New bill lowers bar on defining supplement risk

A new bill in Congress would amend the Dietary Supplements Health and Education Act to keep dosage out of consideration in risk-benefit analysis for dietary supplements. Representatives from the supplements industry, which opposes the change, say the bill is unlikely to pass as it is.

Introduced by U.S. Rep. Susan Davis, D-Calif., the bill seems to be a reaction to the U.S. District Court's April decision overruling parts of the U.S. Food and Drug Administration's ban on ephedra.

Labeled the Dietary Supplement Access and Awareness Act, the bill would legally establish the use of risk-benefit analysis in determining if a product presents "unreasonable risk," the benchmark for banning a substance. The bill would allow the FDA to disallow certain supplements "even though there are uncertainties as to the levels of a dietary ingredient that may present a risk." The bill also states that without sufficient benefit, "the presence of even a relatively small risk of a serious adverse health effect to a user may be considered by the Secretary as unreasonable."

Michael McGuffin, president of the American Herbal Products Association, said the bill is bad science and bad law.

McGuffin pointed out that "the dose makes the poison," quoting Paracelsus, a 16th century physician often referred to as the father of toxicology. "A risk analysis that does not consider the amount of the ingredient stands several hundred years of science on its head," he said in a news release.

McGuffin said the amendment is unnecessary despite some potentially confusing language in how DSHEA determines risk. "I don't believe they need to fix DSHEA; it has more to do with the FDA?s implementation."

Loren Israelsen, president of the Salt Lake City consulting firm LDI Group, said he thinks the bill is unlikely to pass as it stands, and pointed out that Davis, the bill's sponsor, is known for her anti-DSHEA sentiments.

McGuffin agreed that the bill is unlikely to make it into law, and said AHPA would oppose the legislation not only because of the risk-benefit clause, but also because the bill neglects to provide the supplements industry with the same protection the drug industry receives in the adverse-event reporting process.

McGuffin on Tuesday welcomed the appointment of Lester Crawford as FDA commissioner. Crawford had been acting commissioner for the past year, and was confirmed in the permanent role by a Senate vote of 78-16. "The confirmation of Dr. Crawford as FDA commissioner should be seen as good news by responsible marketers of dietary supplements," he said in a statement.