Unless you’ve been living under a rock for the past decade you are probably well aware of the fact the federal government is not happy with dietary supplement industry. Over the past few months there has been quite a bit of rumbling among industry insiders because of some increased enforcement efforts which have included search and seizure, recalls, and even raids by the DEA for alleged contamination of supplements with controlled substances.
The reason for this increased is because of the lack of quality control in this loosely regulated industry. However, it seems the times of loose regulation are over once the cGMP’s (current Good Manufacturing Processes) go into effect this month for the majority of supplement firms whether distributors or manufacturers.
Essentially cGMP’s have been put into place because the loose enforcement of DSHEA (Dietary Supplement Health and Education Act of 1994) didn’t motivate the vast majority of supplement firms to adhere to strict quality control (QC) protocols. The combination of loose enforcement and poor quality control in some cases has allowed some particularly dangerous products to reach the mass market. It has also allowed for products which do not meet label claims to get into the hands of consumers as well.
In reality, some of the new QC protocols and labeling requirements in this newly cGMP regulated era call for stricter measures and oversight than the pharmaceutical industry. Ultimately, these will greatly benefit the vast majority of consumers but there is a very harsh reality which will be faced along the way.
You would have to assume that one of the driving factors in loose QC would be due to costs. It’s not cheap to manufacture, warehouse, or distribute goods under QC protocols which rival the pharmaceutical industry. Climate controlled warehousing, shelf stability, pre and post production testing, and the documentation to serve as proof that all these processes exist and are monitored on a daily business is relatively expensive for a smaller to medium sized supplement firm. Therefore, corners would have to be cut to preserve the coveted profit margin. I should state this now that not all firms cut corners, however relative to the new regulation it would appear that based on the current FDA perspective, they believe the probability is high.
The reality of the situation is that increased costs of production will be carried over to the consumer or some firms which will probably cease to exist. More than likely we will see a consolidation of manufacturing and supplement distribution firms who use third party manufacturing as well. This is the downside of increased production costs. Unfortunately, some very innovative firms that don’t have the proper funding might go by the wayside should they decide to remain autonomous.
Now I don’t want to worry a lot of you out there because believe it not, many firms have already been adhered to cGMP’s for quite some time now. Organizations like the Natural Products Association and the NSF have helped lead the way to offer certification programs to qualify and feature some of the best in the business. Furthermore, brands that are sold in countries which have their own cGMP requirements like Canada and Australia are well ahead of the curve as well. These supplement firms don’t have a lot of maneuvering to do because they’ve been exceedingly proactive in their approach to the new regulatory environment.
Ultimately, the FDA is empowered to protect the consumers and to offer guidance to pharma, the food industry, and the dietary supplement industry. Politics aside, the new cGMP’s are here because the vast majority of supplement firms have been somewhat resistant to implementing proper quality control which would benefit the consumer and ultimately their long term vitality in the evolving regulatory environment. As one industry insider put it, “Can you blame them? The industry should have been doing these things all along.” Wholeheartedly ’d have to agree but sincerely hope it doesn’t stifle innovation to the detriment of the consumer and their access to cost effective dietary supplements.
If you want to actively join in a cGMP discussion on the forum please check out this forum thread linked here.
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