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January 6, 2021

In reply, refer to CMS 610493

WARNING LETTER

Dear Mr. Timmins:

This is to advise you that the US. Food and Drug Administration (FDA) reviewed your website at the Internet address www.totalnutraceutical.com in September 2020 and December 2020, and has determined that you take orders there for the products Lion's Mane -All Natural Supplement, Antrodia Mushroom Powder, Maitake Mushroom Powder, Reishi Mushroom Powder, Cordyceps Mushroom Powder, and Cordyceps - All Natural Mushroom Dietary Supplement. The claims on these websites establish that these 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:

Lion's Mane - All Natural Supplement

Your product page at www.totalnutraceutical.com/lions-mane-supplement contains the following claims:

• "Helps to lower cholesterol"
• "Anti-inflammatory"
• "It has been linked to having positive implications towards reducing cholesterol levels and inflammation"

Antrodia Mushroom Powder

On your product page for Antrodia Mushroom Powder at www.totalnutraceutical.com/antrodia, you claim that your product has:

• "Anti-inflammatory properties," and
• " ... [t]he Antrodia mushroom has long been used as a potent anti-inflammatory for a variety of conditions including liver disease, hypertension ... It is also used to help increase the body's defenses and prevent illness"

Maitake Mushroom Powder

Your product page for Maitake Mushroom Powder at www.totalnutraceutical.com/maitake states that the product:

• "Promotes balanced blood sugar," and that the mushroom has been
• "Found to also have cancer fighting properties"

Reishi Mushroom Powder

On your product page for Reishi Mushroom at www.totalnutraceutical.com/mushroomsreishi, you state the following:

"There are many reported health benefits of the Reishi mushroom. Some of these include:

• Relief of viral infections ...
• Prevention of heart disease
• Reduce high blood pressure
• Lower high cholesterol
• Prevention of prostate cancer
• Strong anti-inflammatory properties"

Cordyceps Mushroom Powder

On your product page for Cordyceps Mushroom at www.totalnutraceutical.com/mushrooms-cordyceps, you state the following:

"There are many reported health benefits of the cordyceps mushroom. Some of these include:

• Cholesterol reduction
• Promotes balanced blood sugar ...
• Faster recovery from bronchitis and respiratory diseases ...
• Anti-tumor ...
• ... enhanced recovery from chemotherapy"

Cordyceps - All Natural Mushroom Dietary Supplement

On your product page at www.totalnutraceutical.com/cordyceps-supplement, you claim:

• "Promotes balanced blood sugar"
• " ... Cordyceps has long been used to treat a variety of health conditions. Its properties range from promoting lower cholesterol to balancing blood sugar levels."

Your Lion's Mane -All Natural Supplement, Antrodia Mushroom Powder, Maitake Mushroom Powder, Reishi Mushroom Powder, Cordyceps Mushroom Powder, and Cordyceps -All Natural Mushroom Dietary Supplement products 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 on the basis of scientific data and information demonstrating 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 Lion's Mane -All Natural Supplement, Antrodia Mushroom Powder, Maitake Mushroom Powder, Reishi Mushroom Powder, Cordyceps Mushroom Powder, and Cordyceps - All Natural Mushroom Dietary Supplement 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 these products safely for their intended purposes. Accordingly, your Lion's Mane -All Natural Supplement, Antrodia Mushroom Powder, Maitake Mushroom Powder, Reishi Mushroom Powder, Cordyceps Mushroom Powder, and Cordyceps - All Natural Mushroom Dietary Supplement products 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 at your facility or 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 or implement corrections to 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/or 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 believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. 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.

Your written reply should be sent to the Food and Drug Administration, Attention: Mark Babbitt, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have any questions, please contact Mark Babbitt at 509-353-2136 ext. 107.

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