Is Bio X4 FDA approved?
We are constantly being asked whether or not Bio X4 has FDA approval on our Bio X4 review. The answer is no. As a dietary supplement, Bio X4 does not fall under the remit of the FDA, which regulates pharmaceutical drugs and food safety.
However, the amount of times we’re asked that question tells us something very interesting about Bio X4.
Like a lot of supplement companies these days, Nucific is clearly presenting itself as a maker of highly effective, powerful nutritional products which could easily be confused for pharmaceutical drugs.
The use of Dr. Amy Lee, whoever she may be, is obviously an attempt to give Bio X4 some medical legitimacy. The idea is to get people thinking that this is something their doctor or pharmacist might prescribe for irritable bowel syndrome or obesity.
So, should Bio X4 be FDA regulated?
Would it be FDA approved?
Let’s find out!
Bio X4 and FDA regulation
As we’ve already stated, Bio X4 does not have FDA approval. No nutritional, dietary supplements have FDA approval as that regulatory body does not regulate such products.
The FDA is responsible for regulating medical products like pharmaceutical drugs, commercially available therapies, and food products.
But as we’re already alluded to, Bio X4 is presented by Nucific as a kind of quasi-medical product, with the backing of Dr. Amy Leee (whoever she is). Nucific also make some “medical-grade” claims about Bio X4, such as that it can help with weight management in obese people, or that it can reduce symptoms of irritable bowel syndrome.
So while Bio X4 is not FDA approved, we feel like it should fall under the remit of some regulatory body. The claims made by Nucific about Bio X4 are substantial enough – and false enough – to warrant control by a government agency.
If you’ve read our full Bio X4 review then you’ll know that we are not at all convinced by the claims made regaridng this probiotic’s ability to help with weight management. This probiotic is no better at helping with weight loss than any other probiotic on the market right now.
The “weight loss” inducing ingredients in Bio X4 are never going to make a significant difference to a person’s waistline or overall ability to maintain a healthy weight.
Green tea extract is a weak fat burner, and the dose used in Bio X4 is low by supplement industry standards. Slimaluma has never been proven to work in independent clinical trials at all.
So while Nucific Bio X4 does not have FDA approval, we think the claims made by Nucific should be sscrutinized by the FTC, the Federal trade Comission. This body does have the power to sanction companies who use blatantly false advertising, just like Nucific do with Bio X4.
The fact Nucific charge sick people $100 for a bottle of a bog-standard probiotic (with some scammy ingredients thrown in) just makes the need for FTC involvement even greater.