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”:
On your website’s “Products tab”:
On your website’s “More Info tab” which is within the Products tab:
On your website’s “White papers” tab:
On your website “About Us” Tab:
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”:
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):
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 at 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

This page was posted on March 28, 2019.

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