In the world of food and supplement safety, achieving Generally Recognized As Safe (GRAS) status is a significant milestone. It signifies that a substance has been rigorously evaluated and deemed safe for consumption. UthPeak™ NMNH, a leading NAD+ booster known for its potential to enhance cellular health and longevity, has recently achieved self-affirmed GRAS status, further solidifying its commitment to safety and quality. But what exactly does it mean for a product to be GRAS certified, and why is this status so important, especially in the supplement industry? Let's delve into the intricacies of GRAS status and its implications for both consumers and businesses.
The Dual Facets of GRAS Status: Notice vs. Self-Affirmed
There are two primary ways to obtain GRAS status: through a GRAS notice submitted to the Food and Drug Administration (FDA) or through self-affirmation by qualified experts.
GRAS Notice
A GRAS notice involves a formal submission to the FDA, where the manufacturer provides detailed scientific evidence supporting the safety of their ingredient. This evidence, typically in published scientific literature and studies from other regulatory and health agencies either in the US or abroad, is reviewed by FDA experts, who then decide whether the ingredient meets the GRAS criteria. If the FDA has no further questions, they issue a "no objection" letter, publicly acknowledging the ingredient's GRAS status.
Self-Affirmed GRAS
In contrast, self-affirmed GRAS involves a thorough safety assessment conducted by qualified experts independent of the FDA. These experts meticulously evaluate the available scientific data to determine whether the ingredient is generally recognized as safe for its intended use. While this process doesn't involve a formal FDA review, it still requires rigorous scientific evaluation and adherence to GRAS standards.
The Importance of GRAS Status
GRAS certification is a crucial indicator of safety and quality in the food and supplement industry. For consumers, it provides assurance that a product has undergone thorough safety evaluations and can be consumed with confidence. For businesses, being GRAS certified streamlines the process of bringing new ingredients to market, as it avoids the lengthy and costly process of pre-market approval for food additives.
In the supplement industry, where innovation is paramount, GRAS status is particularly valuable. It allows companies to introduce new and potentially beneficial ingredients without facing regulatory hurdles, enabling consumers to access cutting-edge products that support their health and wellness goals.
What Is the Difference Between GRAS- and FDA-Approved?
While both GRAS and FDA-approved status indicate safety, they represent different regulatory pathways. GRAS designation signifies that a substance is generally recognized as safe based on existing scientific evidence and a history of safe use. FDA approval, on the other hand, involves a more extensive pre-market review process, typically required for new food additives, drugs and even medical devices.
UthPeak™ NMNH: Safety and Efficacy Take Center Stage with Self-Affirmed GRAS Status
EffePharm has announced that its proprietary UthPeak™ NMNH (reduced NMN) has achieved self-affirmed GRAS status following a recent review by an independent panel of qualified scientific and toxicology experts.
In accordance with FDA requirements, the panel agreed that the data demonstrate that UthPeak™ NMNH can be sold, used, and consumed in the U.S. food supply.
UthPeak™, marketed as "The Next-Gen Super NAD+ Enhancer," is a patent-pending crystalline NMNH that has demonstrated a remarkable 10X surge in NAD+ levels. UthPeak™ is believed to be the first NMNH brand to receive self-affirmed GRAS as a new-generation NAD+ precursor.
"The self-affirmed GRAS status is a testament to the safety and innovation of UthPeak™ NMNH and marks an essential step on our path toward commercialization," said Dr. Jianjun YU, EffePharm’s R&D Director. "At EffePharm, our business philosophy is rooted in delivering unique market value backed by scientific evidence. From our patent-protected crystalline form to extensive clinical studies, we believe UthPeak™ NMNH will provide distinct competitive advantages, enriching our clients' product offerings and enhancing their brand value."
UthPeak™ Preclinical and Clinical Study
UthPeak™ has undergone rigorous toxicology and efficacy tests in animals, revealing its potential benefits in anti-aging, anti-fatigue, sleep quality improvement, brain function enhancement, and cardiovascular health promotion. EffePharm is currently conducting human clinical trials to further validate the safety of UthPeak™ NMNH in humans. These trials are anticipated to conclude by the end of 2024.
These promising findings underscore the potential of UthPeak™ NMNH to revolutionize the NAD+ boosting landscape. Its unique structure allows for a higher conversion rate to NAD+, resulting in elevated intracellular levels of this crucial molecule. However, due to its structural properties, NMNH is highly unstable, making it significantly more challenging to create long shelf-life products compared to NMN and NR. With a dedicated focus on premium anti-aging ingredients, EffePharm's UthPeak™ has tackled these challenges, which, along with its GRAS designation, highlight the company's industry leadership in the transition to a more potent NAD+ future.
A Future of Safe and Effective NAD+ Boosting with UthPeak™ NMNH
The self-affirmed GRAS status of UthPeak™ NMNH marks a significant step forward in the field of NAD+ precursor supplements. This achievement underscores EffePharm's commitment to safety and innovation, paving the way for a future where consumers can confidently embrace the potential benefits of NAD+ enhancement. As research continues and more data emerges, UthPeak™ NMNH supplements are poised to play a leading role in the evolving landscape of healthy aging and longevity. With its unique properties and strong safety profile, UthPeak™ NMNH offers a promising avenue for those seeking to optimize their NAD+ levels and support their overall well-being.
To learn more about UthPeak™ NMNH, visit www.uthpeak.com.
About EffePharm:
Founded in 2017, EffePharm is a biotechnology company specializing in providing advanced wellness solutions to its global users. EffePharm is founded on the belief that everyone should have equal access to health and nutrition. EffePharm advocates for innovative bioscience applications, increased accessibility of nutrition, and improved quality of life. Committed to delivering efficacy-verified products to the market, EffePharm has established a portfolio of over 600 business partners worldwide, benefiting millions of consumers to thrive throughout their health and nutrition journeys.
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