FDA WARNING_LETTER - Eagle Energy USA, Inc. - December 07, 2021

On December 1, 2021, the FDA issued a Warning Letter to Eagle Energy after reviewing their website (https://eagle.energy) and social media (https://www.facebook.com/MyEagleEnergy/) in September 2021. The FDA determined that Eagle Energy's "Caffeine Pen" products, marketed as "Lychee Ice" and "Guarana Berry," are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the FD&C Act.

The FDA stated that the products are labeled for inhalation, not ingestion, and therefore do not meet the definition of a dietary supplement. Claims on the website, social media, and product packaging, such as "boost energy while improving mental clarity, athletic performance and weight loss," "Reduces inflammation," "Strengthens the immune system," and "Uplifting mood and symptoms of depression," establish that the products are intended for use as drugs.

The FDA noted safety concerns regarding inhaled products, including potential for laryngospasm, bronchospasm, tissue toxicity, or undesirable systemic effects. As the products are not generally recognized as safe and effective for their intended uses, they are considered "new drugs" under section 201(p) of the FD&C Act and lack FDA approval.

Eagle Energy must promptly address these violations and notify the FDA in writing within fifteen working days of receipt of the