Today, this industry has many rules—advertising rules, health claim rules, safety rules, etc.—and they impact business no matter where a company chooses to operate. Pete Zambetti of Capsugel, who opens this issue’s International Markets Report (page 32), provides a nice global overview of recent activity, pointing out that while the dietary supplement market is not declining, it is not growing at the rate seen in previous years. The recent deceleration, he says, is a result of a few factors, namely a long-lasting recession, persistent regulatory issues and product saturation. What stands out to me most is the regulatory aspect, because it seems to be the common denominator worldwide in terms of market access and product innovation.
Here in the U.S., companies continue to grapple with constructing permissible product claims as well as new GMP rules. In terms of the former, “Capitol Comments” columnist Todd Harrison provides a nice refresher on structure/function claims (page 24). As for GMPs, the industry is struggling here too. At the recent Council for Responsible Nutrition (CRN) conference, Dr. Joshua Sharfstein, deputy commissioner of FDA, said one third of inspections so far have had serious problems.
Abroad, the regulatory situation is just as complex, especially in Europe. Companies across the Atlantic are frustrated with the growing number of health claim rejections, which, at best, will stifle product innovation in the near future. In Japan, companies are also running into problems with health claims, particularly as they relate to the long-admired FOSHU (Foods for Specified Health Use) system. According to Ron Bailey, author of the Japan update, “Overall, there seems to be much less enthusiasm regarding new FOSHU developments for the first time since the FOSHU category emerged in 1993. The eagerly anticipated expansion of the FOSHU categories to allow fatigue, stress and weight management health claims did not materialize…that costly rejection, combined with the severe global economic conditions and other factors, has resulted in a loss of interest in developing the extensive scientific support targeting potential new FOSHU opportunities.”
In Australia, there are rumors the Therapeutic Goods Administration (TGA) will become stricter with complementary medicines, while in New Zealand, Paul Altaffer and Grant Washington-Smith write, the market “remains as unregulated as ever.” There are plans to harmonize regulations between these markets but they say there is no indication when this process will be completed.
In Canada, the Natural Health Products Directorate is still having trouble clearing the backlog of product license applications, which, author Michael Chernyak says, is causing chaos in the market.
In China, where the dietary supplement market is really starting to heat up, regulatory authorities are just starting to get a handle on this sector. Companies that have been operating there for several years have an advantage because they have already formed the necessary relationships with the right people, which in China is everything. In India, the situation is similar, with a rapidly growing middle class and a regulatory body that is just starting to acknowledge dietary supplements and develop practical rules for the category. In Latin America too, regulatory authorities are moving quickly to keep up with consumer interest in and demand for nutraceutical products.
Our International Markets Report is extensive, covering seven important regions, including Australia/New Zealand, Canada, China, Europe, India, Japan and Latin America. Here you will find important information on the rules you need to know about the regions you want to enter with your business.