What FSMA's intentional adulteration rule means for food and supplement brands

TOP STORY
What FSMA's intentional adulteration rule means for food and supplement brands Upon a cursory reading of the Intentional Adulteration (IA) Rule that is part of the Food Safety Modernization Act, one could certainly argue the burden involved in complying with the rule's requirements, including establishing a food defense plan, far outweigh the remote possibility of an event of wide-scale harm through the food supply occurring. In developing the rule, FDA interacted closely with the intelligence community and the food industry to identify perceived vulnerabilities to the food supply. Read more→

UNPA hosts IA training in Lehi, Utah, Jan. 22. See below or click here for more information.

UNPA NEWS

In three weeks--register today!
December GMP training in Provo, Utah
Former FDA investigator and UNPA's VP, global regulatory & compliance, Larisa Pavlick, will lead the training, which will provide everything you need to know to make sure your facilities are fully compliant with 21 CFR Part 111 before your next inspection. The training is scheduled for Dec.4-5 in Provo, Utah. Click the title to learn more about the training and to register.

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 set for 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.

REGULATORY
Association support split over mandatory FDA dietary supplement product listing Support for a mandatory product listing for dietary supplements—the notion that dietary supplement companies would be required to list all of the retail products they sell in an FDA-operated database—remains mixed.
 FTC and MLM Neora butt heads in court over pyramid scheme allegations FTC has sued a Texas-based multi-level marketer over allegations that it's a pyramid scheme, but the MLM previously known as Nerium International isn't backing down.
 FDA needs new tools in face of CBD explosion FDA needs new tools to effectively deal with an expanding supplement marketplace, according to agency official Lowell Schiller. This is especially true when contemplating the flood of CBD products, with many more yet to come.

FINANCIALS
Nature’s Sunshine Products reports 3Q19 results with continued margin improvement Nature’s Sunshine Products reported its financial results, noting that net sales of $88.5 million were relatively consistent with the prior year and increased 1.1 percent on a local currency basis.
 Reign Energy Drinks drive strong 3Q at Monster Beverage After the launch of Reign Total Body Fuel early in 2019, Monster Beverage has posted an 11.6 percent sales increase.PARTNERSHIPS
Rousselot and By-Health extend strategic agreement for another five years Rousselot has signed a new, five-year strategic agreement with By-Health, a leading Chinese dietary supplement brand. 
 Supply agreement could yield first krill oil-based prescription drug product AkerBiomarine and biopharmaceutical company Acasti Pharma have entered an agreement, whereby Aker will supply krill oil as a core ingredient for a new hypertriglyceridemia drug.

MEDIA WATCH
New York Times tells readers not to take omega-3s In a recent article, The New York Times discouraged readers from taking fish oil and repeated the oft-made claim that the supplement industry is unregulated, recommending that people just “eat a few servings of fish a week, instead.” GOED took issue with the article.

DIRECT SELLING
Herbalife, Younique, LuLaRoe and other MLMs suddenly under fire Lawsuits, pyramid scheme allegations and federal fines have plagued a growing lineup of direct-selling companies in 2019, with makeup purveyor Younique joining their ranks after being offloaded in September for a tenth of its purchase price, potentially indicating trouble for the industry.

HEMP/CANNABINOIDS
Frustrated over FDA’s inaction, supplement sector eyes Congress for CBD fix Industry sources in Washington expressed growing frustration with the agency’s reluctance to allow CBD to be lawfully sold in supplements.
 NBJ: Hemp/CBD raw material sales hit 115-percent growth Hemp/CBD raw material ingredients for supplements alone did $60 million in sales in 2018 and had predictably massive growth of 115 percent, according to NBJ data, with sales projected to reach more than $400 million by 2023.
 New Jersey Senate introduces resolution urging Congress to set safe level of CBD consumption The New Jersey State Senate has introduced a resolution urging the president and Congress to issue legislation that establishes a safe daily level of consumption for cannabidiol.

BOTANICAL ADULTERATION
DNA testing reveals widespread adulteration of herbal products Fresh research utilizing DNA testing technology has highlighted widespread global adulteration of herbal products, with almost one third of items found to be fake, according to the study published in Frontiers in Pharmacology.

RETAIL
Amazon to open its first non-Whole Foods grocery store in 2020 As more hypotheses about Amazon's latest venture into grocery emerge, some experts suspect that the company's new grocery store will take aim at mainstream discount retailers, such as Walmart.

GLOBAL REGULATORY
Germany and EC align in classing CBD as novel food Germany’s federal government now confirms that cannabidiol (CBD) is to be classified as a novel food, citing an absence of evidence of its consumption prior to May 15, 1997.
 U.K. supplement firms targeting elderly shut down by high court A telemarketing firm that sold health supplements at high mark-ups has been ordered by the high court to liquidate after taking advantage of elderly customers.

CLEAN LABEL
Dietary supplement delivery systems: The clean label effect Clean-label demands require that all parties, delivery system manufacturers included, work together.

OMEGA-3s
GOED: Omega-3 clinical trials database will boost claims, help identify research gaps A database that includes 4,000-plus clinical trials on EPA and DHA omega-3s will help companies with claims substantiation and provide ready access to significant scientific data to counter negative consumer media articles, says GOED’s Executive Director Ellen Schutt.
 How a simple nutritional test can help motivate women to take more DHA Proper monitoring of DHA levels in pregnant individuals—and supplementation in those with low levels—can help ensure safer pregnancy.

PROBIOTICS
More validation, standardization and mechanisms of action studies needed to address gaps in probiotics research There is a need for more validated, standardized randomized controlled trials studying the mechanism of action in probiotics research, according to a panel at Probiotics Asia.

PREBIOTICS
Prebiotics group concurs with $5.5 billion figure on global market Growing consumer awareness, along with demand in animal nutrition, is driving the overall growth of prebiotics, which the Global Prebiotics Association says will account for $5.5 billion in sales in 2019.

POLICY
New study shows the EAT-Lancet diet is unaffordable for at least 1.6 billion people The diet recommended by the EAT-Lancet commission to feed the growing global population in a climate-friendly way is "simply unaffordable" for around 1.6 billion people, according to a new study from Tufts.

​MICROBIOME
Scientists in global project to create world’s largest human microbiome database Scientists from around the world are joining forces for the “Million Microbiome of Humans Project” in an aim to build the world’s largest database of the human microbiome.

UNPA MEMBER COMPANY NEWS
Capstone Nutrition wins Utah Manufacturer of the Year for the second year in a row Capstone Nutrition has received the 2019 Utah Manufacturer of the Year Award from the Utah Manufacturers Association (UMA) for the second consecutive year. UMA selected Capstone from among the most "exceptional" Utah manufacturers, who together produce more than $20 billion in economic output.
 CBD product launch part of Nature’s Sunshine restructuring efforts Nature’s Sunshine is the latest company to throw its hat in the CBD ring with a range of products that include added ingredients.

PERSONALIZED NUTRITION
Honing the personalized nutrition cost-benefit question Personalized nutrition is honing in on actionable endpoints that will allow companies to cost-effectively help consumers take control of their personal health, according to Tufts University Professor of Nutrition Jeffrey Blumberg, Ph.D.

MOU PARTNER NEWS
How much alcohol is in kombucha? B.C. health officials are testing to find out After regulators in the U.S. and Australia found alcohol levels in kimbucha as high as those in beer or cider, the health officials at the B.C. Centre for Disease Control are collaborating with the British Columbia Institute of Technology to test alcohol levels in 760 samples of kombucha collected from grocery stores, farmers markets and other retail locations.

MARKETING
Improving your direct response: How to get more from your campaigns Consumer behavior is changing, and marketers must constantly adapt to gain new insights and improve direct campaign effectiveness. What’s needed now is a more thoughtful, full-funnel approach: top, middle and bottom.
 Influencer marketing has peaked. Here’s what’s next Gen Z has a decidedly different approach to shopping, and based on new research from Kantar’s U.S. Monitor, that’s bad news for the many brands pouring their money into influencer marketing.
 Survey: Consumers want brands to take political stands Researcher Sprout Social found that among roughly 1,500 U.S. consumers surveyed, 70 percent said it’s important for brands to take a stand on such matters.

​MARKET RESEARCH
Consumers and brands disagree on customer experience Ask marketers, and 82 percent think they’re doing a fine job of providing a good customer experience, according to Deliver The CX They Expect, a study by Acquia. But only 10 percent of customers strongly agree.

How 'VSCO Girls' are killing makeup sales--and reshaping the beauty industry Investment bank Piper Jaffray released its semiannual teen survey this fall, detailing just how influential the VSCO trend is, noting a 21-percent decrease in cosmetic spending among female teens year over year.

RESEARCH
Study finds leading risk factors and causes of death, disability underrepresented in NIH-supported prevention research A study by National Institutes of Health (NIH) scientists in the Office of Disease Prevention examined NIH grants and cooperative agreements between 2012 through 2017 and found that prevention research projects included an observational design or secondary data analysis, while relatively few included a clinical trial focused on preventing the leading risk factors and causes for death.

Growing body of science supports cognitive role for lutein across the lifespan Studies have shown health benefits for lutein and zeaxanthin for the young and old, and a recent study showed the importance in college students, supporting a role for carotenoids throughout life, according to James Stringham, Ph.D., of the Duke Eye Center.

Probiotic yeast shown to support vaginal health A new clinical study demonstrated the ability of the probiotic yeast strain Saccharomyces cerevisiae CNCM I-3856—branded Quatreflora—to support vaginal health in women.

Sleep, beneficial bacterial and cognition are intertwined New research has shown positive correlations between improved sleep, microbiome status and cognitive function.

Saffron could assist with depression treatment New research funded by Pharmactive Biotech Products has shown that saffron, taken in conjunction with pharmaceutical antidepressants, may assist adults with depression.

Astaxanthin supplement shows promise in brain-health category The antioxidant astaxanthin has been linked to healthier skin, heart health, joint pain, and now, research suggests it may also reduce depression and stress in healthy subjects, as well as improve memory in those with mild cognitive decline.

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.

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