Nutritional Supplements And Contract Manufacturing


The topic of this page, nutritional supplements and contract manufacturing is actually a sub-topic from my article Ingredient quality in nutritional supplements which deals with 'ingredient quality' as one of the key criteria that should be used when evaluating the true standard of supplements. 

That article lists several questions we need to ask of supplement companies in order to draw out often hidden information, allowing us to evaluate different supplement brands.

Some of those questions come from an examination of the content on this page. To view all the questions please use the link above.

Contract Manufacturing

Over 95% of supplements in the USA are contracted out!

To produce a world class supplement that works there is no room for error. This means that you cannot put the control of the manufacture of the products into the hands of a third party manufacturer. When this happens you lose control of vital components: Ingredients, Blending Protocols and Manufacturing Know How! 

The quality of a product is dependent upon not only the manufacturer ensuring that the ingredients they purchase are what the CERTIFICATE OF ANALYSIS (COA) says they are but also that they adopt manufacturing procedures that ensure the supplement contains the correct about and is manufactured professionally. 

Unfortunately the incentive is simply not there for most manufacturers to do this as they are producing for a third party and as such are in a very competitive bidding situation. 

Therefore contract manufacturers (CM) do not have the specific scientific knowledge necessary to formulate professional grade, science-based nutritional supplements!

They do not have the know-how to understand the complex science related to the synergistic reactions of multiple combined ingredients and the metabolic pathways that specific ingredients follow or how they react with bodily fluids.

That’s because their staff are not bio-scientists/chemists. 

Highly qualified bio-scientists do not work in contract manufacturing companies!

Yet contract manufacturers put together numerous ‘ready to go’ supplement formulas and premixes for sale. These offer low levels of efficacy. There are so many variations of almost every nutrient and some of them can vary in price as much as tenfold.

Contract manufacturers generally standardize on one form, normally the lowest cost ones. This satisfies the budget of most would-be supplement companies and also keeps a contract manufacturer's inventory costs to a MINIMUM.

CRITICAL POINT: Industry credibility problems stem from manufacturers who purchase raw materials at ridiculously low prices, well below market price. These companies obviously know such materials are suspect but they don’t test for COA compliance - so they can ignore the red flags. Should any problem ever arise they simply produce a COA showing that the desired properties were present (on paper!).

Supplement formulas created by CM’s are not formulated with the stringent scientific base that highly qualified supplement formulators use in their work. They’re cheap, low potency and there’s a good deal of profit in them – hence their widespread purchase by supplement companies who are really just marketers in disguise. They sell them on the public to make a quick buck.

The wellness benefits they offer the end user – YOU - are little if any.


Let’s look at a basic example:

A contract manufacturer is given a formula by a supplement company. 

This supplement company is one of the thousands out there lacking integrity and values. It does not employ experienced and qualified formulators, does not work with science-based quality standards and has simply put its formula together according to the latest ‘in-vogue’ ingredients with high marketability.

The formula calls for an expensive, popular phytonutrient like Resveratrol (brain, heart, prostate, anti-aging benefits) – but due to a lack of know-how, the supplement company sets no specifications for its use. Unfortunately (for the end consumer) our contract manufacturer only stocks low potency Resveratrol – say 5%, so this is what they put in.

The formula called for Resveratrol and so the CM put in what they had – no questions asked! 

There was no understanding as to whether the Resveratrol used was the most appropriate form (‘trans’- the most bioactive and clinically beneficial form or ‘cis’ the cheaper form) and of sufficient potency and dosage to produce health benefits.

An experienced bio-scientist on the other hand, working for a professional supplement company (and who is formulating a supplement with efficacy as the main concern, not price) would only ever consider ingredients well supported by science.

So in our example above a bio-scientist would firstly study the scientific literature in respect of potencies, ingredient forms and dose rates used in well accepted Resveratrol studies (Resveratrol has been extensively studied) and then evaluate the synergistic effects with the other ingredients.

Only thereafter would the decision be made whether to include Resveratrol at all and at what potency (it may very well require a high potency – 40% or 50%). It certainly would have nothing to do with what potency a given CM has in stock.

The picture I’ve painted for you here is representative of the general situation with CM’s in the US.

There are however some excellent CM’s but they’re few in number. You’ll find them working with some of the leading science based nutritional supplement companies whose complex formulas include exacting raw ingredient specifications.

Industry insiders have told me that you could count the number of these top-notch CM’s on one hand.

They are an exception - not the norm! Sad but true. So if you use nutritional supplements, regardless of price, please keep this in mind.

THE BOTTOM LINE
FOR SAFE, PROFESSIONAL GRADE SUPPLEMENTS


1. SELF MANUFACTURE:


Professional nutritional supplement companies should manufacture their own products. 

When it comes to the industry's best science-based supplements there are many stages of the manufacturing processes that are highly specialized and require trained operators. These require detailed paper trails with multiple personnel sign offs throughout the process. Contract manufacturers do not generally do this.

All incoming raw ingredients must be tested for compliance with their Certificates of Analysis (COA). If this is done in-house then periodic third-party testing should be conducted by GMP certified independent laboratories.

Manufacturing operations must follow pharmaceutical level GMP’s .

Proof for all the above should be available to the public upon request.



2. CONTRACT MANUFACTURING:

The supplement company must have pre-audited the manufacturing facility to ensure:

  1. It meets 'Food' GMP standards but preferably is of pharmaceutical grade 

  2. Supplement GMP’s are followed

  3. It can meet all other required specifications for specialized supplement manufacture
  4. The name of the contract manufacturer(s) should be released upon request so that consumers can visit the manufacturer’s website to read about quality controls.

  5. The supplement company must have proof that the manufacturer tests all incoming raw ingredients for COA compliance. If this is done in-house then periodic third-party testing should be conducted by GMP certified independent laboratories.

  6. Proof for all the above should be available to the public upon request.

Whenever I am asked to comment on the quality of nutritional supplements the first thing I look at is who manufactures them. 

If a supplement company does use a contract manufacturer they need to follow the specifications listed above and all of this must be absolutely verifiable by the public. Unfortunately it rarely happens.

I know of a couple of extremely well-known leading nutritional supplement companies who will not reveal the name of their contract manufacturer.

What are they hiding?

Supplements and contract manufacturing back to Ingredient Quality Article 

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