Market Updates, Regulations

No Substantive FDA Response to CRN Petition on ‘Drug Preclusion’

Due to “competing priorities,” the agency provided no clarification on how it interprets the provision of DSHEA which defines drugs versus dietary ingredients.

Well after a 180-day deadline, the U.S. Food and Drug Administration (FDA) responded to a Citizen Petition filed by the Council for Responsible Nutrition (CRN) which asked the agency to provide clarity on its interpretation of the ‘drug preclusion’ provision of the Dietary Supplements Health and Education Act (DSHEA).
 
However, Cara Welch, PhD, director of the Office of Dietary Supplement Programs, said that the agency hasn’t reached a decision due to competing priorities.
 
CRN originally issued the Citizen Petition in response to a number of questionable stances FDA has taken on ingredients like cannabidiol (CBD), N-acetyl-cysteine (NAC), and nicotinamide mononucleotide (NMN), among others.
 
Each of these ingredients was declared illegal to market as a dietary ingredient by FDA in warning letters due to the fact that they were first authorized for research as Investigational New Drugs (INDs).

But CRN and other critics argue that the agency hasn’t been clear about the evidence it used to reach decisions on these ingredients, and has had inconsistent interpretations of the ‘drug preclusion’ paradigm of DSHEA, which all favor the pharmaceutical industry in the “race to market” established by the law.
 
Points of Contention
 
In CRN’s petition, the association made a number of requests to the agency that it hopes would prevent future dietary ingredient innovators from being blindsided as they were with CBD, NMN, and NAC.

  • Determine that the preclusion date referenced in the statute is the date that the existence of substantial clinical trials are made public, and not the non-public date on which an IND application goes into effect;
  • Determine that “marketing” of dietary ingredients isn’t limited to marketing in the U.S., and doesn’t require “legal” marketing of the ingredient;
  • Determine that evidence of marketing as a food or dietary supplement should be dispositive, unless FDA has met the burden of proving that the marketing was unlawful;
  • Determine that “substantial clinical investigations” refers to clinical trials that are adequately designed and powered to support approval of a drug;
  • Determine that the agency’s prior affirmative statements recognizing the legal status of a particular article as a legal dietary ingredient prevents FDA from subsequently reversing that decision on the grounds of drug preclusion (which was the case with FDA’s prior approval of NMN). 
CRN “Optimistic Balance Will Eventually Be Achieved”
 
CRN noted in a statement that the lack of transparency about which ingredients will be plucked from the dietary supplements market without any predictability has led to supplement companies losing out on investments of millions of dollars researching safety and effectiveness of new dietary ingredients.
 
Still, Steve Mister, president and CEO of CRN, stated that he is optimistic that the agency is capable and willing to strike a balance despite receiving such an insubstantial response to the petition.
 
At CRN’s annual industry conference, Commissioner Robert Califf acknowledged the need for transparency on the issue.
 
“[…] If you’re going to innovate, you’ve got to have a set of rules that ensure that the innovations that you’re making are actually beneficial and not detrimental,” he said during a fireside chat with Mister. “And so, what those rules should be will be a topic of discussion. We’re in favor of innovation.”
 
“We remain committed to helping the FDA understand how vital this issue is to our industry and public health, and how important it is to level the playing field between pharmaceutical companies and supplement manufacturers when it comes to creating incentives for innovating first-to-market products,” said Mister. “If the FDA is truly in favor of innovation, a thorough, if not timely, analysis and response to our petition would be a great place to start. And if FDA continues to believe the current statute is unclear or lacking a balanced approach, we call on the agency to work with us and Congress to address these issues in legislation.”
 
 

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