FDA releases guidance, draft guidance regarding labeling, single-serve packaging

TOP STORY
FDA releases guidance, draft guidance regarding labeling, single-serve packaging
​FDA has released a guidance document regarding Nutrition Facts and Supplement Facts labels and a draft guidance on serving sizes and other miscellaneous topics. The guidance document is in relation to the rules published on May 27, 2016, which, among other things, required the declaration of added sugars, updated the list of vitamins and minerals of public health significance, increased the prominence of the declaration of calories and updated some reference values for nutrients. Read more→

UNPA NEWS
UNPA PCQI training, Dec. 5-7, in Lehi, Utah
Seats are filing up fast! Registration is open for UNPA's new Preventive Controls for Human Food and Dietary Supplements: PCQI Training, Dec. 5-7, in Lehi, Utah. This training is certified by FSPCA in cooperation with FDA and is an integral and necessary requirement of FSMA.

UNPA member discount for AHPA Botanical Congress at SSW
Saturday! UNPA has collaborated with the American Herbal Products Association (AHPA) to extend AHPA member pricing to UNPA members for the 7th Annual AHPA Botanical Congress, to be held on Saturday, Nov. 10, at the SupplySide West trade show in Las Vegas. UNPA members register using the code "BotConUNPA" during checkout at the AHPA website.

REGULATORY
FDA’s Tave addresses three pillars of agency’s supplement approach
Steven Tave, director of the FDA’s Office of Dietary Supplement Programs, discusses the agency's three-pronged approach to dietary supplements, which includes consumer safety; product integrity; and improved decision making, which includes agency efforts to make sure companies are not making unfounded disease claims.

Stakeholders urge FDA to stick to CFUs, dump weight requirements on probiotic labels
FDA’s draft guidance on the labeling of products containing live microorganisms is a step in the right direction, but does not go far enough, stakeholders say.

FDA’s new nutrition label regulation for fat-soluble vitamins
In 2020, FDA expects fat-soluble vitamins to be measured in metric units rather than international units. While IU seemed to be an innovative idea during the time it was introduced, many would agree that this IU system is now outdated.

FDA still finding same cGMP deficiencies in dietary supplement facilities
FDA investigators, who inspect dietary supplement manufacturing facilities for compliance with cGMPs, are still often finding the same deficiencies more than a decade after the regulations were adopted.

FINANCIALS
Sprouts Farmer’s Market reports increases across the board
New stores, product innovation and increased sales at existing stores pushed Sprouts Farmers Market’s net sales up 10 percent from 2017, the company reported. Net income increased 19 percent, while comparable store sales grew 1.5 percent from 2017. Two-year growth in comparable stores came in with 6.1 percent growth.

Herbalife increasingly eyes Asia as growth engine of the future
Herbalife sales rose 15 percent in the 3Q. Record sales in China and the rest of Asia helped drive the result. The company also bucked trends in the MLM sector by posting sales increases in North America as well.

GLOBAL REGULATORY
Italy serves notice of plans to set maximum THC levels in supplements
Italy’s Ministry of Health has notified the European Commission of its intention to set maximum levels of THC (tetrahydrocannabinol) in food supplements.

EFSA provides nutrient advice for muscle and performance health claims
The European Food and Safety Authority has made available guidance in preparing applications in support of nutrition-related health claims pertaining to muscle function and physical performance.

Regulatory roundup: Cranberry extract, bovine protein and shrimp peptide make the cut
The European Commission made a few additions to the Novel Food register as a cranberry extract, bovine whey protein, and shrimp peptide all make the cut.

Gwyneth Paltrow’s Goop under scrutiny over pregnancy supplement claims
A pregnancy supplement regimen offered by Gwyneth Paltrow’s lifestyle brand Goop is the subject of alleged multiple breaches of U.K. advertising and trading standards.

TAINTED PRODUCTS
Industry associations warn consumers about drug posing as dietary supplement
The dietary supplement industry sounded the alarm this week about the dangers of “phenibut,” a substance being illegally marketed in products fraudulently labeled as dietary supplements. Phenibut is not approved as a drug in the United States, nor does it meet the regulatory requirements to be sold in, or as, a dietary supplement.

PRODUCT TESTING METHODS
HPTLC group adds to list of approved methods, plans North American chapter
UNPA MOU partner, the HPTLC Association, an international organization supporting methods development for natural product ingredient identification, is preparing to add 13 more approved methods to its growing list.

ORGANICS
The Organic Trade Association wants to hear the stakeholder ideas to help 'GRO' the industry
Months after USDA unexpectedly and unceremoniously  pulled the plug on plans to implement a federally mandated, organic check-off program, the Organic Trade Association is soliciting ideas to help the industry "GRO" through a voluntary, industry-vested research, promotion and education “check-off like” program.
LEGAL
Groundskeeper accepts final award in Roundup case against Bayer (Monsanto)
​Dewayne Johnson accepted the final $78 million award, reduced from the jury’s initial $289 million award, according to NPR. He alleged that the herbicide caused his non-Hodgkin Lymphoma and that Monsanto failed to warn him of the risks.
HEMP/CBD
Top FDA official: 'Anyone who thinks CBD is lawful is mistaken'“Just because we haven’t taken enforcement action, people seem to think it [CBD] is OK,” said Steven Tave, director of the FDA’s Office of Dietary Supplement Programs, at a recent industry conference. “Anyone who thinks it is lawful is mistaken.”
 FDA gets pressed flat to deschedule hemp-controlled substances actThe World Health Organization earlier this year began to push for CBD to be an ingredient free from any government control. The U.S. FDA is preparing a response to that, because an international ruling that CBD is not a controlled substance would merit its removal from scheduling in the U.S., as well. And that would also remove the rationale put forward by the Drug Enforcement Agency to keep CBD in unsteady regulatory waters. 
 What is CBD being marketed for? Proponents seem deliberately vague on claimsIn this commentary from Nutraingredients-USA’s Hank Schultz, he notes that in the rush to market for CBD products, something seems to have been left by the wayside. What do marketers believe these products will do for people?CANNABIS
Molson Coors: cannabis beverages could be a $3 billion market in CanadaMolson Coors says it is well placed to take a meaningful share of the cannabis market in Canada, when it opens up in the fall of 2019, eyeing the size of a substantial prize.M&A ACTIVITY
PepsiCo and Coca Cola battle it out in functional food and beverage arenaLegacy CPG companies PepsiCo and Coca Cola have each snapped up or invested heavily in a functional food and beverage brands this year.
 Kraft Heinz VC fund takes shape with acquisition of AI firm wellioA month after committing $100 million to launch its venture capital fund, Kraft Heinz has acquired wellio, an AI food-tech company based in San Francisco, as part of its new digital innovation hub, the evolv group.
SPORTS NUTRITION
IP trends in sports nutritionPatent filings directed to sports nutrition continue to generally grow year over year, with a pronounced increase in countries outside the United States.
 Modern men too savvy for brand marketing tactics, research revealsSports nutrition brands must stop trying to sell identities and focus on product functionality as social media is bombarding shoppers with "expert advice" and making them resistant to influence.UNPA MEMBER NEWS
NOW honored for manufacturing excellence at EDAWN awardsThe Economic Development Authority of Western Nevada (EDAWN) named winners of the organization’s 7th-annual Existing Industry Awards, recognizing companies that help form the backbone of Northern Nevada’s regional economy. NOW was honored in the large company category for manufacturing excellence.
MOU PARTNER NEWS
ABC partners with Sustainable Herb Program to promote business, consumer conciousnessThe nonprofit American Botanical Council (ABC) has partnered with the Sustainable Herbs Program (SHP) as part of ABC’s ongoing commitment to medicinal plant conservation and sustainability education. The SHP website is being developed as a new educational resource for the international herb and medicinal plant communities. UNPA is an inaugural underwriter supporting the new program.INNOVATION
New calcium carbonate ingredient enhances porosity, hardness of tabletsA new, porous carrier made from calcium carbonate lends supplement tablets greater porosity and hardness, according to supplier Omya International AG. The ingredient, Omyanutra, also provides a high loading capacity for active nutrients.MARKETING
How google is stealing your ad budget without your knowledgeOwn a small- or medium-sized business and use Google Ads? Google has turned its AI loose on unsuspecting Google Ad customers as a defensive move in an increasingly Amazon-dominated world.
 Just how many brands have become better corporate citizens?Brands have always recognized that they need to become better corporate citizens but has this become a widespread practice? This article cites several great examples of authentic behavior.MARKET RESEARCH
Key researcher explained why some college students may cease supplement useNew Hope’s Rick Polito spoke with the assistant professor who conducted a survey at New York University that found students in Health and Wellness Studies programs more prone to use supplements responsibly, but also more likely to stop taking them altogether.
 Who buys most vegan and vegetarian products? Not vegans and vegetariansThe large percentage of consumers that don’t identify exclusively as vegan or vegetarian but who are purchasing plant-based alternatives is an important reason why plant-based food innovation continues.EMPLOYMENT OPPORTUNITIES

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

Clinical Brand Manager (ND, DC, Nutritionist), posted by OrthoMolecular ProductsRESEARCH
Resveratrol and propolis: Two promising targets to boost gut microbiotaRecent studies have revealed how polyphenols can alter gut microbes, suggesting they are worthy of further examination alongside probiotics to boost health outcomes.
 Leucine-enriched amino acid supplement may increase muscle-mass strength in older adultsResearchers in Japan found evidence that a leucine-enriched, amino acid supplement may increase muscle mass, strength and physical function in a clinical trial involving older Japanese adults.
 Mood support is one way plant-based diets help type 2 diabetes sufferersMood support is one of the mechanisms by which a plant-based diet can help sufferers of type 2 diabetes, according to a new meta-analysis from the University of London.
 Krill oil benefits point to omega-3 oils as effective in CVD riskKrill-derived omega-3 fatty acids appear to reduce fasting levels of blood glucose, a Rimfrost-funded study finds, as researchers point to its supplementation as an effective approach in reducing cardiovascular disease risk.
 AMA: Just one energy drink hurts blood vessel functionYoung, healthy adults experienced notably diminished blood vessel function soon after consuming one energy drink, according to preliminary research from a small study to be presented in Chicago at the American Heart Association's Scientific Sessions 2018, a global exchange of advances in cardiovascular science for researchers and clinicians.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.