Adverse Effects of Dietary Supplements Should Be Reported, Panel Says
A federal advisory board from the Institute of Medicine and the National Research Council on Thursday released a report recommending changes in dietary supplement regulation and defining the limits of FDA's authority to take supplements off the market, the Wall Street Journal reports (Wilde Mathews, Wall Street Journal, 4/2). The panel's four-year study looked at how supplements are currently regulated under the 1994 Dietary Supplement Health and Education Act and examined what scientific and regulatory framework might allow FDA to more rigorously oversee the $16 billion industry (Kaufman, Washington Post, 4/2). Under current law, vitamins and supplements are regulated as food rather than drugs. They can be marketed without prior clinical testing to prove their safety and effectiveness and without authorization from the federal government (Smith, Salt Lake Tribune, 4/2). The panel said that when "clear-cut human data" is not available, FDA officials should follow step-by-step instructions outlined in the report to evaluate a supplement's safety, the AP/Las Vegas Sun reports (Neergaard, AP/Las Vegas Sun, 4/1). Although current law requires FDA to demonstrate "significant or unreasonable risk" from dietary supplements before pulling them off the market, the panel said the stipulation should not be interpreted to mean the agency must "prove that an ingredient is unsafe" (Wall Street Journal, 4/2). The law "permits the assumption, rather than hard evidence, that a product is safe," so determining that an ingredient carries an unreasonable risk can also be based on assumption, panel chair Barbara Schneeman, a University of California-Davis nutrition professor, said, according to the Tribune (Salt Lake Tribune, 4/2). The panel's interpretation of the law "challenges long-held assumptions" about the evidence FDA needs to remove supplements from the market, the AP/Sun reports (AP/Las Vegas Sun, 4/1). The panel's report also recommended the following:
- Supplement manufacturers should be required to share all research, both positive and negative, with FDA (Washington Post, 4/2).
- Manufacturers should be required to file safety information with FDA whenever a product's formulation is changed. Currently, safety information must only be submitted when new ingredients that were not sold before 1994 are added to products.
- Any federally funded studies examining supplements' effectiveness should also report any safety findings (Wall Street Journal, 4/2).
- Because data on supplements' safety is often sparse, FDA should conduct its own research using animal models to assess the risk of negative side effects from supplements (Washington Post, 4/2).
- FDA should receive more funding to regulate the dietary supplement industry (Wall Street Journal, 4/2). Currently, the agency's dietary supplements office receives $10 million in funding each year and has a staff of 25 (AP/Las Vegas Sun, 4/1).