In the previous post (Part 2), we discussed what you need to know about how your supplements are formulated and developed. But how much do you really know about the manufacturing programs and processes? In the third and last part of this blog series, we’re going to share with you the important features of supplement manufacturing and testing.
Is that product you are considering manufactured in a GMP (Good Manufacturing Practices) certified facility?
GMPs are the legal requirements for a sophisticated production system to ensure a dietary supplement product has the correct ingredient identity, strength, purity, safety, and process documentation that matches the content of its label. The processes for producing the product must be followed down to the finest details, testing must be conducted at various stages of the production process, and the documentation must be sufficient to be able to trace and isolate any problem that may occur. The cGMP (current GMP) regulations were developed by the Food & Drug Administration (FDA) to ensure that dietary supplements are manufactured to the highest quality possible from the available technology. You often hear people who are biased against dietary supplements say that dietary supplements aren’t regulated, but FDA’s stringent cGMP regulations are proof that supplements actually are thoroughly regulated.
The FDA is the government agency that enforces GMP requirements all along the chain of custody of a dietary supplement product: from raw material suppliers through the manufacturer to the packager, and on through to the retailer, all are responsible for the quality of the product. FDA does unannounced inspections of all these parties. While they do not offer certifications for cGMP, they will issue warning letters and will shut down a party that fails to conform to cGMP requirements. Independent groups can be hired by a company to inspect their facilities and processes and provide GMP certifications. Among the services they provide are reviewing facility cleanliness and standard operating procedures, monitoring equipment calibration and operation, checking the production line for sources of contamination, verifying quality control overall and generally making sure the finished products’ labels meet FDA specifications.
When the FDA themselves perform an unannounced inspection of a facility that handles dietary supplement products and finds a GMP or other product quality problem, or inaccurate or otherwise illegal labeling, they typically give the facility 15 days to correct the problems. If the required changes are not made, the facility can be shut down and individual staff who knowingly defy the rules can be criminally charged and even go to jail. And FDA is not the only agency that regulates dietary supplements.
Responsible parties in the dietary supplement industry must follow the legal requirements not just of the FDA but of the FTC (Federal Trade Commission, tasked with protecting the consumer against fraudulent marketing or other illegal trade representation), state public health departments, environmental protection agencies, and even California’s Proposition 65 with its long list of toxic substances to avoid. All these regulatory agencies further help protect the public against unsafe or other illegal dietary supplement products.
It’s important to know that your supplements are tested for identity, purity, and potency. Testing is most effectively done on the raw material ingredients before they enter the chain of production. But in-process testing is also necessary, and the finished product must also be tested to ensure the integrity of the entire manufacturing process. Both ingredients and finished products must go through identity and potency verification, heavy metal testing, and microbial testing. All of BrainMD’s products undergo these testing processes, and we employ independent laboratories to do our testing. We also audit our manufacturers, packagers, and testing labs to ensure they have adequate quality control and processing standards in place.
To protect your health and wallet, and to be confident you are getting the highest quality supplements, make sure you are buying products that are manufactured in cGMP certified facilities.
Be vigilant! Be knowledgeable enough to sort the good from the bad. Supplements are an important part of your health regimen and you should be as well informed as you can be about what you’re putting in your body. Your health and safety depend on it.
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