Nucleofill FDA Approved – What’s Its Status?

Last Updated On: October 14, 2024

The FDA’s Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has significantly expanded the agency’s authority over cosmetic products. This act enforces stricter safety standards, such as mandatory adverse event reporting and the power to mandate recalls for unsafe products. These measures ensure that cosmetic treatments undergo rigorous evaluation before reaching consumers, ultimately enhancing product safety.

One treatment that’s been getting a lot of attention is Nucleofill. It’s a non-invasive option that helps boost collagen production and naturally rejuvenates the skin. Many love it for its ability to improve skin texture, firmness, and overall radiance. Nucleofill works beneath the surface to promote healthier, younger-looking skin, offering long-lasting results without more invasive procedures.

This article will explore Nucleofill’s current regulatory status, benefits, and what you can expect from this innovative treatment.

Key Takeaways

• Nucleofill is a noninvasive treatment that boosts collagen production and rejuvenates the skin. However, it is not currently FDA-approved for injection in the U.S., limiting its availability.
• The FDA’s assessment of injectable treatments includes a review of potential side effects and long-term safety. To be cleared for use, injectable treatments must meet stringent U.S. regulations.
• Studies highlight the benefits of polynucleotide fillers like Nucleofill in aesthetic medicine, emphasizing their ability to promote collagen synthesis, tissue repair, and overall skin rejuvenation.
• Nucleofill has shown promising results in improving skin texture, hydration, and overall appearance. While it awaits FDA approval for injection, many are exploring FDA-approved alternatives.

About: Operating since 2016, Med Supply Solutions is known for being one of the industry’s top and trusted suppliers of cosmetic and viscosupplementation products. If you’re looking to buy Nucleofill online, contact our sales department for more information.

NUCLEOFILL™ STRONG

POLYMERISED POLYNUCLEOTIDE

$119.00

Tier pricing

Save 1.68%

3 or more

$117.00 each

Save 2.52%

11 or more

$116.00 each

Save 4.2%

21 or more

$114.00 each

NUCLEOFILL™ SOFT PLUS

POLYMERISED POLYNUCLEOTIDE

$106.00

Tier pricing

Save 1.89%

3 or more

$104.00 each

Save 2.83%

11 or more

$103.00 each

Save 4.72%

21 or more

$101.00 each

NUCLEOFILL™ MEDIUM PLUS

Polynucleotides

$90.00

Tier pricing

Save 1.11%

3 or more

$89.00 each

Save 2.22%

11 or more

$88.00 each

Save 3.33%

21 or more

$87.00 each

Understanding the FDA Approval Process

The FDA plays a critical role in ensuring that cosmetic products like Nucleofill are safe and effective for consumer use. Before any treatment can be approved, it must undergo a rigorous evaluation to assess its safety, efficacy, and compliance with strict regulatory standards.

For cosmetic products, the FDA requires:

• Preclinical studies to test the product’s basic safety.
• Clinical trials to evaluate the product’s effects in humans, including safety, efficacy, and potential side effects.
• Comprehensive data submission that details the product’s formulation, intended use, and results from testing.

Nucleofill must undergo extensive testing to demonstrate its safety and effectiveness for injections. Currently, it is not FDA-approved for this use in the U.S., which limits its availability. The approval process for skin treatments developed abroad can be particularly challenging due to additional regulatory hurdles and the need for comprehensive safety data specific to U.S. standards.

As part of the FDA’s assessment, data on potential Nucleofill side effects and long-term safety are carefully reviewed. Although Nucleofill has shown promising results in other regions, it still needs to meet the stringent U.S. regulations to be cleared for use.

Safety Evaluations and Clinical Trials

Safety checks and testing are essential for ensuring the safety of cosmetic products. A study highlights the benefits of polynucleotide fillers like Nucleofill in aesthetic medicine, particularly in skin rejuvenation. These fillers promote collagen synthesis and tissue repair; experts agree they enhance skin texture, elasticity, and overall appearance.

The study on the effects of polynucleotides in skin regeneration highlights their ability to enhance cellular repair and stimulate collagen production. This aligns with using Nucleofill, which leverages polynucleotides for improved skin texture and elasticity in aesthetic treatments.

Another study emphasizes polynucleotides’ anti-inflammatory and hydrating properties, showcasing their role in promoting skin health. These findings support the application of Nucleofill, which utilizes polynucleotides to provide rejuvenation and hydration, making it an effective option for skin enhancement.

These studies and regulatory insights suggest that Nucleofill is a reliable and effective option for non-invasive skin rejuvenation, offering benefits such as improved skin hydration, texture, and elasticity.

Efficacy and Benefits of Nucleofill

Nucleofill has proven highly effective for skin rejuvenation, delivering smoother and firmer skin. Its unique formula, enriched with polynucleotides, supports the skin’s natural regeneration process, promoting healing and revitalization. This high-viscosity gel protects the skin in three key ways: it hydrates deeply, stimulates collagen production, and enhances tissue repair. 

Patient testimonials highlight the transformative effects of Nucleofill treatments, showcasing improvements in skin texture, hydration, and overall appearance. Users report increased confidence and satisfaction, emphasizing the treatment’s effectiveness and safety.

Image courtesy of Jade Chen Aesthetics

The patient experienced remarkable results from Nucleofill Strong, with significant improvements in skin appearance, including reduced fine lines, enhanced collagen and elastin levels, and a healthier, more hydrated complexion. Recommended sessions are every 2-3 weeks for optimal results.

Image courtesy of The Luxxe Clinic

The patient underwent Nucleofill Soft, a variation of this treatment that works best for areas like under the eyes.

Conclusion

While Nucleofill has not yet received FDA approval for injection in the United States, its ongoing journey through the approval process is one to watch. Clinical trials and safety tests have demonstrated its potential benefits for skin repair and rejuvenation. In the meantime, many are exploring FDA-approved alternatives while waiting for further updates.

As this treatment continues to undergo evaluation, staying informed about its progress will be key for those interested in cutting-edge cosmetic solutions.

FAQs

1. What is Nucleofill, and how does it work?

Nucleofill is a noninvasive skin rejuvenation treatment that uses polynucleotides to promote collagen production, improve skin hydration, and support tissue repair. Over time, it helps enhance skin texture, firmness, and elasticity, offering long-lasting results.

2. Is Nucleofill FDA-approved for use in the United States?

Currently, Nucleofill has not received FDA approval for injection in the U.S.

3. What are the benefits of Nucleofill?

Nucleofill provides several benefits, including improved hydration, enhanced collagen and elastin levels, smoother skin texture, and a youthful appearance. Patients typically notice reduced fine lines, firmer skin, and overall skin rejuvenation.

4. How long do the results of Nucleofill last?

Results can vary depending on the individual, but the effects of Nucleofill treatment generally last for several months. Patients often undergo multiple sessions for optimal, long-lasting results.

References

Nutrition C for FS and A. Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA. Published November 1, 2023. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra 

Terence Myckatyn M | SL, Tuesday F 27. What does an FDA approval mean for cosmetic treatments and devices? American Society of Plastic Surgeons. https://www.plasticsurgery.org/news/blog/what-does-an-fda-approval-mean-for-cosmetic-treatments-and-devices 

Health C for D and R. FDA-Approved Dermal Fillers. FDA. Published online November 4, 2021. https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/fda-approved-dermal-fillers