- Delivery Method:
- VIA UPS and Electronic Mail
Food & Beverages
Recipient NameAdam and Angela Schultz
- Brilliant Enterprises LLC
621 Main Street, Unit 182
Gaylord, MI 49735
- Issuing Office:
- Office of Human and Animal Food Operations Division- East 6
FY 21- HAFE6 WL- 03
July 20, 2021
Dear Adam and Angela Schultz:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://levelupmushrooms.comin June and July 2021 and has determined that you take orders there for the products Lion’s Mane, BoomChaga, CordaCex, and LVL:MAX. We have also reviewed your social media websites atwww.instagram.com/levelupmushrooms and https://twitter.com/LvlUpMushrooms, which direct consumers to your website https://levelupmushrooms.com to purchase your products. The claims on your websites establish that these products 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 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 claims observed on your websites that provide evidence that your products are intended for use as drugs include:
On the product webpage for Lion’s Mane of your website https://levelupmushrooms.com:
• “Protects Against Ulcers in the Stomach: Goodbye Pain”
• “Relieves Depression and Anxiety: We All Need Relief”
• “[R]elieves depression and anxiety…”
On the scientific studies webpage of your website https://levelupmushrooms.com, under the heading “Lion’s Mane Scientific Studies”:
• “Lion’s Mane May Be Effective in Combating Dementia/Alzheimer’s Disease”
• “Lion’s Mane Has Shown In Studies That It Could Reduce Anxiety And Depression”
• “Animal Testing Shows Lion’s Mane Helps Control Diabetes Symptoms By Keeping Blood Sugar Low”
On the product webpage for BoomChaga of your website https://levelupmushrooms.com:
• “Lowers Cholesterol: Live Longer”
• “BoomChaga is 100% Chaga Mushroom. …More importantly, this mushroom is absolutely LOADED in antioxidants which are known cancer fighters.”
• “Chaga contains more antioxidants . . . Antioxidants are those things that you always hear about but don’t know what they do. What they do is … because they repair DNA and ward off cancer. . . . it also improves health by showing its ability to fight inflammation and help with irritable bowel syndrom in other studies.”
• “Data has shown that Chaga could help ward off the following health problems: Diabetes, lrratable Bowel Syndrome, and viral infections such as Herpes.”
On the scientific studies webpage of your website https://levelupmushrooms.com, under the heading “Chaga (BOOMCHAGA!) Scientific Studies”:
• “Potential For Fighting Cancer Due To The Extremely High Level of Anti-oxidants In Chaga”
• “Anti-diabetic Effects”
• “Help For Inflammatory Bowel Disease (irritable bowel)”
• “Anti-viral Effects (herpes simplex)”
On the product webpage for CordaCex of your website https://levelupmushrooms.com:
• “CORDACEX BENEFITS…reduces inflammation, shows cancer fighting properties...”
On the product webpage for LVL:MAX of your website https://levelupmushrooms.com:
• “Our product has helped 100's of people with anxiety and other mental problems...”
On your social media website www.instagram.com/levelupmushrooms:
• “…Feeling a little down and depressed?… Did you know we can help with all that and more with just some awesome mushrooms?... #LevelUpMushrooms . . . #DepressionAndAnxiety #BeatDepression #BeatAnxiety. . .” [From a June 25, 2020 post that includes an image of your LVL:MAX product]
On your social media website https://twitter.com/LvlUpMushrooms:
• “LVL:MAX . . . Protects Against Ulcers in the Stomach: Goodbye Pain… Relieves Depression and Anxiety… Lowers Cholesterol: Live Longer…Lower Inflammation…” [From a Nov 12, 2019 post]
Your Lion’s Mane, BoomChaga, CordaCex, and LVL:MAX 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 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 the FDA, as described in sections 301(d) and 505(a) of the 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 Lion’s Mane, BoomChaga, CordaCex, and LVL:MAX products 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, Lion’s Mane, BoomChaga, CordaCex, and LVL:MAX 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)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your 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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any 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 do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to U.S. Food and Drug Administration, Lauren Sexton, Compliance Officer, 300 River Place, Suite 5900, Detroit, MI 48207 or by email to Lauren.Sexton@fda.hhs.gov.
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food Operations
Division- East 6