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LEGISLATIVE FDA nominee Scott Gottlieb affirms DSHEA in confirmation hearing Nutraingredients-usa.com A staunch affirmation of DSHEA by Scott Gottlieb, M.D., the nominee for FDA commissioner, is a highly promising sign for the immediate prospects of industry cooperation with the agency. Gottlieb’s answer to a question about DSHEA from Sen. Orrin Hatch, R-Utah, is seen as a refreshing change. Acknowledging that he uses supplements daily, Gottlieb said they serve an important role for millions of Americans and he supports consumer access to these products.Read more→ LEGAL
Hi-Tech motions court for reconsideration in DMAA ruling; judge dismisses Bayer class-action suitNaturalProductsINSIDER, Nutraingredients-usa.com Hi-Tech Pharmaceuticals has requested reconsideration of a court ruling that its products containing DMAA are adulterated. The ruling noted that Congress in DSHEA intended that a botanical must have some history of being extracted in usable quantities from a plant. Bayer has had what some observers are calling a quick win in the dismissal of a class-action lawsuit in New Jersey over claims for its Phillips Colon Health probiotics supplement. The plaintiffs claim that the product did not alleviate their symptoms and questioned the substantiation of claims. Read coverage: Hi-Tech asks judge to vacate DMAA ruling in FDA fight→ Judge dismisses suit that questioned substantiation for Bayer’s probiotics claims→UNPA NEWS Register today for UNPA's new DS GMP training course,June 27-28, in Provo, UtahRegistration is now open for UNPA's new, two-day course designed to ensure that your facility handily passes your next FDA GMP inspection or customer or certifier audit. Taught by UNPA's Larisa Pavlick, who has been in more than 200 facilities in her former role as an FDA Inspector with the Denver District Office, this course will cover all aspects of the inspection, with a focus on the key elements of quality: identity, purity, strength and composition. Read more→ Room block closesMay 1for the 2017 UNPA Members' Retreat With the adobe-clad LaFonda on the Plaza as the venue for the 2017 UNPA Members' Retreat, UNPA will welcome more than 100 members to historic Santa Fe, N.M., onMay 22-24. The program offers unparalleled networking and a diverse educational program sure to stimulate all attendees. Room rates are guaranteed untilMay 1, so plan your trip today! Read more→ Register for these upcoming industry events NEW!Natural Health Product Research Society of Canada Annual Conference, May 8-11, Vancouver, B.C. UNPA President Loren Israelsen is speaking. CHPA Dietary Supplement Seminar, May 10, N. Bethesda, Md. UNPA is a host of this event, produced by CHPA; Loren Israelsen is speaking. USP Dietary Supplement Stakeholder Forum, June 7, Rockville, Md. Recently posted atunpa.com: NEW! Washington Update: FDA User fees; Health Savings Accounts, by Peter Reinecke and Patricia Knight, UNPA Senior Political Advisors(requires member log in) "An Industry Perspective on Botanical Quality & Compliance," presentation at ICSB 2017 by Larisa Pavlick(log in) 2017 Expo West Members’ Meeting PPT (log in) “New Dietary Ingredients: Enforcement” presentation at 2017 Expo West by Larisa Pavlick (log in) FDA Inspections, Part II by Larisa Pavlick, UNPA VP, Global Regulatory & Compliance (log in) FDA Inspections 101 by Larisa Pavlick, UNPA VP, Global Regulatory & Compliance(log in) The PPT presentations from NDI III: Roadmap to a Viable NDI Policy, UNPA member price: $295 Plus, updated industry events calendar,Member Memos(log in) and UNPA educational archives (log in).REGULATORY FDA culls 28 percent of registered food facilitiesNutraingredients-usa.com In its latest cleanup of its food facility registration database, FDA has culled an eye-opening 28 percent of existing registrations. While some of this is a natural erosion, the biggest drops were measured among overseas facilities and may be the result of new U.S. regulations requiring that a U.S.-based agent working for a foreign firm must affirmatively respond to FDA. Read more→M&A ACTIVITY Albertson’s considers bid for Whole Foods; Ashland buys Pharmachem in $660 million dealBloomberg.com, Nutraceuticals World TheFinancial Timesis reporting that Cerberus Capital Management, which backs the grocery chain Albertsons, has talked with bankers about making a preliminary bidfor the natural retailer. Speculation has surged since investor Jana Partners suggested earlier this month that Whole Foods consider putting itself up for sale. Ashland Global Holdings has signed a definitive agreement to acquire privately held Pharmachem Laboratories, a provider of ingredients for the global health and wellness industries and products for flavor and fragrance houses. Read coverage: Whole Foods rallies on report that Albertsons is exploring a bid→ Ashland to acquire Pharmachem Laboratories for $660 million→REGULATORY GMP compliance takes significant time, resources, but good record keeping is key to the processNutraingredients-usa.com FDA may be underestimating the time and resources that the supplement industry spends annually on compliance with government regulations, including Good Manufacturing Practices. Spending estimates are close to $1 billion. UNPA’s Larisa Pavlick, a former FDA investigator, noted that she agrees that the time estimate for Table 1 in the Federal Registry document may be underestimated, but added that rigorous record keeping is essential to the process, and there is a clear need for training to develop and establish strong procedures. Read more→ORGANIC NOSB puts off official vote on hydroponics; Number of certified organic farms increase 13 percentThe Packer, Feedstuffs The NOSB's meeting in Denver last week came and went without an official vote on whether produce grown on hydro- and aquaponic systems can be considered organic. Sources say there probably won't be a vote at all this year.Meanwhile, last year, the number of certified organic operations in the U.S. totaled 24,650—an increase of 13 percentsince 2015. That's the highest growth rate since 2008, according to new data from the Agricultural Marketing Service of the U.S. Department of Agriculture. Read coverage: No vote on hydroponics from USDA organic board→ Number of certified organic farms up 13 percent→RETAIL CVS establishes new product testing standards in plan to embrace healthier product setNutraingredient-usa.com, Forbes As part of its corporate makeover, CVS Pharmacy says that it intends to institute new standards for the dietary supplements it sells that will include specific testing requirements. The plan to write standards was announced as part of overall initiatives to embrace a new healthier set of products, food and beauty selections. Read coverage: CVS to institute new testing requirements for dietary supplements→ Can CVS become the Whole Foods of drugstore retailing?→GLOBAL REGULATORY EFSA asks for comments on DRVs for riboflavin; Belgium proposes changes to laws for maximum nutrient levelsNutraingredients.com EFSA has launched a public consultation on its draft scientific opinion on riboflavin (vitamin B2), proposing that the average dietary reference value in adults, infants, children and pregnant and lactating women should be 1.3 mg per day. Several legislative changes are expected in Belgium's General Food Law Act, which may alter existing rules on the maximumlevels for various nutrients, while for some nutrients the maximum levels could be removed entirely. EFSA consults on riboflavin draft opinion→ Belgium proposes legal changes on self-checking and food supplements→OBITUARY ABC mourns passing of botanical research pioneer Fredi KronenbergHerbalGram The industry is mourning the loss of another icon with news of the passing of Fredi Kronenberg, Ph.D., last week, following a lengthy illness. Kronenberg was a pioneer in the area of botanical research in women’s health. Among her many accomplishments, she co-founded and served as the first and only director of the Richard and Hinda Rosenthal Center for Complementary & Alternative Medicine at Columbia University’s College of Physicians and Surgeons in New York City, the first broad-based complementary and alternative medicine program at a major medical center in the United States. Read more→ONLINE RETAIL Study: Online retail sales eclipse bricks-and-mortar buyingMediaPost According to a new study from DigitalCommerce360 in Internet Retailer Top 1000, online retail sales to consumers in the U.S. reached nearly $400 billion in 2016 as measured by the U.S. Commerce Department--a 15.6 percent jump compared with 2015. That’s the biggest increasein three yearsand far outpaces growth in retail sales in physical stores, which reached only 2.6 percent last year. Read more→HEMP/CBD Study estimates hemp product sales at $688 million for 2016Nutraceuticals World The estimated total retail value of hemp products sold in the U.S. in 2016 was $688 million, according to data from the Hemp Industry Association and Vote Hemp. Items such as shelled seed, protein powder, soaps and lotions have continued to increase, complemented by successful hemp-cultivation pilot programs in numerous states. In all, sales of hemp CBD products boosted the industry to a five-year, 22 percent CAGR. Read more→UNPA MEMBER NEWS Whole FoodsMagazinetakes nominations for Retailer of the YearWhole Foods Magazine Is there a retailerthat you feel goes above and beyond in the natural and organic industry? If so,Whole Foods Magazineis now offering the opportunity to anonymously nominate deserving retailers for its 2017 Retailer of the Year award. The winner willbe published in the July issue Whole Foods. Read more→MEDIA NBJ announces annual award winnersNew Hope Network Beneficial bacteria is responsible for two winners inNBJ’sannual awards with the winner of theNBJLarge Company Growth award going to GT’s Kombucha, and the award for Medium Company Growth going to Ganeden. Additionally, two retailers scored the award for education fromNBJthis year. HyVee and Natural Grocers both seek to educate their customers but have different perspectives and strategies for doing so. Read coverage: Ganeden capitalizes on probiotics boom with R&D, IP and integrity→ Two companies seize single venue for consumer health education: The grocery aisle→MARKETING Survey: It’s getting harder for brands to be perceived as 'green'MediaPost With an especially politicized Earth Day this year, new research from Brand Keys reports it’s getting much harder for brands to deliver a “green” message. That’s because, in the last year, people’s emotional expectations of brands’ sustainability efforts are up 33 percent. In the past year, 40 brands scored high enough to be green, but this year only 25 made the cut. Read more→RESEARCH Curcumin for colitis; beetroot slows brain’s aging; grape seed extract protects gut; ashwagandha root enhances cognition; polyphenols support wellnessNutraingredients.com, Nutraingredients-usa.com, Nutritional Outlook A formula that blendscurcumin and turmeric oils may be effective against the activity and inflammatory burden of colitis, suggests a new study published inNature Scientific Reports. Beetroot juice supplementation could improve cognitive function in older people, according to researchers at Wake Forest University, whose research suggests that a combination of beet root and exercise could enhance the brain’s ability to form new neural connections. Proanthocyanidin-rich grape seed extracts may protect the intestines from the deleterious effects of a high-fat/high-carbohydrate diet, according to data from a rat study at the Universitat Rovira i Virgili in Tarragona, Spain. Researchers in India have found that compared to a placebo, adults supplemented with ashwagandha rootextract had improved memory test scores. France-based health and wellness ingredient developer Fytexia has announced the publication of a clinical, double-blind, randomized, placebo-controlled study demonstrating that its polyphenol supplementingredient HolisFit improved the measure of mental and physical wellbeing in overweight and slightly obese volunteers. Read coverage: Cucurmin concoction could combat colitis: Study→ Beetroot’s antiaging effects on brain noted in post exercise study→ Grape seed extract may protect gut from inflammation: Study→ Ashwagandha root extract may improve memory and cognitive functions→ Polyphenol-rich Holisfit may enhance mind-body wellbeing→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. Read more→ Comments are closed.
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