Articles by Kate Quackenbush
Human Clinical Studies
While human clinical studies have long been accepted as the “gold standard” of scientific research, the advent of dietary supplement ingredients being supported by human clinical trials is relatively new.This expensive and time-consuming process did not become common practice in the dietary supplement industry until the last 10 years, when regulatory requirements in the United ...
NDI Update
Industry offers reaction to the FDA NDI draft guidance, NDIN experiences and suggestions for proceeding until a finalized version is put forth.Since the 1994 passing of the Dietary Supplement Health and Education Act (DSHEA), the industry has had limited guidance on the statute requiring the submission of new dietary ingredient notifications (NDINs) to the U.S. ...
Delivering Results
As distribution is a vital link in the supply chain, NIE offers case studies highlighting strategic partnerships that have brought innovative products to market.Entering the Omega Market TogetherIn 2011, TSI (USA), Inc., a Montanabased distributor with nutraceutical products sold in more than 30 countries that credits itself as never having been a typical distributor, was ...
Focus On Food Safety
NIE discusses the implications posed by FSMA with industry representatives, and their work to meet the challenges head on.In 2007, the U.S. Food and Drug Administration (FDA) published a “Final Rule,” establishing FDA regulations, which require current good manufacturing practices (cGMP) for dietary supplements (21 CFR 111). The final rule addresses in particular the identity, ...
Powerful Pairings For Digestive Wellness
As digestive health interests rise, tried-and-true ingredient combinations and innovative delivery methods drive the category.for Digestive WellnessThe market dynamics and trends among the three digestive health ingredient segments—probiotics, prebiotics and enzymes— are very different, according to MarketsandMarkets.com. Prebiotics and probiotics are growing at double- digit growth rates as compared to digestive enzymes, which are experiencing ...
Great To Be GRAS
With increased ingredient safety concerns and an exploding global functional food and beverage market, ingredient suppliers and experts talk about the importance and process of attaining GRAS status, and the role it could potentially play with NDIs.According to the U.S. Food and Drug Administration (FDA), under sections 201(s) and 409 of the Federal Food, Drug, ...
Delivering In Detail
While clients’ quality, cost and speed demands must be met; today’s regulatory environment emphasizes the importance of partnering with a contract manufacturer that can help a company confidently go to market.Every company, regardless of size, has one goal: to be bigger. To grow its product lines, its market share, its customer base and, ultimately, its ...
Defending DSHEA
The Dietary Supplements Health and Education Act of 1994 (DSHEA) amended previous statutes to encompass dietary supplement-specific provisions including the definition of a “dietary supplement,” product safety, nutritional statements and claims, ingredient and nutritional labeling, good manufacturing procedures and the classification of “new” dietary ingredients. While giving manufacturers the ability to use select, approved claims, ...
GMPs: One Year Later
As FDA audits have begun, the consensus is that the industry still has a long way to go proving its compliance, but it’s making a concerted effort to reach that goal. Setting a three-year timeline for industry-wide good manufacturing practices (GMP) compliance seemed ample, but as it has passed and U.S. Food and Drug Administration (FDA) ...
Marketing Immunity
Carefully vetting ingredients and crafting a clear, truthful message can be the keys to boosting immune modulating supplement sales.A December 2009 update on www.flucount.org reported that over a monitored seven-day span, 951 new swine flu deaths (an average of 136 deaths/day) had been reported from 62 nations around the world, and the five most affected ...
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