FDA irked with 'basic' dietary supplement manufacturing violations FDA is disappointed with continuing violations of “basic” manufacturing requirements applicable to the dietary supplement industry. In fiscal year 2019, dietary supplement manufacturing facilities issued an inspection report—or so-called Form 483—for violations of cGMPs were most commonly cited for failing to establish specifications for finished dietary supplements, according to FDA data. Other top violations or “observations” related to failure to establish written procedures for quality control operations and batch production records that did not include complete information. Read more→
Next month in Utah! Limited seating still available!
Intentional Adulteration training, Jan. 22 in Lehi, Utah
Did you know that you're responsible for having in place a plan to deal with adulteration of your ingredients and finished goods? It's all a part of FDA's Mitigation Strategies to Protect Food Against Intentional Adulteration (referred to as the IA rule), part of the Food Safety Modernization Act. Developed by the Food Safety Preventive Controls Alliance (FSPCA), this intensive, one-day certificate course is the "standardized curriculum" recognized by FDA. Join Ned Mitenius, a 30-year veteran in the food processing industry, who will lead the training. UNPA members receive a $200 discount at registration.
UNPA's FSVP training, February 2020 in Utah
Do you import ingredients or finished goods? Do you know your obligations under the Foreign Supplier Verification Programs regulation? Join former FDA Investigator and UNPA VP, Global Regulatory & Compliance Larisa Pavlick for this certificate-based training. Click on the title for more information, why you might need to attend and to register.
Senate confirms Stephen Hahn, M.D., as FDA commissioner Stephen Hahn, M.D., is officially the next commissioner of FDA, following a 72-18 Senate vote. Hahn is most well-known for his research in radiation oncology and is immediately facing pressure from senators to finalize a policy that would ban sales of flavored vaping products.
FDA warns consumers about recalled products months after consent decree A call from FDA to consumers to avoid products recalled as part of an enforcement action underscores how difficult it can be to get offending articles off the market.
U.S. reaches new trade deal with China The U.S. government announced a “phase one” trade deal on Friday that stipulates China will make substantial purchases of U.S. goods and services in the coming years, including from agriculture.
Dupont’s Nutrition & Biosciences, ITT merge to create olefactory giant The recently announced merger of IFF and DuPont Co.’s Nutrition & Biosciences business will create a $45 billion entity catering to the disparate tastes and preferred scents of consumers worldwide.
Natural retailer New Seasons Market sold to Good Food Holdings Portland, Ore.-based, neighborhood grocer New Seasons Market LLC has agreed to be acquired by Good Food Holdings. CEO Forrest Hoffmaster will continue to lead the New Seasons and New Leaf banners.
Revised voluntary hemp guidelines set to take effect Marielle Weintraub, president of the U.S. Hemp Authority, suggests the revised guidelines reflect a greater focus on compliance with current federal regulations.
Most states’ hemp laws conflict with USDA rules Eighty-five percent of states need to revise their hemp laws to comply with a new USDA framework for nationwide hemp production, according to a report from the National Association of State Departments of Agriculture. The group also said it's "imperative" that the FDA quickly set up guidelines for cannabidiol products to ensure that hemp growers have a stable market by next year's harvest time.
Importing hemp into the U.S. remains total ‘crapshoot’ Although the 2018 Farm Bill removed hemp and its derivatives with a THC concentration of no more than 0.3 percent from the Controlled Substances Act, government agencies reportedly face technological challenges testing for the THC threshold at the U.S. borders.
Organic standardization: China enforces revised product list with immediate effect China has published a new list of products that can be accepted for organic certification, which has been enforced with immediate effect. A set of revised certification regulations is set to follow by Jan. 1, 2020.
Does a loophole in organic standards encourage deforestation? Buying products that use organic palm oil doesn't necessarily guarantee that rainforests weren't obliterated in order to produce the ingredient. The National Organic Standards Board is pushing for legislation that will close a loophole to ensure that no organic farming results in the destruction of native ecosystems.
Organic Trade Association receives $3 million boost to organic exports Bolstered by awards totaling almost $3 million from USDA, the Organic Trade Association’s robust export promotion efforts in 2020 and beyond will return to tested venues to build on earlier successes and participate for the first time in potentially significant new markets.
Teamsters urge ‘no’ vote on proposed UNFI executive pay package The International Brotherhood of Teamsters doesn't want United Natural Foods Inc. to reward its executives with double-digit pay raises since the company's stock spiraled downward over the past 16 months. CEO Steve Spinner is up for a 65 percent bonus even though the food distributor's stock has fallen 80 percent since the Supervalu deal closed.
Does the natural products industry have a #metoo problem? The natural products industry presents itself as an oasis of political enlightenment, but women report sexism is still common. The first installment in this three-part Nutrition Business Journal series explores reports of sexual harassment.
Two new bills would blunt impact of family farms on public health and the environment Two pieces of legislation introduced this month seek to give FDA the authority to investigate concentrated animal feeding operations (CAFOs) implicated in foodborne illness outbreaks, as well as banning new large CAFOs. The bills were brought to the Senate by Sens. Kirsten Gillibrand, D-N.Y., and Cory Booker, D-N.J., respectively.
Beyond CBD: The rise of adaptogens, nootropics While the ongoing regulatory rodeo threatens to lasso the widespread acceptance of CBD-infused beverages and foods, a competitive space is taking root. It’s inhabited by adaptogens and nootropics, fueled by startups, whose product benefits are said to range from relieving anxiety and stress to improving digestion.
CBDepot files Novel Food application for synthetic CBD form CBDepot has applied for Novel Food application for a synthetic form of cannabidiol for food supplement use in a move the firm says has a better chance for EU regulatory approval.
Vitamin Angels reaches 2 million pregnant women in 2019 In its 25th anniversary year, Vitamin Angels made significant advances towards its goal of eliminating newborn mortality globally by scaling up its multiple micronutrient supplement (MMS) program. The organization increased its reach from 500,000 pregnant women in 2018 to reaching more than 2 million women in 2019.
New health claims, new science and steady sales. Why 2019 was a solid year for omega-3s The year 2019 was a solid year for the omega-3 business, with sales remaining steady. In the U.S., the market was mostly flat, but strong regional growth in the Asia-Pacific and other emerging markets lead to category growth overall.
Scientists create the largest-ever botanical biodiversity data set Over the last 10 years, 35 researchers have compiled 20 million observational records on the Earth’s land plants in order to create the largest-ever botanical biodiversity data set. The information may help future generations prevent loss of biodiversity, the researchers said.
Obesity is linked to food insecurity and cutting SNAP benefits may worsen both Over 11 percent of households in the U.S. are food insecure, a status that in most cases leads to poorer mental and physical health. Thus, the Trump administration's most recent rule change, which will likely take away SNAP benefits from almost 700,000 people may increase rates of food insecurity and fuel the current obesity epidemic.
UNPA MEMBER COMPANY NEWS
OmniActive continues expansion into key Asian markets OmniActive Health Technologies has entered into an exclusive distribution partnership in China with Shanghai Prochin. Through its distribution reach and relationships with key brands, Shanghai Prochin will market Lutemax 2020 Lutein and Zeaxanthin Isomers to all segments of the nutraceutical industry in China.
Forever Living Products packages 5 million meals to fight world hunger Forever Living Products is hosting a landmark meal packing event to celebrate reaching the company's goal of providing more than 5 million meals to help feed families and combat hunger worldwide.
Two small charities fed hundreds of Wasatch Front Kids: USANA merged them and will serve even more Two nonprofits, Benedict’s Kids Next Door and KidsEat! have been acquired and merged by the USANA Foundation, which plans to provide 3,000 big bags to hungry youths for the holiday school break.
Sabinsa recognized among fastest-growing New Jersey companies NJBIZ has included Sabinsa among its Fast 50 awards, recognizing 50 of the fastest growing companies in New Jersey. The business journal included Sabinsa at number 15.
USP moves 2019 Dietary Supplement Compendium to online platform In response to customer feedback, coupled with the evolving information needs, USP has moved the USP Dietary Supplements Compendium (DSC) to an online platform for the 2019 edition. It continues to provide in-depth, comprehensive information for all phases of development and manufacturing of quality dietary supplements, including quality control, quality assurance and regulatory/compendial affairs.
Wayne State University tackles nutrition shortfall in medical school Medical students at Wayne State University recently completed the school’s first mandated plant-nutrition program.
What I learned in dozens of tests and reports Tom Aarts is on a journey to know his body and its nutrient needs through a series of tests and reports. In this piece for Nutrition Business Journal's Personalized Nutrition issue, Aarts shares what he's learned and what he still wants to find out.
Your brand needs a gender shakeup While most brands still approach marketing from a distinctly male-vs.-female perspective, younger consumers just don’t see it that way. A new report from Forrester finds brands that cling to an either/or mindset have already lost relevance, ceding ground to companies that are happy to navigate a more fluid approach.
Consistent multivitamin use positively associated with adequate intake of micronutrients Multivitamins are the most commonly consumed dietary supplement in the United States and worldwide. With micronutrient insufficiency being more common in middle-aged to older adults, multivitamin use has been shown to improve status in this population.
Consumers take note of probiotics benefits Consumers recognize the benefits of probiotics on gut health and understand the connection between digestive health and overall wellness. Linkage Research and Consulting reported this past June that 87 percent of Americans understand there is a connection between digestion and health, and seven out of 10 stated they were proactive about their digestive health.
Tracking consumers changing view on D2C brands New research from Diffusion PR reports that while 40 percent of the consumers it polled recently have made a D2C purchase this year, they’re considerably less enthusiastic than they were in the prior year’s study, with only 59 percent saying they intend to make a D2C purchase in the next five years, compared to 81 percent in the 2018 study.
Could a simple vitamin deficiency explain some cases of schizophrenia in poorer nations? Researchers linking the effects of vitamin B3 deficiency to incidences of psychosis could be the key to solving the medical mysteries associated with the condition and may provide hopes for those in developing countries.
High EPA dose improves attention in ADHD children Consuming a high dose of EPA improves attention in ADHD children, according to a study jointly conducted by King’s College London and China Medical University in Taiwan.
Zinc supplements may enhance benefits of restricted-calorie diet Obese people following a restricted-calorie diet may experience even greater benefits with zinc supplementation, according to a randomized, placebo-controlled study from researchers in Iran.
Peppermint essential oil leads botanicals pack for IBS help Of the possible Western medicines for irritable bowel syndrome, peppermint essential oil is supported by the most science, but there are other emerging herbal preparations, says a new systematic review and meta-analysis from Australia.
Could chili pepper reduce mortality rate? A ‘high quality’ observational study has concluded regular consumption of chilli pepper is associated with a lower risk of death, but experts have questioned the causality in the results.
Calcium supplements have little place in modern medicine: Controversial review A new review suggests that calcium and vitamin D supplements have little effect in increasing bone density and preventing fractures.
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.