How a regulatory change could impact HCG availability.
What is HCG?
HCG (Human Chorionic Gonadotropin) is a hormone found in the urine of pregnant women. HCG is FDA-approved for the treatment of select cases of female infertility and hormone treatment in men. FDA-approved HCG products are only available in injection-form and require a prescription from a licensed medical professional.
HCG & Weight Loss
In the 1950s a British endocrinologist named Albert Simeons was investigating HCG as a treatment for Frohlich’s syndrome, a delayed development of the genitals in adolescent boys caused by a pituitary gland disorder. During his trials he noted that boys treated with HCG had lost weight and had less appetite. This lead to Dr. Simeons turning his research to HCG for weight loss and he created a diet plan that includes the use of HCG in combination with a very low calorie (500 calories per day) diet.
While Dr. Simeons was able to generate interesting results using his protocol, other researchers have failed to replicate them. A meta-analysis that included more than 20 different studies of HCG found that “there is no scientific evidence that HCG is effective in the treatment of obesity; it does not bring about weight-loss of fat-redistribution, nor does it reduce hunger or induce a feeling of well-being” (Lijesen et al, 1995).
It is important to note that HCG has never been approved for use in weight loss. “Currently, there are no FDA-approved HCG drug products for weight loss. HCG has not been demonstrated to be effective therapy in the treatment of obesity. There is no substantial evidence that HCG increases weight loss” (FDA, 2016).
Regulatory Changes
The FDA is planning to re-categorize a number of approved drugs, including HCG, as “biological products”. This change is to take effect on March 23, 2020 and is expected to impact the availability of HCG in 2020 and beyond.
“On March 23, 2020, an approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) shall be deemed to be a license for the biological product under section 351 of the Public Health Service Act (PHS Act) (see section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009)” (FDA, 2019).
What This Means
To produce a drug product, a manufacturer must submit an application for a new drug approval even if it is an existing drug already on the market. FDA regulations provide exceptions that allow registered 503B compounding pharmacies to produce certain drugs without one of these approvals. These exceptions do not exist for biological products.
As a part of the transition, FDA is converting drug approvals for the impacted products to biological approvals. Because HCG currently does not require a drug approval to be produced by compounding pharmacies, they do not hold such approvals and therefore will not be licensed to produce HCG as of the March 23, 2020 deadline. At the time of this writing, only 3 pharmaceutical companies will be licensed to produce HCG, and it is possible that not all of them will take advantage of that ability.
This means that HCG will be harder to find, and will likely increase in price.
FAQ:
Q: Is compounded hCG safe to use?
A: Compounded HCG may pose safety risks as it is not FDA-approved for uses like weight loss and lacks the quality controls of approved products. The FDA warns that HCG used with very low-calorie diets can cause serious side effects like gallstones, electrolyte imbalances, and irregular heartbeat. For those undergoing treatments like IV injection, it’s essential to discuss potential risks with a healthcare provider. Always consult a healthcare professional before use.
Q: How does compounded hCG differ from regular hCG?
Q: Why is the FDA concerned about homeopathic HCG for weight loss?
A: The FDA is concerned because no HCG products are approved for weight loss, and its effectiveness for obesity is unproven. These products are often paired with very low-calorie diets (VLCDs), which pose risks like gallstones, electrolyte imbalances, and heart issues. Those using IV therapy supplies for weight management should consult a doctor for safer alternatives, as VLCDs require medical supervision.
Q: What are the benefits of using compounded hCG?
A: Compounded HCG helps improve fertility in women, supports testosterone and sperm production in men, and treats conditions like undescended testes in children. For those using IV supplements as part of their treatment, compounded HCG can complement other therapeutic approaches. It may also have other uses based on individual medical needs. Always consult a healthcare provider for guidance.
Q: Where can I obtain compounded hCG?
A: In the USA, compounded HCG can be obtained through licensed compounding pharmacies with a valid prescription from a healthcare provider. However, due to FDA regulations reclassifying HCG as a biologic product, most compounding pharmacies can no longer produce it. For individuals exploring IV starter kits or other medical supplies, Legere Pharm offers approved HCG alternatives. Consult your doctor to determine the best option for your treatment plan.
Jon Legere
Jon Legere is the Director of Marketing at Legere Pharmaceuticals, where he oversees all strategic marketing initiatives, brand development, and customer engagement efforts. With an MBA and 11 years of specialized experience in the dietary supplement industry, Jon brings a wealth of knowledge in consumer behavior, product positioning, and digital marketing strategies. His expertise has been pivotal in driving growth, innovation, and market share for Legere Pharmaceuticals, as he remains committed to promoting health and wellness through cutting-edge supplements.
