FDA enforces CBD claims language as cannabis meeting is set for May

​TOP STORY
FDA enforces CBD claims language as cannabis meeting is set for May FDA has sent three companies marketing CBD products warning letters over disease claims. The warnings are the first issued under FDA’s de facto ‘enforcement discretion’ policy, which will be discussed at a public meeting on CBD set for May 31 in Washington. The letters advised the companies that their products are unapproved new and misbranded drugs. FTC, which regulates advertising claims, also raised concerns that their statements are not adequately supported with "competent and reliable scientific evidence."  Read coverage:
FDA continues to enforce CBD claims language as meeting on botanical is set for May→
FDA, FTC warn CBD marketers claiming to treat diseases→

UNPA NEWS
Registration now open for Preventive Controls Quality Individual training, June 26-28 
UNPA will conduct Preventive Controls Quality Individual (PCQI) training with a focus on hemp and other botanically derived ingredients, June 26-28, in Westminster/Denver, Colo. Registration is now open with a $100 early-bird discount through April 15.


The UNPA Retreat is less than a month away! Register today!
UNPA's annual members' retreat, April 30-May 2, in Charleston, S.C., is less than a month away, and the agenda has been updated with speakers. Are you registered?CBD/HEMP
CBD players must differentiate themselves in the evolving marketThe hemp-based CBD market is growing like gangbusters, but investors want a seat at the table with winners who are going to build value and an esteemed reputation over the long-term.


AHPA issues guidance on hemp and hemp- derived CBD supplementsThe American Herbal Products Association has adopted a guidance policy for dietary supplement and food products that contain hemp and hemp-derived cannabidiol.


Walgreens to sell CBDThe latest mass chain to enter the CBD market is Walgreens. CNBC reported that Walgreens will sell CBD creams, patches, and sprays in Oregon, Colorado, New Mexico, Kentucky, Tennessee, Vermont, South Carolina, Illinois and Indiana. The products will be available in nearly 1,500 stores.


Farmers bet big on the South’s first organic hemp cooperativeThe state of Kentucky is aiming to be “the leader, and the epicenter, of industrial hemp production in the United States,” according to the state’s Department of Agriculture. Farmers at one certified organic hemp cooperative are preparing for an organic hemp “gold rush” because of its rarity in the space and the relatively lengthy time it will take conventional farms to obtain USDA organic certification.
NOCO HEMP EXPO COVERAGE
NoCo Hemp Expo: Hemp opportunity in full flowerThe world’s largest hemp exposition opened last week in Denver to rollicking crowds and was estimated to have attracted 10,000 people and 225 exhibitor booths interested in the plant’s disruptive potential in a wide range of industries.


Hemp entrepreneurs hear benefits and challenges of booming industryColorado Gov. Jared Polis and UNPA President Loren Israelsen were among the speakers at the sixth annual NoCo Hemp Expo on March 29 in Denver. Israelsen told the hemp industry “This is your big moment. [The farm bill] created a lawful pathway,” Israelsen said. “But it didn’t solve all the problems you’re facing now.” An economy panel, including consultants and botanical and legal experts, said that the hemp segment is advancing so rapidly that the timeline of decades in other sectors could be compressed into just years. UNPA's Larisa Pavlick participated in a regulatory panel at the expo.
REGULATORY
FDA, supplement industry eye ways to foster compliance to ingredient notification systemFDA is looking at ways to foster the submission of new dietary ingredient notifications. The notification system, established by law in 1994, may be in need of changes to ensure U.S. regulators have an opportunity to review the safety of new ingredients before they are marketed in supplements.
GLOBAL REGULATORY
EMA confirms original recommendation to not authorize use of omega-3s for heart attackThe European Medicines Agency (EMA) has confirmed its previous recommendation to no longer recommend the use of omega-3 fatty acids for secondary prevention of myocardial infarction, following a request for re-examination.
 EU lawmakers back ban on single-use plastics setting a world standardSingle-use plastic items (e.g. straws, forks, knives, cotton buds) will be effectively banned in the European Union by 2021. Currently, the EU recycles only a quarter of the 25 million [tons] of plastics waste it produces per year. Especially now that China has stopped accepting other countries’ refuse, it’s up to legislators to end the stream of waste and come up with circular solutions. 
 CBD trade group mounts legal actions to challenge possible FSA reclassificationA trade association for the U.K.’s cannabis industry announces its intentions to sue the country’s Food Standards Agency (FSA) over moves to classify cannabidiol (CBD)-containing products as a "novel food."PARTNERSHIPS
Nestlé partners with Amazentis to explore pomegranate metabolite’s anti-aging potentialNestlé Health Science will take an equity stake in Swiss life science company Amazentis and receive global rights to use Amazentis’ Urolithin A technology for dietary supplements, foods, beverages and medical nutrition products.MLMs
Amway: Finally grows after four years of declining salesAmway has been the largest direct seller in the world from a revenue point of view since 2012 and while one company alone is never enough to show an industry trend, the leader’s performance has always been interesting to follow to get some significant clues. Though Amway’s sales are far from its peak, it has reversed its recent decline.M&A ACTIVITY
Nutrition Capital Network deal download: MarchFrom strategic investments to deals in ingredients and pet care, money flew around the natural products industry in March. Nutrition Capital Network reviews recent transactions in healthy snacks and functional foods, as well as the ingredient activity, including the Martin Bauer acquisition of BI Nutraceuticals.
PRODUCT TESTING
Growth of the HPTLC Association shows it is meeting a need, official saysUNPA MOU partner, the HPTLC Association, has formed a North American chapter and has finalized plans for a meeting in November for the volunteer group of interested chemists and other experts from the dietary supplements and herbal products industry.
LEGAL
Class actions take a nutrient content turnClass action lawsuits claiming supplement nutrient-content claims are on the rise, so brands must be vigilant in ensuring all claims meet requirements outlined in FDA’s Federal Food, Drug and Cosmetic Act.INDUSTRY SELF REGULATION
Comment period opens on SSCI standardsThe new Supplement Safety and Compliance Initiative standards, to help drive standardization and transparency in the industry, were formally unveiled at a meeting last week hosted by Walmart. The standard now goes into a 30-day comment period.GMOs
Promotion of the GMO Impossible Burger at  Expo West denounced as deceptiveNatural food industry representatives and consumer advocates denounced Impossible Foods, maker of the GMO-derived Impossible Burger, for promoting their product at Natural Products Expo West, saying they were engaging in deceptive marketing.BOTANICALS
Artemis believes Aronia berry is finally ready for prime timeAronia berry developer Artemis believes that accumulating science is helping to drive the uptake of the legacy North American botanical as an ingredient.
 Paper provides great overview of the challenge of choosing the right botanical test materialsA paper published by a group of medicinal biochemistry researchers provides a comprehensive look at the challenges of selecting well-characterized materials for testing, including a list of recommendations for best practices.PROBIOTICS
Too much misinformation has stemmed from misuse of the probiotics term: Gregor Reid, Ph.D.Sensationalized studies on probiotics, coupled with marketing misuse of the term are fanning the flames of global skepticism, and industry must do better to strictly comply to the scientific definition of the term “probiotics” to help advance this important category, according to Grego Reid, Ph.D., a renowned probiotic expert.
 Market sees growth of synbiotics combination digestive-health productsProducts that offer a combination of probiotics, prebiotics and/or digestive enzymes can appease consumers looking for products to improve gut health, but such products can pose challenges related to formulation, quality and efficacy.MARKETING
Expert vs. influencers: How to push facts without the fameThe key to healthy nutrition is to limit your fat and sugar intake, eat more fruit and vegetables, and choose whole grains and lean protein. It’s not a very captivating statement, but in trying to get people to eat better and stay healthier, nutritionists, dietitians and public health professionals have a tough challenge because sensible messaging is often drowned out.EMPLOYMENT OPPORTUNITIES

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

No posts this week.MARKET RESEARCH
Label Insights survey reveals loosely defined claims still have pull with consumersWhile terms such as “natural” and “clean label” may not have a regulated definition attached to them, these particular descriptors do motivate over half of U.S. shoppers to purchase a product, according to a new survey of 1,000 adults from Wakefield Research for Label Insight.
 Sales of health and wellness related products on the riseThe 2019 Whole Health Survey from Supermarket Newsshows trends and areas of growth in health and wellness categories, including local, organic and diet-specific areas, such as keto. Plant-based products ranked high in trends, including the vast majority of respondents believing those products should have federal regulations surrounding naming and labeling.RESEARCH
Fish oil and vitamin D supplements might offer some health benefitsA recent study has found that vitamin D and omega-3 fatty acid supplements may help prevent heart attacks, strokes, and cancer in people who have never had such problems before. Researchers gave participants 2,000 IU of vitamin D and 840 mg of omega-3s, which adds up to two servings of fish per week.


Probiotics can evolve to be harmful: Experts slam reporting of new mouse study, but note opportunityMultiple experts have questioned news reports claiming probiotics can evolve to do more harm than good—warning that news reports have vastly over-simplified and sensationalized the findings.
 Human study suggests holistic psychological benefit of multi-strain probioticA daily dose of a multi-strain probiotic can provide a significant improvement in mood, with a reduction in depression, anger and fatigue, and an improvement in sleep quality, according to a new study in Italy.
 Phage cocktail shows gut microbiota benefits: Deerland RCT dataSupplements containing a combination of bacteriophages may produce minimal but beneficial changes to the gut microbiota, suggesting a shift towards a “healthier gut environment,” according to a newly published paper in the journal Nutrients.
 Aloe vera does not present risk of increased exposure to hydroxyanthracene compoundsA lead toxicologist from Herbalife Nutrition discusses how her team conducted a study to measure the presence of hydroxyanthracene compounds in Aloe vera, which have raised safety concerns in food supplements used as laxatives in the EU market.
 PrimaVie shilajit may help reduce fatigue, retain strengthA study involving Natreon’s patented PrimaVie shilajit showed the benefits of supplementation in maintaining muscular strength and hydroxyproline levels in recreationally active men. The study was published in The Journal of the International Society of Sports Nutrition.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.