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.




All Supplements aren’t made to the same Quality Standards.

Why does quality matter

If you’ve followed this blog for a while you’ll know I always stress taking only very high quality supplements. In this post I’ll explain why that is and the difference between low quality and high quality supplements. For many products though, quality is pretty easy to see, high quality foods look nice, aren’t moldy, smell and taste good, and don’t make you sick.  Supplements though are different. They all look the same – you don’t taste them and it is hard to tell what is in them.

So you have to trust that the manufacture took care in manufacturing the supplement and followed the proper manufacturing and quality procedures. Each month though ConsumerLabs.com tests a group similar products. It is very common for 15% to 35% to fail because of too little or too much of an ingredient or for undeclared contaminates like lead, arsenic, or mercury.

Doesn’t the FDA inspect product quality?

Many people assume that the FDA insures the product quality and inspects the products. Sadly, like for food, the FDA is primarily concerned about product safety and inspects facilities to insure that they are following proper cleaning procedures, that there isn’t bacteria like listeria or salmonella present in the equipment, that there are rodents present, etc.  What they don’t do is inspect the product to insure that what is supposed to be in the product is in three and nothing else.

They also don’t regulate or inspect that they are using the best form of the ingredients. More about that in other posts, but for say magnesium or vitamin E there are cheap, but poorly absorbable forms, and there are much more absorbable forms, but usually they are much more expensive. So if they say it contains magnesium or vitamin E, the FDA doesn’t care which form, as long as it is properly labeled if they do say which from.

Different types of quality requirements

The basic FDA quality requirement is like discussed in the section above, just insure that the plant is sanitary, safe, and the products aren’t contaminated, and that the product is properly labeled. These guidelines are called cGMP, or Current Good Manufacturing Practices. This is very similar to the food requirements. The FDA doesn’t care if the pizza has an a few extra, or fewer pepperonis, as long as it has some pepperonis and it isn’t moldy.

Prescription pharmaceutical drugs are different though since the active ingredient in each tablet could be just a few milligrams – so a spec of salt possibly. In this case the FDA has much stricter requirements to insure that if a drug should contain 2mg of the active ingredient, that every tablet contains exactly 2mg – not 3mg in one and 1 in another, even though it averages out to 2mg/tablet. There are also much stricter requirements on sanitation to insure that there isn’t cross contamination between different production lines in the same area. You’ll see warnings on foods that they were manufactured in a plant that also processes peanuts. You don’t see a warning label on a drug that it is manufactured in a plant that also makes viagra. There are much stricter requirements that the exact quantity of every ingredient is in each tablet (or capsule, bottle, etc.). There are also very strict documentation requirements.  These much stricter standards are called Pharmaceutical GMP, or Pharmaceutical Good Manufacturing Practices.

The huge majority of the supplement manufactures follow the less stringent cGMP requirements – it is easier, insures basic safety, and is much cheaper to adhere to.  Only a few will follow the much more costly Pharmaceutical GMPs.

Different areas of product qualtiy inspection

If you were to walk through two different plants, one cGMP and the other following Pharmaceutical GMPs below are some of the differences you’d see. I didn’t make these up, in the few examples in both columns these are from actual plants I’ve visited and toured.

Area cGMP Pharmaceutical GMP
Receiving Only some lots of incoming raw materials may be tested. It is optional Multiple samples from every lot are tested to insure that what is supposed to be in the shipment is actually there. Will also test for bacteria and contaminants. A typical ingredient may be subjected to more than a dozen different tests.
Warehouse Optional, but expiration dates will be respected. Expiration dates will be respected plus if the material is prone to break down and lose potency then it will be periodically retested to adjust for the loss of potency.
Measuring out Ingredients Can be done in the open. One person will typically weigh out an ingredient and add to the batch and check it off the sheet. – Measuring will take place in air tight rooms to insure there isn’t any contamination when the containers are open.- Two workers will be present. They will verify the item number, lot number, weight it out and the two of them will double check that every thing is correct and sign off on it.- The dispensing room will be thoroughly cleaned before the next ingredient is brought in and opened.
Manufacturing tablets will be pressed or capsules filled. May be some visual testing that the product looks OK, but probably no in-process testing. At set intervals, typically 30 minutes tablets will be checked for weight, hardness, dissolve-ability, and chemical/biological testing. If there is a problem, production is stopped.
Post Manufacturing Optional, but once a month they may test the finished product to make sure there aren’t any biological contaminants and may test the amount of key ingredients. Every production batch will be fully tested to insure that every ingredient is present in the exact amount and that there aren’t any heavy metal contaminants and no bacterial contamination.There will also be 100% visual inspection of every tablet to insure there aren’t any broken or chipped tablets.
Paperwork The Batch Ticket may be one or two pages long and is filed and retained. The batch ticket may be over 100 pages long with hundreds or thousands of signatures. Quality Control will review the entire document making sure every entry was correct. If where notes of a production problem, then that will be investigated and its potential impact on the product assessed.
General production environment. – Hair nets required- Facility can be a regular warehouse.- Entry allowed by anyone through regular doors.- I’ve actually witnessed dogs running around the production area in one plant and people smoking. (were the owners pets) – Hair/beard nets, gloves, booties, sterile outer garments.- Sealed manufacturing area with positive pressure HEPA filtered air.- Only authorized personnel are allowed inside of the manufacturing area.- Entry is through an air-lock to insure no outside air enters.

– In general the production area will be cleaner than a hospital operating room.

FDA Inspection Periodic to insure it is sanitary. In fact the one with the dogs running around and people smoking passed their FDA inspection a week prior to my visit. If the facility is registered as a Pharmaceutical Facility then the FDA will validate all their procedures and make sure that every written procedure is followed and adheres to the Pharmaceutical GMP requirements. FDA will also inspect the facility for cleanness and sanitation


There are two mindsets of supplement manufactures:

  1. Make the product safe, but at the lowest possible cost. They know the consumers don’t know how to tell one product from another, so put cheap tablets in the bottle and wrap it with lots of hype and slick advertising.
  2. Never compromise on product quality. Use only the best ingredients and insure the quality is perfect for every tablet in every batch. Those who register their facilities as an pharmaceutical drug company with the FDA are then inviting the FDA to audit them to the much stricter Pharmaceutical GMPs.

As a footnote many companies don’t manufacture their own products but will use contract manufactures to do the actual manufacturing and put the burden of quality on them, but the contract manufacture’s charge for the service provided. so you can get a product made with no inspection at all, or they can pay many thousands of dollars more per batch to have the inspection done.  Some companies will say they use contract manufactures who meet pharmaceutical GMP requirements. The reality is that the company may meet those requirements, but they will only follow those procedures if you pay for it – so a deceptive play on words.

Bottom line, you can guess which products I use. It is registered with the FDA as a drug establishment and strictly adheres to pharmaceutical GMPs and has had their compliance verified by NSF, an independent 3rd party certification organization. I spent two full days auditing their manufacturing quality procedures and they are better than many of the biotech and pharmaceutical drug companies I’ve worked with.