Mold Limits for finished product supplements

Hello, 

We manufacuture supplements for menopause and it consists of botanicals/herbals such as black cohosh.  Is there a limit on finished product mold and yeast count for such supplements? We ususally abide by the <100 cfu/g specification.  This specific run is coming back higher on the mold count in the lower thousand.  Any feedback would be greatly appreciated. We are SQF audited and FDA as well. 

Thank you, 

Hello, 

 

We manufacuture supplements for menopause and it consists of botanicals/herbals such as black cohosh.  Is there a limit on finished product mold and yeast count for such supplements? We ususally abide by the <100 cfu/g specification.  This specific run is coming back higher on the mold count in the lower thousand.  Any feedback would be greatly appreciated. We are SQF audited and FDA as well. 

 

Thank you, 

Hi Sarah,

It's a rather "offbeat" query.

Definitely not my area but I would anticipate that any mould count may relate to the processing ?

Be careful with black cohosh.  The FDA does not approve black cohosh as a supplement or as a food in the U S.

It depends on how the typical customer will use the product, but I would recommend looking here:  http://www.ahpa.org/...4-26-121351-030

The FDA doesn't approve any supplements, because they are supplements and not drugs.