Government

Law mandates reporting of supplements' bad effects

The AMA says the measure will help patients become more aware of the problems that can be associated with these products.

By Doug Trapp — Posted Jan. 15, 2007

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Legislation signed into law last month will for the first time require the makers of dietary supplements and other nonprescription drugs to report serious adverse events to the government.

Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, manufacturers and distributors must report this information to the Food and Drug Administration within 15 business days. The law will take effect in December 2007.

The measure requires dietary supplements' packaging to have a U.S. phone number or address where consumers can report adverse events. Those reports must be forwarded to the FDA through its MedWatch forum. Previously, makers of dietary supplements reported adverse events only on a voluntary basis.

The bipartisan legislation was supported by the dietary supplement industry, consumer advocates and the American Medical Association.

Edward L. Langston, MD, chair-elect of the AMA Board of Trustees, said the legislation is a good step toward stronger regulation. "These drugs can cause serious side effects and detrimental reactions when combined with prescription drugs," Dr. Langston said.

A representative of Consumers Union, publisher of Consumer Reports magazine, said the measure is overdue. "We need to do a lot more on the safety of these things," said Bill Vaughan, senior policy analyst at Consumers Union.

Steve Mister, president and CEO of the Council for Responsible Nutrition, said the new law ultimately will prove how safe dietary supplements are. The council represents about 75 companies of various sizes in the dietary supplement industry.

"Our members believe [reporting is] just the right thing for a responsible and mature industry to do," Mister said. He added that a large majority of the council's members already voluntarily report serious adverse events to the FDA. "Our members tell us that they get very few serious adverse reactions and things associated with their products," Mister said.

One of the measure's sponsors, Sen. Orrin Hatch (R, Utah), said the legislation lets consumers know that their adverse event reports will be taken seriously. At the same time, it doesn't restrict access to supplements.

"This bill strikes the right balance between necessary regulation and over-regulation," Hatch said. Nearly 60% of Americans regularly use dietary supplements, he said. Utah, among a few other states, has a significant number of dietary supplement-related businesses.

Years of growth propelled the supplement industry to $20.3 billion in sales in 2005, according to the Nutrition Business Journal and Mister. The market includes multivitamins, which are the best-selling dietary supplements, as well as minerals, herbals, botanicals, sports nutrition, weight management products and specialty supplements such as omega 3, according to Council for Responsible Nutrition spokeswoman Judy Blatman.

A call for more research

Consumers Union's Vaughan wants the FDA to scrutinize the accuracy of supplements' labels and push for clinical trials. Not enough is understood about how these products react with each other and prescription drugs. Also, people sometimes take oversized doses because they don't understand how potent supplements can be, he said.

"These things can kill you," Vaughan said.

The products are regulated under the Dietary Supplement Health and Education Act of 1994, also sponsored by Hatch. Under this law, supplements are assumed to be safe until proven harmful by the FDA.

The agency banned ephedra -- a naturally occurring stimulant used for weight loss -- in April 2004 after receiving more than 16,000 adverse event reports. An estimated 100 deaths were tied to ephedra, including the 2003 death of 23-year-old Orioles pitcher Steve Belcher.

Ephedra, also known as ma huang, has a principal active ingredient of ephedrine. The FDA regulates it in its synthesized form. The agency found supplements with ephedrine posed a particular risk for people with heart disease and high blood pressure.

Marketers of ephedra, however, have argued it is safe in small doses and are fighting the ban in court.

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ADDITIONAL INFORMATION

Reporting adverse events

In December 2006, Congress passed and President Bush signed into law the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which:

  • Requires manufacturers and distributors of dietary supplements and nonprescription drugs to report serious adverse events to the Food and Drug Administration within 15 business days.
  • Defines a serious adverse event as one resulting in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or a medical treatment to prevent any of these outcomes.
  • Requires any supplement or nonprescription drug to have on the label a U.S. address or phone number to which consumers can report adverse events.
  • Allows the general public to report and access adverse event records through the FDA's MedWatch system.
  • Specifies that the submission of any adverse event report is not an admission that the drug or supplement contributed to the adverse event.

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External links

MedWatch, the Food and Drug Administration's safety information and adverse event reporting program (link)

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