Itâs been some time since I last weighed in on industry issues in this column. As those of you know me can attest, itâs certainly not from lack of opinion.
Iâve watched and listened to industry activity and buzz over the past several weeks, pretty sure that in the absence of movement on a US New dietary Ingredient guidance, key areas of activity would continue to be claims and claim enforcement. Another area that bears watching is the very interesting scene in Canada, where industry and pharmacists have been battling for the past several months, further tarnishing the reputation of regulations that when enacted, were described by some as forward-thinking practical regulations developed as a collaborative effort between industry and government. In fact, despite the fact that they involved pre-market approval, they were to support innovation and access, and many hoped they would be an exportable regulatory model.
First, on the subject of claims:
On April 22nd, the Natural Products Association, along with over 40 other trade associations and business groups, sent a letter to Senate Majority Leader Reid and Senate Republican Leader McConnell urging them to oppose the inclusion of provisions that would expand the authority of FTC as laid out in the financial reform bill Restoring American Financial Stability Act (S. 3217), currently pending in the Senate. NPA and others argue that senators should be focusing on strengthening the stability of the economy, rather than âregulating industries that had nothing to do with the financial crisis.â
Marc Ullman, attorney and NPIcenter blogger, comments on specific areas of potential concern to the dietary supplement industry, regarding expanded FTC powers, in his April 19th blog, noting that, under H.R. 4173, the Wall Street Reform and Consumer Protection Act of 2009, the FTC would no longer be required to seek Congressional approval before undertaking formal rulemaking procedures. He observes that theoretically, âIf H.R. 4173 is enacted into law without change, the FTC would simply be able to promulgate a regulation that requires any performance claim for any dietary supplement to be substantiated by two gold standard studies on that specific product.â Given new levels of assertiveness on the part of FTC, as well as suggested new initiatives, while such intent may not be currently evident, that type of action cannot be totally ruled out.
In the current environment, any discussion of claims must also consider the current environment in the EU. Most of us are by now familiar with the rate of negative opinions offered by EFSA on submitted health claims, with companies now making decisions on whether to resubmit with new science or withdraw from the claims game. Two weeks ago, industry upped the ante when over 350 companies, in a mass appeal, called for EU Commissionâs President JosÃ© Manuel Barrosoâs personal intervention to stop the adoption of the list of âpositiveâ functional health claims in batches, claiming that the piecemeal approach would have devastating consequences, especially for those claims that have been in national markets for years. Companies from around the world are watching this process with anguish. Emerging categories with promise are potentially being cut off at the knees with the loss of any research incentive, ironically the reversal of what real industry and consumer needs are.
Switching to Canada for just a minute, and turning again to one of NPIcenterâs blogs, this time provided by Michael Cherniak, a question about the future of combination products in the Canadian NHP market is posed. This has long been a fear in this market as Canadaâs regulators have quickly and easily approved single ingredient, monograph-based submissions, leaving more complex formulas for âlaterâ. Later, in a backlogged environment, may mean never, as many of these products are still stalled. Furthermore, theyâre some of the victims of the current argument between industry and NAPRA (the National Association of Pharmacy Regulatory Authorities), who, earlier this year, determined that since the âdeadlineâ for Canadaâs Natural Health Products Directorate to process all Product License submissions had passed (ignoring the backlog), all non-approved products were declared illegal, infuriating industry and removing numerous products with active submissions in process from shelves. While a Federal government regulatory amendment to address the non-NPN issue has been initiated, the earliest it could appear in Canada Gazette Part I as a draft regulation for public comment is sometime in June, meaning that the better part of a year of business opportunity will have been squandered.
All in all, so much for a pre-market approval mechanism and adequate access to innovative productsâ¦â¦
Itâll be good to reconnect with many of you in a few weeks in Geneva for VitaFoods. In the meantime, Iâll try to put pen to paper a bit more regularly, both here and in my blog.