The Food and Drug Administration (FDA) has urged the court to restore the ban on diet supplements that contains low levels of the weight loss aid, Ephedra . The ban is said to have been lifted by a federal judge owing to gross misunderstanding of the law.
Ephedra was banned two years back due to reports of side effects such as heart attacks, hypertension and an increased risk of illness or injury at any given dose. The U.S. District Judge Tena Campbell in Salt Lake City, stating that it would not apply to diet supplements containing Ephedra up to 10 mgs, ruled the ban last year. The ban was however, challenged by Nutraceutical Corp. The representative of the FDA, Christine Kohl, a representative of the FDA said that the federal judge had not properly understood the law or the duty of the FDA in regulating various diet supplements. ‘Campbell essentially ignored scientific information on Ephedra's effects on the body,’ she said in a statement.The Federal judge ruled that the FDA improperly required Nutraceutical to establish that Ephedra use was related to some benefits, according to the Associated Press. In response, Kohl expressed that the FDA should have had to prove harm.
The FDA ban was based on a doctor’s study that had researched about the benefits and risks of various substances, similar to Ephedra rather than on use of Ephedra use. As Ephedra is classified under the diet supplements category, manufacturers are not required to conduct studies to assess the safety and efficacy of the diet supplements. The amount of data available is therefore very limited.
If the ban were restored, it would essentially give the FDA license to ban any product it believes can cause harm, even if the harm comes only at extremely high doses.
