Dietary Supplement Industry

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Contingent upon the relationship between the new Congress and the Executive Branch, and the subsequent actions taken by FDA and other federal agencies (e.g., the FTC), the year 2015 could potentially be a landmark in regulatory change. The degree of hubris exhibited by the agencies in the coming year will be directly proportional to how much the agencies feel the White House has their back; however, Congress still has the power of the purse, which it can use to punish or reward the agencies through budgetary allocations. For example, do not expect the Food Safety Modernization Act (FSMA) to get beyond the farmer’s front gate, and do not expect as robust an Environmental Protection Agency (EPA) in the coming years. Continued aggressive actions by FDA and the EPA in 2014 and 2015 could result in a backlash response with severe cutbacks in funding for these agencies.

Putting FSMA aside as a subject for another time, the principal actions affecting food and supplement companies in 2015 will be: 1) new Generally Recognized as Safe (GRAS) notification guidelines for both human and animal food, to be published in August, 2) new guidelines for New Dietary Ingredient (NDI) notification submissions, which have been promised and may also define the relationship between NDI notifications and GRAS determinations, 3) possible lawsuits regarding FDA’s new guidelines for medical foods, 4) new testing guidelines—i.e., an update of the FDA’s “Redbook”—with a new emphasis on computational toxicology, and 5) new guidelines for randomized controlled trials (RCTs) used in support of health claims.

 The international market will continue to expand, and it will become more essential for companies to have a global strategy. Industry organizations are working diligently towards unified standards that will make commercialization and the launch process easier.

We will see continued growth and innovation in new delivery technologies for both solid-dose applications and the food/beverage market. We will continue seeing the convergence of functional foods and dietary supplements on shelves in 2015. Cognitive health and stress management will continue to accelerate as health priorities and will continue to trend in terms of product demand, and we will see some new, innovative plant protein sources.

 source: nutritional outlook

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