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The Scary Truth About The Supplment Industry ?
We spent $30 billion a year on supplements, so you would assume that the product we buy are the products the label promises. Someone must be watching out for us ... right ??
We should have entered a new age of supplement quality. You probably shouldn’t dwell on this too much but it wasn’t until June of 2007 that the FDA issued the final rule that establishes good manufacturing practices for the supplement industry.
The Dietary Supplement Current Good Manufacturing Practices (CGMPs) final rule “requires that proper controls are in place for dietary supplements so that they are processed in a consistent manner and meet quality standards” (USFDA 06.22.2007)
The incredible reality is that until this final ruling no one, no agency, no regulatory body, NO ONE was monitoring what was actually contained in our supplement bottles. At long last we had the required labeling, we bought with confidence but in truth, there was nobody checking that the ingredients actually matched up to what the labeling said. That is not to say that everything on the market was bogus, a companies business is very reliant upon its reputation and we would hope that most of the manufacturers out there did their best to supply the best quality that they could. I would however hazard a guess that most of the people buying the vitamin, minerals, herbs and botanicals assumed that there was some sort of quality control in practice, when in fact there was not.
Other industries could not get away with this. If a t shirt said on the label 100% cotton but you could see that it was in fact polyester, you would not buy the t shirt. If you were buying shoes and they said ‘leather’ but they obviously were not leather then you would not buy the shoes either. When it comes to dietary supplements we as consumers have little to go on, we read a label and trust a brand. Times, they are a changing, and The Dietary Supplement Current Good Manufacturing Practices (CGMPs) final rule is long overdue.
A study of Ginseng products (Am J Clin Nutr 2001, 73, 1101-1106) found products with as little of 12% of the active ingredient in the bottle. It also found other ginseng products with 328% of the active ingredient in the bottle.
A study of 59 Echinacea products found that 6 had no measurable amounts of Echinacea at all. Of all 59 products only 31 were found to be consistent with the product labeling (American Intl Med 203, 163, 699-704)
In 2003 the FDA announced the proposed rule to establish manufacturing practices for supplements, the FDA used as argument data that showed 18 soy and/or red clover supplements. Of the 18 products 5 contained only 50-80% of the quantity of isoflavones stated on the label. The FDA also had cited that of 25 probiotic products , 8 contained less than 1% of the live bacteria claimed on the label.
“Houston, we have a problem”.
The Dietary Supplement Current Good Manufacturing Practices (CGMPs) final rule sets industry wide requirements for all domestic and foreign companies that distribute dietary supplements in the United States. The rule came into existence June 2007 but because of the possible disruption it could cause to some companies it has been staggered into 3 phases. The final CGMP becomes effective in June 2008 for large companies. Those companies with less than 500 employees have until June 2009 and those companies with less than 20 employees have until June 2010, at which point all companies should be in compliance with the regulations.
The FDA with the Dietary Supplement Health and Education Act (DSHEA) of 1994 afforded us the protection of proper labeling. The FTC backed that up by overseeing advertising claims made by supplement companies. Even then we still had a slight problem, we had the labels, but could we really be sure that what was in the supplement bottle was actually what was stated on the label. The uniformity and quality of the ingredients was in question and the manufacturing operations had no one to watch over them.
In December of 2006 the Dietary Supplement and Non Prescription Drug Consumer Protection Act was signed. Now, at least we could find the manufacturers in we had something to say. Because of this act companies now have to identify themselves with an address or phone number shown on the label of all their products. We now have someone to complain to. Prior to this act the Office of the Inspector General estimated that less than 1% of adverse events related to dietary supplements were reported to the FDA and even when reported it had been difficult to investigate as the ingredients of the product in question were not certain and the identity of the manufacturer was unknown. The act of 2006 located the manufacturers and The Dietary Supplement Current Good Manufacturing Practices (CGMPs) final rule of 2007 has given the industry standards and proper controls for the manufacturing of dietary supplements.
Under the CGMPs there will be requirements for:
.... Design and construction of physical plants .... Cleaning ... Quality control procedures ... Final product testing or incoming and in-process materials ... Handling consumer complaints ... Maintaining records
This act should be able to prevent : .... Dietary supplements that contain ingredients in amounts more than or less than that which is stated on the label (uniformity). ....wrong ingredient ....other contaminants (bacteria, lead etc) …foreign material in a supplement container .... Improper packaging .... Mislabeling
You should feel reassured that the FDA is involved with quality control. The FDA is much criticized and may not be a Federal Saint but the FDA does have power and it does have the ability to put a company out of business. The FDA is most likely still understaffed and does not work with lightening speed but the wrath of the FDA is a definite deterrent and unscrupulous companies will be forced to think twice.