The action accuses the FDA of being in breach of a Fifth Amendment requirement against vague laws and asks for areas of the rule to be rewritten so that dietary supplement manufacturers understand when they are in breach of the law – which the action argues is not currently the case.
The action, mounted in the same Washington DC District Court where the FDA is being challenged over its treatment of qualified selenium health claims, seeks to make the FDA clarify actions companies are required to take under the GMP (Good Manufacturing Practices) regulations to be in compliance. These include record-keeping requirements and testing standards and methods.
“The GMP rule is enormous in length but flawed in development in that it gives the agency unbridled discretion to act when it perceives a company to be in breach of standards that are not clear,” “It is an unacceptable law,” “If parties do not know what they are required to do to avoid prosecution then that is a bad law and that is the case with the GMP rule. Words like ‘sufficient’ and ‘adequate’ that appear in its text are themselves not sufficient or adequate in lawmaking.” said Jonathan W Emord of Virginia-based law firm, Emord & Associates, which is heading the action.
The FDA has 60 days to respond to the action.