Vitamin Supplement Manufacturers

How Well Has YOUR Supplement Been Put Together?


Manufacturing standards of vitamin supplement manufacturers vary significantly throughout the industry. 

Low quality standards destroy the scientific basis of a supplement formula and affect the composition, safety and efficacy of the end product. In fact, it is in this area that manufacturers and supplement companies hide the most from you!

You can use 'manufacturing standards' as criteria to help identify reliable, high quality supplements from all the impostors in an overcrowded marketplace.


To do this you need to ask some key questions of vitamin supplement manufacturers to help draw out missing information about their products.
Then compare their answers to the ideal answers presented in this article.



Use this information to compare supplement brands and make informed purchasing choices so that you end up with a quality product that really addresses the reasons that you bought it.

If a company won’t answer at least several of the questions listed below then they are obviously worried about their manufacturing standards. This should be seen as a red flag and I recommend you avoid their products.

BORING BORING BORING!

Now, if you’re about to close this page because the topic of how a supplement is manufactured seems totally uninteresting to you please bear with me.

We really don’t need to dig very deeply or get very technical to get the information you need.

This information will help you to:


Be a savvy consumer


Be sure you are using a completely safe supplement


Be sure you’re using a genuine premium grade product


Be sure you’re getting great value for your money



So, let’s get started

To understand the questions to ask, we need to visit 6 key areas.

1) Ingredient quality

2) Contract Manufacturing.

3) Manufacturing Equipment

4) Blending Procedures

5) Tests performed

6) GMP level


NOTE: GMP means 'Good Manufacturing Practices' – these are regulations that describe the methods, equipment, facilities and controls required for producing foods (including supplements) and drugs. There are different GMP levels – such as Pharmaceutical GMP and Food GMP.

There’s a world of difference between these GMP levels and this becomes a key point when looking at nutritional supplement manufacturing standards (more on this further down).


INGREDIENT QUALITY


A finished supplement is only as good as the raw materials used!

So in considering manufacturing standards the logical starting point is to look at the quality of the raw ingredients used. Since there’s a lot to consider in this area I’ve included it in a separate article (including the questions to ask) - if you haven’t already read

ingredient quality in nutritional supplements please take a look before returning here.


CONTRACT MANUFACTURING


The majority of supplement companies contract out their manufacturing. This affects quality control as these companies lose direct control over a crucial part of the production process. To say “not all contract manufacturers are equal’ is an understatement.

There is a handful of excellent contract manufacturers on the forefront of the latest trends and whose operations reach the highest quality standards. Then there is the rest. Some (if you were to see their operations) would scare you into never using any product they ever manufacture on behalf of would-be supplement companies.

I have heard horror stories from ‘in the know’ people about the shoddy practices of certain large scale contract manufacturers. “Cobwebs hanging from rafters”, dirty forklifts driving next to blending and tableting areas”, “holes in the roof”, “no air control systems” and so on.

Most of the best vitamin supplement companies self manufacture. There are however some leading companies who contract out their manufacturing but still achieve very high standards.

Pharmanex is one such example - a large, well known company in the US. I contacted them to say that I was always concerned by companies who use contract vitamin supplement manufacturers and wanted to know what standards they follow and how they maintain quality control.

Their lengthy answer explained that they audited their contract manufacturers before hiring them. There was a long list of exacting specifications for the manufacturing processes and facilities which had to be met before a company could work with them.

In other words the contract manufacturers had to adapt and conform to the manufacturing standards of a professional supplement company –


and that’s the way it should be!


Unfortunately this is a far cry from what happens in most contract manufacturing situations and that’s why it’s a key area that you need to check on.



Bottom line for Contract Manufacturing

For all supplements, except very cheap, mass produced supermarket kinds, self manufacturing is an indication of a professional company who is dedicated to the utmost quality – it highlights companies who are far more than just marketing companies in disguise and out to make a quick buck on consumers lack of knowledge.

I always recommend self manufactured products over contract manufactured ones - assuming all other factors are equal.

This doesn’t automatically mean that products from companies who use contract vitamin supplement manufacturers are always inferior – but it’s more likely as most don’t follow the high standards listed below.

If your supplement company markets its supplements as ‘quality’ products and uses contract manufacturing then the following standards must be in place to guarantee your safety.

  1. The manufacturing facility was pre-audited. Manufacturing specifications were presented to the manufacturer who already meet these or modified their operations to do so.


  2. The standards comply to pharmaceutical GMPs


  3. The facility is regularly audited and inspected by the supplement company.


  4. The facility has been inspected by other regulatory authorities (local, regional, state, national).


  5. The name of the manufacturer must be available to consumers.


  6. The manufacturer should have a high quality website containing detailed information about their operations and quality control systems, and with a contact email address.




EQUIPMENT


Here we are most concerned with the type of blenders used because some are just not up to the task when it comes to mixing complex formulas for quality supplements.

Multi nutrient supplements contain many ingredients, some in extremely small amounts – e.g. 50 micrograms (mcg).
It’s hard to imagine just how small this is.

So is it possible to get the exact amount (+ or – a tiny percentage) into each tablet?

Yes – but not using common blending procedures.

‘Normal’ procedures result in inadequate blending, giving an uneven mix of the ingredients. So in some tablets you won’t get all the ingredients you have paid for and in others you get too much. The heaviest ingredients will settle at the bottom of the mix – this is called ‘stratification’ and is a major concern for reputable manufacturers.

To avoid stratification pharmaceutical methods of blending and validation must be used. There must be multiple blending procedures using the best blending equipment.

An overwhelming majority of vitamin supplement manufacturers DO NOT do this. The norm is to take a macro rather than micro approach by including all ingredients in one huge blend and pouring it into a large inefficient batch blender.


"Multi-vitamins are some of the worst offenders. In a recent study, Linda Shaffer and Michelle of Yale New Haven Hospital, evaluated 257 brands of vitamins bought off the shelf at pharmacies, grocery stores, and health food stores. Many were incomplete or had too little or too much of one or other nutrient. Only 49 were considered adequate…"

Dr. Michael Colgan, Optimum Sports Nutrition, p-210


What type of blender is best?

That depends on several factors but in the case of multi nutrient supplements the overwhelming factor (for you and I) is the precision of the blend.

Let’s take a quick look at the blenders and how good each one is.


There are 4 main categories of blenders used by vitamin supplement manufacturers for dry powder supplement mixes.


  • Convection Blenders:
    Common types are: Ribbon/Paddle/Plowshare


  • Tumble Blenders:
    Common types are: V shape/ Double Cone/conical


  • Pneumatic Blenders


  • 3D Blenders: Pharmaceutical grade



Convection blenders contain a mechanical device which turns or pushes its way through the supplement mix to achieve a blend.

These blenders work well for single ingredients or ingredients which are all the same weight and size but not if mixing a variety of ingredients. They provide a final blend variation of around + or - ten percent.

Due to their low cost they are commonly used by companies mixing multi ingredient blends. This is a poor standard!



Tumble blender - V blender



Tumble blenders are common in the supplement industry and produce very good blends.

The blender rotates about a horizontal shaft allowing for random dispersion and re-orientation of the ingredients. Tumble blenders can be enhanced by many accessories such as internal agitator/intensifier bars to break up and extend low dose ingredients. Final blend variations are typically less than five percent.


Pneumatic Blenders use pulsed/flowed air to lift the ingredients and mix them. These blenders are not suitable for multi ingredient mixes containing varying particle sizes and densities/gravities.



3D Blenders are very expensive state-of-the-art blenders rarely seen in the supplement industry. They are used in the leading pharmaceutical companies but are still not common due to their cost.


3 - D Blender



3D blenders ensure a homogeneous mix with no stratification by using gentle 3 dimensional motion, a bit like a figure 8. They are perfect for precision multi ingredient mixes containing extremely low dose ingredients of varying densities.


BOTTOM LINE FOR FINAL MIX BLENDERS

The minimum standard for blenders in companies manufacturing multi ingredient supplements is a Tumble Blender!

Convection type blenders (such as Ribbon blenders) are not good enough.

If your supplement company uses a 3D Blender you're on a WINNER!






BLENDING PROCEDURES


As I mentioned above the norm in the supplement industry is to weigh out all the ingredients and dump them into a blender. This causes stratification.

The most professional blending procedures (pharmaceutical level) include pre-blending protocols for different categories of ingredients.


For example:

  • low dose ingredients mixed together

  • herbals mixed together

  • amino acids mixed together


Then each of those mixes needs to be remixed into a portion of the bulk mix and in turn that mix is mixed into the total mix and so on. (Is that mixing my words?)


This type of sophisticated blending procedure takes several hours but is crucial to ensure a completely uniform mix.


This is what you want from a supplement company.


Low quality supplements are blended for a minimum of time – usually 20 minutes!


The total amount of blending time is a useful ‘indicator’ of manufacturing quality so we will include this in our questions below.


The size of the batch/mix is important!


It is significantly easier to achieve a uniform blend from say a 100 kilogram batch than it is from a 1000 kg batch. Economic pressures come into play here and can take precedence over ‘good science’ when manufacturing. Inventory turnover also has a major influence.

So, while there is no definitive answer as to the optimal batch size we do know that a smaller fill level reduces the chance of dead-zones forming and so are more in keeping with good science and higher levels of professionalism in manufacturing.

Try asking your supplement company about their batch sizes. I know my company (xtend-life) limits theirs to 65kgs however they’re a smaller company than the other companies whose leading vitamin supplements go head to head in my supplement comparisons .

I’m not suggesting that anything larger than this is wrong.

But - smaller batches produced more frequently allow companies to keep inventory moving rather than gathering dust in a warehouse or distribution centre.


Next step ‘Granulation’ – part of a professional process.



Granulator


After blending is completed the mix should be put through a powder granulator before tableting. This should be done within 24 hours of blending to avoid ‘settling’ of heavier particles.

Granulation is an important part of professional manufacturing because it ensures the integrity of the final blend. This step helps to identify the best vitamin supplement manufacturers because it is often left out by ‘lesser’ companies.

We will be checking on this in our questions to manufacturers



BOTTOM LINE FOR BLENDING PROCEDURES

Look for

  • multiple blending protocols

  • total blending time greater than 2 hours

  • smaller batch sizes

  • Granulation





TESTS PERFORMED

High quality supplement manufacture depends on stringent testing at various stages of the manufacturing process.

Information I collected from a group of well known, ‘quality’ vitamin supplement manufacturers showed almost identical testing during manufacture.

To give you an idea of what these tests are I have listed the most important ones. These are from the Xtend-Life company in New Zealand. The ONLY nutritional health supplements my family and I take. (Presented with permission).


The Quarantine Process (Pre Manufacture)
  • Full microbiological testing. This includes total plate counts for bacteria, mould and yeast, coliforms, E-coli and Salmonella
  • Potency testing, to confirm that the active ingredients are present in the amounts stated in the manufacturers COA (Certificate of Analysis)
  • Heavy metal testing. No contamination with Mercury, Lead, Arsenic or Cadmium.


All materials that are sensitive to room temperature, such as enzymes, are stored at all times in chillers.



The Tableting Process

Periodic tests (every 30 minutes) to ensure that thickness, weight and hardness are within specifications.


Friability, Dissolution and Disintegration Testing.

The tablets are tested for
  • friability (tablet's resistance to crumble/chip/break)


  • dissolution (tablet’s ability to dissolve)


  • disintegration (the fragmentation and distribution of ingredients).


Microbiological Testing

A further set of tests are now carried out to ensure that the tablets have not picked up any contaminants during the manufacturing process. If this test is passed a COA is prepared for that batch and the product is released for bottling and labeling.


BOTTOM LINE FOR SUPPLEMENT SAFETY

In the absence of specific regulatory standards for nutritional supplements (which dictate testing requirements) it’s not possible to offer a definitive ‘bottom line’ for ‘tests performed’. The tests listed above however should definitely be in place for the manufacture of quality products.

Disintegration time is something we can be clear about. The time it takes a supplement to disintegrate is important for absorption of the ingredients. It is well known that some cheap, heavily coated supplements do not break apart and pass straight through the body virtually intact!



undissolved tablets



Poor disintegration is most common with vitamin and mineral supplements – there are many poor quality products available which have been compressed too hard or have insufficient disintegrant levels, or too much binder. Seriously- the market is full of them.


If you chose your supplements according to price you should think hard about this disintegration issue.


Reputable companies test to be sure their products disintegrate in line with United States Pharmacopeia (USP) or British Pharmacopeia (BP) standards!


All claims that products meet any USP/BP standards should have been verified by an independent laboratory (yes - we will check on this too!).




Good Manufacturing Practices (GMP)


There are different levels of GMP! Food GMP’s do not mandate testing! They are primarily concerned with safety (that ingredients used provide a “reasonable certainty of no harm”) and sanitation. They do not regulate dietary supplement quality.

Pharmaceutical GMP’s (Code of Federal Regulations – chapter 21, parts 210 and 211) on the other hand are stringent standards which focus on safety, efficacy, purity and potency of both raw materials and finished product.

There is a minority of vitamin supplement manufacturers who voluntarily manufacture some of their processes in-line with pharmaceutical GMP’s. The choice to do this essentially comes down to cost, integrity and an unshakeable dedication to excellent quality.


This is the ultimate standard you want for your supplement because superior quality, purity, safety and effectiveness are guaranteed - what more could we ask for?



As a supplement consumer, what is of utmost concern (or should be), is whether a supplement company or manufacturer has full compliance with US FDA cGMP (Current Good manufacturing Practises).

In June 2007 the US FDA released its final new rules on GMP for the manufacture of dietary supplements. It's taken the FDA over 5 years to revise these and I believe they are now the MOST IMPORTANT accreditation you need to look for.

NOTE:Depending on the number of employees, companies had until June 2010 to become compliant.

Now, while I’m mentioning the word ‘pharmaceutical’ I’d like to explain the term “pharmaceutical grade processing facility”. This is plastered all over the internet and promoted by many companies in their marketing literature.

Don’t be overly fooled by this. It only means that the manufacturing facility meets hygiene requirements. While this is in itself, an excellent standard (which you want from your supplement manufacturer), it is no guarantee that the sophisticated manufacturing procedures and standards discussed above are being followed.

Pharmaceutical grade facilities do however ensure the integrity of each ingredient and product. Important features include climate control. All production and warehouse areas are maintained at cool temperatures and low humidity.

Positive airflow is used to form a barrier from outside air when doors are open. The air is purified through filtration systems using HEPA filters.

A pharmaceutical grade water system is used in all cleaning operations – this type of system uses filtration and reverse osmosis to remove organic compounds, pollutants, and chemicals.

This is a totally different situation to so many of the contract manufacturers out there whose business consists exclusively of clients wanting basic, low quality supplements, and they don’t give a damn about the excellence (or lack thereof) of manufacturing standards. Just give them the product so they can sell it and make their money.

Sorry to be so harsh here but I really want you to understand just how wide the range of quality is in the supplement industry and just how inferior (and possibly harmful) the bottom end products are.


OTHER IMPORTANT STANDARDS

Over the past few years you’ve probably noticed the letters HACCP
all over the place on food labels, advertising posters and so on – right?

Well these are letters you want to see when it comes to the supplements you buy.

Hazard Analysis Critical Control Points (HACCP) is a worldwide quality system for the food industry but is also used in the pharmaceutical and nutritional supplement industries.

This standard is endorsed by the US FDA and many governmental regulatory bodies worldwide. It involves science based controls for efficiency, hygiene and risk reduction in manufacturing processes.

HACCP certification can be used as a means of assuring the quality and safety of nutritional and dietary supplements!

Other internationally accepted standards which demonstrate a company’s commitment to quality (assuming they are already US cGMP certified) are:


ISO 9000:2000

HACCP-9000 from NSF International. This certification integrates HACCP and ISO 9000 into one management system.


BOTTOM LINE FOR GMP LEVEL


Be a smart shopper – use supplements from vitamin supplement manufacturers who manufacture to pharmaceutical level GMP.


Reputable companies will also have one or more of the following:

  • US cGMP certified


  • HACCP


  • HACCP-9000


  • Pharmaceutical Grade facilities




Manufacturing Standards
The Key Questions to Ask!


Ok, it’s time to sum up by compiling the key questions to ask vitamin supplement manufacturers.

Be sure to clearly mention the name of the product you are interested in as most companies have many products and the answers will differ for some products. Also, certain staff may assume responsibility for answering questions about certain products - so be clear.



QUESTION


IDEAL ANSWER


Do you contract out your manufacturing


No



If you contract out your manufacturing did the manufacturer initially modify or upgrade its facility in order to meet detailed manufacturing process specifications you presented?

Yes


Do you regularly audit your contract manufacturer?

Yes
(At least yearly)

Do regulatory bodies audit your facility or your contract manufacturer’s facility? Who are they?

Yes

(state, regional or national bodies)


What is the name of your contract manufacturer and what is their website address?

Check website for quality control details


What type of blender is used for final mix blending of the following product …………….?

Tumble or 3D blender

(Multi ingredient products)


Is the final blend mix put through a granulator before tableting? If yes how many hours pass between final blending and granulation?

Yes
Within 24 hours


Please describe the blending procedures for (name of product). Are all the ingredients simply put together and fed into a blender?

Look for multiple blending procedures as described above

How long does blending take?

More than 2 hours


What is the weight (in kg) of one mix batch?



No definitive answer to this one. Smaller batch sizes are better


Please list any tests performed during the manufacturing process.

See list above as a guide


Does your product meet USP or BP standards for disintegration?

Yes


Has your product been tested both in-house and independently to verify your disintegration rate claims?

Yes


Which GMP level do you meet for your manufacturing operations or those of your contract manufacturer?

Pharmaceutical grade

Are your manufacturing facilities or those of your contract manufacturer of pharmaceutical grade?

Yes

Do you or your contract manufacturer have HACCP certification?

Yes

Do you or your contract manufacturer have any other ‘standards’ certifications?



ISO 900:2000

ISO 9001:2000

HACCP-9000





Here Are The Answers For Some Of The Leading Supplements Reviewed On My Comparisons Page.

Usana: Essentials (Mega antioxidant & chelated mineral)

Xtend-Life: Total Balance

Source Naturals: Life Force

Pharmanex: Lifepak





Chart Codes:

WR = company won’t reveal the information

DA = company didn’t respond to the question


QUESTION


IDEAL ANSWER


Usana



Xtend-Life


Source Naturals


Pharmanex


Do you contract out your manufacturing?

“No”
No
No
Only for a few specialty products
Yes

Strict specs. given to manufacturer

If you contract out your manufacturing did the manufacturer initially modify or upgrade its facility in order to meet detailed manufacturing process specifications you presented?

Yes
-
-
DA
Yes

Do you regularly audit your contract manufacturer?



Yes

-
-
DA
Yes

Do regulatory bodies audit your facility or your contract manufacturer’s facility?

Who are they?

Yes
state, regional or national bodies
DA
Yes



City & National
DA
Yes


WR

What is the name of your contract manufacturer and what is their website address?

-
-
-
DA
WR

What type of blender is used for final mix blending of the following product …………….?

Tumble or 3D blender
Tumble
3D
Yes


DA
WR

Is the final blend mix put through a granulator before tableting? If yes how many hours pass between final blending and granulation?



Yes

Within 24 hours
WR
Yes


2 Hours

DA
WR

Please describe the blending procedures for (name of product). Are all the ingredients simply put together and fed into a blender?

Multiple blending procedures
WR
Multiple blendings


5 stages
DA
WR

How long does blending take?

More than 2 hours
WR
5 Hours
DA
WR

What is the weight (in kgs) of one mix batch?

Smaller batch sizes are better
WR
65 kg
DA
WR

Please list any tests performed during the manufacturing process.



Microbiolog.
Potency
Heavy Metal
Weight
Hardness
Friability
Dissolution
Disintegrat.





Microbiolog.
Potency
Heavy Metal
Weight
Hardness
Friability
Dissolution
Disintegrat.




Microbiolog.
Potency
Heavy Met.
Weight
Hardness
Friability
Dissolution
Disintegrat.


DA
WR

Does your product meet USP or BP standards for disintegration?

Yes
Yes
Yes
Yes
Yes

Has your product been tested both in-house and independently to verify your disintegration rate claims?

Yes
Yes
Yes
DA
DA

Which GMP level do you meet for your manufacturing operations or those of your contract manufacturer?

Pharmaceutical
Pharma-
ceutical
Pharma-
ceutical
DA
Food

Are your manufacturing facilities or those of your contract manufacturer of pharmaceutical grade?

Yes
Yes
Yes
DA
Yes

Do you or your contract manufacturer have HACCP certification?

Yes
DA
Yes
DA
Joint HACCP and ISO 9000
certification

Do you or your contract manufacturer have any other ‘standards’ certifications?

ISO 9000:2000

ISO 9001:2000

HACCP -9000
DA
ISO:9001¹
DA
HACCP-9001


¹ Currently in registration process.


Ok, let’s move now to another helpful criteria for evaluating and comparing the quality and effectiveness of nutritional health and vitamin supplements –


Best vitamin supplements - How much value for money

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