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DOJ: FDA response on NAC petition is ‘forthcoming’

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The government's response to an amended lawsuit filed by the Natural Products Association reveals FDA may soon answer substantive questions about the legality of NAC in dietary supplements.

The U.S. Department of Justice plans to file a motion to dismiss a lawsuit filed in December by the Natural Products Association (NPA) challenging FDA’s position that NAC (N-acetyl-L-cysteine) is not a lawful ingredient in dietary supplements.

DOJ also signaled in a recent court filing that FDA intends to respond by March 31 to a citizen petition filed by NPA in August 2021.

NPA’s citizen petition requested FDA conclude NAC is not excluded from the definition of a dietary supplement, or alternatively, recommend issuance of a notice-and-comment regulation that would make NAC lawful in supplements.

In a letter to Federal Judge Theodore D. Chuang of the District of Maryland, DOJ trial attorney Noah T. Katzen disclosed the defendants intended to move to dismiss NPA’s amended complaint, or in the alternative, request the court temporarily stay the case.

Chuang is expected to set a pre-motion conference with the litigants to discuss the issues raised by DOJ in its letter. The judge also could determine a pre-motion conference is unnecessary and authorize DOJ to file a motion to dismiss.

According to a case management order signed by Chuang, NPA is not permitted to file a response to DOJ's letter expressing a notice of intent to file a motion. However, the trade association will have a chance to respond to a motion to dismiss—should DOJ eventually file one.

Standing, ripeness arguments

Katzen in his letter to Chuang explained why NPA’s complaint should be dismissed. He argued the court does not have “subject matter jurisdiction” because NPA has no “standing” to sue. NPA “has not alleged that it has or will suffer an injury fairly traceable to FDA’s challenged conduct,” Katzen wrote. “Instead, it alleges only that it has chosen to expend its resources to oppose FDA’s purported interpretation of the statute.”

He further argued NPA does not have “associational standing” since it did not identify injury to a single member of its group. “Although NPA claims that one or more of its members were denied export certifications, it does not specify what ‘concrete’ harm, if any, those members suffered as a result,” Katzen stated.

NPA’s lawsuit noted Amazon removed NAC products from its platform in 2021 after FDA declared in prior warning letters that NAC is not a lawful ingredient in supplements. Katzen, however, suggested any harm to NPA’s members is not traceable to “final agency action” or even FDA’s conduct because the action stemmed from independent conduct by Amazon.

NPA’s claims are not “ripe” either, considering its citizen petition is pending before FDA, Katzen wrote, adding “judicial review at this time would improperly bypass an administrative citizen petition process required by FDA regulations.”

Forthcoming response to citizen petition

Katzen disclosed FDA’s response to NPA’s citizen petition is “forthcoming.”

According to FDA, NAC was first approved as a drug in 1963 and therefore is barred from being marketed in dietary supplements. NPA had argued, in part, that applying a so-called race-to-market provision in the Dietary Supplement Health and Education Act of 1994 (DSHEA) violates a presumption against retroactive application of statutes.

Trade associations, including NPA, have submitted evidence to FDA that NAC was marketed in nutritional products before DSHEA’s passage. “Prior to DSHEA, there was no need for a responsible distributor to be concerned with the approval date of [a] drug/biologic or when a new drug was authorized for investigation,” Dan Fabricant, president and CEO of NPA, wrote in the citizen petition.

Although FDA informed NPA that the agency “intended to address at least the statutory interpretation argument (and, if necessary, possibly the rulemaking request) in NPA’s citizen petition no later than March 31, 2022,” the trade association “did not agree to FDA’s suggestion that the parties ask the court to stay the case,” Katzen revealed. NPA, instead, filed an amended complaint against FDA on Feb. 21.

A citizen petition related to NAC filed by the Council for Responsible Nutrition (CRN) also is pending at FDA.

Citizen petitions filed with FDA can linger for years without a substantive response, but DOJ’s letter indicates a response to NPA’s petition is imminent.

As an alternative request to dismissing the amended complaint, Katzen said the court should stay the case through March 31. “If the court issues a stay, FDA will file a status report seven days after March 31, 2022, to advise the court of its response to the citizen petition,” he wrote.

NPA reiterated its opposition to a stay, according to Katzen. FDA declined to comment on pending litigation.

Attorney Kevin Bell, whose law firm Arnall Golden Gregory LLP (AG) is representing NPA in its complaint, said nothing in DOJ’s letter was “surprising or unanticipated by NPA.”

Fabricant said FDA “has had more than ample time to respond” to his petition, noting Valentine’s Day (Feb. 14) was 180 days from the time his petition was filed. FDA has 180 days to respond to a petition, although it can delay its response if the issues are complex, for example.

“Unless we sued them, I don’t think any of this would be moving on NAC,” he said in an interview after being contacted about DOJ’s letter.

Fabricant said he anticipated FDA, in its response to NPA, would allow firms to market NAC through a policy of enforcement discretion—and return to the “exact same place we were” before the agency proclaimed in 2020 warning letters that NAC was excluded from the definition of a dietary supplement.

But he said that’s not possible.

“Even if FDA says, ‘Hey, we’re exercising enforcement discretion,’” that doesn’t mean Amazon will be comfortable reselling NAC on its website, Fabricant warned. Such a move by the agency also wouldn’t “undo” the harm created by FDA’s denial of certificates of free sale for NAC-containing products, he said.

“You can’t go back to the way it was before,” Fabricant added.

 

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