FDA sued over ‘unclear’ GMP rules

By Shane Starling

- Last updated on GMT

FDA sued over ‘unclear’ GMP rules
The Food and Drug Administration is being sued over its controversial and much-amended GMP regulations on the grounds the 1000-page rule is “ambiguous where it should be clear”, according to the attorney mounting the action.

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 FDA has 60 days to respond to the action which was lodge on Friday.

The agency was not available for comment by the time of publication.

Adequate and sufficient

“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,”​ said Jonathan W Emord of Virginia-based law firm, Emord & Associates, which is heading the action.

“It is an unacceptable law,”​ he told NutraIngredients-USA.com. “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.”

Emord emphasized that the action does not challenge the right of the FDA to administer GMPs, or call for the law to be scrapped.

He said the action had the support of “significant industry players”​ that preferred to remain in the background for fear of falling foul of regulators.

The other plaintiffs in the case are the Alliance for Natural Health US, the Coalition to End FDA and FTC Censorship, and Duke Pearson and Sandy Shaw, two supplement formulators.

One industry observer who was involved in the writing of the 1994 DSHEA (Dietary Supplements and Health Education Act) said the action had "next to no chance" ​of succeeding.

If you would like to comment on this action, click on the 'Have Your Say' button below.

Related topics: Regulation, GMPs, QA & QC

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