Blackstone Labs criminal case shines light on NAC in supplements—again

Editor's note: On Oct. 8, after this article was published, the U.S. District Court continued the case to the two-week trial calendar beginning Nov. 22, 2021.

The federal judge overseeing a criminal trial that starts next week against a manufacturer of dietary supplements and its former executives must rule on a request by the defense to suppress evidence based on allegedly unlawful searches and seizures.

A trial is scheduled to begin Oct. 12 against Blackstone Labs and three of its former executives. The defendants—and several others indicted in 2019 who have since pleaded guilty to certain crimes—were charged with introducing into interstate commerce unapproved new drugs, conspiracy to distribute controlled substances, money laundering and other offenses.

Two affidavits signed by an FDA agent misrepresented the legal status of a number of ingredients, including NAC (N-acetyl-L-cysteine), according to defense lawyers for Blackstone Labs, Phillip Braun, Aaron Singerman and James Boccuzzi.

Authorities in early 2017 searched the premises of Blackstone Labs and a contract manufacturing partner (Ventech Labs) after securing warrants from a magistrate judge, based on affidavits from a special agent from FDA’s Office of Criminal Investigations.

“The two warrants were authorized on the basis of affidavits that did not properly establish probable cause, as each falsely and with reckless disregard for the truth, made affirmative determinations as to the legal standing of ingredients that the FDA itself had not formally addressed,” defense lawyers argued in a motion filed in September.

The court previously rejected the defendants’ arguments, and the motion failed to “mention or challenge the probable cause of mail fraud, wire fraud and conspiracy to commit those crimes,” U.S. Department of Justice (DOJ) lawyers responded this month in a document filed with U.S. District Judge William Dimitrouleas. According to the government, the defense’s motion also did not address Blackstone Labs’ unlawful distribution of a steroid product called Super DMX RX 2.0.

Per DOJ’s response, a court must suppress evidence seized through a search warrant issued based on a deliberately false affidavit.

The defendants’ motion claimed the affidavits signed by FDA’s agent, Kelly McCoy, contained several misrepresentations about the status of ingredients and other issues.

For instance, defense lawyers contested McCoy’s characterization of certain products as “new drugs” because they contained NAC.

“While the affiant claims that FDA approved a drug form of NAC in 1985, there are no drugs containing NAC as an active ingredient listed in the 1985 edition of FDA’s Orange Book,” the motion proclaimed. Lawyers also quoted FDA’s response to a 2016 petition for a qualified health claim; the agency categorized NAC as being a component of a dietary supplement.

However, FDA’s public database suggests NAC was approved as a drug in 1963—well before the 1985 date mentioned in the affidavit, federal prosecutors responded.

The affidavit also is “consistent with a 2010 FDA letter that identified NAC as a drug approved in 1985 and rejected its use as a new dietary ingredient,” they added.

The back-and-forth between the defense and prosecution resembles arguments between the dietary supplement industry and FDA over NAC’s legal status after the agency declared in 2020 warning letters that the ingredient could not be lawfully marketed in supplements.

Defense lawyers alleged McCoy also mischaracterized the status of other ingredients, including DMAA (1,3-dimethylamylamine).

While the FDA agent claimed DMAA was adulterated, the ingredient had been the subject of ongoing civil litigation regarding its legal status at the time of the affidavits, defense lawyers observed. Hi-Tech Pharmaceuticals, a manufacturer of supplements, sparred with FDA for years over the legal status of DMAA. Ultimately, a federal district court and appeals court both sided with the government—and the U.S. Supreme Court refused to hear the case.

But “DMAA’s legality was unsettled at the time of the affidavits, and the potential outcomes were not limited to those presented as facts in the affidavits,” the defendants’ motion stated. “Therefore, the affiant stated as settled law that which remained unadjudicated.”

According to DOJ, McCoy stated Blackstone Labs’ DMAA product, Dust Extreme, was adulterated under the law, even if it qualified as a dietary ingredient, because it would be a new dietary ingredient (NDI) that had not been the subject of a required premarket notification.

Moreover, a judge in 2013 approved a warrant for in rem forfeiture of DMAA, based on FDA’s declarations, DOJ lawyers stated in their response to the defendants’ motion to suppress evidence.

The government added, “While the owner of that seized DMAA filed suit to challenge FDA’s allegations and was still fighting the seizure, there was no reason to believe at the time of the affidavit that the court’s probable cause determination was wrong.”

Defense lawyers also challenged McCoy’s characterization of ostarine in his affidavit as “illegal” and “an unapproved new drug.” According to their motion, FDA had not addressed the issue of SARMs generally, or ostarine specifically, until it issued a public notice in October 2017—after the affidavits were signed.

The defense argued “a public notice does not comply with FDA’s rulemaking authority and does not have the force or effect of law.” Prosecutors countered the defendants haven’t disputed the affidavit’s statement that ostarine-containing products “were not dietary supplements ‘because ostarine is the subject of substantial clinical investigations which have been made public.’”

Under federal law, an ingredient or “article” first studied as a drug is excluded from the definition of a dietary supplement.

“The assertion that Blackstone ostarine products are unapproved new drugs cannot be intentionally or recklessly false when they are in agreement with scientific and legal positions communicated by FDA to the public,” DOJ lawyers added.

The defendants’ request to suppress evidence is among a flurry of motions filed in recent weeks on the eve of trial. As of press time, Judge Dimitrouleas had not ruled on the motion.