Sub-standard Ingredients in Nutritional Supplements

How Do SUB-STANDARD Ingredients Originate?


This topic of this page, substandard ingredients in nutritional supplements 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 competing 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.


Substandard Ingredients - How They Originate

Companies selling supplements have 2 choices for manufacturing - do it themselves or have it done by a contract manufacturer (CM).

Most US supplement companies – more than 95% - don’t have the necessary technical expertise (or funding) to self manufacture. That’s because they are essentially marketing companies - not professional science based supplement companies!

The use of a CM can affect supplement quality for 2 main reasons:

  1. CM’s do not have the qualifications and specific knowledge to formulate professional science-based supplements (yet they go ahead and formulate supplements and premixes forsale.)                                                   
  2. It opens the door for substandard raw ingredients to enter the manufacturing chain.

I’ll explain point number 2 first. Here’s what happens.

Every raw ingredient comes with a Certificate of Analysis (C.O.A.) prepared by the company selling that ingredient.

The C.O.A. contains detailed information about the identity, quality and purity of a specific raw material. It should reflect the true and representative properties of the material in question.

Information included on a C of A varies slightly depending on the material and the users requirements. In general a certificate of analysis will include this type of information:

  • Product identity: product name, item number, batch number, manufacturer, manufacturing/expiry dates.
  • Product source: country of origin, scientific/botanical name, plant part (root, stem etc).
  • Product type: crude material, cut, powder, granular, whole herbal extract, standardized extract.
  • Identification method: microscopic, TLC, FT-IR, HPLC, GC etc.
  • Physical property: color, odor, taste, appearance, bulk density, particle size, pH value, solubility, moisture content, loss on drying, viscosity and refractory index, flow ability, compressibility etc.
  • Chemical assay and method: active or marker compounds, purity or specified ranges, titration, UV-Vis, HPLC, GC etc.
  • Impurities: foreign matter, total ash, acid-insoluble ash, heavy metals, natural toxins, pesticide/fungicide residues etc.
  • Microbiological data: (for sterile material) total plate count, yeast, molds, total coliforms, E. coli, salmonella, staphylococcus etc.

Source: Nutritional Outlook, March 2005 edition

To see a sample COA   please click this link. (Opens a pdf file)


Now based on what you’ve read above I’m sure you can guess the obvious question I’m heading to here: 


Are these all important COA’s trustworthy?

Unfortunately the answer is sometimes ‘NO’- they have been falsified! 

The (current) lack of testing regulations for nutritional supplements means manufacturers are under no obligation to test raw ingredients for conformity with COA’s. 

Supplements in the U.S. are currently monitored by law under Good Manufacturing Practices (GMP) for ‘food’ – and these standards do not mandate testing - only that ingredients used are safe (they provide a “reasonable certainty of no harm”) and that operations are sanitary.

Many CM’s therefore DO NOT TEST - just because it is not required!!! 

They choose to trust the COA thus avoiding the added expense of testing!

THE PROBLEM:

Unscrupulous people working in the industry use this situation to their advantage by adulterating raw ingredients with cheap, ineffective or even dangerous substances/fillers before selling them on to the manufacturers.

Adulterants like heavy metals have been found in supplements coming into the US from other countries. Heavy metals are added to increase the weight of ingredients that are sold by weight.

There are numerous reports of poisoning with lead, copper, and mercury from herbal formulations originating in other countries.(1)-(3) 

Tests continue to reveal dangerous contaminants and poor quality control in supplements ingredients. California investigators in 1998 found that nearly one-third of 260 imported Asian herbals were either spiked with drugs not listed on the label or contained lead, arsenic or mercury”.

Herbal products take a human toll, MSNBC, 3/19/00

This is a main reason why nutritional supplements fail surprise tests by independent companies like consumerlab.com. or those presented in news articles and research studies.

Who are these dishonest people?

Hmmmm - difficult to know and probably not wise to name names. Let me be more general instead. It certainly could be raw ingredient suppliers found in many countries including China. 

Let’s look at China - which has developed itself as a leader in the supply and manufacture of many raw ingredients. China has developed top notch technology; manufacturing facilities; and sells at unbeatable prices. It does a lot of business in the nutritional supplement industry.

There probably isn’t a multi nutrient supplement out there today that doesn’t contain some ingredients which originated in China.

A quality nutritional supplement manufacturer who I recently spoke to said that the Chinese are “notorious for adulterating ingredients”. It's more than likely though that these substandard ingredients are not sold by Chinese manufacturers but rather by Chinese distributors who are in it for a quick buck and can easily set up shop again if they are caught and closed down.

The reality is however that vendors and brokers in America, and other developed countries are just as guilty].

“Researchers at the University of Florida, Gainesville are reporting that eight of the 22 calcium products they tested – including popular national brands such as Caltrate 600 – contained lead, the toxic metal that can lead to anemia, high blood pressure, brain and kidney damage in adults and developmental damage in children.”

Many Calcium Supplements Still Contain Traces of Lead – ABC News, 9/19/00


“… Eight of the 21 brands tested were found to contain high levels of pesticides and some also harbored significant amounts of lead….”

An independent report finds that what’s listed on a supplement’s label is not always what’s inside – Time Magazine, 7/3/00

Even manufacturers themselves get in on the act because there is no regulation which mandates that a finished nutritional supplement be tested to verify label claims.

NOTE: That’s not to say all Chinese companies are dishonest. Many have excellent reputations for quality standards, long-term reliability, intellectual property protection and are used by manufacturers of the world’s best nutritional supplements.

So it’s easy to see why there are so many nutritional supplements in the marketplace which contain substandard or dangerous ingredients. 

Although the amounts of contaminants such as lead are very small, they build up in the body over many years and negative health conditions will eventually appear. It may be 20 years or more down the track and disreputable manufacturers know this - that’s why they don’t care! Profit and greed come before everything else. 


Sources

  1. Baker D, Brender J, Davis K. Cadmium and lead exposure associated with pharmaceuticals imported from Asia: Texas. MMWR Morb Mortal Wkly Rep. 1989;38:612-614
  2. Smitherman J, Harber P. A case of mistaken identity: herbal medicine as a cause of lead toxicity. Am J Int Med. 1991;20:795-798
  3. Shaw D, House I, Kolev S, Murray V. Should herbal medicines be licensed? BMJ. 1995; 11: 451-452


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