FDA’s CBD meeting: The NDI/GRAS question, gaps in data, timeline underscore complexity of issues A May 31 public hearing, hosted by FDA regarding CBD products, was an illuminating day of presentations with multiple viewpoints and interests aired. Several speakers urged FDA to provide clarity to a confused marketplace and do so swiftly. FDA is mulling whether to issue regulations that would permit CBD in conventional food and dietary supplements, but its search to answer questions over safety, effectiveness and other issues could lead to a years-long proceeding. Acting Commissioner Norman Sharpless, M.D., cited “real risks” and “critical questions” that remain regarding the safety of CBD and tetrahydrocannabinol (THC) in FDA-regulated products, including food and dietary supplements. Meanwhile, Ben & Jerry’s announced it hopes to release a cannabidiol-infused flavor as soon as the FDA approves such edibles.
FDA’s CBD public meeting: The NDI GRAS questions, gaps in the safety data and more→
FDA commissioner highlights unanswered questions regarding safety of CBD, THC→
FDA urged to act swiftly to settle confusion in CBD market→
What’s the regulatory path forward for CBD?→
CBD meeting commentary lays bare complexity of regulatory questions→
Ben & Jerry’s plans CBD infused ice cream pending FDA approval of cannabidiol in food products→
NEW! UNPA signs MOU with Hemp Industries Association
UNPA has signed a memorandum of understanding (MOU) with the Phoenix-based Hemp Industries Association (HIA). The agreement is an effort to advance hemp extract product research, safety, identity and quality standards.
Kicking off the new MOU relationship, UNPA’s Larisa Pavlick shared information about Preventive Controls and the upcoming PCQI training on June 26-28, with HIA Executive Director Colleen Lanier. Click on the image for the 5:40 segment about the PCQI training; click on "shared information" above for the full, 21-minute interview.
NEW! UNPA/TraceGains Expert Insights webinar on claims substantiation set for Wednesday, June 19, at 11am MDT
With increased scrutiny from the Food and Drug Administration and the Federal Trade Commission on dietary supplement claims, manufacturers are under pressure to redouble their efforts to ensure they have the records to back up their product claims. This UNPA/TraceGains webinar will explain the current regulatory climate and review new software tools that can help simplify researching and substantiating claims.
GOED, UNPA to host intentional adulteration seminar June 12
In the recent FDA draft guidance on mitigation strategies to protect food against intentional adulteration, which is part of FSMA, FDA defined Key Activity Types that are ‘significantly vulnerable.’ This rule requires a Food Defense Qualified Individual on staff as well as Food Defense Safety Plans. GOED and UNPA are offering a webinar June 12 (free to UNPA Executive Members; $99 for other members) to inform attendees about the rule. which will include a presentation by UNPA's Larisa Pavlick, a former FDA investigator.
In less than three weeks! Need a PCQI? June 26-28 training with a DS, food and botanicals focus
UNPA will conduct Preventive Controls Quality Individual (PCQI) training with a focus on dietary supplements, food and hemp-oil products and other botanically derived ingredients, June 26-28, in Westminster/Denver, Colo. Register today!
New Harvard adverse events analysis slammed by industry expert A new analysis of FDA adverse event (AE) data that calls for reduced access to dietary supplements for children, adolescents and young adults has been slammed by a leading expert in adverse event reporting.
New pregnancy warning re-energizes FDA’s vinpocetine legality probe In a follow up to the UNPA Members' Memo of earlier this week, FDA has warned vinpocetine use by women of childbearing age may cause adverse reproductive effects, such as miscarriage and reduced fetal development. The agency further assured it will continue its administrative proceeding, started in 2016, to evaluate the legality of vinpocetine in dietary supplements.
Enhanced Athlete CEO sentenced to prison for marketing fertilizer DNP as fat burner A judge sentenced to prison 36-year-old Scott Cavell, who marketed a drug as a “fat burner” and called it a fertilizer despite knowledge FDA had not approved the substance for human consumption, according to a U.S. Attorney’s Office announcement.
DSHEA AT 25
Experts reflect on DSHEA, look to its future Dietary supplement executives, the head of a consumer advocacy group, and a Massachusetts physician weigh the pros and cons of the 25-year-old Dietary Supplement Health and Education Act of 1994 (DSHEA) and the forces that led to its enactment. Differences of opinion over the law are striking. The podcast includes comments from UNPA’s Loren Israelsen, NOW’s Jim Emme and Harvard’s Pieter Cohen, among others.
Nagase Group acquires Prinova Nutritional ingredients supplier Prinova Group LLC is set to be acquired by Japan-based chemicals firm Nagase Group. According to the companies, the deal will create a unique food ingredient manufacturing and distribution offering that marries Prinova’s "renowned" expertise with Nagase’s "truly global" footprint.
U.K. site acquisition strengthens KD Pharma’s omega-3 capacity Global omega-3 player KD Pharma says the new site at Seal Sands will expand its capacity for manufacturing omega-3-based intermediates, especially for those used in producing active pharmaceutical ingredients.
Pure Circle expands purchase deal with Merisant for Reb M stevia PureCircle recently announced it has expanded its agreement with long-time partner Merisant to supply the company with ingredients made from next-generation steviol glycosides, such as Rebaudioside M (Reb M).
Food supplement regulation and policy: Five things to look out for With major regulatory and policy developments on the horizon all over the world, it is a significant time for the dietary supplement sector. The International Alliance of Dietary/Food supplement Associations shares five key things to look out for moving forward, including major botanical decisions and governments viewing supplements strategically.
EC report sets out guidance to meet growing global seaweed demand The European Commission released a report offering scientific guidance to help meet the growing global demand for seaweed species now accepted as a novel food.
EU biotech firms unite in pushing for harmonized microbiome-therapeutics regulation European microbiome firms are collaborating to agree on pan-European regulation for microbiome-based therapeutics to keep pace with advances in Fecal Microbiota Transplantation.
Labeling of U.S. probiotics supplements should be improved More than 60 percent of probiotic supplements in the United States may lack sufficient information on their labels to allow consumers to make informed decisions, according to a new study led by Dan Merenstein, M.D., from Georgetown University Medical Center.
Where the 2020 presidential candidates stand on food and farming Check out where the current 25 presidential candidates stand on food and farming issues that are near and dear to the natural products industry. As the article notes, the role that rural voters played in the 2016 election has led many presidential candidates to hone in on and “address the challenges that abound in today’s farm country."
Well explores the social and political underpinnings of health The typical American conversation about health focuses on personal choice as a key driver. But epidemiologist and dean of Boston University School of Public Health, Sandro Galea, M.D., author of Well: What We Need To Talk About When We Talk About Health,says this thinking not only fails to fix America's health crisis, it also diverts us from real issues underlying our nation's poor health.
Caffeine cleared: Energy drinks’ heart effects may not be stimulant’s fault The interaction of common ingredients contained in energy drinks may have a bigger say in the beverage’s effects on cardiovascular factors that affect the heart rhythm, a U.S. study concludes.
Sports nutrition cleans up to appeal to the masses The future of sports nutrition is in clean label as brands work to improve their quality credentials and appeal to a wider audience, says a new deep dive research report from Lumina Intelligence
Pilot study: Blackcurrant extract may aid in post-exercise recovery Consumption of blackcurrant extract before exercise may suppress the amount of oxidative stress in the body, suggesting recovery benefits for use in sports nutrition products.
Amazon poised to unleash a long-feared purge of small suppliers A large, permanent purge of thousands of Amazon’s mostly smaller suppliers is imminent in the next few months. These mom-and-pops will no longer be able to sell in bulk directly to Amazon, making the move “one of the biggest shifts in Amazon’s e-commerce strategy since it opened on the site to independent sellers almost 20 years ago.”
UNPA MEMBER COMPANY NEWS
NOW Health Group taps Peter Wardell to lead Puresource NOW Health Group welcomes Peter Wardell as country leader of Puresource, the company’s Canadian distribution and manufacturing division. Wardell brings nearly two decades of experience in both for-profit and non-profit organizations, most recently with Health First Network in Ontario.
Nutraingredients-USA announced 2019 industry award winners Nutraingredients-USA announced the winners for its 2019 awards honoring the industry’s best in ingredients, products, projects, platforms and individuals. Among the honorees are UNPA members including Elan Sudberg, of Alkemist Labs, who was named a NutraChampion for his tireless behind-the-scenes work on behalf of the industry; Verdure Sciences was noted for its role in the Nutrition Research Project looking at retinyl amyloid pathology and a proof-of-concept trial in Alzheimer’s disease.
Amin Talati now Amin Talati Wasserman LLP Attorney Ivan Wasserman is now a name partner at Amin Talati, which has changed its name to Amin Talati Wasserman LLP. The new name is a reflection of how far the firm has come since it opened a Washington, D.C., office three years ago focused on FDA and FTC regulatory matters, noting that under Wasserman’s leadership, that office is thriving and expanding.
Preparing for FDA’s new era of food safety Acting FDA Commissioner Ned Sharpless provided a glimpse into FDA’s plans to usher the U.S. into a “new era of smarter food safety.” This new era is likely to be more than incorporating new technologies, noted UNPA member Gregory Stephens, of Windrose Partners, but it remains unclear what changes FDA could pursue, although it is generally agreed that regulatory goals will include increased enforcement against dietary supplements containing new dietary ingredients.
Crispr gene editing will change the way Americans eat—here’s what’s coming The first Cripsr gene-edited products will reportedly begin reaching the market this year, and everything from produce to grains to meat may be affected in the near future. This technology is currently unregulated in the U.S., with the USDA having issued a statement last March “saying it would not regulate crops whose genetic changes could have been produced with conventional breeding."
Glyphosate use increases dramatically across the Midwest Farmers in the Midwest continue to use the controversial pesticide glyphosate in spite of its decreasing effectiveness and the thousands of current lawsuits regarding the substance’s adverse effects on human health. The Midwest Center reviewed data with low estimates of pesticide use on farms and still found that use was not slowing.
Safe or scary: The shifting reputation of glyphosate aka Roundup Farmers have been using this chemical, often under the trade name Roundup, for about four decades. But now it's under fierce attack, accused of causing cancer. In three civil cases so far, U.S. juries have ordered Roundup's inventor, Monsanto, now owned by Bayer, to pay enormous damages to cancer survivors, and thousands more lawsuits have been filed. Looks at the history, evidence and stunning turnaround for glyphosate.
Do less and do differently: Why innovation and reduction are both crucial for sustainability-- DSM Nutrition CEO Extensive investment in innovation to develop more sustainable products, as well as ambitious CO2 reduction targets directly linked to the company's bottom line, are two of the key strategies DSM is adopting as part of its sustainability efforts.
MOU PARTNER NEWS
ABC-AHP-NCNPR BAPP receives Nutraingredients-USA Editors Award for Industry Initiative of the Year NutraIngredients-USA has presented its 2019 Editors' Award for Industry Initiative of the Year to the ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP). The editors called BAPP "an exemplary educational resource about adulteration in the botanical supply chain, with its growing body of peer-reviewed literature, laboratory guidance documents, bulletins and newsletters."
‘Mind the Gap’ opens lines of communication for the dietary supplement sector The International Alliance of Dietary/Food Supplement Associations (IADSA) has launched “Mind the Gap,” a new information resource designed to facilitate more effective communication about the benefits of dietary supplements. Available online, the first two entries in the Mind the Gap series focus on vitamin D.
Gen Z wary of business, but eager to see values Email marketers hoping to stir up Gen Z should sober up instead. Gen Z, by a margin of five to one, does not trust business to act in the best interests of society, according to "The Reckoning: Brand Relevance, Respect and the Rise of a New Generation," a study by BBMG.
Vitamins and minerals on the nutritional agenda for a quarter of Europeans More than a quarter of Europeans take a daily vitamin or nutritional supplement as part of a healthy lifestyle, according to findings from the Stada Health Report.
Human Microbiome Project expands toolbox studying host microbiome interactions Results from three long-term studies following host and microbiome characteristics during pregnancy and preterm birth, inflammatory bowel disease and prediabetes have expanded our understanding of how humans and microbes interact and the resulting consequences for our health. The studies were funded as part of a second phase of the National Institutes of Health’s Human Microbiome Project.
Study finds vitamin E levels, physical activity correlated with better cognitive performance in adolescents Out of 120 school students analyzed by Saudi researchers, academic performance was higher for students classified as moderately or highly active physically. Serum levels of vitamin E were also higher in the more active students.
Can potassium intake help with weight loss? Researchers in Israel reported that participants in a dieting study, who showed greater Body Mass Index (BMI) decreases, had higher potassium intakes than those with modest BMI decreases.
Probiotics supplementation may reduce GI symptoms during marathon Probiotic supplementation appears to be a promising strategy to lessen the incidence and severity of gastrointestinal symptoms in endurance athletes, according to a study from Liverpool John Moores University.
Mental health and the microbiome: Mixed findings over probiotics' anxiety impact Probiotics may not be as effective as non-probiotics methods of intestinal microbiota regulation when it comes to relieving anxiety symptoms, according to a Chinese systematic review.
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.
Search and sign up for a variety of FDA Guidances.