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UNPA Digest

FDA plans crackdown on homeopathic remedies

12/21/2017

 
​TOP STORY
FDA plans crackdown on homeopathic remedies
​
NPR.org
FDA says it will take a “new, risk-based” approach to regulating homeopathic products. The agency says it’s seen an uptick in products labeled as homeopathic, as well as an increase in safety concerns and adverse events from the products. Critics of homeopathy have long expressed concerns about evidence, contamination and claims related to homeopathic products. Read more→
UNPA NEWS
Recently posted at unpa.com:
  • NEW! Industry Coalition Reminds Consumers, Retailers, and Product Marketers that Dietary Supplements Cannot Claim to Treat Opioid Addiction
  • NEW! UNPA signs a joint memorandum of understanding with the China Nutrition and Health Food Association to further Sino-U.S. industry cooperation and growth
  • NEW! FDA issues guidance re: refusing entry of food products into U.S. (Member log in required)
  • NEW! UNPA endorses AHPA's Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Material (log in)
  • NEW! Bringing the Best of China to the U.S. Natural Health Market: Three Keys to Find Success, presentation by UNPA President Loren Israelsen at the China Natural Ingredients Industry Conference, Handan, China, Oct. 26. (log in)
  • NEW! Survey results from the 2017 Council for Responsible Nutrition (CRN) Consumer Survey on Dietary Supplements
  • NEW! Holistic Primary Care's Quality Counts:A Clinician’s Guide to Supplement Quality (pdf)
  • NEW! Integrative & naturopathic medicine resources
  • NEW! Testimonials in support of UNPA
  • Multi-trade association SARMs press release in support of FDA action against marketers of bodybuilding products containing these illegal ingredients and being sold as dietary supplements.
  • FDA proposes dropping ‘authorized’ health claim for soy protein and reduced risk of heart disease (log in)
  • Plus, updated industry events calendar,Member Memos (log in) and UNPA educational archives (log in).
LEGISLATIVE
House bill could finally end pyramid-scheme charges leveled at MLMsA bill now before the House of Representatives that seeks to clarify the boundaries of MLM operations is imperfect but better than the status quo, according to an attorney familiar with the sector.

Congressmencomment on FDA’s increased priority of dietary supplement activitiesThree members of Congress this week commended FDA for elevating the Dietary Supplement Program from a “division” to an “office” and for FDA’s inspection of, and enforcement against, dietary supplement manufacturers producing products with potentially harmful ingredients.M&A ACTIVITY
Frutarom acquires patented micro encapsulation iron AB-FortisAB-Fortis is an encapsulated iron system for delivering the recommended daily amount of iron in a single dose.

Amazon buys Whole Foods, Nestle buys Atrium Innovations: Here's a recap of big mergers and acquisitions in 2017It was a year of big M&A announcements. This is a roundup of the major mergers and acquisitions in 2017 relevant to the dietary supplement industry.

M&A activity likely to stay hot for 2018M&A activity for the dietary supplement space is unlikely to slow down anytime soon, according to a new investment report from Green Circle Capital Partners.

BiomX boosts microbiome discovery and development with RondinX dealIsrael-based microbiome firm BiomX says the acquisition of RondinX will fortify the company’s bacterial target discovery capabilities and support its product development pipeline.BOTANICAL ADULTERATION
Cranberry adulteration bulletin released by Botanical Adulterants ProgramThe latest Botanical Adulterants Bulletinsummarizes data on adulteration of bulk cranberry fruit materials with anthocyanin- or proanthocyanidin-rich extracts from other plant species.ORGANIC
USDA puts final ax on organic livestock ruleImplementation of the proposed amendments to the animal welfare standards for USDA’s organic program have been delayed three times by the new administration, prompting the Organic Trade Association to sue the agency in September. Now USDA plans to withdraw the final rule,saying it would“exceed USDA’s statutory authority.”FINANCIALS
GNC’s 2018 outlook clouded with collapse of bond issueWith GNC shares trading near 52-week and all-time lows and the collapse of a planned bond issue, the rumors of a sale of the parent company are likely to gather steam in the coming year.GLOBAL REGULATORY
India supplement industry taking GST introduction in its strideFears that India’s new GST framework could negatively impact food and supplement business have been played down, with two firms saying that the July rule changes haven’t damaged business.

New EU rules for novel foods to take effect in JanuaryMany people working in the nutrition industry feel positive about the EU’s new process for the approval of novel foods, according to research by the organizers of Vitafoods Europe. However, experts are warning there could be adverse implications for some companies’ intellectual property portfolios.PRODUCT TESTING
ConsumerLab.com finds supplements lacking effective doses of berberine and goldensealRecenttests ofpopular berberine and goldenseal supplements revealed that most goldenseal products and one berberine product do not contain the "expected" amounts of berberine.CBD
World Health Organization gives CBD preliminary boost, plans look at cannabis overallCannabis got a big boost from international health authorities this week when the U.N.’s World Health Organization said that CBD should not be scheduled as a controlled substance, an initial finding that comes about a month after the agency reviewed cannabidiol therapies.PRODUCT LABELING
Supplement or food: Product labeling opportunities and limitationsIndustry attorney Justin Prochnow outlines regulatory issues and considerations for claims and whether to label a product as a food, beverage or supplement. Here’s what you need to know as you formulate your product and plan your packaging.SUPPLY CHAIN
Algae is poised to become a mainstream food ingredient, if supply can keep up with demandThe potential applications for algal biomass in foods and beverages run the gamut from smoothies to supplements to animal feed. But the ingredient’s growth potential is limited by the current supply chain, says the CEO of Zivo Bioscience, a U.S.-based R&D company focused on microalgae.BOTANICALS
Kava, the NFL’s newest, safest painkillerWith the opioid crisis, there is a big need for new options to address pain amiong NFL players. Former player Matthew Masifilo thinks kava may address the painkiller problem in football and other sports.

Adaptogens are here to stay, but marketing them effectively will require creativity and innovationInterest in adaptogens, such as ashwagandha, rhodiola, maca, and holy basil, is on the rise among food and beverage formulators, but what do they do, which brands are blazing an early trail, and who is buying the products?CHINA MARKET
IBMand Walmart launching Blockchain Food Safety Alliance with Fortune 500’s JD.comA powerful cohort of companies and retailers is bringing blockchain technology to China in an effort to improve traceability and food safety. The group intends to develop standards for collecting data about the origin, safety and authenticity of food.The top five APAC regulation and policy developments of 2017Rule changes in China dominated the regulatory landscape for the supplement and infant nutrition segments in 2017.UNPA MEMBER NEWS
Thorne Research, Drawbridge Health partner to improve blood testsTo improve the blood draw process in personalized medicine, Thorne announced it will partner with diagnostic testing firm Drawbridge Health to integrate blood draw, integration and stabilization in a single device.NCIH
Hello from NCIH’s new leadership teamNCIH introduces David Shurtleff, Ph.D., as acting director, and Wendy J. Weber, N.D., Ph.D., M.P.H., as acting deputy director.BUSINESS STRATEGY
Tips for established companies to keep innovatingDon’t ignore the small stuff—like emerging market trends or startup competitors. Companies that sniff those out early are more apt to stay one step ahead, says Paul Earle, an adjunct lecturer on innovation and entrepreneurship at the Kellogg School.PACKAGING
Less waste and more clarity and other packaging trends for 2018The natural products industry is leading the way not just in food and beverage trends but in CPG packaging, too.MARKET RESEARCH
New 2018 State of Sustainability in America:16thAnnual Consumer Insights and Trends ReportThis new NMI research uncovers insights into how today’s consumers integrate eco-friendliness into their daily lives and reveals their motivations and the challenges they encounter in their pursuit to become increasingly aligned with a more sustainable lifestyle.

3 ways word-of-mouth influencers will change the way you advertise in 2018Consumers now rely on trusted family and friends to help them make purchase decisions. In fact, word-of-mouth marketing drives $6 trillion in annual consumer spending and accounts for an estimated 13 percent of consumer sales, according to the Word-of-Mouth Marketing Association.

New 7thedition USA report: 2018 Supplements, OTC, Consumer Insights and TrendsAs consumers have many alternatives in their search for health, this NMI research analyzes the nutritional/dietary supplement market and also examines the impact of the role over-the-counter and prescription medications play in consumers’ efforts to incorporate a mix of self-care methods into their current lifestyle.

Probiotics to Protein: Functional claims drive $26 billion pet nutrition market in 2018U.S. consumers today are more keen to pick up a bag of pet food with functional claims and ingredients, such as probiotics, omega- fatty acids or glucosamine, according to the latest pet food market report from Packaged Facts.

Transparency Market Research forecasts growth for the global prenatal supplements marketThe TMR report says increased awareness, thanks to social media, is driving interest in prenatal supplements.RESEARCH
Deep ocean minerals show post-exercise blood flow and anti-inflammation benefitsSupplements containing more than 70 minerals and trace elements derived from the deep ocean may improve blood flow and hemoglobin levels in the brain after exercise, according to a new study from Taiwan.

Low vitamin K linked to heart disease deaths: Dutch dataThere is a strong link to low vitamin K status and cardiovascular mortality, say researchers from Groningen University, who warn that around a third of people may be deficient.

Study finds anti-depressant potential from saffron, botanical expert calls results 'encouraging'Saffron fared better than placebo in improving depression symptoms among mothers with mild post-partum depression, say researchers at Mashad University of Medical Sciences in Iran.

Sinetrol Citrus Extract linked to weight loss in new studyThis third clinical study once again supports Sinetrol's utility in promoting body-fat loss and improved body composition.

Concentrated ashwagandha root extract normalizes thyroid hormone levels, study suggestsThe study found that supplementation with KSM-66 ashwagandha significantly improved circulating levels of thyroid hormones.

Synbiotic supplementation can combat metabolic syndrome: Chinese reviewAltering the gut microbiota with probitoics and prebiotics could help fight metabolic syndrome, say researchers in China.FDA WARNING LETTERS & GUIDANCES
Current FDA enforcement actions and guidancesKeep up to date on FDA’s current enforcement actions, including general warning letters, recall information and GMP compliance issues, with this link to FDA's website.

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