The Editorial Board of The New York Times went off half-cocked yesterday in blaming a former FDA regulator for the agency's delay in acting on weight loss supplements adulterated with a blood pressure-raising chemical called BMPEA. Following the most recent in a series of dietary supplement investigative articles by Times correspondent Anahad O'Connor, the board implicated former FDA division director of dietary supplement programs, Daniel Fabricant, Ph.D., for inaction on the tainted supplements.
(Disclosure: I have known Fabricant professionally since 2002 when he was a graduate student at the University of Illinois at Chicago, and we are both members of the American Society of Pharmacognosy, a professional organization of scientists working on biologically-active chemicals made in nature.)
The reason for the delay, discussed by O'Connor and explicitly stated by the board, is that Fabricant has industrial conflicts of interest: He was president and CEO of trade group, the Natural Products Association (NPA), prior to joining FDA in early 2011 and then returned to NPA in April 2014 after his tenure with the agency.
But in their rush to judgment, the board fails to acknowledge that Fabricant has been the most effective leader of the FDA's dietary supplement division since its inception in 1995. Among his accomplishments in scrutinizing the industry, Fabricant led a daunting effort on removing from the market and prosecuting makers of another series of weight loss and workout supplements containing a similar compound called DMAA and a liver toxin called aegeline. Unlike BMPEA, whose safety is poorly studied, DMAA was associated with several deaths, including four deaths among the U.S. military. A report by the Department of Defense concluded, however, that DMAA could not be conclusively identified as the cause of death.
Under Fabricant's leadership, the DMAA products were taken off the market just over a year after the first adverse reaction reports were received. When reached yesterday at a natural products conference underway at the University of Mississippi's National Center for Natural Products Research, Fabricant said, "Ephedra took 10 years to get off the market," referring to the natural stimulant implicated in the 2003 death of Baltimore Orioles pitcher Steve Bechler. "With the strategy we used for DMAA, we got it off the market in 16 months. I'm proud of that."
Daniel L. Fabricant, Ph.D., CEO and Executive Director of the Natural Products Association (NPA),... [+]
But even this action was criticized by the Times editorial board because other countries acted on the products more quickly. That rather naive attack is understandable as few have a complete understanding of the legal burden that must be met in the United States for the FDA to remove potentially unsafe supplement products. While the Dietary Supplement Health and Education Act of 1994 (DSHEA) does grant some administrative authority to the agency over dietary supplements, it's completely devoid of the premarket safety and efficacy testing required for prescription drug approval. For this reason, herbal and other dietary supplements fall administratively under FDA's Center for Food Safety and Applied Nutrition (CFSAN) and not the Center for Drug Evaluation and Research (CDER).
Led a woefully understaffed division
With DMAA, Fabricant's tiny division of 25 FDA employees had to prove that the chemical was not naturally present in geranium extract, the plant from which companies claimed as the source, or anywhere else in the plant kingdom for that matter. Under Fabricant's leadership, the FDA used a new clause from the Food Safety Modernization Act (FSMA) that DMAA was a new dietary ingredient (NDI) for which no sponsor filed for notification. Once a chemical is isolated from its natural source and added to a supplement after October 15, 1994, it constitutes a new dietary ingredient and must be submitted to CFSAN for evaluation 75 days before the product is marketed, still an unreasonably short period in my professional opinion. Yes, this is a bit wonky, but I offer it to illustrate the shortcomings of dietary supplement regulation in the U.S.
Yet on the case of BMPEA, playing out a year after Fabricant left the agency, the Times editorial board calls the agency's regulation "lethargic" and saying that, "Much of the responsibility for the F.D.A.’s sluggish response must fall on Dr. Daniel Fabricant, who left a senior position at the Natural Products Association, a trade group for supplement makers and sellers, to head the F.D.A.’s division of dietary supplement programs in early 2011 and who jumped back to the trade association as its chief executive in the spring of 2014."
Lethargic and sluggish are adjectives least likely to describe Fabricant by anyone familiar with his research training and subsequent work on dietary supplements. In fact, many in the dietary supplement industry were fearful when Fabricant was first appointed to the FDA because of his outspoken condemnation of unscrupulous manufacturers and pre-existing support of the NDI guidance provisions then under consideration. As one example, Jarrow Rogovin, president of supplement company bearing his name, sent a 15-page letter to FDA Commissioner Margaret Hamburg in August 2011 objecting to Fabricant's hiring because his inside knowledge of the industry might reveal secrets to the regulatory agency.
"Dr. Fabricant’s appointment has sent a ripple of anxiety through our industry, especially at the time of the Comment period for the NDI Draft Guidelines, which are not simply overly burdensome to the industry, but also in the opinion of many – including most respected food and drug attorneys such as Scott Bass and Wes Siegner – in essence dismantle DSHEA. . .
. . .I certainly found him indifferent to the enormous, unnecessary burden, cost and loss of business opportunity that was being imposed on the industry, and the negative effect on consumers: The Draft Guidance in its current form would make most innovative, new supplements – including simple reformulations – cost prohibitive."
Indeed, the primary concern of some in the supplement industry was the effect on revenues that the more stringent requirements would impose. When Fabricant left FDA to return to NPA leadership, Jarrow followed with a letter to the NPA board, this time criticizing Fabricant for his statements to the press that, "The industry is downright scary," and that "70% of companies are not in compliance." The implication is that his return to the trade group will continue to require the industry to comply with higher standards than in the past.
Strong scientific training supported by NIH
So while Fabricant's return to the NPA is perceived by Jarrow as a conflict of interest, so too is the Times board saying that it was a conflict of interest for Fabricant to even have been appointed at the FDA. I can certainly understand the unease felt by those concerned about industry advocates taking on positions that regulate that very industry. But I'm hard-pressed to think of a more qualified candidate than Fabricant to have been in his FDA leadership role.
Fabricant is a very product of a scientific research and training effort undertaken by the National Institutes of Health to improve our understanding of dietary supplements and their positive and negative effects on public health. Fabricant earned his Ph.D. in medicinal chemistry and pharmacognosy at the University of Illinois at Chicago's College of Pharmacy, home to NIH's first Botanical Research Center. There, he trained under the grand old man of pharmacognosy, the late Norman A. Farnsworth, Ph.D. A similarly outspoken personality, Farnsworth held high standards for his students and prepared them with a strong scientific basis in naturally-occurring medicines to pursue careers in academia, industry, and the regulatory sciences (Disclosure: My laboratory group worked with Farnsworth on a NCI program project to identify novel anticancer drugs from natural sources and I served with Farnsworth on an advisory board to NCI's Office of Cancer Complementary and Alternative Medicine.)
Even without training with Professor Farnsworth, it's no surprise that Fabricant is perceived by many as a forceful personality – sometimes even aggressive, arrogant, and a bully. Others see him as a strongly science-based expert is natural products research, regulation, and law, regardless of whether he sits at FDA or a trade organization. He can be terse, but I also find his communications style effective in its clarity and distillation of complex and convoluted landscape of dietary supplements that are regulated as foods instead of drugs.
That said, I certainly differ, sometimes very strongly, with some of his opinions on the public value of dietary supplements and in his organization's defense of homeopathy. But those opinions are based in science and medicine, not personality conflicts. And some of those opinions, to be discussed in a subsequent essay, address what can be done more quickly and efficiently in the regulatory system to ensure safe access to the supplements used by 180 million Americans.
But criticizing Fabricant's public service as FDA's division director for dietary supplement programs is a poorly substantiated stance to be taken by the Editorial Board of The New York Times. The agency may have been slow on the BMPEA issue, but Fabricant is the last person I'd blame.
