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REGULATORY FDA: no safety review in ODI effort; industry expresses growing skepticism about process Natural Products INSIDER FDA's Cara Welch says her agency does not intend to conduct a safety review as part of the initiative to develop a list of “old" dietary ingredients marketed before Oct. 15, 1994. Welch, a senior advisor to the Office of Dietary Supplement Programs, made the comments at last week’s Rocky Mountain Dietary Supplements Forum, hosted by FDA Compliance Group. In a panel discussion, growing numbers of industry stakeholders questioned whether FDA’s plan to develop an authoritative list of ODIs is a futile endeavor and whether the agency can succeed without first determining how the processing of ingredients has changed since the 1990s. Industry thought leaders such as UNPA’s Loren Israelsen comment. Read coverage: FDA doesn’t anticipate safety review in developing pre-DSHEA List→ FDA’s efforts to develop pre-DHSEA list face mounting skepticism→ UNPA NEWS
Only six seats left for PCQI training in Salt Lake City, Dec. 6-8 UNPA members are encouraged to sign up for this 2.5-day Preventive Controls Qualified Individual (PCQI) training, Dec. 6-8, in downtown Salt Lake City. $200 discount for UNPA members. Learn more, including who must be trained, and why it's a very good idea for many other companies to have a PCQI on staff, at the UNPA website. UNPA now offering expanded menu of onsite training UNPA has expanded its menu of onsite training to include GMP auditing, mock facilities inspections, as well as PCQI and FSVP training. Learn why this can be a time-saving, cost-effective option for your company. Recently posted at unpa.com: Larisa Pavlick's PPT presentation at the 2017 Rocky Mountain Dietary Supplement Forum, Oct. 10,in Boulder, Colo.: "FDA Top 10 Citations & Potential Solutions" (Member log in required) Loren Israelsen's PPT for his presentation at the FDA ODI meeting, Oct. 3, in College Park, Md.(Log in) The PPT for the UNPA Members' Meeting at the 2017 SupplySide West (log in) Larisa Pavlick's 2017 SupplySide West Center Stage presentation on FSMA, including PCQI (log in) Nutraingredients-usa.com interview with Larisa Pavlick on FSMA issues, including FSVP Updated PCQI FAQ Plus, updated industry events calendar, Member Memos (log in) and UNPA educational archives (log in). LEGAL ITC requests additional time to rule on Amarin case; FDA asks ITC to refrain from investigation Nutraingredients-usa.com, Natural Products INSIDER The International Trade Commission has requested an additional week to decide whether it will proceed with an investigation requested by pharmaceutical company Amarin concerning certain high-concentrate, omega-3 fish-oil ingredients. The ruling on whether the case, which alleges some formulas violate the company’s patents, can go forward is now expected on Oct. 27. Meanwhile, FDA has asked ITC to refrain from commencing an investigation into the complaint because FDA hasn’t yet determined whether the products subject to the complaint are drugs or dietary supplements. Read coverage: ITC to take an extra week to decide if Amarin’s fish oil complaint will proceed→ FDA asks International Trade Commission to refrain from omega-3 fish oil investigation→ REGULATORY Court fines weight-loss supplement marketers $40 million Imperial Valley News, FTC.gov A federal district judge has issued an order finding several defendants, including repeat offender Jared Wheat, in contempt for violating previous court orders related to the sale of weight-loss dietary supplements. The order imposes a judgement of more than $40 million against the defendants, part or all of which FTC may use to provide refunds to deceived consumers. Read coverage: US District Court imposes $40 million judgement against weight loss supplement marketers for order violations→ US District Court Order, Northern District of Georgia, Atlanta Division→ M&A ACTIVITY Farmed-salmon giant Cooke to pay $500 million for Omega Protein Corp. Markets Insider New Brunswick-based Cooke Inc., the parent company of Cooke Aquaculture Inc., has acquired Omega Protein Corporation, a nutritional products company that is an integrated provider of specialty oils and specialty protein products. The company announced it will acquire all outstanding shares of Omega Protein for $22 per share in cash. Read more→ LEGAL Claims details critical for avoiding class-action suits Nutraingredients-usa.com Attention to detail on labeling and claims issues is critical to avoiding potential class-action settlements, according to attorney Justin Prochnow, a shareholder in the firm Greenburg Traurig, in a presentation at the Rocky Mountain Dietary Supplements Forum. Prochnow cautioned that small mistakes can have big consequences when plaintiff’s lawyers are patrolling the periphery of the industry. Read more→ OPINION Why clean label transparency is more than a fad Natural Products INSIDER As in most industries, consumers elevate the expectation of transparency in dietary supplements. While transparency is increasing in expectation, the industry is struggling to define it and what it should encompass—and also avoid. In this commentary, Scott Steinford, CEO of consulting firm Trust Transparency, discusses how clean label culture is evolving and why it is important for supplements. Read more→ BOTANICAL ADULTERATION BAP publishes bulletin on adulteration of Rhodiola rosea Herbalgram.org The ABC-AHP-NCNPR Botanical Adulterants Program has announced the publication of a new Botanical Adulterants Bulletin on Rhodiola rosea. The rhizome and roots of rhodiola have been used for a number of ailments in traditional herbal medicine, particularly in northern Europe. Modern scientific research on R. rosea began in the 1960s in Russia and established its use as an adaptogen. The bulletin includes information about the production and market importance of rhodiola, its main medicinal uses, a list of the known adulterants, and analytical methods to distinguish R. rosea from closely related species. Read more→ MARKET TRENDS Consumer demand for clean food in sustainable packaging drives sourcing Foodnavigator.com Consumers are demanding pollution-free food sold in biodegradable or recycled packaging. Trailblazing brands are already responding to the trend and “perceived” polluters will have to follow suit, according to a new report from research firm Mintel. The trend will usher in a new era of sustainable sourcing, the company says. Read more→ BUSINESS STRATEGY Gummy company reshapes mainstream supplement aisle with focus on benefits CNBC After selling his successful brand Method to Ecover in 2012, Eric Ryan is turning his focus to Olly, the gummy vitamin company that this article says is reshaping the supplement aisle in big-box retailers, such as Target and CVS. The brand focuses on brick-and-mortar retail and promoting benefits and not its ingredients. Read more→ RETAIL Kroger announces plan to redefine grocery; Whole Foods closes Bellevue 365; Trader Joe's soldiers on; Natural Grocers sticks to standards Project Nosh, Seattle Times, Own Brands Now, New Hope Network The Kroger Co. has announced a plan to redefine the food and grocery customer experience in America, with its Restock Kroger program that it says will redefine the way Americans eat. The Plan has four main drivers: Redefine the Food and Grocery Customer Experience, Expand Partnerships to Create Customer Value, Develop Talent, and Live Kroger’s Purpose. Just one year after it opened, the third 365 by Whole Foods Market store, in Bellevue, Wash., is closing its doors. A spokeswoman for the retailer said the decision was made pre-Amazon takeover and was related to the store’s performance, not an overall reassessment of the 365 concept.Trader Joe’s is among the retailers showing slowed growth this year as the retail environment continues to be characterized by stiff competition. It opened 14 new stores—down from its average of 23 per year over the last 10 years, but the company said it will not slow its pace. Even as Natural Grocers grows beyond its Colorado home base, the health food store holds — and continues to increase — strict product standards. Natural Foods Merchandiser met with Alan Lewis, the company's director of special projects, to learn why this matters in today's competitive natural retail environment. Read coverage: Kroger plans to redefine the way America eats→ Whole Foods closing its 365 store in Bellevue→ Trader Joe's keeps calm and carries on→ Why Natural Grocers champions food standards→ UNPA MEMBER NEWS Ethical Naturals capitalizes on contractions in veg glucosamine market Nutraingredients-usa.com As the list of suppliers of vegetarian glucosamine dwindles, Novata, Calif.-based Ethical Naturals (ENI) is one of the few domestic sources of the ingredient. ENI co-founder and President Cal Bewicke said that these kinds of contractions are not unusual, noting that the glucosamine market has been stable and tracking with the overall industry for a number of years. Read more→ USANA promotes Brian Paul to head its True Health Foundation USANA True health Foundation The USANA True Health Foundation has announce the promotion of Brian Paul to president of the 501(c)(3) organization. Paul has been with USANA for more than 12 years, most recently serving as the foundation's executive director of communications. He has been active in driving the foundation's fundraising efforts, spearheading mission trips and coordinating aid efforts for victims of natural disasters throughout the world. Read more→ HPC publishes open-access clinicians' guide to supplement quality Holistic Primary Care With practitioner sales representing nearly 10 percent of all U.S. supplement sales, generating $3.7 billion in revenue per year, how can practitioners best understand the regulations governing this industry? Holistic Primary Care has just published Quality Counts: A Clinician’s Guide to Supplement Quality, a 24-page report that goes in-depth on the laws that regulate supplements and the quality measures that really count. Wide distribution to medical professionals and consumers is encouraged. Download here→ ORGANIC Rodale Institute leads organic stakeholders in effort to establish regenerative organic certification Rodale Institute Rodale Institute is leading a group of farmers, ranchers, nonprofits, scientists and brands in developing a regenerative organic certification that it hopes will increase soil quality, animal welfare and fairness for food workers. NSF International is currently facilitating a public comment process on the standard. The certification will not compete with or negate organic standards, but instead support them and facilitate practices that go even further. Read more→ PROBIOTICS Probiotics group counters myths about microorganisms Nutraingredients.com What is a probiotic? What are the health benefits of probiotics? Are all probiotics the same? And how to choose a probiotic product? These are the topics of a new video initiative from the International Scientific Association for Probiotics and Prebiotics to help counter myths around the beneficial microorganisms. Read more→ OMEGA-3s GOED hones in on practitioner market to influence consumers Nutraingredients.com A new education program from GOED will target primary care practitioners. The focus of the program is on educating the people most likely to influence consumer purchases of omega-3s, according to GOED Executive Director Adam Ismail, in explaining the association’s development of the program. Read more→ MARKET RESEARCH Millennials seek out probiotics, prebiotics; gummy vitamins predicted to see continued growth Nutraceuticals World Roughly a quarter of U.S. adults seek out foods and beverages with high amounts of probiotics or prebiotics, but interest is higher among millennials. This finding is from a 2017 National Consumer Survey conducted by market research firm Packaged Facts and published in the company's new report, Probiotics and Prebiotics: Food and Beverage New Product Trends. A new report from Transparency Market Research expects the global market for gummy vitamins to rise at a steady CAGR of 5.2 percent for the next few years. The market is predicted to reach $4.17 billion by 2025. Read coverage: Probiotics foods and beverages trending with millennials, natural grocery shoppers→ US gummy vitamins market to reach $4.17 million by 2025→ RESEARCH Glucosamine stops seizures; D-allulose ups energy; seaweed has prebiotic potential; a closer look at tocotrienols; ashwaghanda supports thyroid health Nutraingredients.com, Nutritional Outlook, Natural Products INSIDER Glucosamine could be the key to up-regulating specific proteins in the brain that help to dampen hyper-excitability seen in seizure disorders such as epilepsy, according to new research in rats that was published in the Journal of Neuroscience. In addition to its sweetening properties, d-allulose may aid in weight management by enhancing post-meal fat oxidation and decreasing carbohydrate oxidation, according to researchers from Nagasaki University in Japan.Seaweed-derived bioactive compounds produced using enzymes offer a wealth of opportunities for development of novel prebiotic and nutraceutical food applications, according to research from Flinders University in Australia. An expanding body of research points to the significant benefits of the tocotrienol form of vitamin E. The article discusses the debate over tocotrienols and tocopherols and new research on the former for cardiovascular health, anti-inflammation, bone health and bioavailability. A clinical trial report, published in the Journal of Alternative and Complementary Medicine, evaluated the effects of ashwagandha on thyroid hormone levels. The double blind, randomized, placebo-controlled trial showed that supplementation of KSM-66 ashwagandha can normalize thyroid hormone levels in hypothyroid individuals and also maintain normal thyroid function in healthy people. Read coverage: Could glucosamine supplements help dampen excitability in people with epilepsy and seizures→ D-allulose may enhance energy metabolism in healthy humans→ Enzyme made seaweed compounds show much prebiotic and nutraceutical potential→ Vitamin E: A closer look at tocotrienols→ KSM-66 ashwagandha normalizes the level of thyroid hormones→ FDA WARNING LETTERS & GUIDANCES Current FDA enforcement actions and guidances Keep 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. Read more→ Comments are closed.
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