Some companies are better prepared for regulation than others

By Clarisse Douaud and Laura Crowley

- Last updated on GMT

As new regulation is introduced in the US, those companies
with proven clinical research for their products will be at a
significant advantage, according to market analyst Business

In its report, The Dietary Supplements Market Outlook 2007​, the firm compiled its information and databases to assess consumer trends and the direction of the market. NutraIngredients-USA reported yesterday on Business Insight's prediction that specialty supplements are set to offer the most sales growth potential over the next five years. Today's article focuses on the report's overview of a regulatory climate change in the dietary supplement industry, particularly with the advent of the final GMP rule and AER regulations this year. Not only will these regulations hamper the flow of activity for those companies not prepared for the measures, but they are also likely to bolster the success of those companies that are prepared and for whom the measures signify minimal change. In addition, for such companies, the scientific integrity behind their researched ingredients is likely to spill over to have benefits on the consumer end of things. The analyst highlights specialty categories as benefiting from this in particular. "As more science backs the beneficial influence of probiotics and joint formulations, the consumer will gain in confidence in using supplements in this category and in understanding the benefits from dietary supplements…"​ states the report. The Business Insights report claims the dietary supplement market is facing a difficult time with the changes that are happening worldwide. It posits the recent release of the new regulations in the US as being poised to have a significant impact on the industry. The Good Manufacturing Practices (GMPs) rule was finalized in June and aimed at providing standards for inspectors to check for purity, safety and legality in manufacturing. The Adverse Event Reporting (AER) regulations also came in this year obliging supplement manufacturers, packers and distributors to notify the Food & Drug Administration (FDA) of any serious adverse events reports. These new regulations are thought to have an impact on the industry as it tightens up manufacturing procedures, whilst increased security checks may lead to increased prices. Those products with proven clinical research for their products will be at a significant advantage, according to Business Insights. The new FDA unit relating to food safety may also potentially affect trade both internally and externally, according to the report. Harmonizing the dietary supplements industry is apparently having a negative impact on small and medium-sized businesses with more confusion, financial pressure and barriers to trade. Two-thirds of industry executives consulted for the analysis rated Asia-Pacific as the region that will provide the most growth potential for supplements manufacturers over the next five years. This is because of significant changes predicted in the economic and regulatory structures in this area, specifically in Brazil, Russia, India and China. Meanwhile, the declassification of ingredients in Japan to non-drug status may enhance current market growth and novel innovation within the functional foods and dietary supplement categories, according to Business Insights.

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