New U Life’s Somaderm FDA Approved vs FDA Registered
a review by BenefitPerx CEO, Tom Cioffe
The following is in response to questions raised by various BenefitPerx clients and others, regarding Somaderm and the terms FDA Approved, FDA Clearance and FDA Listed/Registered. Pardon the lengthy response, as we wanted to be sure to respond to all questions, as well as share detailed information on New U Life’s current quality systems. As an investor and client, we have done extensive research on the manufacturing processes.
FDA terminology may sometimes be complex and can be confusing. The FDA uses three terms: Cleared, Approved and Registered.
• FDA Clearance is an indication that a medical device is substantially equivalent to an existing device for a purpose. FDA clearance is achieved through the “510(k)” application process and is used primarily for medical devices. In vitro diagnostic assays are classified as medical devices by the FDA.
• FDA Approval is granted typically for new drugs or devices and assures that the new device is reasonably safe and effective. Approval is granted because of a premarket approval (PMA) application. Occasionally, in vitro diagnostics companies apply through the PMA process, though we usually use the 510(k) approach.
• Manufacturers and distributors of drugs and devices marketed in the United States must Register with the FDA, list their products, and pay a fee. The FDA states that “Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.” Based on these criteria, it would be inappropriate for a manufacturer to claim FDA "endorsement" for registering their company and its products.
As you may know, many hormone therapy drugs, peptides, amino acids and other antiaging drugs and homeopathic supplements have no listing whatsoever with the FDA. On a side note, commonly prescribed hormone therapy drugs (selective Androgen Receptor Modulators, known as SARMs), such as: ostarine, andarine, RA140, ibutamoren, and GW501516 have not been approved by the FDA as currently dispensed, and other hormones such as HCG are currently being used mostly for treatment other that what it was approved by the FDA for.
Below we have compiled a review of New U Life’s regulatory compliance and FDA registered manufacturing protocols. Given the nature of Somaderm and the fact that it is 30x of the preion strength dose of somatropin, a synthetic USP human growth hormone, we are satisfied with the empirical data compiled and available on somatropin. To date there is no requirement that New U Life file for more than the FDA NDC #61877-0005-1, registration. Should the regulations change, we have been assured by New U Life that they would work diligently to meet any updated guidelines.
Here is an overview of the Quality Assurance mechanisms currently in place at New U Life:
REGULATORY COMPLIANCE
New U Life exclusively uses an FDA registered manufacturing facility and complies with all FDA regulations. FDA NDC #61877-0005-1. With our extensive experience in regulatory compliance of over-the-counter products, we can advise and assist with all requirements for FDA product indications, label copy, and ingredient listings. We also file the appropriate drug product listing with the FDA for all drug products manufactured for U.S. sales.
PRODUCT CONSISTENCY & RELIABILITY
According to FDA instruction, New U Life documents every step of the manufacturing operation. We consistently produce products by using quality raw materials, applying strict product testing, and by using standardized manufacturing processes with each order.
INGREDIENTS
Through our worldwide channel of ethical and reliable suppliers, we are able to acquire quality, raw ingredients. We use a USP state-of-the-art water purifying system for all our non-GMO, gluten free, organic alcohol.
QUALITY CONTROL TESTING
A quarantine of all inbound raw materials is mandatory until the quality and identity of those raw materials are verified. All raw material suppliers must provide Certificates of Analysis. During the manufacturing process, all water used undergoes microbiological testing in accordance with USP (United States Pharmacopeia) regulations. It is not until an extensive series of product testing is performed before the product is released.
FACILITIES
We use one of a small number of authorized homeopathic manufacturing facilities in the United States. New U Life is registered with and subject to inspection by the Food and Drug Administration (FDA). We follow all current good manufacturing practices (cGMPs) as set forth by the FDA.
It should be noted that FDA Registration does take significant time and expense to register and indicates a concerted effort by the manufacturer to follow quality protocols during the manufacture and distribution process. Simply put, Somaderm GEL is a 30x of the preion strength dose of somatropin, a synthetic USP human growth hormone that has been used for more than 25 years. Much is publicly and readily available on the use and the results of somatropin.
What makes New U Life’s Somatropin unique and unmatched is the proprietary transdermal method of release of HGH through the skin--a process that no other homeopathic lab has been able to exceed. We hope this helps you in your deliberations. www.hghgel.shop
ABOUT BENEFITPERX: Founded in 2012 BenefitPerx recognized one of the most challenging issues of our time is affordable healthcare. More employers have been forced to restructure their benefit plans, often reducing benefits or shifting to consumer-driven health plans or other high-deductible high co-pay options; many offer no benefits at all.
BenefitPerx addresses this challenge by providing users with low-cost access to the healthcare they need while offering businesses an innovative solution that reduces absenteeism, increases productivity, promotes consumerism and decreases overall costs. Using Telemedicine www.mdlive.benefitperx.com as the core benefit, studies have shown reductions in doctor office visits, ER visits, absenteeism and overall healthcare costs while promoting wellness, prevention and personal responsibility.
ABOUT NEW U LIFE: Founded by a recognized health and wellness innovator, CEO of the pioneering California natural food stores that grew into an online category leader, Alex Goldstein is a certified homeopath, herbalist, respected iridologist and a Nutritional Consultant (N.C.). Goldstein has also created of many exclusive formulas including the one of a kind FDA NDC registered SOMADERM™ Gel.
In short, Alex Goldstein is a force of nature—or should we say, a force for natural foods, nutraceuticals and performance supplements that help people lead their healthiest possible lifestyle. In his 25 years in business, Goldstein has helped thousands of grateful customers with his products and personal counsel, building four successful companies along the way.
Best regards,
Tom
Tom Cioffe CEO
BenefitPerx, Inc
1 Meadowlands Plaza
East Rutherford NJ
C: 561-444-7356
O: 201-701-1050
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