Is Brazen approved by the US Food and Drug Administration (FDA)?
No. Unfortunately, the FDA doesn't have an approval process for ANY supplement. FDA approval is something that is reserved only for pharmaceutical drugs.
What is the difference between a drug and a supplement?
The FDA treats vitamins and supplements differently than pharmaceutical drugs. Drugs are much more closely regulated because they are considered safe and effective to cure, treat, diagnose, or prevent recognized diseases. This requires years of clinical trials to prove safety and efficacy.
The FDA considers vitamins and supplements to be "nutritional". This means that vitamins and supplements are regulated more like food than like drugs. Vitamins and supplements cannot claim to "diagnose, treat, cure, or prevent any disease". You've probably seen this language before on supplement packaging. Because vitamins and supplements are not regulated in the same way as drugs, they cannot make similar claims about their actions.
Does that mean that supplements aren't regulated?
Absolutely not. The FDA still monitors the supplement industry and is in charge of regulating and enforcing this industry. The FDA has set up a series of guidelines called Good Manufacturing Practices (GMP's) to ensure that supplements are produced and distributed safely. Brazen, like all supplement companies, is subject to this FDA regulation and all our products are produced in a third-party certified cGMP facility.