News
2024 Legal Opinions on the Compliance and Clinical Use of Regenative’s Wharton’s Jelly Products
Sep 26, 2024
“At Regenative, we are committed to providing the regulatory clarity and legal protection you need to focus on what matters most — delivering exceptional care to your patients.” – Tyler C Barrett
Request Your Copy of Both the Product and Provider Legal Opinions Today!
(Once you submit your request, our team will promptly get in touch to confirm your details. Upon verification, you’ll instantly receive both of these exclusive 2024 legal opinions, delivered directly to your inbox.)
A Message From Regenative’s CEO
Dear Healthcare Provider,
In the rapidly evolving and often complex world of regenerative medicine, we understand the pressures and uncertainties you face. The exasperating influx of misinformation, unsubstantiated claims, and an oversaturation of misrepresented, unregistered, and recently even some “cosmetic use” and “research use only” products purporting to be 361 HCT/Ps only add to the complexity of navigating the regulatory landscape successfully. For many providers, the challenge lies in distinguishing between legitimate products and those that pose legal and regulatory risk.
Your peace of mind stems from knowing you’re making informed, compliant choices in an increasingly scrutinized field. We know you, like many healthcare professionals, seek definitive guidance — the confidence the product you are using meets the highest clinical standards, and aligns with strict regulatory requirements. As your partner, we strive to rise above industry noise and provide clarity, certainty and support.
To help you gain clarity and confidence, please read the two 2024 legal opinions from healthcare attorney and former FDA Compliance Officer Christine Humphrey Esq. included with this letter. They offer definitive clarity on the safety, efficacy, compliant marketing, and the clinical use of Regenative Labs’ Wharton’s jelly (WJ) products. Our aim is to empower you with confidence in WJ products by following the clear, compliant pathway laid out in these legal opinions.
Key Benefits of These Legal Opinions for Physicians:
Uncompromising Product Compliance in an Increasingly Scrutinized Market
The regenerative medicine field has seen an increase in scrutiny since the FDA’s discretionary enforcement period. The Product Opinion and the Provider Opinion make clear our WJ products are designed and marketed in strict accordance with FDA guidelines, which means you can utilize and market Regenative Labs’ Wharton’s jelly allografts “for homologous use only” with assurance and impunity. This level of legal protection and certainty is vital in a market where non-compliant products are being actively marketed and sold to unsuspecting providers.
Eliminating Legal and Regulatory Risk for Providers
The Provider Opinion highlights three areas of responsibility the provider has in eliminating FDA and FTC exposure, including the importance of product choice, the avoidance of off-label promotion, and deceptive advertising. While you retain the discretion to use these products in ways you believe best serve your patients, adhering to Regenative Labs’ intended use in your marketing and patient communication ensures you remain compliant with FDA and FTC regulations. As long as you are using Regenative’s WJ products and marketing them for homologous use only — providing structural support and cushioning to replace or supplement missing or damaged tissue — you are free to practice medicine with full confidence in your regulatory standing.
We are committed to providing the most advanced regenerative products and the regulatory clarity and legal protection so you can focus on what matters most — delivering exceptional care to your patients.
Looking Forward
The future of regenerative medicine holds exciting possibilities. With our unwavering
commitment to regulatory compliance, patient safety, and innovation, we are confident that Regenative Labs will remain at the forefront of this transformative field. We look forward to continuing to support you in delivering the best possible outcomes for your patients. Our team is always here to answer questions and provide “on demand” support as we navigate this complex regulatory environment together. (800-891-3452)
Your trust in Regenative Labs empowers us to drive the industry forward, and together, we will continue setting the standard for excellence in regenerative medicine.
Thank you for your continued partnership.
Best,
Tyler C Barrett
Chief Executive Office
Regenative Labs
Additional Questions? Call Now or Schedule a Meeting with Us Today!