KGK Goes Big on Scientific and Regulatory Expertise at NPA’s The Big Natural Show
Posted on Wed, 18 Sep 2019 in: All News
The Natural Product Association (NPA) hosted its 3rd Annual The Big Natural conference last week just outside of Washington, D.C., a 2-day event bringing together the most influential leaders in the natural products industry. This coincided with the 22nd Annual Natural Products Day, an advocacy event held on September 10th on Capitol Hill. Also known as “Lobby Day”, industry stakeholders were encouraged to become lobbyists for a day, educating members of Congress and legislative staff about the important role natural products play in keeping Americans healthy.
Establishing safe CBD regulations was a large focus for both Natural Products Day and The Big Natural conference, with KGK offering expertise by way of meetings and presentations, discussing clinically proven health benefits and the need for science-driven approaches to health and wellness claim substantiation.
KGK’s Recap of Natural Products Day and The Big Natural
Sept 10th – Natural Products Day
KGK’s President and CEO, Najla Guthrie, had the opportunity to speak with State Representatives and others on key issues in the natural health products industry, including:
- Asking for a House Amendment to update language that would establish a regulatory framework allowing consumers safe access to CBD.
- HSA, FSA, HRA expansion, revising IRS Publication 502 to allow nutritional and dietary supplements that carry health or structure/function claims to be considered “medical expenses”
- Requesting that List 3 and 4 Tariffs to China, which includes many of the industry’s ingredients used in dietary supplements include an exclusion process that would safeguard against disruption to the industry.
- Updating the ingredient notification system to ensure U.S. regulators have an opportunity to review the safety of new ingredients before they are marketed.
- Amendments to patent eligibility for dietary supplement products.
These crucial conversations were had by many NPA stakeholders and affiliates, including KGK, to help further the growth and safety of Natural Products in the U.S.
Sept 11th – The Big Natural, Day 1
Starting by looking at the historical perspective of dietary legislation in the U.S. and how things have changed over the past 25 years, the need for clearly defined dietary ingredients combined with substantiated health claims was a key focus of the discussion during day 1 of The Big Natural. With the FDA calling for more evidence of safety if considerations are to be given to the inclusion of CBD in food and dietary supplements, KGK was perfectly positioned to share our expertise in clinical trials for substantiating efficacy and safety.
‘Achieving Successful Outcomes and Hallmarks of Quality Clinical Trials’ – a talk presented by Najla Guthrie, President and CEO of KGK Science – looking at the importance of study design in claims substantiation, specifically for finding evidence that is both statistically significant and clinically relevant, and that aligns with FTC Regulations.
‘What You Should Have in Your Substantiation File’ was another talk also presented by Najla Guthrie which dove deeper into the kind of evidence required to successfully move products through the regulatory landscape and into the marketplace. A process that requires expertise, this presentation offered attendees a close look into the FTC Substantiation Standard and what the FTC looks for as well as a 4-step process for creating a substantiation file.
Sept 12th – The Big Natural, Day 2
CBD was a big topic throughout the conference but the discussions on the legality of CBD and pathways to market was of primary significance as regulations in the U.S. are continuing to evolve. Speaking to an informed audience, KGK’s Regulatory Toxicologist, Dr. James Akingbasote, Ph.D. presented `What Clinical Studies You Need for NDI Safety’, looking at how to navigate the New Dietary Ingredient process – of big concern for companies looking to launch CBD and other nutraceutical products into the market. Highlighting what the FDA looks for in NDIs, as well as FDA response letter types and what they mean, attendees were presented with advice on how working with a regulatory consultant, such as those from KGK can ensure that the process is done correctly, saving companies time and money and adding to consumer confidence through FDA recognition.
It was KGK’s privilege to be a Platinum sponsor of The Big Natural show, supporting an event that provides education and opportunity to the natural products industry. As regulations continue to evolve and innovation moves forward, KGK continues to be a trusted supporter for our partners and sponsors who are looking to develop and launch products backed by science and regulatory expertise. Looking forward to next year! #TheBigNatural