Retreat and more to be discussed at SupplyExpo education sessions in Hall A
Senator McCain has retreated, for the time being, from a head on confrontation with both the dietary supplements industry, as well as his colleague and DSHEA co-author, Utah’s Senator Hatch. A letter from Senator Hatch to Senator McCain talks of McCain “agreeing to withdraw …support for the provisions of S. 3002” that Senator Hatch believes “would do great harm to the dietary supplement industry”. Messages circulating late Friday indicated that McCain was, in fact, withdrawing his support from certain provisions of his own Bill with suggestions that revised legislation could be tabled this week, and the possibility of Senator McCain even signing on with Senator’s Harkin and Hatch in upcoming legislation seeking to garner additional resources to assist the FDA in enforcing DSHEA.
This entire episode underscores the vulnerability of the industry in numerous areas. In the absence of an NDI (New Dietary Ingredient) guidance, many companies are currently avoiding the ambiguous submission process, and bringing what just might ultimately be considered new ingredients into commerce every week. And the problem of contamination that is part of the ‘root’ of the sports community argument that led to McCain’s bill, is not going away any time quickly.
So it would seem that this peace is fragile, and that the imminent actions of legislators and regulators may have as large an impact as we’ve ever seen. The Federal Trade Commission has indicated it may be changing the ground rules for claim substantiation, requiring two ‘human’ clinical trials conducted on materials ‘similar’ to the product in question, in order to substantiate a claim. And in Europe, EFSA (European Food Safety Authority) has recently published over 400 new evaluations of Article 13 claim submissions, with very few successes, and notable rejections for probiotics and anti-oxidants.
Returning to the home front, the Proposition 65-based lawsuit against fish oil producers threatens to tarnish the image of one of industry’s golden categories, food safety legislation could open up the door to a double-duty compliance expectation for ingredient suppliers (Food GMP/HACCP versus supplement GMP requirements) and beverage form supplements have now come under FDA’s microscope.
There’s a lot to watch, and fundamentally, no excuse for lack of engagement. If there is a consistent message coming from trade associations, industry champions and legislators alike, it’s to get engaged in the process. While Senator McCain may be beating a retreat, the issues aren’t and some will have dramatic consequences on our industry. Industry executives cannot afford to sit idly by.
Join us this coming week at SupplyExpo as we feature two panels dealing specifically with these types of issues. (All SupplyExpo education takes place in booth 112 in Hall A).
‘Breaking Supply Issues Affecting Your Business’ runs Saturday March 13 from 2:30 until 4:00, with GOED’s Adam Ismail, UNPA’s Harry Rice and CRN’s Andrew Shao. Then on Sunday from 1:00 to 2:45, Michael McGuffin, Marc Ullman and John Venardos will discuss ‘Regulatory Issues to Watch’. Both of these sessions represent great opportunities to dialogue with the experts on the issues (re)shaping our industry.