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Contamination and Impurities Limits for Dietary Supplements

FDA Dietary Supplements Contamination Testing 21 CFR 111 Impurities

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jonathangrayczyk

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Posted 17 March 2022 - 03:09 AM

Hello, I am new to the Supplement world and I was wondering if someone could direct me to where I can find resources to know what the acceptable limits of contamination are for supplements. I have found random pieces of information so far but nothing concrete. I was able to find an elemental impurity list for metals (https://www.pharmout...b-MacDonald.pdf) that I think is good but I'm not sure of. I have multiple methods such as GC-MS, UV-VIS, ICP-MS if I need to purchase it as well as other small stuff such as pH and microbial testing. I am just relatively lost on where to find acceptable limits of contamination and can't really proceed with starting production until I can assure all of my stuff is passing standards. Thank you!!



matthewcc

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Posted 18 March 2022 - 04:00 PM

I see that you're in the United States, so I would start by looking through the Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry here:

https://www.fda.gov/...3)-Download.pdf

This covers a range of hazards that could contaminate or adulterate food.

 

I would also read through 21 CFR § 111.70 What specifications must you establish? here:  https://www.ecfr.gov.../section-111.70.  You will need to research what contaminants could adulterate or lead to adulteration of your product based on your unique product attributes.

 

Dietary supplements are considered food in the US rather than pharmaceuticals, so I would look at food guidance rather than that of pharmaceuticals.

 

I know much of this is focused on regulatory aspects and food safety rather than quality, but that is where I would start.  After that, I would then move on to contaminants that have acceptable limits, such as indicator organisms, etc.

 

If you're selling products in California, or your distributors could do so, then you will need to comply with Proposition 65:  https://oehha.ca.gov...the environment.

 

Matthew



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jonathangrayczyk

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Posted 19 March 2022 - 01:15 AM

I see that you're in the United States, so I would start by looking through the Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry here:

https://www.fda.gov/...3)-Download.pdf

This covers a range of hazards that could contaminate or adulterate food.

 

I would also read through 21 CFR § 111.70 What specifications must you establish? here:  https://www.ecfr.gov.../section-111.70.  You will need to research what contaminants could adulterate or lead to adulteration of your product based on your unique product attributes.

 

Dietary supplements are considered food in the US rather than pharmaceuticals, so I would look at food guidance rather than that of pharmaceuticals.

 

I know much of this is focused on regulatory aspects and food safety rather than quality, but that is where I would start.  After that, I would then move on to contaminants that have acceptable limits, such as indicator organisms, etc.

 

If you're selling products in California, or your distributors could do so, then you will need to comply with Proposition 65:  https://oehha.ca.gov...the environment.

 

Matthew

Thank you so much I really appreciate the advice! I kinda always forget that it's regulated the same as food when I'm trying to figure out to create some of these forms. I really appreciate it.

 

Jon



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