WARNING LETTER
Desert Alchemist LLC
MARCS-CMS 609680 —
December 04, 2020
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Hernán Rafael Castro
Recipient Title
Manager
Desert Alchemist LLC
Tucson
,
AZ
United States
Issuing Office:
Division of Human and Animal Food Operations West IV
United States
December 4, 2020
WARNING LETTER
Ref: CMS Case # 609680
Dear Mr. Castro:
This letter is to advise you that the US. Food and Drug Administration (FDA) reviewed your etsy.com webpage (www.etsy.com/shop/DesertAlchemist) in December 2020 and has determined that you take orders through this third-party online shop for Fortify, Lion’s Mane, The Great Work, Mind Ease, Sweet Balance, Happy Heart, Flair Snare, and Cordycepts sinensis double extract. We have also reviewed your social media websites, www.facebook.com/desertalchemist and www.instagram.com/desert, which direct consumers to your etsy.com webpage (www.etsy.com/shop/DesertAlchemist) where you take orders for your products. The claims on your etsy.com webpage and social media websites establish that your Fortify, Lion’s Mane, The Great Work, Mind Ease, Sweet Balance, Happy Heart, Flair Snare, and Cordycepts sinensis double extract are drugs under section 201(g)(1)(B) 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 violates the Act. You can find the Act through links on FDA’s home page at
www.fda.gov.
Examples of claims observed on your etsy.com webpage (www.etsy.com/shop/DesertAlchemist) and social media websites (www.facebook.com/desertalchemist and www.instagram.com/desert) that establish the intended use of your products as drugs include, but may not be limited to, the following:
Fortify
On your Fortify product page at www.etsy.com/shop/DesertAlchemist:
• “Fortify is an extract made from mushrooms with the best . . . immuno-modulating, antiviral, anti-fungal, and anti-bacterial properties. This is an excellent extract for those people suffer from weak immune systems, hyperactive immune systems, allergic disorders, and is an excellent agent to use as an adjunct therapy to support the immune system during the treatment and recovery of cancer patients.”
Lion’s Mane
On your Lion’s Mane product page at www.etsy.com/shop/DesertAlchemist:
• “Lions Mane Mushroom (Hericium erinaceus) extract . . . This mushroom contains a dipterpenes that Stimulate the production of NGF (Nerve Growt [sic] Factor) protein . . . recent treatment strategies have focused on neurotrophins, such as nerve growth factor (NGF) for myelin sheath repair promotion of axonal regeneration.”
On your store owner description at www.etsy.com/shop/DesertAlchemist:
• “I began making Myco-Floral extracts [myco- refers to mushrooms, an ingredient in your Lion’s Mane product] to help family and friends with neurological problems. After seeing my father’s quick recovery from stroke paralysis.”
The Great Work
On your The Great Work product page at www.etsy.com/shop/DesertAlchemist:
• “The great work is an extract that is made with a combination of 20 different mushrooms that provide support for . . . cholesterol control”
Mind Ease
On your Mind Ease product page at www.etsy.com/shop/DesertAlchemist:
• “Introducing MIND EASE, my new exotic combination of herbs and fungi designed to provide you with a natural alternative to . . . eliminate anxiety. . . Mind Ease has already Sean [sic] amazing results on people who have anxiety and are not affected by other anxiety medication.”
Sweet Balance
On your Sweet Balance product page at www.etsy.com/shop/DesertAlchemist:
• “Sweet balance is a mushroom extract composed of a variety of fungi and flora that Assist in blood sugar control. This extract is excellent for people with diabetes who struggle with blood sugar control. This extract is not meant to replace any kind of blood sugar medication or medical advice. [h]owever, there are many cases of individuals who only use these recipes to control their blood sugar without the need of any medication. This appears to be a natural alternative without the harmful side effects, liver and kidney damage caused by medication.”
On your Instagram page at https://www.instagram.com/desert_alchemist/:
• Posted on March 16, 2018: “Sweet balance is a mushroom extract composed from A variety of fungi and flora that assist in blood sugar control. This extract is excellent for people with diabetes who struggle with blood sugar control. This extract is not meant to replace any kind of blood sugar medication or medical advice. however, there are many cases of individuals who only use these recipes to control their blood sugar without the need of any medication. This appears to be a natural alternative without the harmful side effects, liver and kidney damage caused by medication.”
Happy Heart
On your Happy Heart product page at www.etsy.com/shop/DesertAlchemist:
• “Happy Heart is a blend composed of mushrooms Known for . . . Cholesterol control, increases oxygen uptake, hypertension”
On your Instagram page at https://www.instagram.com/desert_alchemist/:
• Posted on March 15, 2018: “Happy Heart is a blend composed from mushrooms known for . . . Cholesterol control, increases oxygen uptake, hypertension”
Flair Snare
On your Flair Snare product page at www.etsy.com/shop/DesertAlchemist:
• “Flair Snare is a combination of medicinal herbs and fungi . . . These ingredients help regulate acid reflux”
On your Facebook page at www.facebook.com/desertalchemist/:
• Posted on October 14, 2019: “Proud to announce the launching of a new product called Flare Snare a[n] acid reflux, inflammation . . . support.”
Cordycepts sinensis double extract
On your Cordycepts sinensis double extract product page at www.etsy.com/shop/DesertAlchemist:
• “Cordycepts also has immune modulating properties and has shown to significantly stop metastasizing in certain cancerous cells.”
In addition, your Facebook page contains evidence of intended use in the form of personal testimonials that you posted recommending or describing the use of your products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
On your Facebook page at www.facebook.com/desertalchemist/:
• Posted on August 28, 2019: “[G]ave one to a friend who has epilepsy. Taking Lion’s Mane, she had her first month seizure free!!! Now I’m buying this for a friend who has had a stroke”
• Posted on August 30, 2019: “Lion’s Mane was recommended . . . I had not noticed that I was getting cataracts, but they are completely gone now.”
• Posted on October 25, 2019: “I am taking your mushroom medication [which your post identifies as “the great work” and “flair snare”] . . . I contracted lyme disease. Conventional meds did not help but made it worse. . .[Y]our medications show a greater promise in a shorter period of time. My digestive system was instantly healed. Overall movement in my body becomes a little easier.”
Your Fortify, Lion’s Mane, The Great Work, Mind Ease, Sweet Balance, Happy Heart, Flair Snare, and Cordycepts sinensis double extract are not generally recognized as safe and effective for the above-referenced uses and, therefore, the 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 sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. 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” mean 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 Fortify, Lion’s Mane, The Great Work, Mind Ease, Sweet Balance, Happy Heart, and Cordycepts sinensis double extract are intended for treatment of one or more diseases that are not amendable 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 these products safely for the intended purposes. Accordingly, your products fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of this misbranded drug 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 statement 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 your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and the occurrence of other violations. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen 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 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.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Hanna L. Potter, Compliance Officer; 6th Ave and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado, 80225-0087 or via email at hanna.potter@fda.hhs.gov. You may reach Ms. Potter at
(303) 236-3094
if you have any questions about this matter.
Sincerely,
/S/
E. Mark Harris
Acting Denver District Director &
Program Division Director
Office of Human and Animal Food Operations –
Division IV West
Content current as of:
12/15/2020
Regulated Product(s)
Food & Beverages