Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
DEC 10 2015
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Miracle in the Green, Inc.
Attn: Ify Chuke-Nwobi
4520 Old Carriage Trail
Oviedo, FL 32765
Dear Ms. Nwobi:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.miracleinthegreen.com in November 2015 and has determined that you take orders there for the product, "Oringaa (100% Moringa Leaf Powder)." Based on our review, your website promotes Oringaa (100% Moringa Leaf Power) for conditions that cause this product to be a drug under section 201 (g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321 (g)(1)].
The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure mitigation, treatment, or prevention of disease. As explained further below, introduction or delivering these products for introduction into interstate commerce for such uses violates the Act. You may 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 website that provide evidence that your Oringaa (100% Moringa Leaf Powder) is intended for use as a drug include the following:
On the homepage:
• "Moringa is unique in that it is known to cure 300 diseases ....
• "High concentration of natural Anti-inflammatory material Antimicrobial,
Antibacterial, Antifungal, Antitoxins, Antitumors ..
On the webpage titled, "Blog,"
Under the heading, "Spice up your love life with this love potion recipe ... ":
o .. Moringa ... [has] been shown to lower blood pressure ... improve heart health ... "
Under the heading, "ENERGIZE YOUR LIFE IN 5 MINS'':
o "Helps with the management of diabetes. A 2006 study conducted by researchers at the Tokyo University of Agriculture found that Moringa powder lowered blood glucose levels in diabetic rates [sic]:"
o "Leaf tea treats gastric ulcers and diarrhea."
o "Leaves treat fevers. bronchitis, eye and ear infections, inflammation of the mucus membrane."
o "The iron content of the leaves is high, and they are reportedly prescribed for anemia in the Philippines."
o "Dried Moringa leaves treat diarrhea in Malawi, Africa."
On the "Oringaa (100% Moringa Leaf Powder)" product webpage:
• "Moringa is used for "tired blood'' (anemia); arthritis and other joint pain (rheumatism); asthma; cancer... diabetes; diarrhea; epilepsy; stomach pain; stomach and intestinal ulcers ... headache; heart problems; high blood pressure; kidney
stones ... thyroid disorders; and bacterial, fungal, viral, and parasitic infections.''
• "Moringa is also used to reduce swelling ... prevent pregnancy ..."
On the webpage titled, "Testimonials'':
• "I have noticed that it [Moringa] has definitely helped in protecting me against respiratory infections ... I have had zero infections ....."
We also collected promotional material for your product at the 2015 Natural Products Expo East trade show that was held on September 17-19, 2015 at the Baltimore Convention Center. This promotional material includes the website address http://www.miracleinthegreen.com where your "Oringaa (100% Moringa Leaf Powder)" product can be purchased directly. Claims included in this promotional material provide evidence that your product is intended for use as a drug:
• "Manages DIABETES''
• "Cuts HIGH BLOOD PRESSURE''
• "Cures 300 DISEASES"
Moreover, there are claims made on your Facebook page, http:/www.facebook.com/MiracleintheGreen, in posts made by the page administrator on your Facebook Timeline. Your Facebook page provides a link to your website at
http://www.miracleinthegreen.com, where your "Oringaa (100% Moringa Leaf Powder)" product can be purchased directly. These claims provide further evidence that your product is intended for use as a drug:
• On the March 27, 2015 post: "It is an anti-inflammatory''
• On the February 28, 2015 post: "Moringa Powder... can lower the blood pressure ... "
• On the February 12, 2015 post: "Moringa ... lowers blood pressure''
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a "new drug" 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 the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]: see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore. your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore adequate directions for use cannot be written so that a layperson can use these drugs safely for its intended purposes. Thus, "Oringaa (100% Moringa Leaf Powder" is misbranded within the meaning of section 502(t)(1) of the Act, in that its labeling fails to bear adequate directions for use (21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations are not meant to be an all-inclusive list of violations associated with your products or their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
You should take prompt action to correct the violations cited in this letter and prevent their future recurrence. Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond please explain the reason for the delay and the date by which each such item will be corrected.
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to Mabel Lee at U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Brach Parkway, College Park. MD 20740 or via e-mail to email@example.com. If you have any questions concerning this letter, please contact Ms. Lee at 240-402-0972.
William A. Correll. Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition