In the bustling landscape of consumer goods, caffeinated beverages stand out as a daily staple for millions of Americans. A recent shift towards “clean caffeine” and caffeine alternatives has further energized consumer demand for ready-to-drink caffeinated beverages.
Recently, however, the spotlight has turned to the highly caffeinated beverage industry for far less stimulating reasons, as cases of alleged caffeine overconsumption have led to severe health repercussions. As highly caffeinated beverages continue to expand their market share, it is crucial for ready-to-drink beverage brands to carefully consider their product’s caffeination levels and the way those products are labeled and/or marketed.
In this post, we will highlight common pitfalls that brands should be aware of when selling caffeinated beverages and will outline proactive strategies to decrease the risk of potential litigation. While recent headlines have surrounded caffeinated-beverages sold at restaurants, this blog will focus on consumer packaged goods containing caffeine.
Before reading further, it is important to understand that the regulations applicable to your product will ultimately depend on whether your product is categorized as a beverage or a liquid dietary supplement, as further discussed in our free report on functional foods and beverages.
Unlike our neighbors Canada and Mexico, the U.S. does not set a cap on caffeine content in beverages (other than certain sodas) or liquid dietary supplements. Rather, the Food and Drug Administration (FDA) considers whether a product is “safe” for consumers, but only after the product has reached the market.
The FDA has long considered caffeine to be generally recognized as safe (GRAS) for its intended use in carbonated beverages—but only up to a certain point. For example, sodas can contain up to 0.02% of caffeine (roughly 71 mg) in a 12-oz can (21 C.F.R. § 182.1180). However, it’s imperative to note that this 0.02% limit only applies to “cola-like beverages,” leaving the caffeine content of most ready-to-drink beverages up to the discretion of manufacturers.
In other words, ready-to-drink beverages may include more than 0.02% of caffeine so long as the manufacturers self-affirms that the level of caffeine used in their product is safe for its intended use—which such safety evidence does not need to be provided to the FDA.
Although it has not published any guidance regarding caffeine consumption since 2018, the FDA recently published a Consumer Update regarding the risks of caffeine overconsumption. Currently, the implied safety threshold is about 400mg a day for healthy adults—roughly the amount of caffeine in four to five cups of coffee.
While FDA regulations require both beverages and liquid dietary supplements to disclose the presence of added caffeine on their labels (through the ingredient statement), the quantity of caffeine in the product does not need to be disclosed (in most instances). Additionally, manufacturers do not need to disclose on their labels the presence of caffeine included in an ingredient when it presents as a naturally occurring substance in the ingredient. For example, a candy bar containing chocolate must list chocolate as an ingredient , but it need not need disclose that the chocolate contains naturally occurring caffeine. Moreover, liquid dietary supplements that contain caffeine as part of a “proprietary blend” do not need to disclose the amount of caffeine in the product (regardless of whether the product contains added caffeine or caffeine derived from naturally occurring sources). However, a dietary supplement manufacturer could choose to disclose caffeine in the Supplement Facts Panel as its own dietary ingredient (if it is present in the product in the form of caffeine), which would necessitate disclosing the amount per serving in the product.
Unlike beverages and dietary supplements, over-the-counter (OTC) drugs containing caffeine (i) must disclose the caffeine content on their product labels, (i) must provide a health warning to consumers, and (iii) oral dosage format products cannot contain more than 100 to 200 milligrams of caffeine with directions to take every 3-4 hours (i.e., a daily intake limit for an OTC drug of 12,000 mg of caffeine). Common warning statements may read: “The recommended dose of this product contains about as much caffeine as one cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat,” “For occasional use only. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a doctor”, and “Do not give to children under 12 years of age.”
To reiterate, over-the-counter drugs containing any amount of caffeine must disclose the presence of caffeine in the product and indicate the quantity of caffeine on the product label in the Drug Facts Panel, whereas ready-to-drink beverages/liquid dietary supplements can contain any amount of caffeine (so long as the manufacturer has some scientific evidence supporting the safety of the caffeine levels in their product), and manufacturers do not need to indicate the amount of caffeine in their product.
Fortifying Against Litigation
Manufacturers should take caution when formulating a product with any amount of caffeine. Following FDA Warnings concerning high-potency caffeine supplements, many companies marketing highly caffeinated supplements have either reformulated their products to lower caffeine levels or have exited the market. The FDA’s focus for enforcement was bulk products containing pure and highly concentrated caffeine (such as powdered pure caffeine), as consumers are left to portion out a single serving of the product. As recent headlines have indicated, allowing consumers to apportion their caffeine consumption with little to no warnings could be toxic or even fatal—even for otherwise healthy individuals.
As highly caffeinated beverages have continued to take hold of the ready-to-drink beverage industry, so too has the risk of potential civil liability. Unfortunately, even if a company operates in compliance with state and federal regulations, there is a possibility of potential civil suits from consumers, including wrongful death and products liability for insufficient warnings.
How, then, can you fortify your caffeinated product against such liability? Pushing beyond regulatory demands by providing clear labeling denoting the presence and quantity of caffeine in your product is a smart start. Offering a comparative measure—think “coffee-cup equivalent”—can demystify the caffeine content, giving consumers a tangible reference for the stimulant’s potency. Additionally, cautionary notes on caffeine consumption (such as “over-consumption may cause insomnia”) can serve as a valuable tool to educate and protect consumers.
Restraint in caffeine levels per serving is not just prudent, it’s professionally responsible. Recall that moderation is your best defense. An ordinary 8-ounce coffee has about 100 milligrams of caffeine, contrasting with a popular caffeinated lemonade sporting a robust 390 milligrams—without considering customer refills spurred on by loyalty programs.
In the effervescent world of consumer choice, highly caffeinated beverage manufacturers must navigate diligently. Transparency, temperance, and education may present a line of defense against consumer actions, turning a potential liability into an opportunity for consumer trust-building. Stay tuned for developments in this jittery juridical juncture, as we continue to monitor the pulse of caffeinated beverage regulations and litigations.
Husch Blackwell has significant experience advising beverage manufacturers on FDA regulations, including product formulation including caffeine limits, labeling, and appropriate warnings. Contact Megan Beebe or Emily Lyons for further information.