Is Vemma approved or certified by FDA? I am often asked this question, either by potential customers or by my team members who have been asked this question by their customers. I do find this question interesting. Why? Well.. the person who asks this question obviously knows a little bit about FDA but at the same time, he or she really does not understand how FDA works and what FDA does.
U.S. Food and Drug Administration (FDA)
So what exactly is FDA? It is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations. FDA is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, food supply, cosmetics, dietary supplements, and products that give off radiation.
What is Vemma?
Vemma is a company which sells nutritional products or sometimes called dietary supplements. Vemma makes it clear on their website that the products are not intended to diagnose, treat, cure or prevent any disease. Therefore, Vemma products are not medicine or drugs, but merely dietary supplements which have tremendous beneficial effect on some people.
Is Vemma Approved or Certified by FDA?
The short answer is no. In fact, none of the dietary supplements from any company is approved or certified by FDA. Why is that? The answer is simple. They don’t have to. It is not part of FDA’s job to approve these dietary supplements. There is a good webpage about what exactly FDA does in term of certification and approval. Below are short paragraph from the above website:
FDA does not approve health care facilities, laboratories, or manufacturers. FDA does inspect product manufacturers to verify that they comply with good manufacturing practices.Owners and operators of domestic or foreign food, drug, and most device facilities are required to register with FDA. Blood and tissue facilities also must register with the agency.”
Unlike new drugs, dietary supplements are not reviewed and approved by FDA based on their safety and effectiveness. Most dietary supplements that contain a new dietary ingredient (a dietary ingredient not marketed in the United States before October 15, 1994) require a notification to FDA 75 days before marketing.The notification must include the information that was the manufacturer or distributor’s basis for concluding that the dietary supplement will reasonably be expected to be safe. After dietary supplements are on the market, FDA evaluates their safety through research and adverse event monitoring.”
I hope it is clear now. So asking “is Vemma approved or certified by FDA” is almost like asking if Starbuck coffee or KFC is approved by FDA. It is simply not relevant.
Of course, if a dietary supplement causes any major health problem or side effect, this has to be reported to FDA and this has NOT happened to Vemma products. If someone make medical claim about a dietary supplement, FDA will have problem with that. That is why it is important not to make any claims about the products. Remember, Vemma products are fantastic dietary supplements who have some amazing effect on people, but it is not intended to diagnose or treat any disease or illness.