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When Supplements go Bad!!

Updated: Feb 26





If you haven’t heard me say it a million times already, I have been working in the dietary supplement industry for over 18 years now. I have done many jobs in the industry along the way, but where I have learned the most was consulting for supplement companies. The things I have seen and have been asked to do would make your skin crawl.


So, guess what...It is time to share some juicy details. Now, while I cannot divulge company names because of non-disclosure agreements, the stories will still make you think twice before you buy your next bottle of vitamins. I will also add some publicly known stories with links to the information so that you can see that my stories are more than typical in what goes on in much of the industry.


While technically there are regulations on the books, the FDA is very underfunded and inspects less than 50% of supplement companies each year. Whether or not you feel the FDA should be involved in vitamins or not, you should know that there are huge problems that result in not really having a watchdog. Many supplements contain adulterated and harmful ingredients, while others do not have what they claim on the label. The former New York State Attorney General has sued a bunch of vitamin companies for putting no herbs or the wrong herbs in many supplement bottles. It is extremely important that people begin to really take seriously how potentially dangerous it is to have an industry that can sell their products with little to no oversight; an industry that people trust their health in.


Let’s start off with a recent, extra slimy story. I was called in as a consultant to a company that received a very large warning letter from the FDA. It probably would have cost about $300,000 dollars to fix all the violations in this letter. When I arrived there, there were two other consultants there. I sat down at the end of the couch and waited for the rest of the people from the company to join us. Basically, they offered each one of us $20,000 dollars apiece to help them cheat the FDA warning letter. I stood up and said this is everything that is wrong with this industry and walked out. I then went over to the closest bar, had a beer and thought about my life choices.


How about a hepatitis outbreak? In 2013, a dietary supplement, called OxyElite Pro, caused a hepatitis outbreak in multiple states. Several patients even needed liver transplants. Despite multiple reports being filed earlier in the year, it took the company sixty-five days to recall the product. That is unacceptable.


About seven years ago, I was called to visit and inspect a facility. My visit was to start on a Saturday and continue for three more days. My job was to review all their quality control procedures and inspect the facility for ways to improve and comply with FDA regulations. When I arrived at the facility, it only took about ten minutes for me to become absolutely horrified. The company was closed on the weekends. Yet, when walking through the raw material storage area of the warehouse, barrels of raw materials were left open to the air uncovered, and the owner ran his bare hands through the material to show me how wonderful it was.


Next, I was shown to the “manufacturing area”. This consisted of two machines that were not walled off and would have just sprayed powder everywhere, whenever they were run. While I being shown the rest of the facility (and screaming inside about all the violations), I began to notice there was no lab. When I asked about it, they said they did not need one. I had never heard this before. Apparently, he had full trust in his raw material suppliers and that they would never lie to him (this is a whole blog article to itself). This also meant that there was not a way to ensure that the finished product had what it contained on the label. Lastly, I was shown that they put expiration dates and lot numbers on the bottles and were very proud of that. Well, they had no equipment to determine what the expiration date should be, so basically they were just making up expiration dates. I ended the visit on Saturday (after only a couple hours) and just told them there were way too many violations and there was nothing I could do. I still have nightmares about this one. The really scary part is that there are lots of fly by night companies like this...yes, even the big ones people think are great, that is just like this.


How about using a banned antibiotic called chloramphenicol, to clean the machines? This antibiotic was banned in the United States because it can cause aplastic anemia, a form of bone marrow toxicity. Yet, this was exactly what was happening at an enzyme supplier in India, that almost all vitamin companies were buying from. There were lots and lots of companies using them and almost every store in the USA had to pull products from their shelves because of contamination with this. You can be assured when you get supplements from me, you never have to worry about things like this. I know what to ask for, what to test for. I check these things out far ahead of time.



Six years ago, I got an interesting call from a fellow consultant who wanted help with a job he was just hired for. I was intrigued because it was a raw material issue, which is my specialty, so I agreed and met him at the facility. He had refused to give me any details and on the video call, he had a weird smirk on his face. We headed inside to the lab and were handed some interesting test results. This raw material was the same one that they had been buying for years from the same supplier - a very good one, mind you. Yet, these results were extremely strange. I asked to be taken down to the area where the materials were kept, in order to look at the containers the materials came in, the certificate of analysis, and all other paperwork associated with it. The containers looked normal enough, and all the paperwork seemed in order. So it was a bit odd because this raw material supplier does not send adulterated materials and is very well known for superior quality control. I decided to take another look at the container because something did not feel right and I asked for a razor blade. I slowly cut out the label from one of the containers. Sure enough, my feelings were confirmed.


When I cut out the label from the box, it looked like a label was placed on top of another label. We went back to the lab and they got the top layer off, using a special solvent, without damaging the paper underneath. Another raw material supplier had completely faked everything. I asked if they had a new buyer for raw materials. Sure enough, two weeks ago a new buyer had started. Someone had called pretending to be from the normal, good supplier. He was actually a broker for the fake company. The new buyer was so excited to get such a better price than normal that he had just gone ahead and ordered it without really thinking about it.


Thankfully, this company quarantines all raw materials and tests them before using them in the products. So this raw material was put aside and sent back to the fake company, which turned out to be from China, and they would ship the materials to Europe and then pose as good raw material suppliers, constantly changing their name from one company to another to avoid getting caught.


That way they would have all the correct shipping and other paperwork because it would ship out from Europe. The horrible part is that this raw material is just repackaged and sold to another company that does not test, so it means that somewhere out there this raw material was sold as a finished supplement. After figuring out that part of it, and relieving the new buyer of his duties, we headed back up to the lab to try to figure out what it actually was. While the material was not going to be used anymore, all of us were curious to find out what it was. Since the raw material was supposed to be Boswellia (also known as Frankincense), the lab tests should have looked a lot different. I looked at the gummy resin (which appeared to be Boswellia resin, based on its color), smelled it, felt it, and stupidly tasted it (I should not have done that).


As an herbalist one of the ways we learn what herbs are and the properties of them are by organoleptic testing (look, taste, touch, and smell). This, however, is usually done with whole herbs or plant parts, not strange resins from China. Thankfully, this did not turn out to be poisonous, or I would not be writing this article. While I was thinking of all the herbals it could be, based on my inspection, we had it tested for heavy metals. It had way higher levels than any Boswellia; higher than any of us had ever seen (again I should not have tasted it).


Then, I looked back at the test results again. Based on the taste and the lab results, I had them run some tests that would show if it was certain things I thought It might be. While we waited for the results, my friend watched to see if I would keel over or be poisoned, he is a crazy person. The results came back and it was exactly as I thought, not Boswellia at all. It was actually a combination of Guggul, Myrrh, and Propolis resins. These materials are so much cheaper than Boswellia. It was quite an adventure.


These are just a few of 100’s or 1000’s of examples I could give you to make you see the seedy side of the industry and just how deep some of the adulterations go, from paperwork to actual raw material. This is why I stress quality and testing so much whenever you may have a conversation with me about supplements. People really do have no idea how bad it is out there.

The lesson here is to only buy supplements from people with real experience in quality control and who have actually been in the trenches. People who can really explain the true, in-depth details of quality control. People who can actually evaluate a supplement properly because they know the right questions to ask and they know what the answers should be. Every company and store says their products are quality and tested - Those words do not mean anything though if they are not doing the correct tests or even know what to test for.


So, the next time a store says: “yes, our products are safe and tested”, see if they can go into the real details about the product you asking about. Do not give them time to look up the answers. If they are selling quality products with true knowledge of where they are buying, they should know on the spot.


There is no school or course or place they can go to get this information easily, so then how would they know how to evaluate the information they are getting to know if it is valid?

Imagine you are building a rocket ship. You want engineers and people with experience in rocket ships. Would you hire someone to build your rocket ship if they never had any experience building rocket ships? The same standard should apply to the products you are using for your health and putting in your body.



References:

https://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/

https://www.naturalproductsinsider.com/legal-compliance/hepatitis-outbreak-linked-usplabs-dietary-supplement-shows-limitations-fda-medwatch

https://www.nutraingredients-usa.com/Article/2013/11/04/Antibiotic-tainted-enzymes-find-way-into-products-in-US-Canada-EU-and-Japan

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