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WARNING LETTER
CMS# 610361

Mr. Lenny John Dorr
Manager
Mushroom Revival, Inc.
301 West Avenue, Unit 5501
Austin, TX 78701

Dear Messrs. Alexander Dorr and John Dorr:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://www.mushroom-revival.com/ in November 2020 and has determined that you take orders there for the products Cordyceps Militaris, Reishi, and Mush-10. The claims on your website establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of website claims that establish that your products are intended for use as drugs include:

• The product page for Cordyceps Militaris shows a link titled “Visit Our Know Your Mushrooms Page for More Info.” Your “Know Your Mushrooms” page for Cordyceps (Cordyceps Militaris) states, under the “IMMUNE” tab, “Cordyceps may contain anti-viral properties . . . and alleviate respiratory diseases. One of the most effective mushrooms for chronic viral infections.”

• The product page for REISHI shows a link titled “Visit Our Know Your Mushrooms Page for More Info.” Your “Know Your Mushrooms” page for Reishi (Ganoderma lucidum) states under the “RELAX” tab, “Reishi is typically known for its bitter taste caused by the terpenoid constituents, which support an anti-inflammatory response. Notably, Reishi’s triterpenes inhibit the release of histamine, thus preventing allergic reactions and inflammations with oleic acid. As an antihistamine, Reishi provides a relaxing effect to asthmatic symptoms.” Your “Know Your Mushrooms” page for Reishi states, under the “IMMUNITY” tab, “It is often and historically used in protocols for the treatment of cancer due to its revered immunomodulating and tonic qualities. With anti-tumor, antimicrobial, and anti-inflammatory properties, this mushroom is a top pick for immunity!” Your “Know Your Mushrooms” page for Reishi states, under the “ADAPTOGENIC” tab, “From its immunomodulating effects, to its anti-inflammatory effects . . . Reishi is one of the most potent adaptogens out there.”

• The product page for MUSH 10 Tincture states: “Naturally anti-inflammatory” and provides a link to your FAQ (Frequently Asked Questions) page, which includes a question “ARE MUSHROOMS REALLY MEDICINAL?” with an answer including “Many studies have shown fungal compounds to have effective adaptogenic, immunomodulating, anti-inflammatory, antiviral, antibacterial, antifungal, anti-allergic . . . properties among many others.”

• On your “Know Your Mushrooms” page for Maitake (Grifola frondosa) (an ingredient in your MUSH 10):

    • Under the “Blood Sugar Levels” tab: “Maitake has been used in protocols to prevent and support diabetes. Studies show that Maitake increases the production of insulin and controls glucose levels, resulting in a decrease in blood sugar levels.”
    • Under the “IMMUNE” tab: “Maitake’s strong immunomodulatory properties, like polysaccharides and beta-glucans, make Maitake highly regarded clinically for cancer and chemotherapies.”
    • Under the “MORE INFO” tab, it states “***Maitake has traditionally been used in Japan . . . to prevent cancer and high blood pressure.”

• On your “Know Your Mushrooms” page for Shitake (Lentinula edodes) (an ingredient in your MUSH 10):

    • Under the “IMMUNITY” tab: “Shiitake has been shown to contain powerful anti-viral, antimicrobial, and anti-candida properties, that help us fight infections. Lentinan, the third most widely prescribed anticancer drug in the world, is a beta-glucan derived from Shiitake that has been shown to trigger the production of T cells and natural killer cells.”
    • Under the “MORE INFO” tab: “[S]hiitake has been used to treat high cholesterol, atherosclerosis, colds and flu.”

• On your “Know Your Mushrooms” page for Turkey Tail (Trametes versicolor) (an ingredient in your MUSH 10):

    • Under the “IMMUNE” tab: “Turkey tail, known as a potent immuno-modulator, may help the body manage infections . . .. Krestin (PSK), developed by the Japanese, and Polysaccharide Peptide (PSP), developed by the Chinese, are two types of polysaccharopeptides extracts found in this mushroom. These extracts are chief ingredients in anticancer drugs developed to boost the immune system before and after treatment in chemotherapy and radiation . . ..”

• On your “Know Your Mushrooms” page for Poria Cocos (Wolfiporia extensa) (an ingredient in your MUSH 10):

    • Under the “RELAX” tab: “In traditional Chinese medicine, Poria has been used for anxiety, restlessness, tension, nervousness, and sleep problems (insomnia).”

• On your “Know Your Mushrooms” page for Chaga (Inonotus obliquus) (an ingredient in your MUSH 10):

    • Under the “IMMUNE” tab: “Studies show that Chaga contains anti-retroviral properties, supporting against RNA viruses which insert a DNA copy of their genome into the host cell in order to replicate. An important example of Chaga disrupting the assembly of this DNA is in HIV. Betulinic acid, primarily growing in the bark of white birch, is a triterpenoid which possesses these properties and contains anti-parasitic and anti-inflammatory constituents. Studies suggest that Chaga is useful in the treatment of some cancers, if used long-term. Russian clinicians report that this mushroom supports appetite and pain management in cancer patients.”
    • Under the ”MORE INFO” tab: “Traditionally, Chaga has been used in Russian folk remedies for stomach problems and immunity, including cancers, ulcers, and gastritis.”

• On your “Know Your Mushrooms” page for Meshima (Phellinus linteus) (an ingredient in your MUSH 10):   

    • Under the “IMMUNE” tab: “Due to it’s [sic] polyphenols, beta-glucans, and intense antioxidant effects, Japanese, Korean, and Chinese practitioners used meshima for defending against and treating cancers.”

Your Cordyceps Militaris, Reishi, and Mush-10 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)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the 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 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 Cordyceps Militaris, Reishi, and Mush-10 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, Cordyceps Militaris, Reishi, and Mush-10 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 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 that your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to correct the violations cited 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 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 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 corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions about the content of this letter, please contact Ms. Aveta at 718-662-5576 or E-mail at lillian.aveta@fda.hhs.gov.

Sincerely,
/S/

Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1