FDA sends warning letters on illegal ingredients, signals new ingredient scrutiny

TOP STORY
FDA sends warning letters on illegal ingredients, signals new ingredient scrutiny FDA has issued 11 warning letters to companies with non-NDI ingredients in their products. Eight of the warning letters concerned the stimulant DMHA and the other three involved phenibut. The recent slew of warning letters on DMHA and phenibut signals new scrutiny on the part of FDA of ingredient status without reference to other issues, says attorney Claudia Lewis, who heads the FDA practice for the law firm Venable. Read coverage:
FDA sends warning letters on illegal ingredients in sports and weight loss products→
With recent warning letters, ingredients regulatory status takes center stage→

UNPA NEWS
Registration for the UNPA Members' Retreat closes tonight at midnight!
There's still time to register, but don't delay! Registration for this year's retreat closes at midnight tonight. The entire UNPA staff looks forward to hosting you in scenic Charleston, S.C., starting Tuesday night!

Need a PCQI? We can help you with that...
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. Registration is open!

View UNPA's Expo West Members' Meeting presentation
View and download the PPT presentation from UNPA's 2019 Expo West Members' Meeting on March 6. Access requires member login.

Expert Insights OnDemand: Highlights of the inaugural Nutraingredients-USA Sports Nutrition Summit
Highlights from the inaugural Nutraingredients-USA Sports Nutrition Summit, held in San Diego, in January 2019, are now available to view OnDemand. Presenter Stephen Daniells, Editor-in-Chief of NutraIngredients-USA, discusses the state of the sports nutrition market; how formulators can get a quick overview of the state of the science; the white spaces in the market; and cutting-edge technology.

'Insidious: How synthetic biology threatens your natural ingredient supply chain' PPT is now available 
The PPT presentation from the UNPA co-sponsored session, “INSIDIOUS: How synthetic biology threatens your natural ingredient supply chain,”  presented at Expo West on March 6, is now available for viewing and downloading.

CBD/HEMP
Pennsylvania woman sues CBD company after failed drug test A lawsuit filed in California blames a marketer of CBD products for failing to disclose that consumers could fail a drug test by taking its products. The complaint alleged that Koi CBD LLC advertised its products as being free of THC—the psychoactive compound responsible for the “high” from using marijuana—and legal in all 50 states.

Vitamin Shoppe to carry CBD following FDA’s move to exercise enforcement discretion Industry attorneys point to FDA’s announcement to exercise “enforcement discretion” related to foods and supplements containing CBD as a factor driving mass-market retailer activity in the category, including The Vitamin Shoppe’s recent move to carry CBD supplements.

Cosmetics industry taking long-term view of CBD’s benefits Brand owners will research CBD’s purported benefits in cosmetics now that FDA has clarified the ingredient can be lawfully sold, an industry executive said.

USDA provides path for hemp seeds imports just in time for spring plantings Responding to requests from U.S. producers and hemp seed exporters, the U.S. Department of Agriculture, which regulates importation of all seeds for planting to ensure safe agricultural trade, has provided an alternative path for the safe importation of hemp seeds in the U.S., from Canada as well as other countries.

LEGAL
FTC settles $26 million case over fraudulent cognitive support claims The nootropic category is again under the microscope as the Federal Trade Commission has announced the settlement of a case over unsubstantiated cognitive support claims that generated a combined $26 million in fines.

DSHEA AT 25
In conversation with Scott Bass and Loren Israelsen The brilliant strategy of Sen. Orrin Hatch, the upswell of grassroots consumer pressure and the ‘highly unusual’ personal intervention of an FDA commissioner. The development and passage of DSHEA is a fascinating story. This two-part interview with attorney Scott Bass and UNPA's Loren Israelsen is perhaps the best synopsis of the behind-the-scenes machinations of the passage of this monumental legislation.

25 years of DSHEA: A GMP auditor’s perspective EAS Consulting’s Tara Lin Couch remembers supplement manufacturing before GMPs were issued as the “wild, wild west.”

M&A ACTIVITY
Unilever gives supplements another chance with Olly acquisition The U.S. arm of global consumer products giant Unilever will acquire San Francisco-based supplement brand Olly. With functional foods and gummy supplements ranging from multivitamins to beauty-from-within, Olly fits in the cross section of Unilever’s two flagship categories: beauty and personal care and food and refreshments.

PARTNERSHIPS
DSM partners with personalized supplement gel-pack company Panaceutics DSM has partnered with Panaceutics, which makes personalized nutritional gels and purees, to compete against the personalized packs of pills that dominate supplement subscription services.

REGULATORY
Added sugar labels could pay for themselves and save nearly a million lives. Why haven’t we seen them yet? FDA announced three years ago that it would be making “sweeping changes to Nutrition Facts panels on packaged foods”—one being the inclusion of “added sugar” labels. The food industry complained that two years wasn’t enough time to increase the size of the calorie count or calculate the amount of added sugars in each product, but a new study makes the case for faster action.

BOTANiCALS
How strengthening botanical-ingredient verification helps build consumer trust As consumer demand grows for natural products, that growth drives the need for research of the product’s botanical ingredients. The Natural Health Products Research Alliance is creating new, mutually agreed upon standards and disruptive molecular biotechnology for ingredient testing and authentication.

Many blends on the market are without tests verifying their makeup, expert asserts Testing of complex mixtures becomes an ever more pressing issue in the dietary supplement industry with the proliferation of proprietary blends.

INVESTMENT
Microbiome startup Viome lands $25 million funding from investors Wellness startup Viome has raised $25 million in funding from investors, including Salesforce CEO Marc Benioff. Viome analyzes customers’ microbiomes through stool samples and subsequently makes food recommendations for health or weight loss. Microbes make up more than half the cells in the human body, and founder Naveen Jain says that the company is in the midst of several clinical studies with 15 or so separate diseases.

GLOBAL REGULATORY
Heinz reels from latest probiotic health claim rejection by EFSA The European Food Safety Authority has rejected a health claim related to a probiotic that claims to boost the immune system against pathogens in the gastrointestinal and respiratory tract.
KRATOM
Opioid users call kratom a godsend: FDA calls it a menaceThe steep rise in the number of people suffering opioid addiction has helped spawn the widespread use of another substance—kratom.RETAIL
How grocers survive the Amazon eraThe traditional American supermarket appears to be dying—food nationwide is being increasingly channeled through a handful of companies, such as Amazon, Walmart, FreshDirect and Blue Apron. But one man is hoping to turn things around: Supermarket architect Kevin Kelley has spent decades “honing his vision for what the grocery store should do and be.”
 Whole Foods 500th store in Atlanta may be the last of the flagship storesLearn why the “Amazonation” of Whole Foods could spell the end for flagship stores, such as the newest 500th location in Atlanta. Amazon products are “suitably downplayed” here, and the focus is on local, community and pushing the boundaries of foodservice.SPORTS NUTRITION
IAAF statement on optimizing sports nutrition points to food-first philosophyThe International Association of Athletics Federations (IAAF) has released its consensus statement on sports nutrition for athletes. It preaches a food first philosophy as well as a personalized approach.
 Sports nutrition products widely used but risky for athletes and warfighters, experts sayThe uncertain nature of ingredients in certain sports supplements and the floride claims on some of these products creates risk for athletes and warfighters, according to panelists from the World Anti-Doping Agency and the Uniformed Services University at the recent ICSB conference.
 Plant-powered proteins thrive in sportsnutrition sectorThe value of the sports nutrition market is set to grow by around 8 percent per year to reach more than $17 billion globally in 2021, according to Innova Market Insights’ forecasts. The mainstreaming of the market has led to a surge in interest in plant-based alternatives with the traditional dominance of whey and other dairy proteins now being challenged.UNPA MEMBER COMPANY NEWS
Alkemist Labs partnership to help improve GMP compliance, GRAS, NDI application processTo help eliminate gaps where many companies are failing GMP audits, NDI applications and other regulatory-related responsibilities, Alkemist Labs is collaborating with REJIMUS, a regulatory management solutions provider, to offer clients comprehensive GMP compliance solutions.MOU PARTNER NEWS
NCNPR announces course schedule for Natural Products Training Laboratory at Ole MissThe National Center for Natural Products Research’s Natural Products Training Laboratory at the University of Mississippi will offer a range of botanical and dietary supplement training courses designed for individuals in the dietary supplement industry to gain a working knowledge of HPTLC equipment, practical training and understanding of laboratory techniques, as well as courses conducted with NSF on GMPs, labeling compliance and supplement claims substantiation. Courses are scheduled in June and September.PERSONAL CARE
EWG adds new brands to its EWG verified certification programWith thousands of consumer products on the market, it can be overwhelming for consumers to know which ones are safe and healthy for their family. The Environmental Working Group's EWG VERIFIED™ mark does the work for them, by verifying that products displaying the mark are free from EWG's chemicals of concern and meets its strictest standards for health. More than 1,300 personal care and cosmetic products have now been approved.PACKAGING
Smart packaging to grow 11 percent annually reaching $39.7 billion by 2020Smart packaging and connected packaging is on the radar of senior executives and is attracting significant investment, according to survey of executives from Deloitte.
 Package label language most important way consumers learn about brands, survey showsNew consumer research shows that brand loyalty is a key element of success in the dietary supplement industry. And much of what consumers associated with brands has to do with packaging, according to the proprietary research from Aker Biomarine.ENVIRONMENTAL POLICY
High CO2 levels will wreck plants' nutritional value, so don’t plan on surviving on vegetablesKristie Ebi is the lead author from the Intergovernmental Panel on Climate Change’s widely read report regarding the need “to limit global warming to below 1.5 degrees Celsius.” Now, she’s making the case that global warming will soon destroy the nutritional quality of our food and is calling for more investment from governments and food companies in “interventions that could support the nutritional quality of crops."PERSONALIZATION
We now live in a world with customized shampooMany companies are diving into the world of personalization—Gatorade, for one, now has a system that uses “a sophisticated analysis of an individual’s perspiration” to personalize his or her beverage. Another company doing well in the space is Care/of, which creates personalized vitamins, and Prose, which offers customized haircare.SUPPLY CHAIN
Supply chain transparency: A practice of trust through legitimacy, from farm to forkThe demand and requirements by consumers and regulators for supply chain transparency is at an all-time high and only will strengthen.INNOVATION
Lipofoods creates soluble curcumin for beauty beveragesFunctional food ingredient developer Lipofoods has revealed a “highly bio-available” micro-encapsulated curcumin ingredient for use in beauty-from-within beverages.INDUSTRY PHILANTHROPY
Vitamin Angels hopes to break intergenerationcycle of malnutrition in Central AmericaNon-profit Vitamin Angels wants to strengthen its partnership network in Central America to address transformative change for women and children facing malnutrition, says Elizabeth Carrera, program manager for Latin America and the Caribbean.EMPLOYMENT OPPORTUNITIES

UNPA member companies have posted the following employment opportunities. To include a job posting, email editor@unpa.com.

Clinical Product & Program Manager,  Lake Barrington, Ill., posted by Ortho Molecular ProductsRESEARCH
Analysis of data from 30 studies finds linoleic acid cuts CVD riskA study published in a major journal shows a cardioprotective role for linoleic acid, an omega-6 fatty acid, further complicating the message about the role of fats in the diet.

New data supports tocotrienols' role in increasing skeletal muscle weightA study on obese mice revealed a correlation between supplement with tocotrienols and an increase in skeletal muscle weight and muscle fiber.


Mexican study suggests potential prebiotics activity of mango peelMango peel may selectively boost the growth of beneficial bacteria and open up opportunities to use the waste material as a prebiotic ingredient, suggests a new study from Mexico.


Cannabidiol could help deliver medications to the brainAlthough much more research is needed to verify these claims, scientists have now shown that CBD could have use as a “Trojan horse,” helping medications "slip" across the blood-brain barrier and into mouse brains. The researchers reported their results in the ACS journal Molecular Pharmaceutics.


Vitamin D may help regulate immune systemScientists at the University of Edinburgh have uncovered fresh insights into how vitamin D affects the immune system and might influence susceptibility to diseases such as multiple sclerosis.
 Black cumin seed extract shows positive effect on metabolic health fatty liverA study published by the Journal of Nutrition & Food Sciencesshows TriNutra’s extract of Nigella sativa or black cumin seed oil, ThymoQuin 3%, had beneficial effects on metabolic function and fatty liver. 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.