As dietary supplement firms prepare for their initial (or follow up) GMP compliance inspections, it pays to have the advice of a consultant and/or a lawyer up front. Fixing problems on the back end is inevitably more expensive, said attorney Ivan Wasserman.
Adverse event reporting, amphetamine-like substances showing up in products and NDI notifications are all prominent blips on FDA’s radar, said Loren Israelsen, president of the United Natural Products Alliance.
Buoyed by recent investment from DSM, the CEO of Chromadex says the company is not scared to spend big to develop ingredients that stand up to increased scientific scrutiny and resonate with the market.
Despite tightening supply chains and increasing prices for many natural products, there exist opportunities to increase efficiency and ultimately cut costs for manufacturers, says George Pontiakos, CEO of BI Nutraceuticals.
Knowing what identity tests to perform and knowing how to perform is more important than ever for botanical product manufacturers, said Roy Upton, executive director of the American Herbal Pharmacopoeia.
Dietary supplement use isn’t just about health; certain supplement regimens can be shown to deliver significant cost savings, said Steve Mister, president of the Council for Responsible Nutrition.
Nestlé may have canned Jenny Craig, and regulators clamped down on the sector's claim-making, but weight management products are booming globally, especially in increasingly image driven emerging economies like India and Brazil. It has pushed beyond...
Innovative Canadian company MicroPharma is leveraging half a billion dollars-worth of microbiome research to launch microbiome supplements any day now, the company’s CEO told NutraIngredients-USA.
The United Natural Products Alliance is expanding in a focused state-by-state approach as a way to most effectively cultivate the next generation of legislative advocates who can take over in Washington, said UNPA president Loren Israelsen.
It has been described as the ‘hottest ingredient in the mineral category’, and leading mineral supplier Albion most definitely agrees as sales of its magnesium ingredients now account for 40.6% of Albion mineral sales.
Omega-3 ingredients sourced from algae has been a rising trend in the marketplace, and EPA-only products are an even newer development. Israel-based Qualitas Health is covering both bases with the launch of its new ingredient branded as Almega PL.
New ‘suspect alkaloids’ are finding their way into the controversial pre-workout supplement sector, and potentially dangerous products will continue to flourish in the marketplace while there is wider support from the industry, according to the CEO of...
Few would argue that the Dietary Supplement Health and Education Act has helped foster an innovative and thriving industry. But the last twenty years haven’t been a bed of roses for probiotics suppliers, at least not in area of researching ingredients...
Premium products, mega-spend marketing, and global ambitions are driving growth for Swisse Wellness, says its CEO, days after inking a ‘game-changing’ deal with PGT Healthcare giving it access to over 50 countries.
One year on and 'GMPs' and 'concern' continue to be used together by Dr Daniel Fabricant, Director of the Division of Dietary Supplement Programs at the agency, with many of the compliance issues still basic.
Finished product testing has been predicted to be a key focus for regulatory enforcement as FDA inspectors gain more experience and move beyond the first tier GMP compliance issues, but much of the industry is not yet ready for this increased scrutiny,...
From California to Washington, and from Connecticut to Vermont, initiatives to label the presence of ingredients derived from genetically modified foods are dominating headlines. Despite this, the CEO of BI Nutraceuticals doesn’t think we’ll see government...
US-based foods and supplements manufacturer, Now International, hasn’t sat on its hands since the EU’s new health claim laws kicked into play in 2008 – taking pre-emptive action to keep abreast of the new formulation and health claims landscape.
French supplier Roquette is putting its R&D supplements facility up for rent by any party seeking to develop food supplements and food products – whether they are its own customers or not.
Quality control in the food supplements sector is an ongoing mission that remains top of the agenda at the group that most prominently represents both global and national players – IADSA - especially as new regions adopt GMP rules for the first time.
Food fortification with neural tube defect (NTD)-reducing folic acid is mandatory in 75 nations, but concerns over cancer and other health issues mean Europe lags far behind – a situation that needs to change and quickly, says DSM thinktank, sightandlife.
Industry must not drop interest in mechanism focused, lab-based, in vitro studies in favour of chasing human trial data, according to Dr Charles Czank of Leatherhead Food Research who argues that both in vitro and in vivo data are vital for a health claim.
Differing regulatory environments can play havoc with a company's research plans, say consultant Joerg Gruenwald, PhD. But recent, sometimes bitter, experience with the European Food Safety Authority has shed some light on how to negotiate this...
Recent research results about the effectiveness of omega 3 fatty acids in the prevention of secondary heart attacks have been generalized to cast doubt on the value of the ingredients' overall effectiveness in cardiovascular health. This is unfortunate,...
Genetic modification of oil seed crops will form an important part of the future omega-3s supply picture, according to Adam Ismail, executive director of the Global Organization of EPA and DHA Omega-3s (GOED).
New research results are driving interest in vitamin K2, according to NattoPharma CEO Hogne Vik. But the company has also developed a new, more potent powder form that is helping to raise the ingredient's profile.
Nations and populations are in peril of being swamped by the cost of their healthcare systems unless a severe nutrition policy rethink can occur, says a leading academic.
Personalized nutrition has been the Holy Grail of nutrition science. Dilip Ghosh, PhD, tells how the industry is getting closer to delivering on the promises that this approach implies.
Exposing healthy people to modified pathogens in a controlled clinical trial setting could be an exciting new way for industry to overcome the challenges of health claim substantiation, says Nizo Food Research expert.
The industry’s big names have been complying with GMP regulations for years, but low barriers to entry have made it easy for less serious companies to do business with low GMP compliance, says the chief of BI Nutraceuticals.
Giant of probiotic supply, DuPont, is not afraid to admit its European business has been altered by the rejection of probiotic health claims under the EU nutrition and health claims regulation (NHCR).
Current compliance levels to good manufacturing practice (cGMP) are ‘all over the place’, but ‘for the most part there is an increase in compliance’, says the CEO of Alkemists Laboratories.
The cardiovascular health segment is here to stay, with the surge in product demand by baby boomers ensuring that growth will continue, says Cal Bewicke, president of Ethical Naturals Inc.
One of the most interesting new product launches at Supply Side West last week was stress-buster Zembrin, the first patented, standardized and clinically studied extract of Sceletium tortuosum, a succulent plant known by the San people of South Africa...
Supplement manufacturers – particularly smaller companies – need a ‘cultural shift’ to cope with the demands of good manufacturing practices (GMPs), says a former associate chief counsel with FDA.
It’s 100 years since Casimir Funk came up with the term ‘vitamin’, but with an ever-increasing global population and negative reports in the media of their ‘ineffectiveness’ for select health conditions, what does the future hold for the humble vitamin?
About 60% of elderly hospital patients in the UK are malnourished according to recent data from the British Dietetic Association, a problem companies like Danish firm Arla Food Ingredients are trying to tackle with a new whey form.
By applying physiological stressors like partial sleep deprivation, it is possible to test the effects of dietary supplements in healthy populations and stay compliant with DSHEA, says Dr Jay Udani, CEO of Medicus Research.
Roquette is intensifying its research efforts into the protein potential of various plant forms, and used HIE to launch a pea form targeting sports nutrition products.
The practice of dry labbing in the industry is continuing, and the practice is becoming more sophisticated, increasing the need for continued vigilance, says Frank Jaksch, CEO of Chromadex.
The results of the recent elections mean that it’s business as usual for the dietary supplements industry, and the defeat of Prop 37 in California is not the end of the genetically engineered food issue, says Steve Mister, President and CEO of CRN.
Consumer demand for personalized nutrition, and the response of healthcare practitioners to the potential for more holistic approaches to patient care and potential additional revenue streams are driving growth in this market channel, says a leading...
Despite the ‘NO’ vote on Prop 37, the momentum behind sourcing non-GMO ingredients remains as strong as ever, with non-GMO Project verified sales up 66% and a new class action lawsuit against a major food brand over ‘all-natural’ claims on products containing...
The challenge of getting beneficial omega-3 fatty acids into finished products is a big one for the food ingredients and manufacturing industry. But how can suppliers and manufacturers work to get these ingredients into a wider range of products?
Once GMP inspectors from the FDA move beyond the first tier of GMP compliance, the next big wave of warning letters from the agency could be on the issue of finished product testing, says a leading quality and regulatory expert.
Recent studies using DuPont’s HOWARU strain combination, combined with a better understanding of ‘the rules of the game’, will lead to positive health claims in Europe, DuPont’s Scott Bush has confidently predicted.
Strong enforcement from FDA on cGMPs (current good manufacturing practices) will continue, says FDA’s Dr Daniel Fabricant, but given that many GMP basics are still not being met and the Agency's limited resources, many of the issues seen today may...
