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cGMP Certification: Does It Matter?

cGMP Manufacturing

These days, supplement companies flaunt the fact that their prodcuts are manufactured ina GMP compliant facility.  As a marketing tool, this is just another seal of approval they can post on their website, but as a consumer, does this really mean anything?

Does the average person have any idea what GMP Certification even entails?  Let’s take a look

What Does cGMP Mean?

cGMP stands for current Good Manufacturing Practices.  It’s essentially the FDA’s guidelines for all manufacturers of food, drugs, dietary supplements, and cosmetics, and cGMP certification is what the FDA awards manufacturers that adhere to these guidelines. The overall goal of the certification is to ensure the safety and quality of the prodcuts, but like most things in life, this is easier said than done.

As with any industry that is semi-regulated, a code of best practices is generally viewed as a good thing.  GMP Certification mandates:

  • Facilities must adhere to certain cleanliness and hygienic standards
  • Certain environments must be controlled to prevent contamination
  • Manufacturing procedures must be clearly defined, adhered to, and documented
  • Changes to procedures are validated to ensure compliance
  • Instructions for employees is clearly written and easy to understand
  • Operators of equipment are properly trained
  • Strict measures are put in place to prevent cross contamination
  • Records are kept throughout the entire process of manufacturing
  • A recall system exists just in case
  • Defective products are examined and procedures are amended to prevent future defects

Those are just ten of the many hundreds of criteria that determine whether a company passes or fails an FDA inspection.

In the last few years, the FDA has inspected over 600 dietary supplement manufacturing facilities for current Good Manufacturing Practices.  Out of those 600 facilities, over 400 failed some aspect of the inspection and were issued Form 488.  Form 483 is basically the FDA’s way of saying “Here are the issues with your facility.  Fix them and you won’t have any problems from us in the future.”

Of course, many of these companies failed for not adhering to basic protocol such as:

  • Maintaining A Clean Facility
  • Testing Raw Ingredients
  • Possessing A Master Manufacturing Record (how they products are made)

These are just a few of the major issues.  There are hundreds of rules that companies break all the time, but when it comes to cleanliness, ingredient testing, and abiding by a strict protocol, it would appear that many manufacturers are slacking!

What makes this whole situation even worse is the fact that there are A LOT more than 600 facilities pumping out supplements all over the country.  The FDA only knows about the ones that to adhere with cGMP.  For every cGMP compliant manufacturer, there are easily 10 more that are so under the radar that the FDA’s guidelines are none of their concern.

Most Supplements Are Not Properly Tested

Most  supplement companies, who use various third party contract manufacturers to actually make the products, trust (blindly, of course) that the ingredients are present at the required doses and that the formula is free of any contaminants or unncessary fillers.  Very few supplement companies will pay for the manufacturing of their products and then go and incur an additional, often very large expense to have the products tested.

Instead, most supplement companies rely on a Certificate Of Analysis from their manufacturer, assuring them that each ingredient is pure and of good quality.  While it is true that cGMP manufacturers are obligated to do this type of testing, as the FDA recently found out first hand, many of them don’t!

There are a few types of tests that can be performed to ensure the quality, purity, and safety of a supplement:

  1. Heavy Metal Testing – A supplement is tested for various metals–including lead, cadmium, mercury–known to be harmful above a given concentration 
  2. Microbial Testing – A supplement is tested for various types of bacteria–such as e. coli and steph aureus–known to cause health issues
  3. Ingredient Identity Testing – A supplement is tested to confirm that the ingredients are the same ingredients listed on the label, at the same doses.

Testing for the presence of heavy metals and contaminants is one thing which many manufacturers can do relatively cheaply (so they might), but identity testing—testing to see if the ingredients are really the ingredients listed on the label—can get quite complex from a chemistry standpoint so it’s quite expensive from a business standpoint.

For this reason, many manufacturers simply rely on the Certificate Of Analysis from their bulk ingredient supplier which means…

A Manufacturer Certificate Of Analysis Means Nothing

Since time is money for manufacturers, most of them just skip the process of identity testing themselves and instead rely on COAs from their bulk ingredient suppliers who, by the way, are ALL in China.  So next time you see a supplement claiming to be “made in America”, that may be true, but guaranteed EVERY SINGLE ingredient it contains was produced in China.  They really do make every over there, especially chemicals.

So basically, if you’re a supplement company owner who requests a COA from your manufacturer to make sure your supplement checks out, you’re most likely actually getting a COA from somebody half way across the world, who sells that ingredient for a living, and isn’t subject the same chemical safety laws that you are.  Do you think a COA from that guy would say that the ingreident isn’t pure?!

Even if your manufacturer claims they ran the tests themselves and shows you a COA with the results, do you really trust them?  Think about it…Supplemenet manufacturers are basically wholesale ingredient suppliers who make your product taste good and look pretty, but really make their money by buying massive amounts of ingredients and bulk and marking them up.

Most of their total cost is the cost of the ingredients themselves, so what’s the easiest way for them to make additional profits?  Use less ingredients and hope their customers don’t notice!  And unless their customers (supplement companies) are willing to incur the additional expense of Third Party Testing, they’ll never know.

Third Party Testing: The Only Way To Trust A Supplement

At this point, you might be getting depressed because we’ve established that most supplement companies, supplement manufacturers, and ingredient suppliers can’t be trusted and usually nobody in the chain bothers to test the product to see if they’re getting ripped off, so you have know idea if you’re getting ripped off…

But don’t worry, there is one way to take any supplement and be 100% completely sure that it:

  • Contains What It Says It Does
  • Doesn’t Contain Contaminants
  • Doesn’t Contain Dangerous Additives

It’s called Third Party Testing and it’s the only way to be completely sure that what you’re taking is legit.

What Is Third Party Testing?

Third Party Testing is when a product is taken straight off the line and sent to a chemical analysis lab that has no affiliation with the product or company that makes it.  That’s what “Third Party” means.  You see, if you’re manufacturer claims they test their products and presents you with a COA, they could just be lying.  Maybe they just went on Excel and made a fake COA because they know you’re not a chemist.  These things happen…

The only Certificate Of Analysis that is guaranteed to tell it like it is one from a Third Party Chemical Testing Lab who’s business is simply to test chemicals and report accurate results.  They don’t care about you, your brand, your company, your starving children that won’t eat if your product fails this test and doesn’t sell…They just test the product and report the results.

Needless to say, this can get pretty expensive, especially when it comes to unique ingredints that don’t have well-established testing methods.

All chemicals can be identity and purity tested, but if your pre-workout contains 10 ingredients and some of them are weird herbs which contain obscure bioactive components, Third Party Testing can be VERY expensive.

That’s why companies don’t do it!  Well that, and maybe they’re scared of what they might find out.  After all, the way this industry runs, it’s really the manufacturers that have the most control over the finished products.

Most brand owners simply come up with a formula and the design of the product and the manufacturers take care of the rest.  With such a high level of autonomy, it’s no wonder why so many manufacturers end up doing shady things to make more money.

So, Does cGMP Certification Matter?

Yes, it matters…but just because a supplement was manufactured in a cGMP compliant facility does NOT mean it’s a quality supplement.  The FDA doesn’t check in on these guys once a week.  It’s more like once a year, so that leaves a lot of time for the procedures and protocols that comprise what the FDA considers Good Manufacturing Processes to get pushed aside in the interest of cutting costs.

Doing things by the book takes time effort and when you get paid by the amount of product you can pump out in a day, time + effort = money.  This simple mathematical truth is why the majority of manufacturers, cGMP or not, will cut corners if they think they can get away with this.

In my recent article, Why You Really Can’t Trust Most Supplement Companies, I cited various incidents of adulteration and inaccurate label claims and concluded that the only real way to confirm the quality of any supplement is to Third Party Test it.  You should give that article a read if you’re ready to face the facts about this industry and adopt   a “trust no one” policy, but the reason I bring it up here is because many of the supplements which have failed purity/identity/contaminant tests were produced in facilities that were allegedly cGMP compliant.

This is proof that cGMP Certification doesn’t hold much weight by itself.  It still takes an ethically upstanding contract manufacturer to produce safe, quality supplements.  Just because they’re GMP Certified doesn’t mean they won’t under-dose your supplements.  Or worse, perhaps they do everything by the book EXCEPT that whole identity testing part which is the only way to determine whether an ingredient they purchase in bulk is really that ingredient.

Any manufacturer that skips this important step in the quality control process could easily be putting impure or adulterated ingredients in their customers supplements without even knowing.

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