Body building

One other Complement Scandal?

You may remember that in 2016 I was in a terrible situation with a supplement manufacturer. Simply put, I worked for a company called Prime Nutrition and designed some formulas for them. For several reasons, I became suspicious and paid to have the products tested to see if the right ingredients and doses were actually in the product. You failed miserably. What was on the label was not included in the products. I still have the test results. It’s that simple. The manufacturer in question was Duracap Labs. They were run by Wes Hauser and Ben Mesika. Wes admitted that he did something wrong.

Finally, a quote from Wes Houser from DuraCap on this topic:

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“John Meadows directly accused Duracap of underdosing the Teacrine levels in Intra-MD EAA +. Intra-MD EAA + samples were sent for testing and confirmed that this was indeed the case. Although this situation was unfortunate for Prime Nutrition customers, we guarantee that all products we manufacture will in future comply with the information on the product label. “

I decided not to take legal action and set off. They were later charged with adding illegal substances in dietary supplements that were unknown to the customer. You can read about it here or in many other sources.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nutracap-labs-llc-604298-05212020

Wes Hauser eventually made a deal with the government to help them in another case and got out lightly. You can read about it here. Wes then reappeared and founded a new company called NutraCap Labs, based in Atlanta. I started to hear he was back in business and it was frankly shocking given the pattern.

Last November, NutraCap Labs was inspected by the FDA. There was a warning letter. Warning letters can be common, especially after about 2010, when the FDA issued certain Good Manufacturing Practices (GMP) that need to be documented, followed, etc. Many good companies received warning letters as they adjusted to the new rules. I think generally over 95% of the manufacturers out there are probably doing a great job and should be welcomed.

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However, this warning letter contains a number of problems that are very alarming for those familiar with the manufacture. This was not just a letter in which you could clean up your records.

The FDA points out some very important issues, two of the bigger ones include:

1.) The BPR (Batch Production Record) and the product labels do not match. The BPR is used to actually mix and manufacture the product. It is the recipe. So what was built and bottled is NOT what the label says in the random batches sampled by the FDA. Let me repeat that what is on the label is not in the bottle. This was a random sample. It is reasonable to assume that many other products would fail if tested on this basis.

2.) The tested product is also marked as “adulterated” because DMHA (an unapproved stimulant) was found in it. Product adulteration was an earlier crime for the owner, but continues to occur despite the charges from previous years. Even if it is not on the label, it should not be included in the supplementary period. It’s obviously not on the label and shouldn’t be found in supplements.

NOTE: The exact products and ingredients tested are given in the letter. This serves to protect trademarks, but can become public at some point.

There are other violations here that you will find relating to missing tests, labels, really any kind of quality control, etc., but I wanted to point out the more outrageous problem, which is simply that what is in the bottle is not matches what is on the label. The FDA has made this crystal clear in its sample.

The facts speak for themselves. This should be unacceptable to you as a consumer, and we go far beyond the “simple paperwork mistake” of someone who has done multiple manufacturing operations. Wes also owns Genone Labs.

It’s also disappointing that, given the history, supplement brands would opt for such businesses here, but I think the idea of ​​making more money (better margins) can be pretty convincing to some.

I’m sure it will turn out which brands are using NutraCap Labs to make their products fairly quickly. Lets see what happens.

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