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Personalized nutrition takes giant steps forward, observer says Truly personalized nutrition and health care was a promise seven years ago. Now it’s a reality, according to industry consultant Marc Brush, who was an invited attendee to the recent Personalized Lifestyle Medicine Institute’s Thought Leader Consortium. Brush lauded the program and specifically noted the presentation by Albert-Lazlo Barabasi, Ph.D., professor at Northeastern University and Harvard School of Medicine, who cited the study of genes as related to disease, has moved well beyond the search for one gene marker. There is now enough information to take a systems approach to manage disease. Read more→ TOP STORY
Happy birthday DSHEA! Now is it time to change you? October marks the 25th anniversary of the Dietary Supplement Health and Education Act (DSHEA), the 1994 law that gave dietary supplements in the U.S. a regulatory category of their own. DSHEA opened the door to the $40 billion market that exists today. Nutritional Outlook asked a handful of supplement industry stakeholders about how DSHEA has aged—and what a DSHEA 2.0 should look like. They offer insights as to what, if any, changes to the law are needed and whether there should be revisions in the way FDA polices the market. Read more→ TOP STORY
UNPA SSW Members' Meeting set for Oct. 17 in Las Vegas, 8-10am PDT If you'll be at SupplySide West next week, plan to join the UNPA staff to hear the latest insights and news from the UNPA team, Thursday, Oct. 17, from 8-9 am, in the South Seas Ballroom J, with a one-hour member meet-and-greet to follow starting at 9 am. Click on the link below to RSVP. There is no charge to attend and morning beverages will be served. RSVP here→ Agenda:
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Survey: Consumers support mandatory dietary supplement registration The majority of consumers support a requirement that manufacturers of dietary supplements provide FDA a list of their products and ingredients, according to a survey from The Pew Charitable Trusts. The survey also found that 1 in 8 consumers said they or a family member had experienced an adverse event--a finding which has been criticized as a faulty statistic by industry group CRN, which noted that the possible universe of people expanded but was not reflected in the calculations. Read coverage: Survey: Consumers support mandatory dietary supplement registration→ CRN takes issue with how Pew reported adverse event finding in recent survey→ TOP STORY
U.S. retail sales of herbal supplements increase by 9.4 percent in 2018 U.S. consumers spent an estimated $8.84 billion on herbal dietary supplements in 2018, according to the American Botanical Council’s (ABC) 2018 Herb Market Report, which appears in issue 123 of ABC’s quarterly, peer-reviewed journal HerbalGram. This represents a 9.4 percent increase in total U.S. sales from the previous year—the strongest sales growth for herbal supplements in two decades. CBD, mushroom and immune health products drove the record sales for the year. ABC’s 2018 market report is based on U.S. retail sales data provided by SPINS and Nutrition Business Journal. Read more→ TOP STORY
FDA to transition to a new portal for NDI, structure/function submissions Companies submitting NDIs and structure/function claims will see a different interface starting in early September. The agency is calling the new systems CFSAN Online Submission Model. It will replace the current electronic submission system known as FDA Unified Registration Listing System. Read more→ TOP STORY
Issue of FSVP compliance is coming to a head as FDA issues first warning letter Facilities that are subject to FSMA inspection are struggling with the Foreign Supplier Verification provision of the law, according to new data. The issue is coming to a head with the first FDA warning letter for an FSVP failure. Read more→ TOP STORY
Synthetic ingredients' regulatory uncertainty still a problem for supplements, whether in Amarin’s omega-3 battle or in NDI guidance FDA’s stance on synthetic botanicals is as problematic and unresolved today as it was for the industry back in 2016 in the NDI draft guidance process. As recently as last week, the topic was top-of-mind, when industry associations submitted public comments to FDA in response to the agency’s invitation to the public to submit ideas about how it should improve the way it regulates dietary supplements. Read more→ TOP STORY
CBD is on fire, but market remains dogged by regulatory confusion and unclear terminology surrounding hemp The U.S. market for foods and beverages featuring hemp-derived CBD could be worth $2.5 billion by 2023, or 10.5 percent of an estimated $23.7 billion market for CBD products, according to a new report from Brightfield Group. The estimate is based on the assumption that FDA will create a legal pathway forward for CBD. Read more→ TOP STORY
Food and supplement industries battle sharply higher tariffs The dietary supplement and food industries face continued tariff challenges, including a recent increase to 25 percent for many dietary ingredients imported from China and new retaliatory tariffs from India on nuts and produce coming from the U.S. Industry leaders, including several trade associations, have fought the tariffs via Congress, submitting comments and participating in public hearings on the China tariffs, but exclusion from the tariffs is far from a guarantee. Read more→ |
