Red Dawn Energy Supplements Contain Ingredient that Has ‘No Place Being in Any Food Product,’ Class Action Alleges

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Evol Nutrition Associates’ Sleepwalker and Red Dawn energy supplement products contain “unapproved and unsafe dietary ingredients” whose risks are not adequately disclosed to the public, a proposed class action alleges.

The 14-page complaint claims the supplements, which come in pill and liquid form, contain a central nervous system depressant and anti-anxiety medication called Beta-phenyl-gamma-aminobutyric acid, or “phenibut,” whose array of unpleasant side effects, unbeknownst to consumers, include dizziness, nausea, poor balance, fatigue and “feelings of electric shocks in the arms and legs.” In larger doses, phenibut, which the lawsuit says is prescribed in “Russia, Ukraine, Belarus and Latvia” for a number of conditions ranging from depression to post-traumatic stress disorder, can cause breathing troubles and unconsciousness, according to the case.

“Simply put, Phenibut is a dangerous drug that has no place being in any food product,” the suit, filed in New York federal court, asserts, alleging the defendant formulated the products with unsafe and unapproved ingredients in order to compete in a robust energy supplement market. 

The suit says the FDA in April 2019 warned Evol Nutrition Associates that their products containing phenibut were misbranded. Per the lawsuit, phenibut has also drawn regulatory scrutiny in Hungary, Lithuania, Italy and Austria over withdrawal and overdose concerns. 

According to the lawsuit, Evol Nutrition Associates markets and retails the Sleepwalker and Red Dawn supplements as able to provide extra energy and mood enhancement, and labels the products as containing a “proprietary blend” or “proprietary focus/mood blend” of ingredients. The ingredient at issue, phenibut, has never been approved for use as a dietary ingredient and is not generally recognized as safe by the FDA, the complaint says, meaning the supplements are “misbranded and adulterated” under federal and state laws. 

“Misbranded and adulterated food products cannot legally be manufactured, held, advertised, distributed or sold,” the case scathes. “Thus, misbranded and adulterated food has no economic value and is worthless as a matter of law, and purchasers of misbranded food are entitled to a full refund of the purchase price.” 

In addition, the lawsuit claims the plaintiff and other proposed class members have experienced “a number of side effects” related to their consumption of phenibut along with the other ingredients in the supplements. According to the case, the plaintiff, a Rome, New York resident, bought several of the defendant’s products in the last four years on the belief that they were safe, lawful supplements that would provide an energy boost similar to that of coffee. After the plaintiff consumed the Sleepwalker supplements, however, he experienced “dizziness, nausea, or fatigue” for more than 12 hours before disposing of the products given the side effects “were so pronounced,” the suit says. 

As the case tells it, the plaintiff’s experience is not unusual with the defendant’s supplements as other consumers “have reported feeling unwell after ingesting a single serving.” 

In plain language, the lawsuit alleges the defendant markets its supplements as safe and effective when they are not. The supplements, the case says, contain an unapproved drug prescribed in “Russia, Ukraine, Belarus and Latvia” to treat “insomnia, depression, stuttering, vestibular disorders, irregular heartbeat, and post-traumatic stress disorder.” Despite its apparent prevalence in the four countries, however, “no good scientific evidence” supports the use of phenibut to treat the aforementioned conditions, and the substance “seems to be used primarily as a recreational drug,” the lawsuit claims. 

According to the suit, those who take phenibut regularly, or even once, in some cases, can develop a dependence. Those who take it regularly and then stop may experience withdrawal symptoms that can include decreased appetite, nausea, muscle aches, anxiety, agitation, sleep trouble and seizures, the case says, claiming little scientific research exists to indicate what would be considered a “safe” dose of phenibut for an adult. 

The lawsuit alleges that none of this has stopped the defendant from selling the supplements without disclosing the potentially harmful effects of the ingredients used therein:

Consumers would not have bought the Sleepwalker and Red Dawn energy supplements, or would have paid less, had they know the “true nature” of the products, the suit says. The lawsuit aims to represent New York residents who bought the Sleepwalker (liquid and capsule form) and Red Dawn (liquid form) products between March 23, 2018 and the present. 

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