CRN On IMF Screening, NPA On SSCI Audits, New Products: Health And Wellness Industry News
This article was originally published in The Rose Sheet
Executive Summary
Mood Uplift from Gaia Herbs; Chewpod sleep and go gum in US; Arjuna offers ashwagandha extract; CRN urges laerts, recalls from FDA's improved import screening; and NPA-led initiative completes pilot audits.
CRN urges alerts, recalls from FDA's improved import screening
FDA should use information it's gaining from improved searches at international mail facilities of suspect shipments of products labeled as dietary supplements to help prevent distribution of adulterated products and violative ingredients, says the Council for Responsible Nutrition. "If FDA is serious about tackling the problem of tainted products containing illegal drug ingredients, the agency should use the intelligence it gathered to follow through on its allegations with enforcement. We encourage the agency to issue recalls and import alerts so that business partners and recipients of these ingredients here in the U.S. can be on alert to discontinue their affiliations with potentially nefarious sources or to implement heightened testing of incoming ingredients," said CRN President and CEO Steve Mister in a March 27 statement.
FDA on March 21 announced that a pilot program using ion spectrometer portable screening devices found undeclared drug ingredients in 65% of tested products labeled as supplements at two international mail facilities. The agency is implementing the devices at two additional IMFs and will refine its use of the device and eventually install it in all nine US IMF facilities. (Also see "Ion Spectrometer Improves FDA's Import Screening: Health And Wellness Industry News" - HBW Insight, 26 Mar, 2018.)
CRN also cautions FDA against taking its findings out of context and making generalizations about the supplement industry because it targeted high-risk packages at IMFs. The agency "specifically identified products it suspected of containing illegal ingredients, and unfortunately, in many of those packages, it found them. High-risk international mail packages are not a representative sample of the US marketplace," Mister said.
NPA-led initiative completes pilot audits
The Supplement Safety & Compliance Initiative of the Natural Products Association and major dietary supplement, natural food and mass merchandise retailers will use data from its pilot audits of manufacturing facilities to help establish benchmarks for audits across the industry. NPA on March 22 announced the completion of SSCI audits in the pilot program conducted at facilities operated by Schwabe Group's Nature's Way brand, US Pharma Labs Inc. and [GNC Holdings Inc.]'s Nutra Manufacturing divisionThe audits revealed discrepancies between different auditors, providing data needed to develop benchmarks and refine SSCI's guidance document and audit tool, NPA said.
NPA, national health and wellness retailers Vitamin Shoppe Inc. and GNC, mass merchandise retail giant Walmart and leading natural products chain Whole Foods Market launched SSCI in January 2017 to reduce supplement safety risks, recalls and harms by delivering equivalence and convergence between effective supplement safety management system. It also targets creating global supplement harmonization through standard benchmarking, focuses on the entire product life cycle and welcomes all certifying bodies to participate. (Also see "NPA, Retailers Tackle Accountability: Health & Wellness Industry News Roundup" - HBW Insight, 12 Jan, 2017.)
gaia herbs' Mood Uplift combines extracts including St. John’s Wort, oats, passionflower, blue vervain, schisandra, ginkgo and others.
Mood Uplift from Gaia
Gaia Herbs LLC's Mood Uplift supplement expands its portfolio of herbal wellness products that combine herbal extracts that have been traditionally used to help the body cope with daily stress, nourish the nervous system and support a positive mood. "We created this product to help consumers access some of the most synergistic herbs we know of to help improve emotional and mental wellbeing,” said Elena Lécué, the Brevard, N.C., firm's xecutive vice president sales and marketing, on March 6. Mood Uplift combines extracts including St. John’s Wort, oats, passionflower, blue vervain, schisandra, ginkgo and others traditionally used to help the body cope with daily stress, and utilizes nervines – plants that support the nervous system – to help promote a balanced mood. It is available at retailers nationwide at a suggested retail price of $29.99 for a 60-capsule bottle. Gaia Herbs products are sold through national and independent health food stores across the US, trusted online retail sites and GaiaHerbs.com.
Khloros brings its Chewpod energy and sleep-aid gums to the US. Chewpod sleep and go gums in US
Chewpod functional gum formulated for increased energy or for sleep help is available in the US from Khloros Innovation Inc., a Canadian maker of chewable supplements. "We are looking forward to growing and expanding in the US as we believe there is a great opportunity for functional gums and chewable tablets and their benefits especially knowing that global consumption of energy gum has grown an average of 6.6% every year for the past six years," said Joey Thiffault, co-founder and president of Quebec-based Khloros, on March 21. The firm's Fastactiv technology allows users to control their state of mind on demand by quickly delivering energy or sleep aids easily absorbed by the body. The Energy On Demand version blends natural essential vitamins and energy supplements including vitamins B6 and B5, caffeine, taurine and guarana seed extract. Sleep On Demand is formulated to combat fatigue due to shift changes, jet lag and occasional sleeplessness with a blend of melatonin and natural sleep supplements vitamin B6 and amino acids.Khloros, which received a $120,000 grant from Canada's Economic Development Agency in 2012 to support its product development, said Chewpod products are available for purchase on Chewpod.com and via Amazon at $5 for a four-serving pack, $18 for four packs and $40 for 10.
Arjuna offers ashwagandha extract
Arjuna Natural Ltd. launches Shoden, its all-natural ashwagandha extract standardized to contain more than 35% glycowithanolides-the most active components of the plant extensively used in India for centuries to reduce symptoms of anxiety and stress. Arjuna on March 26 said it has invested in ongoing clinical studies of Shoden at research institutes and results of the first study will be published in a few months. The Indian firm said some alkaloids in ashwagandha are toxic and it is technically challenging to remove them and make the product safe to use, but it developed a proprietary method of purification, based on traditional Indian processes, that targets and removes only toxic alkaloids while retaining the beneficial bioactive ones. The proprietary product has a high amount of glycowithanolides in comparison to other ashwagandha extracts in the market, Arjuna says. Ashwagandha, also known as Indian winter cherry and Indian ginseng, is an important herb in traditional medicine in India and has been used in Ayurvedic and indigenous medicine for more than 3,000 years. The firm cited Innova Market Insights reports of more than 18% average annual growth 2013-2017 for ashwagandha product launches, and 49% of those launches in 2017 featured an energy claim for the ingredient.
From the editors of the Tan Sheet. Our dietary supplement industry coverage now is published in the Rose Sheet, with articles emailed to readers daily and available on this page of the website.