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Sen. McCaskill Asks FDA for More Guidance on NDI Enforcement

Sen. McCaskill Asks FDA for More Guidance on NDI Enforcement

In a letter to FDA, Sen. Claire McCaskill indicated FDA’s enforcement against companies for noncompliance with the NDI notification requirement under DSHEA has been light--an observation at least one industry lawyer agreed with.

U.S. Sen. Claire McCaskill (D-Missouri) recently urged FDA to elaborate in a guidance document how it will take enforcement action against dietary supplement manufacturers that fail to submit notifications to regulators before marketing a new dietary ingredient (NDI).

In draft guidance that was published in August, FDA said one of its objectives was to increase compliance with the NDI notification (NDIN) requirement that is laid out in the 22-year-old Dietary Supplement Health and Education Act (DSHEA).

“As currently written, the draft guidance includes little discussion of FDA enforcement authority," McCaskill wrote in a Dec. 12, 2016 letter to FDA Commissioner Robert M. Califf, M.D. “This is particularly alarming given that FDA has the sole authority to bring enforcement actions against companies for failure to file an NDI notification."

The senator, a ranking member of the Senate’s Special Committee on Aging, appeared to question whether FDA has taken sufficient enforcement against the supplement industry for noncompliance with the NDIN requirement.

“From 1994 to 2004, FDA sent no warning letters and took no enforcement actions against manufacturers for failing to submit an NDI, and between 2012 and June of 2015, they conducted fewer than 60 enforcement actions, including warning letters," wrote McCaskill, a former state county prosecutor.

This year alone, however, FDA issued six warning letters to firms marketing products labeled as containing Acacia rigidula without submitting required NDINs. Similarly, the agency sent 14 warning letters last year to firms marketing products labeled as containing DMBA without submitting required NDINs.

But Marc Ullman, a lawyer in New York who counsels dietary supplement firms on FDA regulations, said the senator had a point. He described as “woeful" the agency’s enforcement on NDI issues, especially when the issue involves competitive concerns.

Innovative companies that have complied with the NDIN requirement have filed complaints with FDA regarding “scofflaws who haven’t bothered to submit NDIs and are selling objectively inferior product," said Ullman, of counsel to the law firm Rivkin Radler LLP. However, with a few notable exceptions, FDA hasn’t acted where competitors have suffered an injury, he proclaimed.

“And it seems the only time FDA thinks that the failure to file an NDI is important when it’s a matter of competitive injury is when it moves to protect pharma, like with lovastatin or now with CBD," he said in a phone interview, referring to the pharmaceutical industry. “But if pharma isn’t the aggrieved party, nothing happens."

FDA suspects underreporting of NDINs based on anecdotal evidence, but regulators have difficulty tracking compliance since they aren’t aware of the number of NDIs released into the market each year. However, the agency has estimated there are more than 55,600 dietary supplements on the market, with 5,560 new dietary supplement products introduced annually.

Since 1994, FDA has received approximately 900 NDINs, Cara Welch, Ph.D., senior advisor to FDA’s Office of Dietary Supplement Programs, said in an emailed statement in August. Excluding NDINs that are resubmitted, FDA had received 610 unique NDINs as of the end of March 2016, she added. In a 2015 document, FDA reported receiving an average of 55 notifications per year over the past three years.

In the draft guidance, FDA indicated an investigation into a possible failure to submit an NDIN “would typically depend on factors relating to public health, such as potential for risk, extent of public exposure to the ingredient, and association with adverse events."

McCaskill argued such an explanation “will not provide a strong deterrent against non-compliance."

“FDA must make clear to manufacturers that any failure to comply with the notification requirements of DSHEA will be investigated and appropriate enforcement actions will be taken," the senator wrote.

"We appreciate Senator McCaskill’s input," Marianna Naum, an FDA spokeswoman, said when asked for comment on the recent letter. “We intend to carefully review all comments that we receive on the revised draft NDI guidance and we will give full consideration to those comments as we work to develop a final guidance."

Duffy MacKay, senior vice president of scientific and regulatory affairs with the Council for Responsible Nutrition (CRN), said while his trade organization appreciated the senator’s interest in supplements, some of her suggestions in the four-page letter to FDA would eat up “resources without a clear benefit to protecting public health."

In commenting on FDA’s openness to developing an authoritative list of old dietary ingredients that would be exempt from an NDIN under DSHEA, McCaskill recommended the agency publish information establishing the basis for its list, in addition to the form in which the ingredients appeared before 1994.

“There are many ways that FDA could use its resources to improve transparency, compliance, and public health—but making a database of 22-year-old purchase orders and catalogues has questionable value," MacKay said in an emailed statement.

McCaskill further requested FDA publish a list of all submitted NDINs, including the names of the ingredient and company, FDA’s response to the notification, and a link to the notification on the Federal Register. FDA already makes such information public, though as INSIDER reported in October, the agency is about two years behind in publishing the data, and McCaskill said “finding these notifications is a time-consuming and cumbersome process."

Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA), isn’t opposed to making the NDI information readily available to the public. But Fabricant, who previously served as the lead dietary supplement official at FDA, indicated the guidance should clarify ingredients are not adulterated simply because they aren’t on the list.

Fabricant also supported further clarification in the guidance on FDA’s enforcement strategy.

“You know, is it just going to be a technical adulteration," such as a new probiotic strain, he asked in a phone interview. Or will FDA take enforcement action based on the potential for harm to the public?

“Where are the priorities ranking?" Fabricant said.

Pieter Cohen, M.D., of the Cambridge Health Alliance and Harvard Medical School, who has researched several different supplements that have been tainted with pharmaceutical ingredients, agreed FDA enforcement was an important component to the guidance.

“While the guidance cannot correct important flaws in DSHEA, overall, it serves as an advance in respect to clarifying many areas of controversy and, if industry compliance is high and FDA enforcement is aggressive, it would lead to safer dietary supplements for American consumers," he wrote in comments filed with FDA.

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