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FDA Rules for Current GMP Effective June 25th
This week is another important milestone for the Dietary Supplement industry. June 25, 2009 is the deadline the FDA (Food & Drug Assoc) has given for medium sized companies, (those with more than 20 employees) to comply with cGMP or Current Good Manufacturing Practices. What this means to the consumer is another step closer to more consistency in over the counter herbal supplements and all dietary supplement. The cGMP regulations protect the consumer by providing standards for ensuring purity, identity and strength of composition for each product produced.
All told it’s taken 14 years to get to this point. The FDA made allowances for smaller businesses to comply giving them an additional 3 years if they had less than 500 employees. Companies with greater than 500 employees were required to comply one year ago, June 2008. Finally, those companies with fewer than 20 employees have an additional year to comply with the new regulations, until June 2010.
The best producers in the dietary supplement industry have been complying with the FDA regulations for years and these regulations have no major effect on them. Now the smaller companies need to comply, bringing standardization in the supplement industry. Most likely it will also give third party certification companies an even more important role, proving to the consumer that products truly contain the amount of supplements listed on their label. No doubt manufacturer will begin putting pressure on their suppliers to give proof of the purity of their raw materials taking some of the testing burden of themselves. Down the road this may lead to increased cost of raw materials as product testing becomes more the norm rather than the exception.
Although this may lead to some retail price increases, overall it is extremely beneficial for the consumer. Products will me standardized and hopefully as a result more effective. Of course, unscrupulous manufacturers exist in every industry and those adding prescription medications into an “herbal supplement” may still find that without FDA inspectors knocking at the doors for regular inspections it is all to easy to provide tainted products. This is where third party independent testing is crucial. FDA will never have enough in their budget to run from factory to factory and oversee these regulations. Consumers must be diligent in knowing where their products are manufactured and by whom. They must do some minimal research at places like consumerlabs.com to get the independent assessments on product effectiveness and discern whether minimum standards for product purity, identity and strength our actually met. At least the FDA has raised the bar and companies must follow. As a consumer of dietary supplements all I can say is it’s about time.
