FDA announces plan to modernize supplement regulation

TOP STORY
FDA announces plan to modernize supplement regulation 
​As a follow up to UNPA's Feb. 11 Member Memo, we share industry media coverage of FDA's lengthy statement revealing plans to strengthen the agency’s regulation of dietary supplements, where FDA Commissioner Scott Gottlieb, M.D., expressed concern that changes in the supplement market may have outpaced the evolution of the agency's own policies and its capacity to manage emerging risks. At the same time, FDA took action against 17 companies making illegal Alzheimer's treatment claims, and response to the announcement was mixed. The commissioner’s remarks also open the door to the industry to engage, and it should prove it is ready to do so, says NBJ Editor Rick Polito. Read coverage:
FDA commissioner announces plan to modernize regulation of dietary supplements→
FDA enforcement action on Alzheimer's claims ensnares 17 companies→
FDA's willingness to explore reform of DSHEA draws mixed reactions→
Supplement industry should say yes to FDA commissioner’s invitation→

UNPA NEWS
FSVP training: Next week! LIMTED SEATING STILL AVAILABLE! This course, Feb. 19-20, in Lehi, Utah, is designed to help participants understand the role of food importers under the Foreign Supplier Verification Programs (FSVP) rule, part of the Food Safety Modernization Act (FSMA). The training covers the FSVP requirements for dietary supplements, including for raw materials distributors, manufacturers and processors importing components and for those importing finished products from foreign suppliers.

Registration now open for the 2019 UNPA Members' Retreat! NEW! Register today and reserve your hotel room for UNPA's annual Members' Retreat, April 30 - May 2, in Charleston, S.C. The above link will provide more information and access to the registration form. See you in Charleston in late April!

RSVP for Expo West Members' Meeting and Open House, March 6 RSVP for UNPA's annual Expo West Members' Meeting and Open House and Meet & Greet, Wednesday, March 6, from 8-10am, at the Anaheim Hilton & Towers Avalon Ballroom. No charge to attend and morning refreshments will be served!

UNPA announces winner of 2019 regulatory concerns survey; seeks additional member input Virginia Hill, M.S., RAC, director of regulatory affairs for UNPA member Pharmavite, is the winner of the $50 gift card drawing for participation in the UNPA 2019 regulatory concerns survey. Congrats, Virginia! We'd still like to get your feedback on a number of regulatory topics. Please see the attached survey, designed to capture your top 2019 regulatory concerns. What can UNPA do to best serve you and to address those concerns? This poll should take you less than 15 minutes. Your feedback is essential to help us plan our training and education schedule for 2019.

FINANCIALS
USANA posts sales increase as China’s direct-selling clampdown looms USANA reported $1.19 billion in annual revenue in its 4Q earnings statement. The company now derives more than 80 percent of its revenue from the Asia-Pacific region.

Natural Grocers reports strong sales profit growth for first quarter Co-president Kemper Isely points out that the Colorado-based natural products retailer has increased sales growth for seven consecutive quarters. The company reported same-store sales increased 5.5 percent and net sales rose 9.4 percent from Q118 to $221.5 million.
 
Hain Celestial reports decreases in sales, gross margin and income Hain Celestial Group saw sales drop 5 percent to $584.2 million in 2Q19. The company’s new CEO Mark Schiller says it has too many SKUs and is losing distribution, but he remains optimistic.

GLOBAL REGULATORY
France provides updates to vitamin A use in food supplements France’s Directorate-General for Competition, Consumer Affairs and Fraud Control has published a new update for maximum levels of vitamin A (retinol) in food supplements.

CBD frustration: Aussie supplement firms thwarted by rules, while pharma advances march on Pharmaceutical firms are making strides in Australia's medical cannabis space, but supplement and nutraceutical firms will have to wait a long time before they can do the same, says Complementary Medicines Australia CEO Carl Gibson.

'Misbranded nutraceuticals': Indian trade body chief calls for partnership, not punishment, from regulators A trade association director is calling for better multi-sectoral cooperation in India- to minimize the need for authorities to clamp down on nutraceutical and supplement companies in India for labeling violations.

Norway’s food authorities warn of caffeine-containing energy drinks' effect on kids Children and adolescents who excessively consume caffeine-containing energy drinks over a short period of time can experience sleep problems, anxiety and heart palpitations, according to the Norwegian Food Safety Authority.

Italy’s ad regulator bans question posed on cranberry supplement’s anti-infective claim Italy’s advertising watchdog has ruled an ad that posed the question, “Infections of the urinary tract?” as misleading to consumers regarding the product’s ability to prevent cystitis.

CHINA REGULATORY
China direct selling: All 91 firms summoned to regulatory meeting amid 100-day clampdown China’s State Administration for Market Regulation and Ministry of Commerce summoned all 91 direct selling firms operating in China to meet as part of the “100-day operation” to clean up the health food market.

UNPA MEMBER PERSPECTIVE
You can build your own car top shower, but should you? In this commentary, Alkemist Labs’ CEO Elan Sudberg strongly suggests substandard testing practices are the biggest threat to the industry, fostering poor quality and efficacy, sabotaging repeat purchases,and handing ammunition to industry critics. He notes proficient testing requires years of experience, but he also offers things to consider before developing an in-house identity testing program for raw materials and finished products.

M&A ACTIVITY
A major step for personalized nutrition: Viome to acquire Habit from Campbell Soup Microbiome-based personalized food startup Viome has entered into an agreement to buy fellow personalized nutrition company Habit from Campbell Soup Co.

ORGANICS
Organic industry is not giving hydroponic growers a warm embrace Hydroponic, aquaponic and aeroponic growers are able to earn an organic certification, but the Center for Food Safety wants a “flat prohibition on hydroponic production operations ever being allowed to use the USDA organic label.” This is largely because organic farming improves the soil and biodiversity of a given piece of land, and by not meeting this standard, these companies violate organic practices.

Can eating organic lower your exposure to pesticides? A new California-based study followed 16 people who transitioned to a 100-percent organic diet and found that their exposure to four classes of pesticides was reduced an average of 60 percent over just six days. Following the study’s release, Friends of the Earth announced it would be launching a campaign called Organic for All, which aims to make organic options more widely affordable.

UNPA COMPANY NEWS
Informa sells UBM Life Sciences media brands to MJH Associated for $100 million A year after joining British events and publishing company Informa plc, UBM Life Sciences will change hands. Informa has agreed to sell several media brands from within its Life Sciences Group to New Jersey-based healthcare publisher MJH Associates for “just over $100 million.”

Sabinsa Shagandha ashwagandha root extract 2.5 percent meets USP monograph as verified by Alkemist Labs Sabinsa has raised the quality bar for the popular adaptogen ashwagandha with Shagandha Ashwagandha Root Extract 2.5 percent USP from Withania somnifera, which is assured to comply with the U.S. Pharmacopoeia-National Formulary (USP-NF) monograph. The company chose botanical specialist Alkemist Labs to test the ingredient to confirm that it meets the USP monograph.

PARTNERSHIPS
Lonza, Quadra expand Canadian distribution agreement Lonza Consumer Health & Nutrition and Quadra Chemicals have expanded their distribution agreement. Quadra will now distribute Lonza’s entire consumer health and nutrition ingredient range in Canada.

MEDIA WATCH
The 'strange science' behind the big business of exercise recovery From sports drinks to protein powders—there is a whole industry of products and services designed to help us adapt to and recover from exercise. Science writer Christie Aschwanden, author of Good to Go: What the Athlete in All of Us Can Learn from the Strange Science of Recovery, discusses whether any of it works.

HEMP/CBD
Charlotte’s Web, Elixinol offerings reflect growing success of CBD market Charlotte’s Web Holdings Inc. became a public company in 2018, highlighting a milestone event in the rapidly growing cannabidiol/hemp extracts market in North America; Elixinol Global Limited also announced raising A$40 million (US$28.7 million) in a secondary offering. The funds raised by both companies reflect the growing demand for CBD.

OMEGA-3s
New DHA test could help more mothers carry babies to full term Omega-3 testing firm OmegaQuant has launched a new test aimed at lessening the risk of pre-term births by providing expectant mothers with information on their DHA levels.

RETAIL
This startup is Trader Joe's meets Costco, with a splash of Brandless Direct-to-consumer startup Public Goods combines the most popular aspects of retailers, such as Costco, Whole Foods, Brandless and Everlane to create a high-quality, low-cost online retail platform that offers consumers a year-long membership for $59.

CONTRACT MANUFACTURING
How are contract manufacturers dealing with increased scrutiny in the supplements industry As demand grows for higher levels of traceability, transparency and quality control, dietary supplement and food/beverage manufacturers are feeling the heat—as are the contract manufacturers they work with. In this roundtable, contract manufacturers speak out about the challenges and opportunities they face in this new era.

PERSONALIZED MEDICINE
Personalized nutrition: Translating research to solutions Epigenetics, advances in metabolomics and sequencing of the microbiome are among the scientific discoveries identified as most pertinent to the evolution of personalized nutrition.

REGENERATIVE AGRICULTURE
Certifying regenerative agriculture with the ROC label Although used for many years, regenerative agriculture emerged as a trend only five years ago when the Rodale Institute began to strongly advocate the concept and created a Regenerative Organic Certified (ROC) label for food products. The label is intended to go further rewarding farms and the food businesses to which they sell, not only for soil health and land management, but also for animal welfare and farmer and worker fairness.

TRANSPARENCY
How to maintain trust in nutrition science Patrick Stover, Ph.D., vice chancellor for agriculture and life sciences at Texas A&M University, was part of a panel that released its recommendations on maintaining trust in nutrition science. The panel was part of the American Society for Nutrition, which published the report, “Best Practices in Nutrition Science to Earn and Keep the Public’s Trust.”

'Clean label' brands leave themselves open to plaintiff’s attorney tactics Clean label is a hit with consumers, who are looking for short ingredient lists, but lawsuits are putting pressure on brands to be clearer about what’s in their products.

INGREDIENT TRENDS
2019 ingredient trends to watch in foods, drinks, and supplements: Lutein Lutein, an essential nutrient for healthy vision at every age, is outperforming growth of any other eye-health ingredients in U.S. conventional multioutlet sales channels over the 52 weeks ending November 4, 2018, according to data from SPINS. This week Nutritional Outlook also looks into collagen and turmeric as ingredients to watch.

MOU PARTNER  NEWS
ABC publishes updated monograph on scientific and clinical research for pycnogenol The American Botanical Council has published an updated, ingredient-specific monograph that summarizes selected scientific and clinical studies of Pycnogenol, a patented dietary ingredient derived from French maritime pine bark. The revised monograph, updating a 2010 publication, describes a total of 63 human clinical trials on Pycnogenol—46 more than were included in the original monograph.

APAC MARKET
How Singapore became SEA's leading food and nutrition hub in 20 short years Singapore is rightly proud of its status as South East Asia's (SEA) leading food and nutrition hub, but the city-state is refusing to rest on its laurels and is now striving to develop a thriving startup scene and tackle challenges around food safety, security and advances in manufacturing.

MARKETING
Dietitian’s view: Should celeb Instagram ads be banned? Celebrity endorsements on social media could be exacerbating a nationwide rise in diet deficiencies, according to a British Dietetics Association spokesperson, in response to a doctor’s call to ban all celeb social media ads for diet products.

MARKET RESEARCH
Five superstars for liver health The liver health category brought in around $31 million to dietary supplement sales across multiple sales channels, according to data from market research firm SPINS. This article looks at ingredients leading the category and the research that supports them.
 BCAA’s winning the consumer engagement game online In the U.S., branch chain amino acid products are grabbing engagement with consumers, demonstrating the most average reviews per product, according to data from Lumina Intelligence.

RESEARCH
Inexpensive supplement for women increases infant birth size A daily nutritional supplement before conception or in early pregnancy may provide enough of a boost to improve growth of the fetus, according to a National Institutes of Health-funded study. The supplement consists of dried skimmed milk, soybean and peanut extract blended into a peanut butter-like consistency and fortified with essential vitamins, minerals and protein and fatty acids often lacking in the women’s diets.

Probiotic approach to tackle depression suggested as study finds gut-brain link Further evidence of the link between gut bacteria and mental health was outlined this week as Belgium researchers identified gut bacteria linked to depression and an ability to produce neuroprotective compounds.

Compound from Vietnamese herb shows promise in fight against sarcopenia A compound isolated from Gynostemma longipes, a plant from a group of climbing vines in the gourd and melon family, has been shown to stimulate muscle growth in a mouse-cell model.

Magnesium linked to lower weight, waist size and blood sugar: Mexican study Higher intakes of magnesium are associated with lower Body Mass Index, smaller waistlines and lower blood sugar levels in Mexicans, according to researchers at Mexico’s Institute of Public Health.

Paper in prestigious journal underpins vitamin K2’s role in cardiovascular health A recent paper funded by a Norwegian research grant reinforces a developing story that vitamin K2 is important for cardiovascular health as well as bone health.

​Mango leaf extract linked to sprint muscle performance Supplementation with the polyphenol mangiferin combined with luteolin could enhance sporting performance, with improvements seen in muscle performance during a series of sprint exercises, according to Spanish researchers.

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. 

Search and sign up for a variety of FDA Guidances.