Industry should engage in dialogue to address ‘ineffective regulation’: Arch Intern Med commentators
The commentary, published in the Archives of Internal Medicine on July 9, 2012, was described as “needlessly scary” by the Natural Products Association (NPA). The commentary’s authors, Donald Marcus, MD, and Arthrur Grollman, MD, read our coverage, and we now offer them the opportunity to respond to the criticisms.
We will provide NPA and CRN a right to reply the letter below, to the published on Monday.
The following was submitted by Drs Marcus and Grollman.
To the Editor,
Our commentary, “The Consequences of Ineffective Regulation of Dietary Supplements. Marcus DM and Grollman AP. Arch Intern Med 2012; 172:1035-1036”, summarized recent information concerning the health hazards of non-vitamin, non-mineral dietary supplements. That category includes traditional medicinal products, such as herbal remedies, that were inappropriately designated dietary supplements by the Dietary Supplement Health and Education Act (DSHEA) of 1994.
The commentary was criticized in this newsletter on July 16 as inaccurate and “needlessly scary” by a spokesperson for the Natural Products Association (NPA). Another organization, the Council for Responsible Nutrition (CRN), also voiced criticism of our commentary in another trade publication on July 12 (Natural Products Insider). The critics repeated the contention of the dietary supplement industry that DSHEA provides the Food and Drug Administration (FDA) with the authority to effectively regulate dietary supplements.
The limited authority of the FDA to regulate dietary supplements has been noted repeatedly during the past decade, and it was discussed at length in the Government Accountability Office (GAO) report that we cited. Pages 21-23 of the report list problems in three key areas that limit the FDA’s ability to identify safety concerns: lack of information about the identity and location of dietary supplement firms; lack of comprehensive information on the types and contents of dietary supplements that are on the market or their ingredients; and lack of information about product safety.
With regard to safety, at present companies are required to report only serious adverse events, which are defined as a life-threatening event or inpatient hospitalization, and not mild or moderate events. The limitations of that regulation are illustrated by a recent outbreak of selenium poisoning in 201 people, which was caused by a dietary supplement that contained 200 times the labeled concentration of selenium. Despite the chronic disability caused by the poisoning, manufacturers would have been required to report only one of the 201 cases.
The spokesman for CRN stated in the July 12 newsletter, “FDA has mandatory recall authority” to withdraw products it thinks are dangerous. However, the GAO report states on p. 25, “Once FDA has identified a safety concern, the agency’s ability to efficiently and effectively remove a product from the market is hindered by a lack of mandatory recall authority.”
The factors limiting the FDA’s recall authority are discussed on pages 25 and 26, and a table on p. 26 lists dietary supplement ingredients that have been banned in other countries but not in the United States.
In the July 16 newsletter, the NPA spokesperson stated that “The commentary relies on an old Office of Inspector General report from 2001 to produce an inappropriate estimate for the supposed number of annual adverse event reports.” In fact, our statement about an FDA estimate of 50,000 adverse events annually is based on the GAO report that was published in 2009.
The spokespersons’ criticisms of our paper are general in nature, and they do not address the data that are the basis of our commentary. In fact, the comments suggest that the critics are unfamiliar with the contents of the GAO reports and other publications that we cited. The NPA and CRN consistently reject all criticisms of the dietary supplement industry, and deny the validity of negative clinical trials of dietary supplements.
The industry would be better served by engaging in a dialogue that addresses the substance of problems associated with non-vitamin and non-mineral dietary supplements than by misleading public relations statements.
Donald M. Marcus, MD
Arthrur P. Grollman, MD
