Consumers have become increasingly concerned about the use of genetically modified organisms (GMOs) in food production — an occurrence that has contributed to the popularity of products that have not been genetically engineered (GE) through modern biotechnology.
A comprehensive clinical testing program is essential to the success of virtually all health products. Writing in the International Probiotics Association blog, Josh Baisley, associate director of clinical trials for Nutrasource, notes that ensuring the stability of a probiotic for the duration of clinical studies is a vital aspect of analyzing the outcome. Due to inherent properties of probiotics, exposure to unfavorable conditions can have serious impacts on the study product, among other advice. Baisley suggests sponsors should consider sending research sites additional product that will be used to test, and demonstrate, the survivability of the probiotic through shipment to the CRO/site, and during storage.
When Congress passed the Dietary Supplement Health and Education Act in 1994, dietary supplements were placed in a unique marketing position. Unlike prescription drugs, which must be rigorously tested to prove both safety and efficacy before they are approved by the Food and Drug Administration (FDA) for commercial release, dietary supplements can go to market immediately. The FDA monitors the “claim” to ensure there is no implied cure wording and the Federal Trade Commission (FTC) assesses the truthfulness of the label claim only if there is a complaint.
The FDA's New Dietary Ingredient (NDI) draft guidance, released this past August, continues to shake up the supplement industry. Companies are struggling to understand what the new guidelines mean and exactly how the changes will impact their product lines once implemented.
There is more than one successful pathway to market. Understanding the regulatory nuances of each, and developing a solid product plan in advance, is essential for staying on time, on budget and keeping consistent with your brand strategy.
As the dust settles from another outstanding SupplySide West show, we take a moment to recap key highlights from the event.
Trend-spotting on the show floor
The convention hall was buzzing with activity as vendors, suppliers and retailers talked shop and did business. As expected, the latest and greatest products were on full display. Here are a few key themes we spotted:
As the probiotic segment continues to trend upward, more companies are investing in well-designed clinical trials to support efficacy.
One area that has presented substantial learning opportunities, and has helped shape the future of probiotic clinical trials, is the study of antibiotic associated diarrhea (AAD) and probiotic intake.
As the global voice of probiotics, the International Probiotics Association (IPA) has been working jointly with industry, government and academia to advance probiotic technology, research and product development.
Choosing a contract research organization (CRO) is one of the most important steps in a dietary supplement research and development plan.
With summer coming to a close, it's time to shift our mindsets away from backyard barbecues and toward our packed fall calendars.