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Three Cs to Getting Value from Your Clinical Trial

The dietary supplement industry continues to grow despite potentially restrictive regulations and an increasing burden on the healthcare system.

The global market for supplements increased to $96 billion in 2012, and is expected to hit $104 billion by 2013; showing positive trends for the global nutrition industry (NBJ Global Supplement & Nutrition Industry Report 2014). Though the global nutrition market was expected to grow 2.5%, the predictions are that this number will be exceeded to a 7.6% growth of the industry for 2013 (NBJ Global Supplement & Nutrition Industry Report 2014). Sports nutrition, homeopathy, and specialty supplements achieved the greatest growth in 2012 (NBJ Global Supplement & Nutrition Industry Report 2014).

The United States continued to generate the majority of supplement sales followed closely by Europe, Japan, and Canada. The 78 million maturing baby boomers (US Census Bureau) are focused on improving their health, contributing to the  growth of the nutrition industry. The US supplement industry is growing at the rate of 7.5%, China at 11.9%, while Latin America achieved the highest supplement industry growth in 2013 at 12.9%. Western Europe has only achieved a 1.9% growth rate, reflecting the regulatory challenges faced by the industry in this part of the world.

The growth of the global nutrition industry has resulted in regulatory agencies evaluating their current policies in order to manage consumer demand and provide safe and efficacious products. Growth of the nutrition industry is expected to continue despite the regulatory requirements being tightened in the big markets across the globe: China has put in place more stringent registration and enforcement; Japan is working towards implementing a system similar to DSHEA; the ASEAN countries are moving towards harmonization of different laws and standards; in the UK, herbs and botanicals are expected to meet the standards of herbal medicines; and in Canada, the registration process for natural products and supplements are to be fully implemented in 2014. Countries that hold the highest standards are expected to lead the way to the biggest markets (NBJ Global Supplement & Nutrition Industry Report 2014).

Claims are quickly becoming the point of differentiation between one company’s product and a competitor in the booth space next door. However, the confusion surrounding regulatory processes and the clinical research required to support product claims has proven to be a deterrent to engage in research. The media bias towards supplements spurred on by the increasing number of FTC lawsuits targeting companies for false advertising have cast a shadow on the industry; a stigma that can only be overcome by proving safety and efficacy through clinical research. 2012 and 2013 saw an increase in the number of companies that are moving towards putting science behind their products.

However, this step continues to cause much trepidation to an industry already burdened with stringent regulatory expectations. The Evidence-Based Medicine model of efficacy is entrenched in the minds of regulators as the bar for claims substantiation.

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