the US Food and Drug Administration (FDA) deals with that is less than clear. If the letter of the law is intended to be black and white, what emerges in regulatory practice is often gray in hue, offering challenges and opportunities for regulators and industry.
In recent years, one gray area of increasing public health concern has been caffeinated beverages, and especially those loaded with enough stimulating materials to (quite literally) kill someone. Long favored by college students during final exams and other periods of stress when work takes precedence over sleep, energy drinks have become an increasingly ubiquitous presence on store shelves and in advertising.
The problem, to paraphrase the regulatory gray area, is this: Where does a caffeinated beverage like soda-a food-end, and an energy drink-potentially a liquid dietary supplement-begin?
Faced with mounting concerns about the safety of energy drinks relative to more conventional beverages, FDA embarked on an investigation in 2012 to determine if the products and their food additives were safe for consumption.
As FDA explained at the time: "So-called 'energy' products are relatively new to the market, and manufacturers of these products have labeled some as dietary supplements and others as conventional foods. FDA regulates both dietary supplements and conventional foods under the Federal Food, Drug, and Cosmetic Act (the FFDCA), but the requirements for them are different."
The difference, it said, was that certain food additives cannot be used unless they have been approved first by FDA or been found to be "Generally Regarded as Safe" (GRAS) by outside experts. While dietary supplements are regulated somewhat more strictly than food products, FDA noted that dietary ingredients in supplements also do not require preapproval to be used in the supplement, and that the onus is placed on FDA to determine if an ingredient is unsafe for use in a product.
The main difference, FDA explained, has to do with safety reporting. Manufacturers of food are under no obligation to report adverse events to FDA, while manufacturers of dietary supplements must do so within a mandatory 15-day reporting period.
Obviously, then, FDA would prefer that the manufacturer of a potentially dangerous product be compelled to report adverse events, and thus be regulated as a dietary supplement instead of a food product.
But with so many products on the market, and no clear consensus on how to categorize products, this goal posed something of a tricky dynamic for FDA.
Now, though, regulators have offered up a guidance document intended to clarify between regular beverages-which is to say, food-and liquid dietary supplements like energy drinks.
The 13 January 2014 guidance document, Distinguishing Liquid Dietary Supplements from Beverages, contains a long list of factors that differentiate the two, as well as a number of related products like beverage powders intended to be made into drinks.
Perhaps the biggest point of differentiation has to do with labeling claims. Per legal and regulatory definitions, supplements are meant to supplement the diet. Foods and beverages, meanwhile, are edible substances meant to consumed as part of a regular diet. So if a product contains claims-written or visually represented-that would insinuate that a product isn't intended for regular consumption, it's probably a dietary supplement.
This can venture into gray areas, such as if a beverage claims to be "refreshing" or used to "rehydrate" someone, such as a sports drink, but FDA maintained that those claims would likely fall under the definition of food.
From there, all sorts of factors come into play: the product's name, packaging, recommended daily intake, serving size, directions for use, marketing practices and composition of ingredients. For example, FDA notes that if a product instructs the consumer to use the product with a frequency that is similar to other dietary supplements, such as twice per day with food, it may be considered a dietary supplement.
Likewise, if a product is marketed in a way that is similar to other liquid supplements, FDA may determine that it is a supplement. For example, an energy drink maintaining that it has the caffeine of several cups of coffee would contrast with the marketing of a traditional food product.
Similar products, such as powdered "premix" products, will generally be considered dietary supplements, though concentrates and syrups will not be considered so.
What the guidance lacks is any sort of demarcation between supplement and food. Rather, FDA lists a myriad of factors that it would take into account when making such a determination for reporting or enforcement activities. But like any guidance document, it is only a recommended approach, leaving open other interpretations-and legal challenges from both regulators and consumers alike.
While the guidance has been finalized, what remains to be seen is whether it introduces more clarity to a sector which sorely needs it, or just raises more questions.
Distinguishing Liquid Dietary Supplements from Beverages