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.
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 FDA with the Dietary Supplement Health and Education Act (DSHEA) of 1994 afforded us the protection of proper labeling. 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 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. 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.
" Houston, we have a problem".
In December of 2006 the Dietary Supplement and Non Prescription Drug Consumer Protection Act was signed. 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.
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.
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).
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.
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. 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.
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