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Wednesday, June 01, 2011

Moringa Oleifera Up Against FDA Misuse of Power.

 Hello Friends,

The problems of importing Moringa or other products from foreign countries is a road fraught with roadblocks, sometimes ending in the loss of your shipment and money.  This is our experience below.

This is how the FDA shut our business down last January. What happened to our business is happening all over the United States. You need to hear this story before you make the decision to import herbs. Our business was new, not a year old yet. We had started on a shoestring budget. We had ordered two previous shipments of Moringa powder, caps, and teas from India by Fed Ex. Those first two shipments were delivered without a hitch. We were not expecting trouble. 

At this point in the business, we decided to change companies because we wanted to carry Organic Certified Moringa products. We wanted to give my customers the best product available. We spent two months checking out companies and their claims of organic status. Most of them could not give me proof when pushed. We finally found a company who had real certifications and a good reputation. They told us they would ship the order by a air freight shipping company, not UPS or Fed Ex. We agreed, having no idea what we were in for by agreeing to that shipping procedure. We had no real import experience from a business standpoint. That was our first mistake, lack of experience. Always go through a import specialist. You have to pay them but their expertise is needed to get your shipments through the system.

The Nightmare Begins:
The shipment came into LA, then was trucked down to San Diego to a holding office. I had no idea that I was required to obtain a custom broker for the needed paperwork to get the package released. We called around and were shocked at the cost. The lowest custom broker charged three hundred dollars. The paperwork takes time to be approved. The holding office gives you three, free days, then they charge $30 dollars a day hostage fees. Even with the paperwork, you must then wait until customs clears it. It took over the three free days, for customs agents to even get to our package.. Customs flagged it for intense examination. That means they take it apart and send in samples. This can take days or weeks depending on the time. It was a week before the holding office let us take the package home, even though we could not use the product or sell it. It had to wait to be cleared by the FDA and Customs office first. We left with paying the holding office over a hundred dollars. So we bring it home, torn apart by customs and the FDA. Agents. Customs had taken out $25.00 of product for samples, so that was irritating. It is interesting that in the end, more product was missing than marked on the FDA paperwork. The agent had gone back to inspect my order three times, even though the samples were removed the first trip. So what did she do the other two visits. Even the holding office, said that was strange behavior. We now have the order in the house but can't touch the product. We call all our customers and give them the bad news. The order cost which originally $400 had now incurred another $400 in expenses.

Delay After Delay:
Well it seemed that the labs were jammed so it was a month before they would tell us anything. We had no idea what compliance issues the order might have. After 4 weeks, they informed us that the order was refused. Stress when up several hundred points with that call. We had to wait for another week to receive their official letter.

#1 Problem Was Label Violations: The
product did not express the weight of the product in ounces an pounds. The labels would have to be reconditioned. Problem is you must have a permit to touch the product, its label, or make changes to the label. That would cost lots of bucks plus months of paperwork. You must pay for the inspections to get the reconditioned labels approved. You have three tries at your cost, and then you lose. They give you no help. There are 15 pages of FDA label regulations to suffer through, even to the label size and where on the bottle they must go. There are rules to font sizes and approved label fonts. You are supposed to hire a specialist to help you figure this all out. I asked questions, and they refused any answers.

Customs Issues:
Customs had an issue with the label because it did not state,'Product of India', on it. Now the label stated that the leaves were grown and manufactured in India on two parts of the label but did not state the exact words they wanted. Customs would allow me to add those precise words but FDA rules said I couldn't without the proper paperwork from them. I was sick.

How To Comply:
When I called the FDA to understand how we could comply with the ounces and pounds issue, they said they could not give us any legal advice. We were advised to obtain a FDA lawyer to determine how the label should be correctly brought up to compliance.That would cost several hundred dollars and time. We found out the lawyers only win against the FDA about fifty percent of the time. We did not have the money.

Greatest Problem # 2:
The label from the Indian company gave the website address and phone number for problem issues. That was up to speed according to FDA rules. In India, Moringa is used to prevent health problems like high blood pressure and diabetes. They make many health claims for the medicinal benefits of Moringa on their websites. This is against the FDA law here. You cannot state health claims for your herbal products in most cases. If you do, the herb is then considered a drug and subject to millions of dollars of research and years of double blind studies. So because of that, I was in violation of 'the importation of an unapproved drug '. There was no way to bring this up to compliance. My product was refused entry.

Send Back or Destroy:
Now I was given two choices, I had to export it back to India or destroy it under FDA supervision. I could not abandon it for then I would be charged three times the worth of the package. If I did not bring the product back, I was subject to be put in jail. The cheapest route turned out to be to have it destroyed under supervision. The import broker was allowed to do that in their facility at the cost of another $200. If I had a large order or cargo shipment, it could have cost thousands of dollars more for the destruction procedure. Sending it back would have even been more money. It was very painful both mentally and financially to destroy a perfectly good shipment. The stress of the whole thing made me sick. I lost all of my customers who could not wait to buy their product, they needed it now. The business was shut down with no product to sell and $1000 was out in customs and custom broker charges. We were told by the holding company, that the FDA always gives packages that don't come through Fed Ex, a intense examination. He told us that it was happening more often. It is interesting to note,  that the same agent who inspected our package, and deemed it with violations, got paid to destroy it. There was never any explanation to why more product was missing than listed on the paperwork. Our custom agent, said that happened all the time. Where does that unlisted missing product go? You might also find it interesting, that a friend ordered the same exact shipment, except through another state, and her order was passed through customs with flying colors. All these questions have no answers. All that red tape, delays, and trumped up violations make the FDA a lot of money. It also puts companies out of business.


Problem #3:  Now that the package was refused entry, our company was put on a red flag list for the future. We were a new importer, who had imported a package that did not pass inspection. We would then be given this treatment the next time around. Moringa leaves would be considered a unapproved drug in the future by the San Diego Customs off ice and the FDA there. So importing in the future would be impossible. This is exactly how it went down. It cost us money and the Moringa sales part of our business. Right now it is hard to buy the Moringa powder in the United States as a reasonable cost. All the India companies state health claims on their sites, because Moringa is used by Indian physicians for health and the prevention of disease. So none of the companies labels are going to pass the FDA criteria.

Difference Between A Personal Order and Business Order for Resale:
When you order Moringa product personally from these companies, the shipment is given a special pass through as a personal order. If you import it as part of a business, you are subject to intense regulations and inspections. That is how we got my first orders through Fed Ex and did not even realize how we got it so quickly and easily. It still has to go through inspection but is passed through by an exception of law as a personal order. As a business, you are supposed to have FDA resale clearance.



What Now? We have moved to Nevada now which may help but after losing all that money, my incentive to order from India is filled with doubt and fear. It could happen again with another shipment. If you are a small company, you cannot afford the money to go through this. Our whole first season of sales was lost to those costs. We were new, starting with a shoestring budget. Even with a larger company, fighting the FDA can cost thousands of dollars, losing in the end. This is just my story, and the loss, although devastating to us, was nothing as compared to other companies. In some future blogs, I will give you real life experiences that are happening everyday. This is how the FDA is putting companies out of business. You are accused of selling unapproved drugs, if you state anywhere that herbs or vitamins might help or prevent a health problem. Every vegetable or spice has healthy benefits including garlic and cayenne. So are they going to stop us from buying garlic cloves or cayenne. This is an incredible misuse of their power. So this is why I am not selling Moringa products at the present time except through Amazon. I don't have to worry about losing my shipment to FDA red tape. Amazon can afford to refund your money, if you can't receive your products.

Importing herbal products is a highly risky business even with experience. I would ask you to fully research this topic before you spend any money. It can be a real nightmare.  I do hope with this  and other stories, you will see the discrimination and efforts by the FDA to stop the sale of herbal supplements. It is happening now folks. We need to stand up to the FDA and this misuse of power.

God Bless You, Kate The Herbladyisin


Update of this blog post:  2016

This blog was written right after we imported what I had researched to be a good quality Moringa company from India. It had a valid organic certificate and was stated to be tested in India.  At the time we were enraged at the FDA but in the end it was for the good that they took the shipment.  

I  later realized that an organic certificate from India does not mean the products are safe. It does not mean the products do not contain insects, dirt, or other contamination. It means that the lab test may have been falsified or the sample so small that it tested safe but the rest of the powder was not.  

Once you are flagged by the FDA, you are fighting an uphill battle that involves money and lawyers. They are vague on the complaints against you and what you need to do to comply. There are acres of pages with vague rules and regulations. Very few companies win against the FDA and if they do, it is because of lawyers they hired who are experts in this kind of law.

Please go to my article directory to view the articles I later wrote on this subject 

The issue with the FDA on health information not being allowed on products period unless it is tested to the point of drugs is an injustice. There is evidence in thousands of research papers on herbs and vitamins but is not accepted by the FDA or the AMA.

As of Sept, 2016 we are no longer selling Moringa products. Later I did find great quality Moringa products and we sold them for several years. The problem with selling high quality Moringa products is that you are competing against cheap, unsafe products from many sellers. Customers have no idea of the sludge they are buying.  I am now devoting my time to education on the subject and will be finishing a project in 2 months that demands an unbiased viewpoint.  If we are selling products, it is a conflict of interest. So that is why we made our decision. 




 


Updated 9-10-2016

Goodnight,
Kate Freer, The Herbladyisin

Growing and Using Moringa and Healing Herbs Blog  

http://www.alternativemedicine-womenshealth-articles.com Please visit this site to read all my articles on Moringa, women's health, herbs, and alternative medicine.



















 

4 comments:

  1. Kate, this is an amazing and trajic story. I found your blog while searching for people living in the Nevada desert as I am. We are in the Northeast corner of Nevada. I imagine you are in southern Nevada. I can relate to your frustrations with the government buerocracy. The moringa sounds very intersting and I am going to look into it. It gets too cold to grow it outdoors for me, so it looks like just a few potted plants for tea and things. I will be reading over your blogs trying to learn more about Moringa. It sounds like something I would like. Once I ordered coca leaves from south America. I was worried about it getting through, but no problems at all. It makes wonderful tea. Like Moringa I would need a greenhosue to grow it myself, but I'm not detered. I just need a bigger greenhouse. Thanks for the blog. I will be coming back from time to time to check on your progress. Keep your chin up, and fight on.

    ReplyDelete
  2. I like to start gardening of moringa in tropical Africa but I have no any experience of gardening in tropical Africa. Please any experienced can guide me to plant moringa in tropidcal Africa.

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  3. Dear Kate,

    Thanks for your mail. Please let us know, if you want the best quality Moringa products to be delivered directly at Nevada. Our Moringa products are shipped out from USA. You can email us at info@moringaexports.com

    ReplyDelete
  4. We get many health benefits from plants. Moringa is a one example. Moringa is a useful health drink. It is best ingredient for diabetic medicine. Its drink tea also helps in weight management. Your blog gives me good information.

    ReplyDelete