Inspections, Compliance, Enforcement, and Criminal Investigations

Green Supreme Inc. 1/15/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390

 

WARNING LETTER
16-PHI-02
 
 
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
January 15, 2016
  
Nyron L. Ligo, Owner
Green Supreme, Inc.
3647 New Castle Road
West Middlesex, PA 16159
 
Dear Mr. Ligo:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.greensupreme.net in November 2015 and has determined that you take orders there for your “Green Supreme Barley Power,” “Green Supreme Plus Cayenne,” “Green Supreme with Chromium Picolinate,” “Green Supreme Petal Soft,” and “Green Supreme Super Prostate” products. The claims on your website establish that the 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 website claims that provide evidence that your products are intended for use as drugs include:
 
On your website’s “Home Page”:
  • “Barley Grass has the ability to counteract inflammation…Our Products are Recommended by Bill Henderson in his book “Cancer Free” Cancer Patients…”
On your website’s “Products tab”:
  • “Green SupremeTM with Barley Power…fight disease…if you are ordering for a cancer patient please call the office”
  • “Green SupremeTM plus Cayenne…cleanse the venous system of plaque…lowering blood pressure, lowering cholesterol and triglyceride levels, and relieves the stiffness and pain of arthritis…”
  • “Green Supreme with Chromium Picolinate…decreases LDL levels (bad cholesterol), helps to normalize blood sugar, and thus is beneficial for both diabetics and hypoglycemic…reduced heart disease risk, and helping to keep arteries, veins and capillaries clean.”
  • “Green Supreme Petal SoftTM… muscular tremors…migraines, anxiety, and depression…”
  • “Green Supreme Super Prostate…containing standardized saw palmetto extract (clinically proven to prevent benign Prostate enlargement)…”
On your website’s “More Info tab” which is within the Products tab:
  • “The Young Green Leaves of Barley: Barley Power…Powerful antioxidants, beta carotene, and chlorophyll to protect against degenerative diseases: Cancer, Arthritis and others…”
  • “Green Supreme with Cayenne Our Barley tablets have 240 mg of barley to 100 mg of cayenne.  The two nutrients work together to lower cholesterol levels and triglycerides…”
  • “Green Supreme with Chromium Picolinate… decreases LDL (bad cholesterol). And helps to normalize blood sugar levels, thus it is helpful for both diabetics and hypoglycemics.”
  • “Super Prostate…NOW, Super Prostate from Green Supreme, contains standardized saw palmetto extract (clinically proven to prevent benign prostate enlargement)…”
On your website’s “White papers” tab:
  • “What is Green Supreme Barley Power?...Some of green barley’s benefits are listed below: …BETA CAROTENE & CHLOROPHYLL: Both act as powerful antioxidants to protect against degenerative diseases such as cancer…”
  • “Barley Power Green Supreme with 40,000 Heat-Unit Cayenne™…lowers blood pressure, … lowers cholesterol and triglyceride levels, and relieves the stiffness and pain of arthritis…Our barley/cayenne tablets…work together synergistically in such areas as arthritis control, lowering blood pressure, and lowering levels of cholesterol and triglycerides…”
  • “Barley Power Green Supreme with Chromium Picolinate™… decreases LDL (bad cholesterol) levels; diabetics and hypoglycemic; …lowers heart disease risk; helps keep arteries, veins and capillaries clean…”
  • “Green Supreme Petal Soft…to diminish… muscular tremors,…migraines, anxiety and depression.  Several have taken estrogen (Premarin) and Progesterone (Provera) but were afraid of its reported health risks…Our Petal Soft is formulated to keep…bones from becoming fragile…VITAMIN B-6…depression…EVENING PRIMROSE OIL…Contains Omega 6 & 9 fatty acids which are anti-inflammatory…”
On your website “About Us” Tab:
  • “Armed with positive performance results against the wiles of cancer, Green Supreme, Inc., sent 500,000 Green Supreme Tablets to Chernobyl for the children who were victims of the nuclear fallout.  A study was performed by doctors of the Children of Chernobyl and the results to improved blood counts…”
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of “Green Supreme Barley Power,” “Green Supreme Plus Cayenne” for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
 
On your website “Testimonial tab”:
  • “ULCERS…My mom told me about Green Supreme. I started taking it – no more ulcer upset…”
  • “BLOOD PRESSURE TRIGLYCERIDES CHOLESTEROL…In six weeks time my blood pressure came down to almost normal…my cholesterol dropped 50 points. Green Supreme Barley has helped my husband’s breath and arthritis and stomach problems.  It has brought his triglycerides down from 280 to 160.  I quit my medication for my blood pressure and cholesterol because of the side effects…after taking Green Supreme Barley…my blood sugar is under control, no diabetes, the weight has dropped from 236 to 186 lbs…”
  • “LUPUS A little note about Green Supreme, I started taking barley grass about two years ago.  At that time my Lupus pills cost…Six to eight months after being on Green Supreme my doctor said, “you are better than when you first started coming to me…blood tests are great, you don’t look like you have lupus.”
  • “LEUKEMIA I have leukemia.  My platelet count was down to 7500…I started taking 10 to 20 Green Supreme barley tablets a day.  My platelets went up and I am in remission…”
  • “CANCER… I was diagnosed with stage four non-Hodgkin’s lymphoma…Then I discovered Green Supreme Barley Power and started taking it.  In two weeks I lost 80% of my cancer.  My next CAT scan showed me to be cancer-free and I have been free of cancer ever since… I have introduced several cancer patients to Green Supreme Barley Power and they, too, are having good results.”
  • “ANGINA I started taking your Green Supreme Barley with Cayenne about one year ago. Seven weeks into using them I noticed a change in my angina attacks.  They were fewer and a lot less severe and I didn’t use nitro, as much. I then added your cayenne capsules to my regimen and now my angina is a faint memory.”
We also conducted an inspection of your dietary supplement own label distributor, located at 3647 New Castle Road, West Middlesex, PA, from September 2, 2015 through September 14, 2015. Over the course of the inspection, our investigators collected a catalogue with an order form used in connection with your products. Claims included in this catalogue provide evidence that your “Green Supreme Barley Power,” “Green Supreme Plus Cayenne,” “Green Supreme with Chromium Picolinate,” “Green Supreme Petal Soft,” and “Green Supreme Super Prostate” products are intended for use as drugs:
 
In your catalogue (distributed to new customers with your products):
  • “Green Supreme™ Barley (Young Green Leaves)…reported to be Very Beneficial…Arthritis…Diseases and Illnesses.”
  • “He uses Green Supreme™ for the anti inflammatory properties…He declares the anti inflammatory properties of barley reduces pain and swelling of arthritic conditions.”
  • “What is Barley Power?...The nutrients and some of its many benefits are listed below:…Beta Carotene & Chlorophyll: Both act as powerful antioxidants to protect against degenerative diseases such as cancer.”
  • “People say that Barley has helped with Blood Disorders, Arthritis, Allergies, Stomach Problems, Cholesterol, Blood Pressure, Triglycerides…Doctors have told us the Leukemia Society has confirmed that degenerative diseases such as cancer and arthritis will not grow in an alkaline system!”
  • “Reported Benefits from Satisfied Customers Taking Green Supreme Products…Breast Cancer…I have been taking Green Supreme plus Green Supreme with Cayenne…the reason I received such a great report last time. The…scan I just had showed no signs of cancer…Colon Cancer…I credit Green Supreme for my cancer-free report…Lymphoma…with the help of Green Supreme, the cancer will…be in remission…”
  • “Green SupremeTM with Chromium Picolinate…increases HDL, (good cholesterol) levels, thus is beneficial for both diabetics and hypoglycemic…lowers heart disease risk, helps keep arteries, veins and capillaries clean…”
  • “Petal Soft…Our Petal Soft…relief from…muscular tremors,…migraines, anxiety, depression… insomnia…”
  • “Green SupremeTM Super Prostate Male Concerns…Green Supreme’s Super Prostate contains standardized saw palmetto extract (clinically proven to prevent benign prostate enlargement)”
Your 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)]. New drugs may not be legally introduced of delivered for introduction into interstate commerce without prior approval from 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 new drugs on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 
 
Further, your “Green Supreme Barley Power,” “Green Supreme Plus Cayenne,” “Green Supreme with Chromium Picolinate,” “Green Supreme Petal Soft,” and “Green Supreme Super Prostate” products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their 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)].
 
(b)(3)(A)
 
This letter is not an all-inclusive list of violations that exist in connection with your products. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. 
 
You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice. 
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.   
 
Your response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or Lynn.Bonner@fda.hhs.gov.
 
Sincerely,
/S/
Anne E. Johnson
Acting District Director
Philadelphia District
 
 
cc:       
Pennsylvania State Department of Agriculture
Attention: Dr. Lydia Johnson, Director
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408

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