FDA's Welch says cGMP compliance still deficient in fundamental areas
Natural Products INSIDER
Dietary supplement companies cited last year by FDA for cGMP violations are still coming up short in meeting fundamental requirements, said Cara Welch, Ph.D., senior advisor to FDA’s Office of Dietary Supplement Programs (ODSP) in an interview. “Unfortunately, what we’re still seeing is that the most frequently reported observations during the inspections are deficiencies in some of the fundamental aspects of the cGMP compliance system." Read more→
Registration now open for UNPA FSVP training, Feb. 28-March 1, in Sandy, UtahThis course is designed to help participants understand the role of importers under the Foreign Supplier Verification Programs (FSVP) rule, part of the Food Safety Modernization Act (FSMA). Foods covered under the new rule include dietary ingredients, raw materials used in dietary supplements and natural products marketed with a Nutrition Facts panel as a food product. The course will focus on the expectations of the new rule and will explain the requirements of importers. Many importers are already outside of compliance with this law, published in 2015. Only 24 seats remain!
Sponsorships for the 10th Annual UNPA Members' Retreat are now availableSponsorships for the 10th Annual UNPA Members' Retreat, to be held in Park City/Deer Valley, Utah, May 8-10, are now available. Sponsorships are an effective way to support UNPA, increase your company’s visibility and get your products and services in front of a highly desirable and targeted audience: the UNPA membership. For more information, contact Kira Olsen, 801.474.2572, x107.
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FDA denies qualified health claim for vitamin D and MS risk reductionOnce again, FDA has denied Bayer’s request to approve a health claim linking vitamin D to the reduced risk of multiple sclerosis on the grounds that the available scientific evidence does not meet the agency’s "high standards" for support.LEGAL
Supreme Court to consider civil price-fixing case against Chinese vitamin C makersThe Supreme Court recently said it would hear an antitrust case involving price fixing by Chinese vitamin C makers, agreeing to decide whether U.S. judges must defer to legal submissions made by the Chinese government.LEGISLATIVE
Advocates oppose N.Y. bill that would restrict who can give nutrition adviceA bill that seeks to restrict the ability to provide nutrition advice to only a small group of accredited professionals has advanced farther than it ever has in the New York State legislature.M&A ACTIVITY
Nature’s Bounty acquires The Best Bar EverSports performance and supplement-maker Nature’s Bounty acquired “real food-based” nutrition bar brand The Best Bar Ever last week. The purchase adds a clean-nutrition halo brand to Nature’s Bounty’s growing portfolio of sports and nutrition products.
U.K. trade show organizer Informa to purchase rival UBMBritish events organizer Informa Plc said this week it's having a go at buying rival UBM Plc, a decade after merger talks between the two broke down. Informa is also the owner of the U.S. natural products industry events SupplySide and the Natural Products Expos.
Craft Technologies merges with Eurofins NA Food GroupThe Eurofins North America food division announced the successful purchase of Craft Technologies Inc., a contract laboratory providing analysis of nutrients, vitamins, carotenoids, bioflavonoids and phytochemicals.
Is Nestlé leading the charge in $4 billion race for Merck’s vitamin and supplements business?Multiple reports peg Nestlé as the front runner for Mercks’ consumer health business. However, Nestlé may still face competition from Reckitt Benckiser and Mylan.
Croda acquires marine biotechnology companyCroda International Plc, which creates and sells specialty chemicals, has acquired Nautilus Biosciences Canada Inc., a marine biotechnology company based in Charlottetown, Prince Edward Island.
TricorBraun acquires leading healthcare packaging companyTricoBraun, a packaging-solutions company, has acquired Package All Corp., a 33-year-old healthcare-focused packaging distributor, headquartered inBayport, N.Y. As a result of this transaction, Package All has become a wholly-owned subsidiary of TricorBraun but will continue to be led by its current executive team.
Instacart acquires Canadian voice-shopping startup UNATAThe deal gives Instacart—the grocery-delivery company that partners with local stores to offer same-day deliveries—new kinds of e-commerce tools. It will also help it to expand in Canada.FINANCES
An obscure tax law might force Newman’s Own to put itself up for saleNewman’s Own Foundation is shining light on a provision in federal tax law that could impact for-profit companies with similar business models, in which 100 percent of their profits go to charity. The foundation is facing a 200-percent tax hike that would damage its ability to give grants at the level it has been doing, company leaders said.GLOBAL REGULATORY
Lonza’s hopes for an L-carnitine claim dashed by EFSALonza’s assertion that L-carnitine contributes to normal lipid metabolism was rejected by EU authorities, who could not find a link between the supplement and a ‘beneficial physiological effect.’FSMA COMPLIANCE
BI says steam sterilization gives it a leg up on FSMA supply chain ruleWith 15 years of data, BI Nutraceuticals says its steam sterilization protocol is the most highly developed in the dietary supplement industry and is part of what enables the company to fully comply with FSMA requirements.2017 REVIEW
Year in review: Direct Selling’s 2017 in the newsA compilation of memorable news pieces from last year from The World of Direct Selling. Includes stories about UNPA MLM members and insights on doing business in China and India.2018 OUTLOOK
Expect changes for the nutraceutical industry in the year aheadIn this commentary from Gregory Stephens of UNPA member Windrose Partners, Stephens looks at how the industry has changed in the last year, what is constant and the new opportunities to pursue, noting that to succeed in a complex, emerging environment, don’t react; be the agent of change.APAC NEWS
Faster authentication process pioneered in Hong Kong for TCM and herbal productsA new method of analysis promises to speed up the authentication process for Chinese herbal medicines in a move that could boost industry transparency and reduce fraud.
Herbalife’s new personalized nutritionprogram, Gene Start, debuts in South KoreaHerbalife has chosen South Korea for the launch of its new personalized nutrition program, Gene Start, as it seeks to capitalize on growing APAC demand for customized health solutions.
China dominates 2017 APAC food scandal chart as tougher regulations take their tollNine out of 10 Asia Pacific breaches of food and beverage regulations in 2017 occurred in China, a new report reveals.PERSONAL CARE
Natural and organic cosmetics: The new ISO standard continues to be debatedThe ISO 16128 standard for the international harmonization of definitions for natural and organic cosmetic products and their ingredients, the second part of which was released last September, is disputed on various points by several European private label companies. But for cosmetics industry representatives, it is an important step forward towards greener cosmetics.HEMP/CBD
Hemp industry to AG Sessions: ‘We’re street legal’The U.S. attorney general's "backward" war on drugs threatens the hemp industry. Should hempsters be worried? Here's the Hemp Industries Association's response.
Independent health food stores embrace CBDCV Sciences Inc. maintains relationships with natural product stores across the United States, reflecting retailers’ strong interest in CBD (cannabidiol) and similar products derived from hemp.UNPA MEMBER NEWS
Essential Formulas debuts new Dr. Ohhira packagingEssential Formulas has announced the launch of its redesigned vertical packaging and expanded product information for its Dr. Ohhira’s Probiotics.As a pioneer in the probiotic industry, EFI understands that the rapidly growing market presents an opportunity and a responsibility to lead the natural product industry in offering comprehensive product information.
NSF AuthenTechnologies adds new leadershipIn a move meant to more closely align its Calif.-based DNA testing lab with NSF International’s core scientific testing and research services, the global public health organization recently appointed Jesse Miller, Ph.D., to lead NSF’s AuthenTechnologies.
NOW Foods and AlgeaHealth launch organic microalgal astaxanthinThe astaxanthin capsules contain AlgaeHealth’s AstaZine natural astaxanthin, derived from organic Haematococcus pluvialis microalgae. Astaxanthin is a carotenoid antioxidant that evidence suggests scavenges free radicals and supports healthy immune function and healthy aging.
USANA lands deal with USA Nordic: Becomes official supplement coordinator of winter organizationWinter is here and USANA, the cellular nutrition company, continues to join forces with the north's elite winter sports organizations as it becomes the Official Supplement Supplier of USA Nordic. America's top ski jumpers and Nordic Combined athletes join fellow United States teams as the latest to trust USANA's high-quality supplements as they look to competing in Korea next month.INNOVATION
Startup Birdnip launches nootropic supplement for dogsWith powdered Bacopa monneri, Rhodiola rosea, shiitake mushroom, kelp, carrot and beet, start-up Birdnip wants to improve cognitive function in dogs with its debut product Nootrodog. But will a nootropic supplement for our four-legged friends have legs?SOCIAL RESPONSIBILITY
Reactions vary to Blackrock exhorting firms to have social purposeBlackRock, which manages more shareholder equity—$1.7 trillion in active funds—than any other entity, is telling corporate America that it must have a “sense of purpose” if it wants its support, and it asserts that “the time has come for a new model of shareholder engagement—one that strengthens and deepens communication between shareholders and the companies that they own.”MOU PARTNER NEWS
American Botanical Council publishes 7000thherbclip research summaryAn essential research and educationalresource for scientists, researchers, health professionals, industry members andothers, HerbClips are two- to three-page summaries and critical reviews of scientific journal articles that cover medicinal plant-related human clinical research, analyticalmethods, regulatory data, market information, ethnobotanical reviews, conservationand sustainability studies, and more.TRADE ASSOCIATIONS
AHPA welcomes Dr. Holly Johnson as new chief science officerThe American Herbal Products Association announced that Holly E. Johnson, Ph.D., a pharmacognosist with more than 20 years of experience, will serve as its new chief science officer. Johnson joins AHPA after serving as laboratory director for UNPA member Alkemist Labs.MARKET RESEARCH
Consumer interest in genetic make up, personalized health and beauty continuesAccording to Euromonitor International's report, “Top 10 Global Consumer Trends for 2018,” growing curiosity about genetic make-up and a rising interest in personalized health and beauty are fueling a global market expected to soar by 2022.
Consumers confused by food and health messagesU.K. consumers think that information about diet and health is confusing, and they would rather believe the internet than a dietitian. In a survey of 2,000 consumers in the U.K., U.S., Spain and Australia, conducted by New Nutrition Business, 79 percent said they find messages surrounding health, food and nutrition confusing.
Aging population drives functional food ingredients marketRadical penetration of social media of late, on the back of growing ubiquity of smartphones, has helped spread awareness regarding the need for particular ingredients in the daily diets of individuals who suffer from specific deficiencies, according to a new report by Transparency Market Research.
Most popular supplement for Saudi women revealed as study shows increased useDietary supplement usage has increased significantly among women in Saudi Arabia over the last two decades, say researchers in the country.RESEARCH
Could melatonin promote healthy aging?Lack of melatonin has been widely linked to sleep disorders and disturbances in the human circadian rhythm or body clock. But the hormone may also benefit sleep-related aspects of other conditions, say researchers in a new review from Israel.
Vitamin D deficiency may increase metabolic syndrome risk after menopause: Indian population studyIndian women with vitamin D deficiency have a higher risk of metabolic syndrome, according to a study of rural women in West Bengal and published in PLOS One.
Fortification plus supplements could be key to healthy vitamin DCombining multi-food fortification with additional vitamin D supplementation could be a viable strategy in achieving healthy levels, according to researchers from the Technical University of Denmark.
Iodine deficiency may reduce pregnancy chancesWomen with moderate to severe iodine deficiency may take longer to achieve a pregnancy, compared to women with normal iodine levels, according to a study by researchers at the National Institutes of Health published in Human Reproduction.
Probiotic reduces levels of potentially harmful gut bacteria in infants in new studyAccording to a statement from Evolve BioSystems, the study “marks a major milestone in gut health as it’s the first ever to demonstrate that a probiotic can substantially and beneficially remodel and protect a baby’s gut.”
Omega-3 supplementation can shorten hospital stay for post-op gastrointestinal cancer patientsParenteral omega-3 fatty acid supplementation can benefit gastrointestinal cancer patients after operations, according to 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.
Search and sign up for a variety of FDA Guidances.