Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772
June 30, 2017
WARNING LETTER 520950
UNITED PARCEL SERVICE
Delivery Signature Requested
Sharon L. Bush, Owner
Nature’s Health Company, LLC
1916 Forest Knoll Drive
Hoover, Alabama 35244-1430
Dear Mrs. Bush:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility, Nature’s Health Company, located at 1916 Forest Knoll Drive, Hoover, Alabama, on February 6, 2017. Additionally, we conducted a review of your website, www.natureshealthcompany.com in April, 2017. Based on our inspection and subsequent review of your website, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA’s Internet home page at www.fda.gov.
In April, 2017, we reviewed your website at the Internet address www.natureshealthcompany.com and determined you take orders there for the products Ojibwa Herbal Tea Formula, Acai-Acai Berry Fruit, Blood Sugar Support, Graviola, Maca, and Super Strength Prostate Formula. The claims on your website establish these products are drugs under Section 201(g)(1)(B) of the Act [21 United States Code (USC) 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.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Ojibwa Herbal Tea Formula
Your website provides an “anecdotal history” of a nurse who reportedly used a tea with the same four ingredients as your Ojibwa Herbal Tea Formula product to treat cancer. As the FDA investigators discussed with you during the inspection, this “anecdotal history” provides evidence that your product Ojibwa Herbal Tea Formula is intended for use as a drug. Some of the relevant language from this part of your website is as follows:
- “[B]uy our product with confidence since it contains the same 4 ingredients, in the same proportions reportedly given by the medicine man.”
- “Woman had been diagnosed with breast cancer”
- “[A]unt was diagnosed with inoperable cancer, Rene began giving the tea to her aunt.”
- “[C]ombination of these four particular herbs somehow seemed to cause the different organs in the body to "normalize" helping the body's own immune system to fight and correct whatever was wrong.”
- “She operated a Cancer Treatment Clinic in Canada using her special tea...”
Acai-Acai Berry Fruit
- “Acai berries can help the body get rid of toxins that can cause illness such as cancer, heart problems, high cholesterol and stress related illnesses.”
- “Acai is also reported to… help maintain healthy cholesterol levels in the normal range…”
- “Free radicals can cause DNA damage which can start cancers and other serious diseases. When so many cells become damaged, we … develop more sickness and disease. Supplementing with Acai berries can help.”
Blood Sugar Support
- “Natural Support for Blood Sugar Levels”
- “Blood Sugar Support Formula can help you keep your sugar levels balanced”
- “Diabetes a Common but Potentially Serious Problem”
- “Blood Sugar Support Formula – to help maintain blood sugar levels in the normal range”
- “These ingredients provide a totally natural, yet highly effective natural approach to supporting blood sugar levels.”
- “GRAVIOLA IS THE SUBJECT OF CANCER STUDIES”
- “Graviola has been a subject of several different cancer studies with interesting results.”
- “We suggest you like to read some if the information from a news release by the HEALTH SCIENCES INSTITUTE January 2001, NEWS ALERT, No.7. as well as information from RainTree Nutrition’s Tropical Plant Database.”
- Excerpt from Health Sciences Institute release identified above: “Graviola is 10,000 times stronger in killing colon cancer than Adriamycin, a commonly used chemotherapeutic drug.”
- “Some suffer … sexual dysfunction …”
- “Maca has been made famous for its positive effects on sexual dysfunction…”
- “[H]elp women with menstrual pain
Super Strength Prostate Formula
- “Prostate cancer is the second leading cause of death for men … “
- “After reading some of the Clinical Trials and Studies, (references provided) and the positive results achieved in those studies using these various ingredients, we formulated our "Super Strength Prostate Formula."
- “Saw Palmetto Extract is commonly used for treatment of common, age related, prostatic hyperplasia.”
- “May protect against viruses”
- “Believed to diminish age related prostate symptoms and may actually reduce the size of the prostate”
- “[H]elps decrease liver damage and cirrhosis”
- “VIT-E substantially reduces the risk of prostate cancer.”
- “[T]here were 41 percent fewer deaths from prostate cancer that those not receiving Vitamin-E.”
- “[H]istorically been used for urinary tract infections.”
In addition, when scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use. For example, under 21 Code of Federal Regulations (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 is an example of a reference citation used to market one of your products for disease treatment and prevention on your website, which is evidence of the product’s intended use as a drug:
Super Strength Prostate Formula
“This special combination of carefully chosen ingredients makes our new Super Strength Prostate Formula special[.] 3 Super Strength Prostate Formula Capsules Contain: . . . Tomato Powder 15 mg. . . . *A study at HARVARD MEDICAL SCHOOL showed measurable relationship between lycopene found in tomatoes and prostate cancer. Researchers at the Mayo Clinic, Cornel University and the Harvard University School of Public health have linked lycopene to good health. You will find more detailed information by reading the study:
*(Clinton SK, Emenhiser C., Schwartz S.J., Bostwick D.G., Williams A.W.,Moore B.J., Erdman J.W Jr., Dana-Faber Cancer Institute, Harvard Medical School, Boston, Massachusetts, Cis-trans Lycopene isomers, carotenoids, and retinol in the Human prostate. Cancer Epidemiol Biomarkers Prev;5(10):823-833,Oct 1996).”
Your Ojibwa Herbal Tea Formula, Acai-Acai Berry Fruit, Blood Sugar Support, Graviola, Maca, and Super Strength Prostate Formula 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 USC 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 USC 331(d), 355(a)]. FDA approves a new drug based on scientificdata and information demonstrating the drug is safe and effective.
A drug is misbranded under Section 502(f)(1) of the Act [21 USC 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 USC 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your Ojibwa Herbal Tea Formula, Acai-Acai Berry Fruit, Blood Sugar Support, Graviola, and Super Strength Prostate Formula 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, your Ojibwa Herbal Tea Formula, Acai-Acai Berry Fruit, Blood Sugar Support, Graviola, and Super Strength Prostate Formula 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 USC 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates Section 301(a) of the Act [21 USC 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 and 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 but not limited to seizure and/or injunction.
Please respond in writing within 15 working days of your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. You should include in your response 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 15 working days, state the reason for the delay and the time within which you will complete the corrections.
Please send your reply to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Nashville, TN 37217. Any questions you may have regarding this process should be directed to Mr. Rivero at (504) 846-6103.
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East
This page was posted on April 30, 2019.