Last week, we published a letter to the editor from Donald Marcus, MD, and Arthrur Grollman, MD, in which they defended their allegations from a commentary published in the Archives of Internal Medicine.
The NPA and CRN have now responded to the letter, noting that over-reliance on a report from 2009 from the GAO may have led the Drs Marcus and Grollman ‘astray’.
Response from Cara Welch, PhD, Sr. Vice President, Scientific & Regulatory Affairs
Natural Products Association
“I understand the authors want to insist their points are valid but I still disagree with their commentary and now with their recent response. The authors discuss the 2009 GAO report’s reference that FDA has limited authority to regulate dietary supplements but FDA officials have regularly testified they have all the tools they need to effectively regulate supplements. This is straight from the horse’s mouth.
Regarding the authors statements on adverse event reporting, they are postulating incomplete knowledge about their own citation. The 2009 GAO report is referencing a 2008 federal register notice which references the 2001 OIG report and all the way back to a 2000 FDA-commissioned study. This estimate -- that one-percent of adverse events are reported -- pre-dates the 2006 AER law requiring dietary supplement manufacturers to report serious adverse events so, yes, it is old and inappropriate for reference in either the 2009 GAO report or this 2012 commentary.
The authors dispute the fact that FDA has mandatory recall authority by referencing the 2009 GAO report; however, FDA was given mandatory recall authority in the Food Safety Modernization Act signed in 2011. Again, depending solely on this 2009 GAO report is leading the authors astray.
Finally, the authors criticize the industry for not engaging in a dialogue that addresses the substance of problems. This industry advocated for the 2006 AER law mentioned above as well as supporting the mandatory recall authority provision in FSMA – just two examples of how the industry addresses problems.”
Duffy MacKay, N.D., Vice President Scientific & Regulatory Affairs, Council for Responsible Nutrition (CRN)
“The authors seem well-intentioned; however, they do not appear to fully understand dietary supplement regulation. For example, while they may be correct in citing that the GAO report noted that FDA “…is hindered by a lack of mandatory recall authority,” they seem unaware that subsequent to that report, a new law was passed which provides the agency with mandatory recall authority. That is simply fact. As importantly, one of the reasons that CRN strongly supported passage of that law was for that very provision.
We are surprised by the authors’ attack on CRN’s character, so to speak. In fact, if one reads CRN’s quotes in Natural Products Insider, it’s hard not to agree that those quotes are reasonable, rational, and factual. We chose at that time not to issue a statement attacking the authors; preferring instead to provide our comments to the scientific journal, pointing out inaccuracies in the commentary. That letter to the editor is pending publication.
Further, it is unfortunate the authors believe we are “denying the validity of negative clinical trials of dietary supplements.” That is not true. What we have questioned—and the authors should be aware that many others in the nutrition science community are also questioning—is whether RCTs, long considered the gold standard of drug research, are an effective way, specifically the only effective way, to study nutrients. The very nature of science is the opportunity for high level discussion with the scientific community, to question the results, and to be open to other viewpoints.
We would welcome that discussion, as well as a dialogue on dietary supplement industry regulation, with the authors. At the end of the day, we may simply agree to disagree, and they are entitled to have their say, but so are we.”