Daniel Fabricant’s tenure at FDA was marked by a number of bruising encounters with the industry he was appointed to regulate. As the saying goes, regulators regulate. And Fabricant may have been tough on supplements: He told the Nutrition Business Journal earlier this year, "We are taking a much more assertive approach when it comes to dietary supplements at the agency." As part of this more assertive approach, Fabricant trumpeted moves such as the destruction of $30 million worth of DMAA and OxyElite Pro sales last year as proof that FDA was making use of all the tools GMP regulations and FSMA dropped into their toolbox.
But for those who will cry “revolving door,” Fabricant’s term was a departure from the usual revolving door between industry and regulated industries. In many cases the industry that has their man installed to run the regulatory apparatus sees its fortunes lifted as the new regulator hands the industry gifts it had long sought. However, Fabricant turned that calculus on its head by aggressively holding the industry’s feet to the fire.
Not that it wasn’t needed in some cases. For example, the Food Safety Modernization Act of 2011 brought GMPs to the ingredients sector of the nutrition industry, hastened the implementation of NDIs, and put pressure on foreign suppliers to up their game. On the GMP front, the FDA under Fabricant contended that supplements manufacturers had a woeful 30 percent compliance rate (pharmaceutical drug companies are up around 60 percent compliance, and foods are close to 75 percent). That 30 percent number is an embarassment, though many question it because the FDA would not release inspection results, and many violations are easily remedied Standard Operating Procedure-type misdemeanors. For the so-called responsible supplements industry, GMPs were generally met and this measure of quality production helped those elite companies differentiate in the marketplace.
But in the instance of the New Dietary Ingredients (NDI) rule-making of 2011, the FDA guidance draft was met with universal derision from the supplements industry, recalling the days of the 1970s pre-Proxmire Amendment, when the FDA sought to limit the potency of supplements. The NDI guidance document seemed to the supplements industry as a potential rule that was written by a vociferously anti-supplement FDA and not one that, on the surface, was headed by a former supplement industry insider. Industry heavyweight Senator Orrin Hatch (R-UT) had to step in and get the FDA to stand down. The NDI draft is still in draft form.
As for Fabricant’s return to NPA, the trade group experienced tremendous retail membership growth under the 2000-09 tenure of David Seckman, and had a strong legislative and regulatory advocate in Seckman’s predecessor, Michael Ford, who was there in the political run-up to the passage of the landmark DSHEA legislation of 1994 that liberated the supplements industry to innovate and market their products.