FDA Finds Problems at 62% of Supplement Manufactures

Consumer Labs today reported that the FDA has found 62% of the 483 dietary supplement manufacturing facilities failed their inspections in 2014.  These were for noncompliance with the current Good Manufacturing practices (cGMP) which they are required to follow. Sadly they only inspected a small number of the total number of manufactures.

The FDA reported an average of 6 infractions per facility. The most common infractions were:

  • Not conducting at least one appropriate test or examination to verify the identity of a dietary ingredients and/or
  • Not establishing product specifications for the identity, purity, strength, and/or composition of the finished dietary supplement.

The list of results by manufactures inspected can be found on the ConsumerLabs.com website. This site requires a member sign in.  I am a member and reviewed the list and there are some big names that received letters. There are challenges though, with seeing if your favorite company was inspected and how they did for several reasons:

  • Most retailers and distributors don’t manufacture their own products. They outsource the manufacturing to contract manufactures who actually produce the product for a number of different companies.  So you buy Brand X, but Brand X doesn’t have a manufacturing facility because they contract with Company Z to do the manufacturing. The inspection would be of Company Z, not the brand you buy.
  • There are a very few manufactures of dietary supplements, such as the one I use and recommend, who are registered with the FDA as pharmaceutical drug manufactures and must adhere to much more stringent pharmaceutical Good Manufacturing Practices. So this company would fall into a different category of FDA inspections.
  • Only a small percentage of the total number of manufacturing facilities were inspected. So if your favorite company isn’t listed it isn’t because they passed or failed, but just weren’t inspected this year.

So what do you do?

  • Figure than when you look at the vitamin aisle at the health food store that over half the bottles on the shelf came from manufactures who failed their inspection.
  • Look to 3rd parties for validation of your brand. Some good sources are:
    • ConsumerLabs.com. This is a membership site but they routinely examine and test a number of different products each month.
    • NSF.org  Is the public health and safety organization. NSF certifies facilites  and also lists products they’ve approved Safe for Sport – they they insure don’t have any unlisted contaminants.
    • PDR.net – This is the Physicans Desk Reference for pharmaceutical drugs.  There are a few high quality supplement brands who are listed in this reference.  If it is listed in the PDR, your doctor knows it is safe and high quality.
    • Comparative guide to Nutritional Supplements – This publication has ranked over 1,600 different products on a 0-5 scale. The initial rating is based on the label, so no testing. But for those who were rated a 5, then they are invited to have 3rd party labs verify their products and they must have their manufacturing facilities tested as well.

The brand I use has passed all the above tests and has been the #1 ranked product in the Comparative Guide to Nutritional Supplements in all 5 editions.  Ask me and I’ll tell you who they are.

 

 

 

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