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WARNING LETTER

December 1, 2021

RE: 617712

Dear Eagle Energy:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://eagle.energy in September 2021 and has determined that you take orders there for “Caffeine Pen” products packaged as “Lychee Ice” and “Guarana Berry” (hereinafter referred to as your “Caffeine Pen” products). We have also reviewed your social media website at https://www.facebook.com/MyEagleEnergy/. This social media website directs consumers to your website https://eagle.energy/ to purchase your products. The claims on your website, social media website, and product packaging, establish that your products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Furthermore, the use of your “Caffeine Pen” products raises safety concerns for the agency because the ingredients and/or impurities in oral inhalation products may trigger laryngospasm or bronchospasm, may be toxic to the tissues in the upper or lower airways, or may be absorbed and exert undesirable systemic effects or organ toxicity.

You appear to be marketing your Caffeine Pen products as dietary supplements. For example, your website and product package describe your Caffeine Pen products as “natural energy supplement[s].” However, your products’ labeling states that they are intended for inhalation. For example, your website describes your products as an “inhalable caffeine alternative.” The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i), 21 U.S.C. 321(ff)(2)(A)(i), as a product that is “intended for ingestion.” Your “Caffeine Pen” products are not intended for ingestion. Therefore, your “Caffeine Pen” products do not meet the definition of a dietary supplement under the FD&C Act.

Based on our review of your website, social media website, and product packaging, your Caffeine Pen products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.

Examples of some of the claims observed on your website https://eagle.energy, your social media website https://www.facebook.com/MyEagleEnergy/, and your product packaging that provide evidence that your products are intended for use as drugs include, but may not be limited to, the following:

On the website https://eagle.energy/:

• “Our Caffeine Pen TECHNOLOGY

Backed by an unwavering commitment to research, quality and innovation, Eagle Energy utilizes a proprietary, plant-based formula—including guarana extract, ginseng extract, and vitamin B12—and a customized heating system engineered to deliver a natural, effective, and inhalable caffeine alternative.”

• “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.”
• “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.”

• “Ability to control the effects

Ingested caffeine stays in your system for over 5 hours, which can cause jitters and impact sleep. However, when inhaling caffeine, it metabolizes quite quickly and lasts about 1 hour. Which means with Eagle Energy, you can control the level and duration of your energy boost.”

• “Is it safe to inhale caffeine?

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. We also know that the natural caffeine stimulants in guarana absorb and metabolize quickly, lasting about 1 hour. The recommended serving size is 5 to 20 breaths, depending on your caffeine sensitivity. Unlike drinking caffeine, there are no side-effects like jitters, stomach-ache, and other gastro-issues.”

• “How long does an Eagle Energy Booster last?

Each Eagle Energy Booster unit offers approximately 400 breaths, assuming 3 seconds per inhalation. Depending on your caffeine sensitivity, the serving size is 5 to 20 breaths.”

From your blog articles on the webpage: https://eagle.energy/blogs/news:

• “[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.

Increases energy
Ginseng can help fight fatigue, promote energy, and enhance physical activity.

Sharpens brain function
Ginseng has been shown to improve mental cognitive functions and increase feelings of calmness while being a natural mood booster.”

• “Vitamin B12 is a nutrient that helps keep the body’s nerve and blood cells healthy and helps make DNA, the genetic material in all cells. Vitamin B12 also helps prevent a type of anemia called megaloblastic anemia that makes people tired and weak.

And as Healthline reports, in addition to cell formation and energy boosting qualities, Vitamin B12 has even more science-based health benefits including:

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”

• “[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.”

On your Facebook social media website at https://www.facebook.com/MyEagleEnergy/:

• On your November 16, 2020 post: “10/10 would definitely get again! I love the lychee ice so much! I have really bad GERD and this surprisingly helped tremendously.”
• On your November 23, 2020 post: “Fun Fact: Eagle Energy contains Vitamin B12 which not only reduces fatigue, but also regulates mood, supports memory and brain health.”

On your product packaging:

• “GUARANA

The seeds from guarana fruit contain stimulants that boost energy while improving mental clarity, athletic performance and weight loss.”

VITAMIN B12
An essential energy super supplement, Vitamin B12 helps keep the body’s nerve and blood cells healthy, reducing fatigue.

GINSENG
Ginseng is a potent antioxidant known to boost brain function. It can also strengthen the immune system, reduce inflammation, and increase energy.”

“1. How does Eagle Energy compare to the boost I get from an energy drink?

When you inhale Eagle Energy’s natural, plant-based caffeine, you will start to feel an energy boost in about 5 minutes. A sugar-filled energy drink takes over 30 minutes to take full effect. There is also no sugar or calories in Eagle Energy, which means no weight gain or sugar crash.

2. Will the caffeine in Eagle Energy give me the jitters?

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.

3. Caffeine can give me a stomach ache—will Eagle Energy?

The natural caffeine in Eagle Energy comes from guarana berries, which when consumed in microdoses, does not irritate the stomach or cause other gastro-issues.”

Your Caffeine Pen products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. No approved applications are in effect for your products.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to address the violations cited in this letter. Failure to promptly address these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.

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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within fifteen working days, state the reason for the delay and the time within which you will do so.

Your written reply should be directed to the U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to [email protected].

Sincerely,
/S/

Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration