FDA to transition to a new portal for NDI, structure/function submissions

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→

UNPA NEWS
UNPA announces December GMP training in Provo, Utah
Former FDA Investigator and UNPA's VP, global regulatory & compliance, Larisa Pavlick will lead the training, which will provide everything you need to know to make sure your facilities are fully compliant with 21 CFR Part 111 before your next inspection. The training is scheduled for Dec.4-5 in Provo, Utah. 

Expert Insights webinar to address vulnerability assessments and actionable steps for FSMA compliance
Ned Mitenius, founder/principal, Periscope Consulting LLC, and Larisa Pavlick, VP, global regulatory & compliance, UNPA, will discuss the Vulnerability Assessments requirement of the Food Safety Modernization Act (FSMA) Intentional Adulteration Rule. Vulnerability Assessments are required to provide for the identification of Actionable Process Steps. The webinar will take place on Oct. 3, from 11:00 am to 12:30 pm.

UNPA to host annual members' meeting at SupplySide West, Oct. 17
Hear the latest insights and news from the UNPA team at the annual SupplySide West Members' Meeting, Oct. 17, from 8-9am with a one-hour member meet-and-greet to follow starting at 9am. Click on the title above to RSVP. There is no charge to attend. See you there!

Access UNPA's analysis of CBD comments to FDA
The Aug. 22 UNPA webinar, a review and analysis of the comments submitted to FDA on cannabis and CBD by UNPA President Loren Israelsen, is now available for OnDemand viewing at the link embedded in the above title.

UNPA team leads podcast discussions on hemp and CBD
UNPA's Loren Israelsen recently discussed the status of hemp and CBD in conversation with TraceGains' CEO Gary Nowacki. Listen to the podcast, "CBD: Fad or Trend?" here. In another podcast, UNPA's Frank Lampe discussed the state of hemp/CBD regulation in conversation with Pete Thornton of Chatanooga, Tenn.-based Landrace Biosciences, A GMP-certified, bulk CBD product manufacturer. The interview series, geared for the hemp industry, is called, "Call Me Cannabinoids." Listen to it here.

REGULATORY
Court decision lends support to synthetic botanicals in supplements Industry legal experts offer perspective on the recent decision in the U.S. Court of Appeals for the Eleventh Circuit, which offered an analysis on synthetic botanicals and dealt what could be the final blow to DMAA (1,3-dimethylamylamine), a controversial ingredient that FDA has described as an “amphetamine derivative that has been marketed in sports nutrition and weight-loss products.”

AHPA analyzes FDA recall data Out of 803 recorded recalls initiated in 2019, 14 of them, or 1.7 percent, involved dietary supplements, and only three were Class I recalls, the most serious recall class.

ADVERSE EVENTS
Vitamin E suspected in serious lung problems among people who vaped cannabis It's still a mystery—what's causing the cluster of severe respiratory illnesses among people who've used e-cigarettes, but health officials say that state lab tests detected high levels of synthetic vitamin E in cartridges of cannabis vaping products used by people who vaped and suffered serious lung damage.

M&A ACTIVITY
Vitamin Shoppe gets competing bid A new player has entered into Vitamin Shoppe negotiations, although the retailer would not identify the new bidder.

SUPPLY CHAIN
Flooding raises turmeric supply concerns in India Flooding in parts of India is expected to impact the country’s turmeric supply, with some estimating that yield will be 20 percent lower, leading to possible pricing increases.

ORGANICS
Veteran policy experts form organic industry watchdog agency Beyond Pesticides, a Washington, D.C.-based public interest organization founded in 1981, has announced the formation of its new investigative arm, OrganicEye, which will focus on defending the time-honored philosophy and legal definition of organic farming and food production.

HEMP/CBD
Licensed hemp acreage has quadrupled since 2018 Vote Hemp has released its 2019 U.S. Hemp Grower License Report, showing that 13 more states have developed hemp programs for a total of 34 participating states, which have licensed a total of 511,442 acres for hemp cultivation, a 455 percent increase from 2018.

Some hemp producers now eligible for crop insurance for crop year 2020 USDA’s Risk Management Agency announced that industrial hemp growers will be able to obtain insurance coverage under the Whole-Farm Revenue Protection program for crop year 2020 if their hemp is grown for fiber, flower, and seeds.

Responsible CBD market closing the gaps between testing and supply chains Industry associations, testing labs, suppliers and finished-product manufacturers are exercising due diligence, each in their own way, to self-regulate and promote responsible behavior, claims and best practices in an immature hemp and CBD market.

TRADE
U.S. farmers on China tariffs: This isn’t just a chess match What is the trade war between the United States and China doing to the country’s farmers? Hear it directly from farmers in this video recorded at the Farm Progress Show in Decatur, Ill.

GLOBAL REGULATORY
VKM: Combining fluoride supplements, tablets and toothpaste may exceed upper intake levels Norwegian authorities say that taking daily fluoride-containing supplements with fluoride tablets and toothpaste may cause individuals to exceed the tolerable upper intake levels for the nutrient.

Germany to ban glyphosate Germany will ban the use of the weed killer glyphosate at the end of 2023 and limit its use before then, according to Reuters, which cited a statement from the Environment Ministry.

Slovakia softens regulatory stance on CBD supplement use Slovakia looks to have eased its stance on cannabidiol (CBD) use as the country's government deletes it from a list of psychotropic ingredients, essentially classifying CBD as a non-regulated substance.

BOTANICALS
BAPP publishes saw palmetto berry extract laboratory-guidance document The ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) announced the publication of a new Laboratory Guidance Document on Saw Palmetto Extract, which is among the top-selling botanical dietary supplements in the United States, with a combined $35 million in sales for both mainstream and natural channels, according to the latest HerbalGram Herb Market Report for 2018.

APAC MARKET
China’s new Free Trade Zones: Regional supplements exports to benefit, but inconsistent regulations still a hurdle China’s addition of six new Free Trade Zones will strengthen regional trade for supplements and functional foods, but a lack of harmonized regulations means it would not fulfill its potential, according to industry players.

PERSONNEL
Supporting women to make an impact Companies are finding that investing in diversity and inclusion initiatives and empowering employees to take the lead can result in greater employee engagement and even benefits to the bottom line. Balchem discusses the benefits of its BWIN women’s leadership initiative.

PERSONALIZED MEDICINE
New test strip detects NO levels A new nitric oxide test called MyFitStrip is offering what the company calls a “next-generation saliva test strip” to detect dietary inorganic nitrate and the presence of the healthy oral microflora.

UNPA MEMBER COMPANY NEWS
Transparency: The next generation Consumers would rather see “third-party tested” than “we test our own ingredients” on a CBD label, says Elan Sudberg, CEO of UNPA member Alkemist Labs, in this commentary.

MARKET RESEARCH
Whole Foods' survey reveals millennials support mission-based brands and transparent food sourcing Quality is driving millennial food shopping more than ever with nearly 70 percent of respondents to a national online survey conducted by Whole Foods Market saying that they are willing to spend more on “high-quality food items” that are responsibly sourced and have a clear mission.

​RESEARCH
Study reveals omega-3 is gold standard in mental health nutrients Omega-3 has been revealed as the most effective supplement for improving mental health, in the world's largest review of research into nutrient supplementation in people with mental disorders. The review was published in World Psychiatry.

Vitamin E study reveals new remarkable insight New insight shows that even though vitamin E is fat-soluble, you don’t have to consume fat with it to enable absorption. Apparently, the vitamin E will sit in the intestinal cell and wait for the next meal to come along.

Popularity of vegan diets may contribute to choline deficiency A new report in the British Medical Journal says that the increasing shift toward plant-based and vegan diets risks a deficiency of choline, an essential nutrient found in animal-based foods that contributes to brain health.

Enough data backs benefits of timed nutrient delivery to support call for more research Specific timing of nutrient delivery can have sports nutrition benefits, but the research is still very much in its infancy and as yet does not support much in the way of definitive recommendations, according to a review in the Journal of the International Society of Sports Nutrition.

RCT supports efficacy of non-animal chondroitin for joint benefits Supplementation with non-animal supplement chondroitin sulfates (Mythocondro) may improve knee function, pain and inflammation markers in overweight people with knee osteoarthritis, according to results of a pilot study from Italy.

Choline must be integrated into the prenatal supplement regimen The importance of choline during the first 1,000 days after conception is increasingly understood by the medical community, and dietary supplement manufacturers are beginning to recognize the potential choline offers, according to a new review in the Journal of Dietary Supplements.

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.