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NPA Files Citizen’s Petition with FDA on Specific CBD Relief Requests Enforcement Discretion on Drug Exclusion Clause for a single product to Review Premarket Notifications of CBD, consistent with the Law as cbdMD Safety Data is Submitted

NPA Files Citizen’s Petition with FDA on Specific CBD Relief Requests Enforcement Discretion on Drug Exclusion Clause for a single product to Review Premarket Notifications of CBD, consistent with the Law as cbdMD Safety Data is Submitted
NPA Files Citizen’s Petition with FDA on Specific CBD Relief Requests Enforcement Discretion on Drug Exclusion Clause for a single product to Review Premarket Notifications of CBD, consistent with the Law as cbdMD Safety Data is Submitted
February 22, 2022

WASHINGTON – The Natural Products Association (NPA) today in a Citizen’s Petition to the Food and Drug Administration (FDA) requested the FDA either:

  1. determine cannabidiol (CBD) is not excluded from the definition of a dietary supplement under 21 U.S.C. §321(ff)(3)(B) allowing the Commissioner the ability to exercise enforcement discretion in a specific and selective manner consistent with the premarket safety review of a new dietary ingredient notification or
  2. recommend the Secretary of Health and Human Services (HHS) issue a regulation after notice comment, finding CBD would be lawful.

NPA’s full Citizen’s Petition can be viewed here, and was submitted alongside new dietary ingredient notification by the company cbdMD for a regulatory determination on one of its products.

“For more than four years, the dietary supplement industry has done all but beg the FDA to make safety determinations for CBD.  In that time, 36 U.S. states have established regulatory standards and the European Union has decided on an interim level for CBD consumption. While we wait for a broader regulatory path for CBD, today’s action by NPA paves the way for the agency to review individual products and render an opinion on a case-by-case basis,” said Daniel Fabricant, Ph.D., President, and CEO of NPA.

NPA has also filed a citizen’s petition and lawsuit against the FDA on NAC which can be viewed here and here.

“Both issues surrounding NAC and CBD are glaring examples of the FDA fundamentally failing consumers and industry. Today’s citizen’s petition positions NPA to have all options available and will ensure CBD’s regulatory uncertainty is rectified,” said Fabricant.

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