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  • Shelly Albaum

Supplemental FDA Petition Comes to New York


ChromaDex today filed a letter with Judge Caproni in the Southern District of New York bringing to the Court's attention the supplemental petition that ChromaDex delivered to the FDA earlier this week. You can read the letter here:

Cooley's Letter Regarding Supplemental FDA Petition

We predicted earlier this week that the supplemental petition would strengthen ChromaDex's motion to dismiss Elysium's complaint in the SDNY, and ChromaDex apparently agrees. The letter, excerpted below, points out that

1. Elysium's complaint rests on allegations arising from the FDA petition

2. FDA regulations allow ChromaDex to supplement the original petition

3. The supplemental petition requests additional FDA action

4. Discovery was stayed pending resolution of motions to dismiss

5. Mediation was completed without settlement

6. The motions to dismiss are fully briefed and ripe for oral argument and/or resolution by the court

Moving On...

I think it's very likely that Elysium's complaint based on the FDA petition will be entirely dismissed, for the reasons discussed here. So in the coming weeks the legal suspense will mostly likely focus on:

1. Whether Elysium's IPR challenge to the '086 Patent gets dismissed the way its challenge to the '807 Patent did, and

2. How much of ChromaDex's BIG Complaint survives Elysium's motion to dismiss, which you can read about here:

____________________________

Excerpt from ChromaDex's Letter to Judge Caproni regarding ChromaDex's supplemental FDA petition:

...As discussed in more depth in the Supplemental Petition, ChromaDex requests that the FDA take the following additional administrative actions:

ChromaDex filed the original Citizen Petition with the FDA on August 18, 2017 (the "Petition"), requesting that the agency take action under its discretionary authority to investigate, seize, and enjoin the sale of BASIS, a dietary supplement product marketed by Elysium Health, Inc. ("Elysium"). Elysium filed a response to the Petition with the FDA on September 22, 2017. The FDA has not yet issued a decision on the substantive merits of the Petition.

ChromaDex filed the Supplemental Petition with the FDA on January 16, 2018 to request that the agency take additional administrative action. The submission is authorized under FDA regulations permitting supplementation at any time prior to a final decision. 21 C.F.R. § 10.30(g). The Supplemental Petition is attached hereto for reference as Exhibit A.

As discussed in more depth in the Supplemental Petition, ChromaDex requests that the FDA take the following additional administrative actions:

1) State in a public guidance or similar announcement that the guidelines published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH") addressing residual solvents in drugs do not apply to dietary supplements;

2) Issue an order pursuant to Section 413(b) of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") that nicotinamide riboside chloride ("NR") is not reasonably expected to be safe if it contains new impurities such as toluene or any other Class 1 or Class 2 drug solvents that were not included in the toxicology studies conducted to establish the safety of NR for its intended use; and

3) Finalize the 2016 FDA draft guidance on New Dietary Ingredient Notifications ("NDINs") and clarify that the FDA will prioritize enforcement of the NDIN requirement established in Section 413(a)(2) of the FD&C Act in circumstances where a dietary supplement manufacturer has taken the necessary steps to comply with the notification requirement , but other manufacturers continue to distribute products containing the same New Dietary Ingredient without complying with that law.

These requests call for the FDA to take actions that fall under the agency's broad "authority to promulgate regulations for the efficient enforcement" of the FD&C Act, 21 U.S.C. § 371(a}, as well as its specific responsibility to issue regulations implementing statutory requirements from the FD&C Act pertaining to New Dietary Ingredients, 21 U.S.C. § 350.

As the Court is aware, Elysium's complaint in the above-captioned action rests on allegations of defamation and deceptive business practices arising from the Petition...ChromaDex moved to dismiss on October 19, 2017...and the parties completed briefing that motion on November 9, 2017...

The court issued an order on November 3, 2017 (Dkt. 27) ordering the parties to mediation, which was completed (without settlement) on Friday January 12, 2018, and staying all discovery pending the resolution of any motions to dismiss. The motions to dismiss are, therefore, ripe for oral argument and/or for the court to take under submission.

#CDXC #ChromaDex #ElysiumHealth #Litigation

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