Business ProfileforEnvizion Medical, Inc.

In May 2018, BBB requested the business substantiate claims regarding its advertisement to sell HCG injections for the purpose of weight loss. Specifically, the company makes the following claims on its website, http://www.envizionmedical.com/weight-loss/hcg-diet.aspx:

Per BBB standards outlined in BBB's Code of Advertising (Section 34, Claimed Results). Claims relating to performance, energy savings, safety, efficacy or results for a product or service should be based on recent and competent testing or other objective data. Advertisers should be prepared to substantiate such claims.

On May 21, 2018 BBB received the business response which stated:

It seems as though you were misinformed on both points.
HCG (a hormone found in humans) is FDA approved for the onset of puberty in boys and for fertility in women. It is safe and has very few side effects, none of which are life threatening. It is most often used off-label for weight loss.
It is NOT illegal, however it requires a prescription. That is a big difference. Any references to the legality of HCG products have to do with over the counter supplements that advertise as HCG, as it can not be purchased without a doctor's prescription.

According to the FDA (https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm281834.htm):

"5. Are prescription HCG products safe and effective for weight loss?
No. FDA-approved uses for prescription HCG products include female fertility and select hormonal treatment in males, and FDA has not approved prescription HCG for any other uses, including weight loss. Current scientific evidence does not support the claim that HCG is safe and effective for weight loss or for the treatment of obesity. In fact, FDA labeling for the approved HCG drug products requires the following statement about the use of HCG for weight loss:
"HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or 'normal' distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets."

FDA is aware that healthcare professionals sometimes prescribe prescription injectable HCG for unapproved uses such as weight loss. FDA understands that sometimes approved products are used to treat conditions that the products were not approved for (i.e., "off-label" uses). The "off-label" use of products usually presents greater uncertainty about both the risks and benefits because less information is available on safety and effectiveness. Unexpected adverse events may occur in this context. FDA has received reports of serious adverse events associated with the use of HCG injections for weight loss including cases of pulmonary embolism, depression, cerebrovascular issues, cardiac arrest, and death."