We have written several times about the FTC’s effort to rein in what it sees as unsubstantiated cognitive improvement claims (see prior blogs: Brain Training, Lumosity, Word Smart, and Your Baby Can Read). Well, the states appear focused on this segment, too. On October 7, 2016, after two years of litigation and a trial, Judge Beth Andrus of the Superior Court of King’s County Washington issued a 59 page opinion resolving claims the Washington State AG had made against the makers of 5-Hour ENERGY® for alleged deceptive advertising in violation of the Washington Consumer Protection Act (CPA). For those of you who do not watch TV, browse the Internet, visit convenience stores or spend time with college students, 5-Hour ENERGY® is an “energy drink” marketed as a dietary supplement, with ingredients consisting of caffeine, B vitamins and other nutrients. The court found for the AG on some claims and for the defendants on some others. How the court reached its decision is worth spending a little time if you have the energy.

The case arose out of a multi-state investigation that began in 2012. While the other states appear to have closed their investigations, in 2014, Washington State sued and subsequently filed an amended complaint in 2015. At trial, the court considered live or deposition testimony from close to 20 scientific experts, including a former Director of the FTC’s Bureau of Consumer Protection, Howard Beales. The legal framework used by the court mirrored that used by the FTC in determining whether the claims were deceptive. The court considered five claims at trial, assessing the company’s advertising to determine whether the claims were made, and then the substantiation to support the claim if made.

1. Did defendants violate the CPA by claiming that the non-caffeine ingredients in 5-hour ENERGY® provide energy, alertness and focus (Vitamin Claim)?
2. Did defendants violate the CPA by claiming that the effects of 5-Hour ENERGY® are superior to consuming the equivalent amount of caffeine (Superior to Coffee Claim)?
3. Did defendants violate the CPA by claiming that Decaf 5-Hour ENERGY® provides energy, alertness, and focus (Decaf Claim)?
4. Did defendants violate the CPA by claiming that consumers would not experience a “crash” after drinking 5-Hour ENERGY® (Crash Claim)?
5. Did defendants violate the CPA by claiming that doctors had recommended 5-Hour ENERGY® (Ask your Dr. Claim)?

Vitamin Claim

The court found that the company’s ads expressly claimed that the vitamins and nutrients in 5-Hour ENERGY® play a role in providing energy, alertness and focus. The court then did an incredibly thorough review of the science on the beneficial effects of B vitamins and other nutrients in the product, noting the science showing they aid metabolism, increase blood flow, and promote general health. The court found that the amounts of these nutrients in 5-Hour ENERGY® were sufficient to achieve the beneficial effects. As a result, the court found that this claim was properly substantiated and that the AG had failed to prove the claim was deceptive.

Superior to Coffee Claim

The court also found that the company claimed that the key vitamins and nutrients in the product work synergistically with caffeine to make the beneficial effects of the product last longer than caffeine alone. Here, the court found that the science, while supporting a claim that the nutrients promote energy, alertness, and focus, did not support a claim that the nutrients worked synergistically with caffeine to enhance the benefits of caffeine. The court rejected arguments that the standard for this claim should be low given the relatively benign nature of the claim; instead, the court found that, because the claim was health related, the relatively high level of substantiation typically required for dietary supplement claims was needed. The court pointed to the absence of a study directly measuring the claimed synergistic effect and rejected claims based on studies that generally showed that the nutrients aided blood flow as insufficient to support the superior to coffee claim. The claim was therefore deceptive. This aspect of the ruling serves as a good reminder that claims need to match the science and that any health claim is likely to be subject to rigorous scrutiny.

Decaf Claim

Defendants sold, but only advertised sparingly, a decaf version of the product that purported to provide five hours of energy. The court found that, while there might be some science for an “energy boost” from the nutrients without caffeine, there was (not surprisingly) not sufficient science that the nutrients alone provided the promised five hour boost. Therefore, this claim was deceptive. As someone who could never understand why anyone drinks de-caf, this part of the decision seemed a no-brainer.

Crash Claim

To differentiate itself from other energy drinks, the defendants claimed that 5-Hour ENERGY® would not result in the energy “crash” that came from using its competitors’ products. The court rejected the AG’s argument that this claim was deceptive. The court found that the main problem with the AG’s allegation was that there was no accepted meaning or understanding for what “crash” meant. The court accepted defendants’ argument that, as used in their advertising, crash meant “sugar crash,” and the court further accepted that, because there was no sugar in 5-Hour ENERGY® (as there was in competitors’ products), there would be no sugar crash. The court rejected the AG’s efforts to equate crash with caffeine withdrawal as lacking in scientific basis.

Ask Your Doctor Claims

Defendants tried a short-lived campaign aimed at creating the impression that doctors would recommend 5-Hour ENERGY® to their patients. The company had undertaken surveys to try and back up the claim. The court found the questions in the survey biased and the results cherry-picked. As a result, the court found that, while the statistics displayed in the ads might have been literally true, the impressions left by the ads were not. The court rejected defendants argument that, even if the ads were not accurate, they were not materially misleading as they demonstrated what doctors would have said if properly surveyed. The court spent a fair amount of time discussing survey methodology, and that discussion is worthwhile for anyone working frequently with surveys, especially professionals.

The court will next be considering an appropriate remedy after hearing further from the parties.

The case provides important reminders on several key points: 1) State AGs, as well as the FTC, are active in policing dietary supplement claims, especially cognitive claims; 2) what constitutes a “health” claim will be interepreted broadly; and 3) claims need to stick closely to the science, as such claims will be scrutinized closely so that claims that go beyond what the science says will not be found to be substantiated. I trust you had the energy, alertness, and focus to make it through this rather long blog post.