GMPs
First up is the interview with FDA’ Dan Fabricant, PhD, who told us there is not a clear indication there will be a drop in GMP non-compliance anytime soon, and that is a concern for the Agency. Please click here to watch the interview.
Staying on the GMP topic, Aaron Secrist from NOW Foods answered yes to our question: Is finished product testing the next big wave in GMP warning letters?
Stepping back from looking at the next tier of GMP issues, we asked Elan Sudberg, CEO of Alkemists Laboratories, to give us his view on the current level of compliance. His opinion: Compliance levels are ‘all over the place’.
Jason Sapsin, a former associate chief counsel with FDA, told us that dietary supplement companies – and the smaller companies in particular – need a ‘cultural shift’ to deal with GMPs.
George Pontiakos, chief executive of BI Nutraceuticals, added that the marquee players in the industry have been complying with GMPs since before GMPs were a regulatory issue. However, the industry was getting bad press because low barriers of entry have enabled ‘drifters, cobblers, and vermin’ to establish a business presence.
Prop 37
California voted ‘no’ on Prop 37 – the initiative to label GMOs on food products. Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), told us that the industry will have to continue to grapple with this issue of genetically engineered food.
“What is clear from California is that that particular ballot initiative was not the right one […] I think other states will now look at it. We’re likely to see legislatures or ballot initiatives in nearby states and California may revisit it.”
Anne Brown, senior manager of the food ingredients marketing group at The Scoular Company, said that, while Prop 37 supporters lost the battle, they may ultimately win the war.
Vitamins & clinical benefits
2012 is the 100th anniversary of the vitamin. We talked at length with DSM Nutritional Products’ Dr Deshanie Rai about global population demands, ‘confusing’ media coverage and if we can expect any new vitamins anytime soon…
Dr Jay Udani from Medicus Research also joined us to talk about how to show a clinical trial benefit in health populations. Please click here to watch the video.
Dry Labbing
At last year’s SupplySide West, we interviewed Frank Jaksch, CEO of Chromadex, about the practice of dry labbing – where research or analysis is claimed to be done, but in reality the conclusions are guessed at or copied from other sources without actually doing any analysis.
One year on, we followed up with Jaksch on the subject. Has dry labbing gone away? No, he said, it’s ‘mushrooming’ and ‘metamorphosing’. Please click here to watch the video.
Market opportunities
We also explored various market opportunities for supplement manufacturers and ingredient suppliers. Jeff Hilton from Salt Lake City’s Integrated Marketing Group told use that customized nutrition I driving growth in healthcare practitioner channel.
Good news has also been predicted for the probiotics sector, with Scott Bush, VP of Marketing - Nutrition and Health, DuPont, that the company is building its science portfolio and it is confident of achieving a positive health claim in Europe: 'Our probiotic science will lead to an EFSA health claims approval', he said.
Looking at specific market segments, Elzephan Hotam, CEO of Enzymotec USA, told us that there are ‘huge’ opportunities in the emerging cognitive health market, while Cal Bewicke, President of Ethical Naturals, Inc., said that US population demographics will continue to drive cardiovascular category growth.