By Sean Moloughney, Editor01.27.23
FDA announced Jan. 26 that “the existing regulatory frameworks for foods and supplements are not appropriate for cannabidiol” and it wants guidance from Congress on “a new regulatory pathway.”
Natural Products Association (NPA) President and CEO Daniel Fabricant, PhD, didn’t mince words, saying the agency’s action amounted to “an astonishing dereliction of duty, especially compared to the agility and professionalism the agency showed it was capable of during the pandemic.”
“After more than a decade of promises, hearings, data sharing, market proliferation, and states filling the regulatory vacuum, the FDA’s Dietary Supplement Division claims it cannot do what Congress authorized, which is to regulate dietary supplements under the law,” Fabricant said.
“But it gets scarier,” he continued.
When reading between the lines of FDA’s statement, “the agency appears to be saying that it would prefer to defy and attack DSHEA and develop different regulatory paths for ingredients at its own discretion. That could include requiring premarket approval, unnecessary testing, or who knows what. That is an especially dangerous precedent not only for CBD but for the entire natural products industry and ingredients like hemp that clearly fall under the agency’s jurisdiction.”
In its response letter to NPA’s petition, FDA said it’s not aware of any evidence “that would call into question our conclusion that CBD is excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act.”
In the same letter, the agency acknowledged that it previously stated in 2018, when Scott Gottlieb was FDA Commissioner, “we were willing to consider the possibility of rulemaking under section 201(ff)(3)(B) of the FD&C Act to create a regulatory pathway for CBD dietary supplements by removing the exclusion.”
However, “we also made clear that we would only do so if we could determine that CBD products would satisfy the relevant safety standards in the FD&C Act.”
FDA previously rejected two NDINs for CBD in July 2021, from Irwin Natural and Charlotte’s Web, citing the exclusion clause and “significant concerns” about safety.
In its petition, NPA said cbdMD's dossier contains substantial data that specifically addresses FDA’s previous concerns about hepatotoxicity and reproductive toxicity.
“Further, cbdMD has sold millions of products to consumers in the last few years and has never received an adverse event report from a consumer. cbdMD has thus conducted the robust testing that demonstrates that its products are reasonably expected to be safe and should allay any concern for the public health, thereby warranting that the Agency fulsomely review and respond to any data submitted by cbdMD concerning its CBD ingredient.”
NPA also noted safety data “was well-received” by FDA officials during a pre-NDIN meeting.
Still, FDA rejected NPA’s request, saying nothing is stopping cbdMD from filing its NDIN.
At the same time though, the agency said in its response letter: “The Petition does not identify any legal obligation for FDA to analyze an NDIN’s safety data when the relevant ingredient or product cannot legally be marketed as a dietary supplement. If cbdMD does not anticipate that they will benefit from the submission of an NDIN for a product that they think is likely to be excluded from the dietary supplement definition, then it is their prerogative not to bring such a product to market (and therefore not to submit such an NDIN)."
“We couldn’t be more disappointed and will look for relief with every branch of government and will need the help of our members to right the wrong,” Fabricant said.
Natural Products Association (NPA) President and CEO Daniel Fabricant, PhD, didn’t mince words, saying the agency’s action amounted to “an astonishing dereliction of duty, especially compared to the agility and professionalism the agency showed it was capable of during the pandemic.”
“After more than a decade of promises, hearings, data sharing, market proliferation, and states filling the regulatory vacuum, the FDA’s Dietary Supplement Division claims it cannot do what Congress authorized, which is to regulate dietary supplements under the law,” Fabricant said.
“But it gets scarier,” he continued.
When reading between the lines of FDA’s statement, “the agency appears to be saying that it would prefer to defy and attack DSHEA and develop different regulatory paths for ingredients at its own discretion. That could include requiring premarket approval, unnecessary testing, or who knows what. That is an especially dangerous precedent not only for CBD but for the entire natural products industry and ingredients like hemp that clearly fall under the agency’s jurisdiction.”
Exclusion Clause or Safety Concerns: Which Precedes the Other?
FDA has stated that under the Dietary Supplement Health and Education Act (DSHEA), ingredients are excluded from the definition of “dietary supplement” when “an article” is approved as a new drug or authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.In its response letter to NPA’s petition, FDA said it’s not aware of any evidence “that would call into question our conclusion that CBD is excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act.”
In the same letter, the agency acknowledged that it previously stated in 2018, when Scott Gottlieb was FDA Commissioner, “we were willing to consider the possibility of rulemaking under section 201(ff)(3)(B) of the FD&C Act to create a regulatory pathway for CBD dietary supplements by removing the exclusion.”
However, “we also made clear that we would only do so if we could determine that CBD products would satisfy the relevant safety standards in the FD&C Act.”
cbdMD Safety Data Investment
In order to provide safety data while protecting intellectual property, NPA had requested FDA examine new scientific data from cbdMD (NYSE American: YCBD), which spent about $1 million to develop its safety dossier, if the agency would agree to earnestly review the data “on its scientific merits and not on a broad policy statement on drug exclusion,” and issue an New Dietary Ingredient Notification (NDIN) response letter.FDA previously rejected two NDINs for CBD in July 2021, from Irwin Natural and Charlotte’s Web, citing the exclusion clause and “significant concerns” about safety.
In its petition, NPA said cbdMD's dossier contains substantial data that specifically addresses FDA’s previous concerns about hepatotoxicity and reproductive toxicity.
“Further, cbdMD has sold millions of products to consumers in the last few years and has never received an adverse event report from a consumer. cbdMD has thus conducted the robust testing that demonstrates that its products are reasonably expected to be safe and should allay any concern for the public health, thereby warranting that the Agency fulsomely review and respond to any data submitted by cbdMD concerning its CBD ingredient.”
NPA also noted safety data “was well-received” by FDA officials during a pre-NDIN meeting.
Still, FDA rejected NPA’s request, saying nothing is stopping cbdMD from filing its NDIN.
At the same time though, the agency said in its response letter: “The Petition does not identify any legal obligation for FDA to analyze an NDIN’s safety data when the relevant ingredient or product cannot legally be marketed as a dietary supplement. If cbdMD does not anticipate that they will benefit from the submission of an NDIN for a product that they think is likely to be excluded from the dietary supplement definition, then it is their prerogative not to bring such a product to market (and therefore not to submit such an NDIN)."
“We couldn’t be more disappointed and will look for relief with every branch of government and will need the help of our members to right the wrong,” Fabricant said.
