Dr. Rath Health Foundation

Dr. Rath Health Foundation

Responsibility for a healthy world Dr. Rath Research Institute 100+ Studies Published In PubMed

Appeals Court Backs FDA Ban On Ephedra – The Wider Implications

September 2006 – The recent ruling by a three-judge panel of the 10th U.S. Circuit Court of Appeals – which found that the Food and Drug Administration (FDA) was correct in conducting a risk-benefit analysis to determine if ephedra presents an "unreasonable risk of illness or injury" – could have profound implications for the future regulation of all dietary supplements sold in the United States.

The ruling, handed down Aug. 17, overturned an April 2005 ruling by the District Court of Utah that the FDA was incorrect in using risk analysis to support its ban of ephedra. Significantly, therefore, when conducting its analysis of ephedra, the FDA had refused to acknowledge any benefits for the herb, and as such the Court of Appeals' ruling has now seemingly set a very dangerous precedent.

Essentially, if in future the FDA decides, when conducting a risk-benefit analysis, that a dietary supplement's benefit is non-significant, then any level of risk could now seemingly qualify as "unreasonable risk of illness or injury", as provided for under section 4 of DSHEA. For example, if the FDA decides that there is no benefit from consuming supplements containing vitamin C in levels above the recommended daily amount (RDA) – currently set at a mere 75 mg/day for females and 90 mg/day for males – then the fact that vitamin C can cause diarrhoea above tolerance levels could potentially result in an "unreasonable risk of illness or injury" classification and subsequent restrictions upon its sale.

As such, given that many of the benefits attributed to dietary supplements effectively put them in the area of what is currently defined as drug use, the implication is that the FDA can in future simply decide that such benefits do not apply to products regulated as supplements, and assign the benefit portion of the resulting risk-benefit analysis to zero. By establishing this precedent, and ruling in favor of this methodology, the court would therefore seem to have tipped the regulatory scales significantly in the FDA's favor.

Nutraceutical Corp., one of the original companies to challenge the FDA ban, is currently reviewing available options and may seek a rehearing in front all 19 judges of the tenth circuit.