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Dietary supplement industry sues FDA over ban on obscure drug

The Natural Products Association says the agency is taking action against sellers of NAC while also claiming it has not yet made a final determination as to the substance’s legal status.

BALTIMORE (CN) — A powerful trade association claims in a federal lawsuit against the Food and Drug Administration that the regulator is illegally trying to retroactively prohibit sales of NAC, an obscure drug used to counteract aspirin overdoses.

“Hundreds of popular dietary supplement products containing the dietary ingredient NAC have been on sale in the United States to consumers who have come to rely on them,” according to the lawsuit filed in Baltimore federal court late Monday. “There is no evidence in the public record that NAC is harmful or injurious to consumers when the supplement is used as directed.”

The complaint, filed on behalf of the Natural Products Association by attorney Kevin Bell of the Washington firm Arnall Golden Gregory, is the latest skirmish is a decades-long battle over dietary supplement regulation. For decades the supplement industry has accused the FDA of overregulation.

In 1994, the Dietary Supplement and Health Education Act, known as DSHEA, gave the supplement industry the upper hand, forcing the government to prove ingredients are harmful before taking action, and grandfathering in ingredients marketed before the law’s passage. Since then the industry has accused the FDA of sloppy science whenever it has acted.

The industry often has won, and it has grown significantly in recently years.

NAC is the popular name for N-acetyl cysteine, a drug approved in 1963 to counteract overdoses of aspirin. Dietary supplement manufacturers tout its antioxidant effects and sell it under brand names like Protocol for Life, Immune Therapy and Life Extension.

“There's evidence it can help prevent kidney or neurologic damage caused by some drugs,” according to WebMD. But “optimal doses of NAC as a supplement have not been set for any condition. Quality and active ingredients in supplements may vary widely from maker to maker.”

The Natural Products Association's lawsuit says the FDA has stealthily cracked down on NAC sellers by sending warning letters and pressuring Amazon to shut down sellers on its online platform, and denying export licenses to sellers while also claiming it has not yet made a final determination as to the substance’s legal status.

“They haven’t really engaged the industry in any way that’s really transparent on this issue,” said Dan Fabricant, CEO and president of the Natural Products Association and a former FDA dietary supplement division director.

The regulatory agency was seeking data about when NAC was first marketed in supplements as recently as Nov. 24, but the warning letters calling the substance illegal went out last summer, according to Fabricant.

"Shouldn’t they have met their evidentiary burden back then?” he said in an interview.

The lawsuit points to an even earlier case, in 2017, when the FDA raided a Florida company called Blackstone Labs LLC, charging its owners criminally for distributing NAC, among other products.

“In fact, the FDA has taken final agency action as evidenced by its unambiguous representations to the Court in the Blackstone case, thereby establishing FDA’s final agency action ripe for review under the Administrative Procedure Act," the complaint states.

Fabricant says that, under the FDA’s interpretation of federal law, the agency could criminalize the sale of almost any common drug that is also used in supplements, including common B vitamins, which are also found in foods and approved as drugs. “By FDA’s logic they could go after niacin,” he said.

“The legislative history shows that the [DSHEA] drug provision was not intended to apply retroactively,” the complaint states. “Further, the purpose of that provision was to incentivize the development of new drugs after DSHEA’s enactment. Drug development would not be incentivized by precluding the sale of an ingredient that has been sold both as a drug and as a dietary supplement for many years before DSHEA was enacted.”

The FDA did not respond to a request for comment.

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