DC judge rules 'as expected' in GMP challenge case

By Stephen Daniells

- Last updated on GMT

The plaintiffs have not decided if they will appeal...
The plaintiffs have not decided if they will appeal...

Related tags: Gmps, Judge, Rulemaking, Dietary supplement

A case challenging the dietary supplement good manufacturing practice (GMP) regulations has been dismissed by the US District Court for the District of Columbia.

The case - Alliance for Natural Health US et a;. v. Sebelius et al.​ – accused FDA of being in breach of a Fifth Amendment requirement against vague laws and asked 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 argued is not currently the case.

The plaintiffs were listed as the Alliance for Natural Health US, the Coalition to End FDA and FTC Censorship, and Duke Pearson and Sandy Shaw, two supplement formulators.

In her decision, available here​, US District Court Judge Beryl Howell stated: “The Court concludes that the challenged sections of the GMP Final Rule did not exceed the FDA’s statutory authority, are not impermissibly vague under the due process clause, and are not arbitrary and capricious under the [Administrative Procedure Act (APA)]. Accordingly, summary judgment is GRANTED for the defendants and DENIED for the plaintiffs.”

Expected result

Speaking with NutraIngredients-USA, Steve Mister, president & CEO at the Council for Responsible Nutrition (CRN) said the case was not a big issue, “because of how it turned out”​.

“The decision came out as expected,” ​he added, “and we’re quite pleased with that.”

“The reality is that consumers need GMPs in order to have confidence in the products. GMPs represent standards of quality and this is what we need,” ​added Mister.

Mister’s views were echoed by Cara Welch, PhD, vice president, scientific & regulatory affairs at the Natural Products Association (NPA). “The majority of the industry thinks that GMPs are a great initiative,”​ she said.

“I don’t think anyone was too surprised by the decision, and now it is time to move on an ensure GMP compliance,” ​added Dr Welch.


It is not known if the door is now closed on this case. Jonathan Emord of Virginia-based law firm, Emord & Associates, which led the action, told NutraIngredients-USA.com that his clients have not yet decided whether to file an appeal.

Emord added that the court’s decision “rests on an erroneous interpretation of the unambiguous provisions of 21 USC 342(g)(2). In that subsection, FDA is authorized to prescribe cGMPs for supplements but only under certain conditions. In particular, the Section includes this prohibition: FDA ‘may not impose standards for which there is no current and generally available analytical methodology’.”

“The GMPs adopted by FDA include no reference to a current and generally available analytical methodology despite imposing standards governing every aspect of supplement production, holding, storage, and distribution. Thus, the statute’s direct command, and condition precedent, was violated by the agency in the GMPs.

“In addition, Congress expected in this Section, and the Fifth Amendment requires, sufficient clarity of regulation so that the regulated class can discern what is expected of it. The GMPs lack that requisite clarity.

“The GMPs carry with them the potential for criminal prosecution (a finding of adulteration permits criminal enforcement under the FDCA). In such a circumstance greater precision is required than in the ordinary civil context.

“In short, the GMPs are so vague as to permit criminal prosecution without the regulated class knowing that its action gives rise to a crime,”​ he added.

Related topics: Regulation, GMPs, QA & QC

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1 comment

My Money is on Emord on appeal

Posted by Robert Snyder, JD., MPH.,

First, very well written article. Procedural matters are sometimes hard to follow and get lost in translation.
Second, Emord's point is articulated well. Vagueness and overbreath is all too common in statutory language, and this is just another example.
Keep fighting the good fight, Mr. Emord.

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