Eagle Energy USA, Inc.
FDA issued a warning letter to Eagle Energy USA, Inc. in December 2021 regarding its inhalable 'Caffeine Pen' products (Lychee Ice and Guarana Berry), finding them to be unapproved new drugs under the FD&C Act. The company's website, Facebook page, and product packaging made drug-like claims about treating GERD, boosting immune function, reducing inflammation, improving memory, and preventing osteoporosis, among others. Because the products are intended for inhalation rather than ingestion, they do not qualify as dietary supplements, and no FDA-approved applications exist for them. FDA demanded a written response within 15 working days and warned that failure to act could result in seizure and/or injunction.
Flagged claims (11)
Unleash the natural POWER OF GUARANA Harvested from the lush Amazon rainforests of Brazil, guarana is nature's caffeine. The seeds from guarana fruit contain stimulants that boost energy while improving mental clarity, athletic performance and weight loss.
Unlike drinking caffeine, which stays in your system for over 5 hours and can cause jitters, Eagle Energy metabolizes quite quickly and lasts about 1 hour. So, you can control the level and duration of your energy boost, avoiding the jitters.
GINSENG Ginseng is a potent antioxidant known to boost brain function. It can also strengthen the immune system, reduce inflammation, and increase energy.
Vitamin B12 also helps prevent a type of anemia called megaloblastic anemia that makes people tired and weak.
10/10 would definitely get again! I love the lychee ice so much! I have really bad GERD and this surprisingly helped tremendously.
[L]ychee is known as the 'Queen of Fruits' due to its long history of health benefits, including boosting immunity, regulating blood pressure, and aiding weight loss.
Fun Fact: Eagle Energy contains Vitamin B12 which not only reduces fatigue, but also regulates mood, supports memory and brain health.
Yes. Based on over a decade of third party research on micro-dosing botanicals and vaporizer technology, Eagle Energy uses a lower temperature threshold than typical vaporizers to avoid the creation of unintended byproducts, as well as plant-based stimulants which are known to be easy on the lungs and airways when absorbed, compared to synthetic stimulants.
[G]inseng is generally believed to restore and enhance wellbeing along with the following evidence-based health benefits: Reduces inflammation A potent antioxidant, Ginseng has been shown to help reduce inflammatory markers and protect against stress. Strengthens the immune system Ginseng can boost immune function and help prevent infections.
Supporting bone health and preventing osteoporosis Eye health and reducing macular degeneration Uplifting mood and symptoms of depression Improving memory loss Promoting healthy hair, skin and nails
Developed as a healthy caffeine alternative, Eagle Energy is the first and only energy supplement that boost energy with natural, plant-based ingredients, including guarana, ginseng and vitamin B12. Safe, effective and easy to use—welcome to the future of caffeine.
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps that you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to promptly address these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
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