Highlights from FDA’s public meeting on responsible innovation in dietary supplementsDietary supplement industry leaders and consumer advocacy groups turned out in force at the highly anticipated public meeting in College Park, Md., on May 6, for the FDA public meeting on responsible innovation in dietary supplements. Among the topic discussed was whether the Health Canada model might improve FDA’s approach and if DSHEA provides enough authority to the agency. Comments came from key industry groups and thought leaders, including Steven Tave, of FDA’s Office of Dietary Supplement Programs, UNPA’s Larisa Pavlick, VP of global regulatory and compliance, and others. Read coverage:
15 Highlights from the FDA’s public meeting on responsible innovation in dietary supplements→
NDI problems take center stage at FDA public meeting→
Could Canadian model improve FDA’s approach to supplements?→
Lawyers: FDA has adequate authority under DSHEA but must act quickly to enforce→
Need a PCQI? June 26-28 training with a DS, food and botanicals focus
UNPA will conduct Preventive Controls Quality Individual (PCQI) training with a focus on dietary supplements, food and hemp-oil products and other botanically derived ingredients, June 26-28, in Westminster/Denver, Colo. Register today!
NEW! Expert Insights OnDemand: Ten kinds of synthetic biology likely to affect your clean-label product
Jim Thomas, co-director of ETC Group, provides a detailed look at 10 new and emerging genetic technologies that may impact the supply chain for food and dietary supplement ingredients.
Lunch with the senator
UNPA President Loren Israelsen had scheduled a lunch on Tuesday in Salt Lake City with Melanie Bowen, Sen. Orrin Hatch’s longtime state director. Imagine his surprise when a guest joined them—the senator! Highlights from the lunch conversation: The Hatch Foundation, based in Salt Lake City, is proceeding and will soon announce a location. Matt Sandren, former Hatch chief of staff, is the foundation’s executive director, and Bowen is the community outreach director. Other topics of discussion: prospects for Senate leadership on dietary supplements, an archive of DSHEA documents and the senator’s desire to continue to help industry, with his caveat that it still needs to help itself.
U.S. organic sales break $50 billion mark in 2018 Clean, transparent, fresh, sustainable, environmentally friendly, animal humane, high-quality and social activism are terms all identified with organic, and in 2018 these concepts helped push organic sales to unprecedented levels: a record $52.5 billion, up 6.3 percent from the previous year, according to the 2019 Organic Industry Survey released by the Organic Trade Association.
FDA: We do not have policy of enforcement discretion for CBD products As reported last week to Hemp Extracts Committee members, despite comments made by former FDA Commissioner Scott Gottlieb, M.D., to the contrary in March, FDA does not have a policy of enforcement discretion with respect to products derived from cannabis and its components, including cannabidiol (CBD), according to Steven Tave, speaking on a panel at the Dietary Supplements Regulatory Summit on May 14. In a statement of clarification, the agency said available data leave open questions as to the safety and efficacy of these products.
Study finds CBD can treat opioid addiction A new study finds that cannabidiol (CBD) could be an answer for medical professionals looking to treat the epidemic of opioid addiction ravaging the country. In the report published in the American Journal of Psychiatry, researchers found that patients treated with CBD reported experiencing lower cravings for heroin or other opioids than did patients who were either given a placebo or no treatment at all. In other CBD research, a retrospective case series published in The Journal of Alternative and Complementary Medicine found that administration of oral CBD in addition to routine psychiatric case was associated with post-traumatic stress disorder reduction.
Fate of hemp seized by Idaho police in hands of appeals court The question now facing the U.S. Court of Appeals for the Ninth Circuit is whether Idaho authorities had the right to confiscate the goods or whether U.S. law preempted them from interfering with the interstate transportation of hemp sourced from a grower in Oregon and destined for Colorado.
Hemp, CBD: What the mainstream media is getting right and wrong CBD is rapidly emerging into the mainstream market, but awareness and sophistication regarding the ingredient in mainstream media is both uncertain and uneven. Taking a look at one week’s worth of coverage offers manufacturers some clues in terms of which issues need to be cleared up–and who is responsible for doing the clearing.
BBB Labs launches quality assurance seal for its hemp extracts We’re no longer in the ‘Wild West’ when it comes to hemp-derived CBD, but buyers can still get burned if they don’t do their homework, says Colorado-based BBB Labs, which has launched a quality assurance seal for its hemp extracts to reassure partners and consumers that they are getting what they think they are getting.
Asia, Europe prop up LifeVantage’s earnings Dietary supplement marketer and UNPA member LifeVantage recorded 11 percent year-over-year growth in its most recent quarter, buoyed by strong results in Taiwan and Europe. In its most recent quarter, LifeVantage recorded $56 million in revenue, which was among the company’s best quarters in its history.
FDA proposes new name for healthier alternative to sodium The Food and Drug Administration issued a draft guidance last week that would allow manufacturers to change the name of "potassium chloride" on ingredient labels to "potassium chloride salt." Potassium chloride is different than sodium chloride (what is found in a salt shaker) because even though it tastes and acts like salt, it does not add harmful sodium to the diet, according to FDA.
UBiome suspends founders, sales of microbiome tests in wake of FBI raid Testing company UBiome has suspended its co-founders in the wake of an FBI raid in its San Francisco offices. In late April, FBI agents searched the company offices in an investigation allegedly into the company’s billing practices, according to a Wall Street Journal article.
Nutraceuticals Group acquires exclusive rights to H2OSlim Nutraceuticals Group has acquired the exclusive rights to offer the patent-pending Spanish ingredient H2OSlim to the U.S., Canadian and Korean supplement manufacturing markets. The ingredient is positioned to compete with chitosan, because it is sourced from common mushrooms rather than the shells of crustaceans, which has an allergen warning and marine heavy-metal concerns.
Hepatitis cases linked to turmeric supplement rumbles on as incidences rise to nine Italy’s National Institute of Health reports five new hepatitis incidences linked to the consumption of turmeric-based food supplements bringing the total to nine cases.
BSCG puts out advisory lists of ingredients to augment FDA effort UNPA member Banned Substances Control Group has published its own list of ingredients that show up in dietary supplements but are of dubious regulatory provenance. Oliver Catlin, president and founder of the product testing company, said it wanted to give further visibility to other ingredients that play in the penumbra of legality but might not yet rise to the level of official FDA enforcement.
Could food safety be improved if FDA has more independence? Did you know that the head of the Department of Health and Human Services can veto FDA rulemaking? This is why “seven of America’s most recent FDA commissioners co-wrote a piece of commentary urging [for FDA to become an independent agency] in Health Affairs journal.” DHHS has shelved many FDA rulings, including the agency’s attempt to prohibit raw milk.
Lawmakers schedule psychedelic decriminalization hearing in Oakland On the heels of Denver’s groundbreaking decision to decriminalize psilocybin mushrooms, Oakland, Calif., “is moving to consider a measure that goes even further by calling for an end to arrests and prosecutions of people for possessing additional psychedelic drugs such as mescaline cacti, ayahuasca and ibogaine.” Studies have demonstrated that these psychedelics could be useful for treating conditions such as substance abuse, OCD and treatment-resistant depression.
Probiotics quality: Expert review encourages industry adoption of third-party certification The time is now for industry to voluntarily improve the transparency of probiotic product quality, even in the absence of regulatory requirements, says a recent review. A U.S.-based research team identified several ways for probiotic product manufacturers to improve manufacturing processes and communicate quality to end users.
Podcast: The evolving ‘biotics’ category in natural health products The “-biotics” market appears to be growing by CFUs with new ingredients, such as post- and psychobiotics. In this podcast, attorney Ivan Wasserman, managing partner of UNPA member Amin Talati Upadhye LLP, discusses the growth of these -biotics in the marketplace and the regulatory challenges they face.
Cubiq Foods talks celi-cultured fat: New source of EPA and DHA could give fish oil, krill, and algae a run for their money A new source of "more affordable" long-chain omega-3 fatty acids could give fish oil, krill and microalgae a run for their money and open up new fortification opportunities for food manufacturers, claims Barcelona-based start-up Cubiq Foods, which has developed a platform to produce EPA and DHA from fat tissues from poultry stem cells.
UNPA MEMBER COMPANY NEWS
Sabinsa achieves USP GMP audited status for three additional sites Three additional Sami-Sabinsa Group Manufacturing units have been audited by the United States Pharmacopeia (USP) and received GMP compliance certificates for the Kunigal unit and the Dobaspet unit, both in Bengaluru, India, and the Hyderabad unit in Telangana state, India. The company’s Nelamangala site in Bengaluru received a USP GMP certificate earlier this year.
Whole Foods set to ban plastic straws Whole Foods Market said it will be the first national supermarket chain to eliminate plastic straws from its stores. The Austin, Texas-based specialty grocer said that by July it will remove plastic straws from all Whole Foods-operated venues, including Allegro coffee bars, juice bars, and cafes.
Personalized profits: Big money moves into personalized nutrition After years hovering on the horizon, personalized nutrition has solidified into business models that investors and big companies can get behind. Do recent deals mean personalized medicines will meet the promise? Big money travels with a deep bench for due diligence and the herd mentality of studied minds suggests the proverbial next big thing is closer than it’s ever been.
Why successful supplement brands don’t lead with the science Science is critically important because it ensures that your products are effective, and you’re using the right ingredient in the right dose. But when everyone is making the same claims, science becomes the cost of entry at best and just noise to the consumer at worst, according to UNPA member Pure Branding’s Yadim Medore in this commentary.
Are brands exiting an era of search? Search, which has been a staple for many brands and advertising campaigns, might become an “old-school” marketing and advertising media. That’s according to data released in April from Borrell Associates. The 2019 Benchmarking Local Media’s Digital Revenues report shows the industry might be exiting the era of traditional search-engine dominance.
Most Americans concerned about food product safety, yet few research claims UNPA member NSF International released a new study showing 61 percent of Americans are concerned about the products they put in, on and around their bodies. However, 34 percent say they rarely or never research product claims and almost half (46 percent) of Americans say they have purchased a product despite being unsure of the validity of product claims.
Millennials and Gen Z distrust business Marketers attempting to sell to millennials and Gen Zers may have their work cut out for them. A new study by Deloitte documents some grim findings: For one, economic and social/political optimism are at record lows, and millennials are suspicious of business leaders' "impact on society, their commitment to improving the world, or their trustworthiness."
Study linking vitamin D to autism retracted over reliability issues Editors of the Journal of Child Psychology and Psychiatryhave withdrawn a paper said to be the first randomized controlled trial looking into vitamin D supplement links to autism after concerns over the findings’ reliability.
Collagen plus resistance training better than training alone for body mass muscle protein changes: RCT Adding collagen supplements to resistance training may lead to greater improvement in muscle strength, body mass and fat-free mass than training alone, according to a new RCT from Germany.
Experts call for clinical trials to validate joint supplement’s link to CVD risk A report from the British Journal of Medicine claiming glucosamine supplement use relates to lower cardiovascular event risk has been met with a cautious welcome by medical experts, who urge the need to establish cause and effect.
Prebiotic combination may boost flu vaccine efficacy A combination of human milk oligosaccharides, prebiotic short-chain galactooligosaccharides and long-chain fructooligosaccharides may enhance the immune response to the flu vaccine, says a new study in the Journal of Nutrition.
Maqui berry extract shows potential to improve dry eyes: RCT A standardized maqui berry extract may improve symptoms of dry eye, with greater tear production and less eye fatigue, according to a new study from the Journal of Traditional and Complementary Medicine, scientists from Orthomedico Inc. and the Ario Nishiarai Eye Clinic in Japan.
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.
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