SomaDerm: A homeopathic gel explained
SomaDerm gel is a homeopathic product manufactured by New U Life that is applied topically to the skin. According to the manufacturer, its formulation is designed to support the body's own production of human growth hormone (HGH) using a blend of highly diluted, or homeopathic, ingredients, including somatropin. While conventional medicine uses HGH therapies to treat specific medical conditions under strict medical supervision, SomaDerm is sold as an over-the-counter supplement, often through a multi-level marketing (MLM) structure. The company promotes it as a powerful anti-aging solution with a range of benefits, but these claims have not been substantiated by robust, independent clinical trials.
The ingredients inside SomaDerm
SomaDerm contains a mixture of active and inactive ingredients. The active ingredients are highly diluted according to homeopathic principles. Homeopathy is a system of alternative medicine where a substance is repeatedly diluted to the point where very little, if any, of the original substance remains.
- Active Ingredients: The formulation includes homeopathic preparations of somatropin (30X), Glandula Suprarenalis Suis (adrenal gland, 6X), and Thyroidinum (bovine, 8X). A dilution of 30X, for example, means the substance has been diluted 30 times with a 1-to-10 ratio, resulting in an extremely minimal concentration.
- Inactive Ingredients: The gel base and other botanical components include purified water, aloe vera leaf, green tea leaf, licorice root, chaste tree fruit, epimedium leaf, ginkgo biloba leaf, velvet bean seed, and wild yam root, among others.
FDA registration vs. FDA approval
One of the most significant points of confusion surrounding SomaDerm involves its regulatory status. New U Life frequently publicizes that SomaDerm is an "FDA-registered" product. It is critical for consumers to understand the distinction between FDA registration and FDA approval.
- FDA Registration: The company is simply stating that its manufacturing facility is registered with the FDA, and it has listed the product with a National Drug Code (NDC). The FDA requires manufacturing facilities and drug listings for many products, but this does not imply the FDA has reviewed or endorsed the product's safety or effectiveness.
- FDA Approval: This is a much more rigorous process. To be FDA-approved, a drug must undergo extensive scientific testing and clinical trials to demonstrate that it is both safe and effective for its intended use. Prescription HGH therapies are FDA-approved and can only be administered by licensed medical professionals. SomaDerm, as an unapproved homeopathic drug, has not met these standards.
Mounting controversy and lack of scientific support
SomaDerm has faced significant scrutiny over its marketing claims and scientific backing. The Direct Selling Self-Regulatory Council (DSSRC), an independent industry watchdog, has investigated New U Life multiple times and found its claims to be unsubstantiated.
In 2020, DSSRC referred New U Life to federal agencies like the FDA and Federal Trade Commission (FTC) after the company failed to comply with recommendations to discontinue unsupported product and health claims. This referral was partly spurred by a lab report from the FDA indicating SomaDerm contained little to no HGH. Furthermore, DSSRC reports highlighted numerous unsubstantiated health claims, including testimonials suggesting the gel could treat the COVID-19 virus.
Comparing SomaDerm to medically-prescribed HGH therapy
To highlight the differences between SomaDerm's approach and that of conventional medicine, consider this comparison:
| Feature | SomaDerm Homeopathic Gel | Prescription HGH Therapy |
|---|---|---|
| Regulatory Status | FDA-registered facility, but product is unapproved and unproven. | FDA-approved, requiring extensive clinical trials for safety and efficacy. |
| Ingredient Concentration | Homeopathic formulation means extremely low, likely negligible, concentrations of active ingredients (e.g., somatropin 30X). | High, standardized concentrations of bio-identical HGH (somatropin). |
| Administration | Transdermal gel applied to thin areas of skin. | Injections administered subcutaneously. |
| Medical Oversight | Sold over-the-counter without a prescription or required medical supervision. | Requires a doctor's prescription, diagnosis, and ongoing medical monitoring. |
| Treatment Purpose | Marketed for anti-aging and general wellness, with unsupported claims. | Treats specific medical conditions like HGH deficiency, Prader-Willi syndrome, or wasting due to AIDS. |
| Scientific Evidence | None for safety or effectiveness; claims contradicted by regulatory bodies. | Extensive clinical evidence supports its use for approved conditions. |
| Potential Risks | Unknown due to lack of testing; risk of delaying proper medical treatment. | Known, monitored side effects include fluid retention, joint pain, carpal tunnel syndrome, and potential for insulin resistance. |
Potential consumer risks and the bottom line
Beyond the lack of proven effectiveness, using unapproved supplements like SomaDerm carries several risks. First, the ingredients and their effects are not verified, meaning consumers do not truly know what they are absorbing. Second, focusing on unproven remedies can lead individuals to delay seeking legitimate medical care for age-related health concerns, which could have serious consequences. Finally, the unsubstantiated claims and promotional tactics have raised red flags with regulatory bodies, indicating a need for consumer caution.
For those interested in hormone health and aging, the most responsible approach is to consult with a qualified healthcare professional. They can provide an accurate diagnosis, recommend proven treatments, and monitor for potential side effects. Relying on an unproven, homeopathic product for significant health benefits is not supported by science or regulatory bodies. For more information, the FDA provides detailed information on its stance on unapproved drugs, including homeopathic products, and advises on how to report adverse events, which is a valuable resource for consumers. A good place to start is the FDA's website on drug safety.
Conclusion: Navigating the claims of SomaDerm gel
In summary, SomaDerm gel is a product marketed by New U Life as a transdermal, homeopathic HGH gel intended for anti-aging and wellness. While the manufacturer's facility is registered with the FDA, the product itself is not FDA-approved, meaning it has not undergone the rigorous testing required to prove its safety or efficacy. Investigations by independent regulators have found its health claims to be unsubstantiated and have referred the matter to federal agencies. The key takeaway for consumers is to be aware of the difference between FDA registration and approval, to recognize that homeopathic formulations contain negligible amounts of active ingredients, and to seek evidence-based medical advice for health concerns instead of relying on unproven supplements.
Disclaimer: This article provides information for educational purposes and is not a substitute for professional medical advice. Always consult a healthcare provider before starting any new supplement or treatment.
