legal news that affects everyone in this industry

Qualified Health Claims - Set Them Free!!
In the several years after DSHEA's passage in 1994, FDA steadfastly refused to approve any type of health claim on a dietary supplement that was truthful and non-misleading. FDA's intransigence resulted in a round of First Amendment freedom of commercial speech lawsuits that the agency consistently lost - and not just lost but lost big. ...more

Burden, burden, who's got the burden?
On April 13, 2005, the U.S. District Court for the District of Utah invalidated FDA's final rule banning all dietary supplements containing ephedrine-alkaloids. The Utah federal court entered an injunction stopping FDA from taking any enforcement action to block manufacturers from selling supplements containing 10 mg or less of ephedrine-alkaloids per daily dose. The FDA's final rule - issued in February 2004 - had required dietary supplement manufacturers to prove an ephedrine-alkaloid dietary supplement created a significant benefit; otherwise, if FDA subsequently found any evidence of health risk associated with the supplement, the product would be considered by FDA to be an adulterated dietary supplement for which an agency enforcement action would follow. The Utah federal court, however, rejected the FDA's interpretation of the dietary supplement adulteration provision in the Food Drug and Cosmetic Act. ...more

As goes Europe, so goes the world?
On April 5, 2005, the Advocate General's office of the European Court of Justice issued an opinion that the European Union's (EU) Food Supplement Directive is "ill-designed and grossly insufficient." The Advocate General's opinion represents the final legal review of this piece of EU legislation before its ban on unapproved vitamins and minerals goes into effect August 1, 2005. ...more