- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameChristian Grantham
- Half Hill Farm Inc
110 W. High Street
Woodbury, TN 37190
- Issuing Office:
- Division of Human and Animal Food Operations East V
November 3, 2020
WARNING LETTER 609440
Dear Mr. Grantham:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.halfhillfarm.com in August 2020 and has determined that you take orders there for the products Reuma-Art X-Strength, Turkey Tail Mushroom Dual Extract, Cordyceps Mushroom Dual Extract, Lion’s Mane Mushroom Dual Extract, Chaga Mushroom Dual Extract, Red Reishi Mushroom Dual Extract, and Propolis Extract. The claims on your websites establish that your products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (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 FD&C Act. You can find the FD&C 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:
On your product webpage for Reuma-Art X-Strength:
- “Reuma-Art X-STrength helps to reduce inflammation caused by arthritis, gout, rheumatism, tendonitis, fibromyalgia, and migraines. Reuma-Art could also help to improve muscle pain, joint pain . . .”
o “Stinging Nettle: A plant rich in Vitamin A, C, and E that possess anesthetic and diuretic properties. An antioxidant that may be used as an astringent and anti-inflammatory”
o “Garlic: . . . May help . . . by acting as an anti-inflammatory.”
o “Celery: . . . The non-starch polysaccharides in celery are important in producing anti-inflammatory benefits.”
On your product webpage for Turkey Tail Mushroom Dual Extract:
- “Turkey tail are known to have anti-cancer, antiviral, antibacterial and antifungal effects as well as immune modulating effects.”
On your product webpage for Cordyceps Mushroom Dual Extract:
- “Studies show many benefits to using cordyceps mushroom extracts including a reduction of inflammation and oxidative stress, the leading causes of most disease.”
- “Cordyceps also increase the body’s natural production of nitric oxide. . . improving lung and liver function.”
- “Cordyceps militaris produces cordycepin, a bioactive compound with antitumor activity in various cancers.”
On your product webpage for Lion’s Mane Mushroom Dual Extract:
- “Lion's Mane mushrooms have also been used for over 2,000 years in Chinese medicine for digestive diseases.”
- “Studies linked below show extracts of Lion’s Mane mushrooms are active against ulcerative colitis, Irritable Bowel Disease, pancreatitis, Crohn’s Disease and gastrointestinal cancers (liver, colon, gastric).”
- “Unique compounds of Lion’s Mane mushrooms . . . also help reduce blood sugar and regulate lipid levels in blood.”
On your product webpage for Chaga Mushroom Dual Extract:
- “Chaga mushrooms have been used as folk medicine in Russia for centuries, more recently in treating the side effects of cancer treatments. Extracts of Chaga mycelium reduce oxidative stresses that lead to many diseases . . .. Studies of Chaga also show antifungal, antiviral, antibacterial, and anti-inflammatory properties. Compounds from both hot water and alcohol extractions . . . have anti-cancer properties and make Chaga a great candidate as an adjunct therapy. Chaga helps balance the immune response to allergies as well as overactive autoimmune responses.”
On your product webpage for Red Reishi Mushroom Dual Extract:
- “Reishi are known to have anti-cancer, antiviral, antibacterial, and antifungal effects as well as a wide variety of immune modulating effects.”
On your product webpage for Propolis Extract:
- “Antioxident [sic]: High concentrations of flavinoids and phenolic acids in propolis reduce oxidative stress . . . Oxidative stresses cause cells to die leading to a variety of diseases like cancer, diabetes and heart diseases.”
- “Anti-inflammatory: . . . Unresolved chronic inflammation can lead to many diseases like atherosclerosis, Alzheimer's, Parkinson, asthma and cancer. Many studies show the flavinoids and cinnamic acid derivatives in propolis reduce inflammatory responses.”
- “Antiviral: Studies show flavinoid rich propolis interferes with the RNA synthesis of herpes simplex 1 and 2, influenza, H1N1, HIV and other viruses.”
- “Antibacterial, Antimicrobial: Propolis is effective against Gram-positive bacteria like Streptococcus mutans, which causes tooth decay and heart disease, Lactobacilli, and Staphylococcus.”
- “Antifungal: Propolis is active against dermatophytes and yeasts, including several Candida strains - some resistant to known antifungal agents.”
- “Antiprotozoal: Propolis shows activity against parasites that cause many diseases in humans. Studies show propolis is active against trichomoniasis, toxoplasmosis, giardiasis, Chagas disease, leishmaniasis, Giardia lamblia, Trichomonas vaginalis, Toxoplasma gondii, Leishmania donovani, Trypanosoma cruzi, and malaria.”
- “Antitumor: Propolis acts against cancer cells by blocking oncogene signalling [sic] pathways, decreasing cancer proliferation by decreasing cancer stem cell populations and increasing cancer apoptosis. Propolis is active against colorectal, human breast, human tongue squamous cell carcinoma, and human prostate cancer cells. Studies show flavonoids from propolis could play a protective role against the toxicity of the chemotherapeutic agents or radiation therapy.”
In addition, when scientific publications or references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of citations as listed on your website used to market Turkey Tail Mushroom Dual Extract for disease treatment and prevention and are thus evidence of your product’s intended use as a drug:
- “FDA Approves Bastyr Turkey Tail Trial for Cancer Patients – Baastyr [sic] University – November 30, 2012”
- “Turkey Tail mushrooms and our personal fight against cancer – Half Hill Farm – December 6, 2013”
- “Complete clinical summary: Turkey Tail – Memorial Sloan Kettering Cancer Center.”
Your Reuma-Art X-Strength, Turkey Tail Mushroom Dual Extract, Cordyceps Mushroom Dual Extract, Lion’s Mane Mushroom Dual Extract, Chaga Mushroom Dual Extract, Red Reishi Mushroom Dual Extract, and Propolis Extract 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), 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 FD&C 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 Reuma-Art X-Strength, Turkey Tail Mushroom Dual Extract, Cordyceps Mushroom Dual Extract, Lion’s Mane Mushroom Dual Extract, Chaga Mushroom Dual Extract, Red Reishi Mushroom Dual Extract, and Propolis Extract products are intended for prevention or 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 Reuma-Art X-Strength, Turkey Tail Mushroom Dual Extract, Cordyceps Mushroom Dual Extract, Lion’s Mane Mushroom Dual Extract, Chaga Mushroom Dual Extract, Red Reishi Mushroom Dual Extract, and Propolis Extract products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the FD&C 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 FD&C 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 marketed 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 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.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Christopher N. Dedeaux, Compliance Officer, via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or at 404 BNA Drive, Suite 500, Nashville, TN 37217. You may reach Mr. Dedeaux at 504-846-6122 or via email at Christopher.Dedeaux@fda.hhs.gov if you have any questions about this matter.
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East