Friday, September 20, 2013

Moringa, Drugs, and Spices That Come From India...Are They Safe To Eat?

I get several calls a week on why I will not buy or sell Moringa from India or Moringa that has not been tested and bottled in a US lab....this is the answer below. 

Is the product you bought from India Safe? This includes spices such as Turmeric and even some of the drugs you may be taking. 

No... they are probably NOT safe even if the product is organic certified or packaged in an India lab. 

I receive 3 calls a week on this subject referring to products customers have bought from other companies who sell India Moringa. They want my opinion. 

My answer and the evidence is given below.  This article shows how spices, drugs, and Moringa grown and packaged in India are inferior in quality. It demonstrates how bad the India labs for their quality control procedures.

My Moringa caps come from Moringa grown in Honduras and is tested for Mold, bacteria, E-Coli  and bottled in a US lab. 

Twenty-Five percent of the black pepper, cumin, chili, or cardamon you use in your cooking is imported from India. India is the largest exporter of spices in the world!

Look at the evidence below from three different articles on India labs. This evidence supports my answer on the safety of products from India including Moringa powder.

The second part is on my experience trying to import organic certified Moringa powder from India several years ago. It is why I no longer sell product grown or packaged in India or China.  My experience proved that organic certified from India can be grossly contaminated. Herbs in India are not regulated to the extent of drugs. So if drug production fails the FDA inspections, what quality does the herb production have?  
Two of the articles were published this week on three India labs that failed inspections for drugs they produce. Drug production undergoes more intense examination than herb production does. This statement was repeated on purpose.

So the fact your Moringa product was produced by an India lab or is organic certified does not mean much. Please read the full articles that these excerpts come from. It will open your eyes to the truth. 

First Article excerpts

'MUMBAI, India (AP) -- Shares in India's largest pharmaceutical company plummeted Monday after U.S. regulators issued an import warning on one of its factory's products for failing quality control inspections."

With revenues of $2.3 billion for the last fiscal year, Ranbaxy is the leading drug maker in India's $26 billion generic pharmaceutical industry, but it has been plagued with problems in the U.S.

In May, the company's American subsidiary agreed to pay $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators, the largest financial penalty against a generic drug company for violations of the Federal Food, Drug and Cosmetic Act, which prohibits the sale of impure drugs. 

In late 2012, another subsidiary, Ranbaxy Pharmaceuticals Inc., was forced to halt production of a generic version of the cholesterol drug Lipitor to investigate how tiny glass particles got into the ingredients used for dozens of batches that had to be recalled. It was Ranbaxy's second recall of the drug in three months.

Two years ago, the FDA struck a deal that required Ranbaxy Laboratories Ltd. to undergo extra oversight and review from a third-party and improve its drug making procedures. "

 Read the full article Here

Second Article and Three excerpts from this article........

"New Delhi: Many Indian drug makers find themselves on wrong side of American rules, the US health regulator FDA says they are finding contaminants like filth, pesticides and insect parts in drugs manufactured here, but similar problems exit in many other countries as well."   

Listing out the problems encountered by its investigators in India, FDA said these were similar to those seen around the world and include issues associated with quality systems implementation, data integrity, and validation of various processes used in manufacturing or testing.

"FDA also encounters adulteration with contaminants that shouldn't be there, like microbiological agents (such as salmonella, listeria), or products identified with unapproved chemicals or pesticides, or presence of filth (such as foreign bodies, insect parts).

Third article on violations by other India labs:

"With regard to the second company, Himachal Pradesh-based Sentiss Pharma (formerly Promed Exports), the FDA said the company failed to establish adequate systems for monitoring environmental conditions and for cleaning and disinfecting the room and equipment in aseptic processing areas.

At least six Indian drug makers have been issued such warning letters so far this year by the FDA, which has also ordered recall of certain drugs manufactured in India.

Wockhardt and Fresenius Kabi received warning letters last month, while Hospira Healthcare India and RPG Life Sciences got such letters in May.

Besides, the FDA recently also clamped down on 15 companies globally, including Gujarat-based Amrutam Life Care, for illegal sale of drugs labelled as dietary supplements and ayurvedic products for treating diabetes.

Others having faced FDA action for non-compliance with various US regulations include Ranbaxy, Dr Reddy's Labs, Sun Pharma, Cadila, Aurobindo Pharma and Glenmark. "

My own experience below importing organic certified Moringa: This is the original Hold Notice by the FDA. Contaminated organic certified Moringa powder and caps packaged for resale in the United States: 
The yellow below highlights the contamination found in that shipment:

United States Food and Drug Administration
Notice of FDA Action
Southwest Import District
FDA will not request redelivery for examination or sampling, if the products not released by FDA are moved, following USCS conditional release to a location within the local metropolitan area or to a location approved by the FDA office at the number below.

All products in this entry not listed above may proceed without FDA examination.  This notice does not constitute assurance the products involved comply with provisions of the Food, Drug, and Cosmetic Act or other related acts, and does not preclude action should the products later be found violative.
Entry Number:
February 18, 2011
Notice Number:
Date Received: January 28, 2011
Port of Entry:
2501, San Diego, CA 
Arrival Date:
January 27, 2011
Ferrer Brokers
9840 Via De La Amistad
Suite B
San Diego, CA  92154
Broker Box:
Importer of Record: Lona Cathryn Freer, Alpine, CA  91901-5409
Lona Cathryn Freer, Alpine, CA  91901-5409
The following products are subject to refusal pursuant to the Federal Food Drug and Cosmetic Act (FD&CA), Public Health Service Act (PHSA),or other related acts in that they appear to be adulterated, misbranded or otherwise in violation as indicated below:
Product Description
Respond By
March 11, 2011
You have the right to provide oral or written testimony, to the Food & Drug Administration, regarding the admissibility of the article(s) or the manner in which the article(s) can be brought into compliance.  This testimony must be provided to FDA on or before the dates shown above.
Please direct your response to:
Brett W. Podoski, Compliance Officer (CTNH)
U.S. Food and Drug Administration
9777 Via De La Amistad, Rm. 128
San Diego, CA 92154
(619) 661-3250 ext. 117
(619) 661-3195 (FAX)
2 Page:
Notice Prepared For:  The District Director, U.S. Food and Drug Administration
Notice Prepared By:   CAW
FD&CA Section 501(a)(2)(A), 801(a)(3); ADULTERATION
The article appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. Actual charge:
501(a)(1) Filth findings: sample was found to contain over 1800 insect fragments in six subs examined for an average of 300 insect fragments per sub.  One sub also contained 3 rat/mouse hair fragments.

FD&CA Section 502(b)(2), 801(a)(3); MISBRANDING
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs. The quantity of contents statement on the product labeling is listed in grams only and lacks the US customary terms of avoirdupois pounds and ounces.

FD&CA Section 505(a), 801(a)(3); UNAPPROVED NEW DRUG
The article appears to be a new drug without an approved new drug application. Product making drug claims: per website www. - prevents 300 diseases, stabilizing effect on blood pressure, and control of glucose levels in diabetes

This is the shipment that came with glowing reports from the agency that gave this well known company the organic certification.  I lost a lot of money on this shipment. It was destroyed at the customs office.  This is why I don't buy product grown and packaged in India.

God bless all of you!