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Pesticide analysis for dietary supplements

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matthewcc

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Posted 07 November 2023 - 11:49 PM

Hi, I was wondering about, for pesticide analysis for dietary supplements in the United States, is there a minimum number or a recommended list that we should be testing for?  Our third-party lab tests for about 483 pesticides, and then you look at the AOAC Official Method 2007.01, they list about 20 pesticides, and I see that they comment in the method, “These were representative pesticide analytes chosen in representative matrixes, and the method is expected to be applicable to many other similar pesticides and matrixes.”  https://nucleus.iaea...es/fcris/Shared Documents/SOP/AOAC_2007_01.pdf

 

This is becoming challenging for us because when we test for 483 pesticides, chances are we have a hit and (depending on maximum residue levels/tolerances) then we have to reject ingredients and it is difficult to get ingredients to make products.  We would prefer to test for a shorter, more manageable list if we can.  I think I know part of the answer and regulatory agencies won't tell us what pesticides we have to test for, and we don't want to "test ourselves out of business."

 

We have SQF and NSF GMP certifications and follow 21 CFR Part 111 and 117.

 

Matthew



Evans X.

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Posted 08 November 2023 - 10:42 AM

Greetings Matthew,

 

I don't think you will "test yourselves out of business", as it should be unlikely you have a hit if you don't get your raw materials from ambiguous suppliers. Generally there are usually two major packages of substances according to quantity (400+, hence the 483 you mentioned and a 550+). Unfortunatelly in a thorough inspection you can't really show that you only tested 20 substances and these can represent the rest.

However don't get discouraged as I find it unlikely that you will have issues of finding traces of pesticides. I work in an ISO 17025 accredited laboratory and I have many examples of raw materials (not just end product were there is mixing of other materials also resulting in further dilution if there were traces) that we have no detection/quantification of said substances, when the producers follow good producing practices and the instructions for the right application of pesticieds etc.

 

My opinion is to go forth with the recommendation from your lab.

 

Regards.



matthewcc

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Posted 08 November 2023 - 02:38 PM

Hello Evans X., one thing I should have made more clear is that we are in fact seeing a significant portion of the dietary ingredients have hits for pesticides.  That tends to happen more often when they are not certified organic and when they are coming from outside the United States.  Often that happens with an obscure pesticide that has zero tolerances for the crop/item.  Then, when we go back to the supplier to let them know about the rejection, they often say that they only test for the USP (United States Pharmacopeia) panel of pesticides, which lists maybe 50 pesticides or so.

 

We had one supplier say, "It does not make sense that DEET would be found in (ingredient name), or any of our (product line), nor at such high concentration as 0.387ppm.  We are not testing for DEET as it is not covered in the (name of screen in Europe) for botanicals, given lack of applicability.  Nor is DEET included in the (company name) 300+ multi-residue screen for botanicals which we test on occasion..."

 
Another one I heard that is common is, "we provided you with our generic material that meets and is compliant with USP standards. As far as we are aware, most manufacturers accept the USP standard for pesticides and work with material that is compliant with USP standards as this is the standard for the U.S. If anything else is needed, please feel free to let me know."

 

So there is a lot of pushback from suppliers.  They are not finding the same pesticides that we are.  I do not think it is going to test us out of business.  (Rather, the company owner, CEO, and Director of Operations get upset when we are out of a product for any length of time.)  However, it is making it at least difficult, if not impossible, to acquire conforming lots of certain ingredients, and that causes us to be out of a product until we can get a conforming lot. 

 

One ingredient had samples from four different suppliers (all that we tested) fail for pesticides, and another ingredient had samples from at least two different suppliers fail for pesticides (acquisition of samples and testing might still be underway).  I believe all those suppliers are testing for USP, and often they don't test every lot.

 

Which labs are testing for the USP panel, and why are they able to get away with that when labs like yours and ours are testing for 400+?

 

Matthew





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