A week ago, the official date for compliance with supplement GMPs passed for US mid-sized companies. A couple weeks earlier, Natural Products Association CEO David Seckman announced his resignation to assume responsibilities with the Food Processing Suppliers Association, which even earlier, had announced its intention to partner with IFT for an upcoming event in Chicago next year.
Amidst the backdrop of a struggling economy, domestic and international, these are significant occurrences. SIDI, (Standardized Information on Dietary Ingredients) the collaborative effort from the industry’s trade associations to better present ingredient data to manufacturers in a standardized format appears to be gaining momentum (learn more about it at an upcoming educational session at Expo East in Boston), and supplements at least are getting repeatedly slammed in the media. Iovate’s Hydroxycut products have been recalled after a recent series of Serious Adverse Event Reports, FDA’s enforcement activities have dramatically stepped up, making it clear to anyone in or following the industry that a new operating and business model is emerging around us. Although it may seem like, as an industry, we are getting picked on by regulators, recent food safety actions would suggest this is not the case. All consumer goods are facing increased safety scrutiny.
Reading that paragraph back, it seems like a foreboding mid-year review.
All is not bleak. The supplements market, while still feeling the bite of the economy largely in the form of trading down of brands, has weathered so far better than many if not most other sectors. On the ingredient side, companies that are reporting, talk of neutral to slightly positive sales, and of those operating in multiple sectors, the health and nutrition divisions are holding their own, while still being victim to overall corporate dictates and direction – hence cash flow management extremes, stalling of major spend, delays in product launch etc.
End of a Chapter
The end of July marks the end of a 9 year tenure for David Seckman, CEO of the Natural Products Association. It’s especially interesting for me as David’s time in the position roughly corresponds to my own time in this industry (wow, how time flies). In fact, he was the first Trade Association head that I met and over the course of the years has been a source of guidance, information and insight to me personally and to many in this industry. Under his watch, the Association has been very active, in Washington and elsewhere (including physically moving to Washington from California). I had the opportunity to chat briefly with David a couple weeks ago and talk about his legacy and next steps. David was quick to thank the members and the NPA staff and point to legislation enacted in recent years where the Association had been quite active: AERs, the Anabolic Steroid Control Act of 2004, and most recently, the dietary supplement GMPs. Seckman spoke about the new Association office in China, the raw ingredient testing program there and affiliation, the first of its kind, with USP. He noted the grant received from the US Department of Commerce, the change of name from NNFA and the expansion of scope of the association’s activities including certification, of its inroads into health and beauty and household products. Our dialogue progressed into the activities of the Natural Products Foundation, and overall, as David put it, a renewed ability to just ‘get stuff done’.
When asked what the future may hold as he brings his expertise to Food Processing Suppliers Association, Seckman noted expanding that organization’s advocacy, helping it work more closely with IFT, essentially using the same skills he brought to bear on this industry. Given the tenure of 23 years for the last Executive Director of FPSA, it’s clear that David will quickly make his mark on that sector as well, and he will be missed in this one.
David’s closing comments to me and words for the industry were, “ It’s a very passionate, great industry. We need to continue to be vigilant on business and political fronts. As Senator Hatch put it, if you’re involved in business and not politics, you might not be in business any more. As Senator Harkin said on our sick healthcare system, we need to find a way to become mainstream, viewed as such in the public eye.”
With GMP compliance now expected of mid-size companies, the stakes are bigger than ever…and so is public scrutiny…and criticism. From my own recent dialogue with the ingredient community, many are positioning for what they anticipate will be different expectations from manufacturers and their (suppliers) ability to add value and security to the sourcing process. SIDI is one example, but there are others evolving too and don’t be surprised to see a new philosophy of contracts emerging in the marketplace recognizing the impact that ingredient supply can have on GMP compliance. Also, it’ll be interesting to see how change control is communicated from supplier to manufacturer as seemingly innocuous manufacturing process change back in the supply environment may have far reaching consequences downstream. My crystal ball tells me that watching the contracts and communication of changes will be an excellent bellwether as to how industry is adopting the philosophy of GMPs.
Stay tuned for what promises to be an interesting half of 2009.