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  5. Eagles Song Health and Wellness LLC - 609733 - 10/28/2020
  1. Warning Letters

WARNING LETTER

Eagles Song Health and Wellness LLC MARCS-CMS 609733 —

Delivery Method:
Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Thomas Zellers/Janice Zellers
Recipient Title
Owner
Eagles Song Health and Wellness LLC

206 Rhodena Drive
Coupeville, WA 98239
United States

Issuing Office:
Division of Human and Animal Food Operations West VI

United States

October 28, 2020

In reply, refer to CMS 609733

WARNING LETTER

Dear Mr. and Ms. Zellers:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.eaglessongthrivecafe.com in August and October 2020, and has determined that you take orders for the products Greens Hornet Tonic Alchemy, Senior Sage, and Organic Cacao Paste. The claims on your website establish that the products are drugs under section 201 (g)(1 )(8) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321 (g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

Greens Hornet Tonic Alchemy

On the Greens Hornet Tonic Alchemy, 8 oz. and 16 oz. webpages found at the www.eaglessongthrivecafe.com website, under the product description:

• "Many of our wonderful customers have shared with us their health improvements after incorporating the Greens Hornet Smoothie into their morning routine. These include: *Reversal of Type II Diabetes ... *Allergies *Migraine Headaches ... *Cholesterol Lowering *Blood Pressure Lowering"
• "*Note: Greens are alkalizing to the body . . . Disease won't thrive in an alkaline body."

Additionally, disease claims were found under the ingredients listed on the Thrive Greens Ingredients Page, linked within the product descriptions for Greens Hornet Tonic Alchemy, 16 oz and 8 oz webpages, found at the www.eaglessongthrivecafe.com website.

Reishi Mushroom
• "Reishi Mushroom contains chemicals that seem to have a variety of potentially beneficial effects, including activity against tumors (cancer) ... Reishi mushroom is used for: ... viral infections such as the flu (influenza)[,] lung conditions[,] heart disease[,] high blood pressure[,] high cholesterol[,] kidney disease[,] cancer[,] liver disease[,] HIV/AIDS[,] altitude sickness[,] chronic fatigue syndrome (CFS)[,] insomnia[,] stomach ulcer[,] leaky gut[,] herpes pain"

Olive Leaf
• "Olive Leaf benefits include: protecting the body from viruses, bacteria or retroviruses[,] viruses including herpes and shingles[,] anti HIV ... colds, flus and pneumonias"

Gymnema Sylvestre Leaf
• "ymnema [sic] Sylvestre Leaf benefits include: diabetes[,] blood sugar lowering ... anti-bacterial[,] lowering of cholesterol and triglycerides"

Spirulina
• "Spirulina benefits include: ... A healthy inflammatory response"

Chlorella
• "Chlorella benefits include: ... prevention of anemia ... improving your digestive system (constipation ... )[,] fighting cancer by increasing interferon levels ... normalizing blood pressure and blood sugar"

Moringa Powder
• "Moringa benefits include: ... Healthy blood sugar levels - antioxidants and unique regulating compounds help control blood sugar ... decreased depression and anxiety ... helpful for diabetes[,] improvements in arthritis[,] high blood pressure reduction[,] improvements in cancer"

Astragalus
• "Astragalus will support the following conditions: chronic illness[,] general weakness ... diarrhea reduction[,] uterine bleeding reduction[,] shortness of breath[,] wasting disorders[,] numbness and paralysis of the limbs[,] chronic ulceration and sores"

Matcha Green Tea Extract
• "Matcha Green Tea has the following benefits: ... Fights against viruses and bacteria ... Lowers cholesterol and blood sugar"

Stevia Leaf
• "Benefits of stevia leaf are as follows ... regulation of glucose level in the bloodstream[,] stabilizes sugar level in diabetic patients ... high blood pressure (hypertension) lowering without side-effects"

Bitter Melon
• "Benefits of Bitter melon include: ... Anti-diabetic ... Helpful in respiratory diseases like asthma, bronchitis, rhinitis, and pharyngitis[,] Inhibits an enzyme called guanylate cyclase, which is linked to the development of cancer"

Rhodiola
• "Benefits of Rhodiola are as follows: ... Improvements in neurological disorders like depression, anxiety ... Effective in treatment of sleep disorders ... Improves ... premature ejaculation[,] Cardiac or heart related health concerns. It helps in treating hypertension and stress-induced cardiac disorders. It also helps in regulating heart beats and prevents arrhythmia."

Ashwaganda [sic]
• "Ashwagandha health benefits: ... Significant Anti-Inflammatory Properties[,] Osteoarthritis reduction in inflammation, pain and disability[,] Anxiety and Panic Attack reduction"

Acidophilus
• "Prevents and treats diarrhea. Reduces overgrowth of pathogens in your digestive tract. Relieves Irritable Bowel Syndrome, Crohn's disease, and gut dysbiosis. Decreases frequency of vaginal yeast infections and urinary tract infections ... May treat respiratory infections like sinusitis and bronchitis."

Senior Sage

Under the product description on the Senior Sage webpage found at the http://www.eaglessongthrivecafe.com/ website.

• "Inflammation (Protection from Disease)"
• "Inflammation in the body results in disease ... Senior Sage is a great way to reduce or eliminate inflammation."

Organic Cacao Paste

On the Organic Cacao Paste webpage found at the http://www.eaglessongthrivecafe.com/ website, under the product description:

• "Health Benefits of Raw Cacao: ... *Dilates Bloods Vessels and Reduces Blood Clotting *Assists in Regulating Heartbeat and Blood Pressure *Reduces the Risk of Stroke and Risk of Heart Attacks ... * Acts as an Anti-Depressant and Balances the Mood *Balances the Brain Chemistry"

Your products Greens Hornet Tonic Alchemy, Senior Sage, and Organic Cacao Paste are not generally recognized as safe and effective for the above referenced uses and, therefore, your products are "new drugs" under section 201 (p) of the Act [21 U.S.C. § 321 (p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug based on scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products Greens Hornet Tonic Alchemy and Organic Cacao Paste are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Greens Hornet Tonic Alchemy and Organic Cacao Paste fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331 (a)].

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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 correct all violations noted in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: Amy R. Glynn, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have any questions regarding this letter, please contact Compliance Officer Glynn at 425-302-0411.

Sincerely,
/S/
Miriam R. Burbach
District Director
Program Division Director

 
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