Editor’s note: This is part two of a two-part series about a recent FDA meeting between dietary supplement trade associations and FDA officials. Read part one here.
Top FDA officials were recently made aware of regulatory issues of concern to dietary supplement trade groups, including the marketing of “tainted” or drug-spiked products, the CBD quandary facing the industry and inconsistencies in FDA inspections.
Council for Responsible Nutrition (CRN) President and CEO Steve Mister was among the trade association executives to meet on Jan. 3 with FDA officials, including FDA Commissioner Robert Califf, M.D.
The principal purpose of the virtual meeting was to discuss a report facilitated by the Reagan-Udall Foundation, which was focused on recommendations and findings concerning the human foods program.
Califf also provided industry stakeholders an opportunity to raise issues with FDA.
CRN’s Mister weighs in on tainted products, drug preclusion
In an interview, Mister recalled noting that FDA’s Office of Dietary Supplement Programs (ODSP) does not lead many investigations involving “tainted”—or drug-spiked—products being marketed as dietary supplements. While Mister said he acknowledged these products are both “an unapproved new drug and a mislabeled supplement,” he expressed concerns that the Center for Drug Evaluation and Research (CDER) appears to control the investigations rather than ODSP.
Mister said he raised concerns as well about CDER leading decisions that a specific ingredient is precluded from being marketed in dietary supplements due to its investigation or approval as a drug.
“And I made the point that people who know the industry [and] understand the regulation of the industry ought to be in a driver’s seat when FDA is making decisions that are going to impact the supplement industry,” Mister continued. “And that people at CDER should not be running those investigations and making those kinds of decisions.”
He also discussed the need for better coordination regarding day-to-day inspections between the Office of Regulatory Affairs (ORA), which oversees FDA audits of manufacturing facilities, and ODSP.
Finally, Mister noted FDA doesn’t have adequate resources to oversee the dietary supplement industry.
“The resources and the funding for this now $56 billion industry are hopelessly behind where they need to be for enforcement and oversight,” Mister said in the interview, and FDA must acknowledge that fact and “do some things to beef up the staffing and funding for dietary supplements.”
UNPA’s Israelsen provides input on CBD, NDIs and GRAS
The nearly hour-long meeting represented a rare opportunity for industry executives to have the ear of top FDA officials.
The last meeting between industry trade associations and FDA brass—specifically then-FDA Principal Deputy Commissioner Joshua Sharfstein, M.D.—took place during the Obama administration and was focused on tainted products marketed as dietary supplements, some industry leaders recalled.
“We’ve all searched our memories and are quite certain there have not been any commissioner-level meetings with the [dietary supplement] industry in the last 30 years, if ever,” United Natural Products Alliance (UNPA) President Loren Israelsen and his group’s senior political advisors, Peter Reinecke and Patricia Knight, said in a joint statement.
Combined, Israelsen, Reinecke and Knight have well over a century (120 years) of legislative and industry experience, Israelsen said. All three of them were involved with the drafting and negotiations of the Dietary Supplement Health and Education Act of 1994 (DSHEA), either as an industry stakeholder (Israelsen) or as senior staff members to former Sens. Tom Harkin (Reinecke) and the late Orrin Hatch (Knight).
Israelsen, Reinecke and Knight said they were pleased to have the “opportunity to start a dialogue at the highest levels of FDA” and they “hope it can be the beginning of a productive and constructive dialogue.”
FDA had no comment for this story as of its publication date.
Israelsen recalled being the fourth person of five trade association executives to offer comments to FDA officials. He said he generally agreed with commentary by his colleagues regarding “obvious gaps in enforcement” and how FDA has relied on its drug powers rather than other authorities to target unlawful supplements.
“Specifically, I noted that enforcement is [FDA’s] No. 1 job, and to remove unlawful, unsafe products from the market,” Israelsen remarked in an interview. “And we wish that they would really spend more time doing that. Even when we call them and tell them or send them a product, very little seems to happen.”
“Bad actors,” he said in a follow-up interview, “seem to act with impunity in plain sight” and have calculated the risk of FDA enforcement is low enough they’re willing to incur the risk to make a quick buck.
He also stressed the need to resolve the years-long debacle over hemp-based CBD, which has been widely marketed across the U.S. and remains subject to a patchwork of state regulations rather than a federal regulatory framework.
“The 2018 Farm Bill clearly intended that there be a hemp CBD industry of some kind, but years later there isn’t any organized path to market,” Israelsen commented. “Billions of dollars and a whole bunch of companies have gone bust as a result.”
Separately, Israelsen mentioned challenges regarding the new dietary ingredient (NDI) notification process to FDA and GRAS (generally recognized as safe) self-affirmation—two federal regulatory mechanisms that supplement brands rely on to establish the safety of their ingredients.
“The NDI process really doesn’t work” for a number of reasons, Israelsen said. “In the meantime, industry has looked to GRAS affirmation as a means to establish product safety.”
FDA officials “don’t like GRAS very much and yet nothing gets done to resolve that situation,” he added.
Israelsen expressed concerns to FDA officials about challenges associated with the growing number of FDA determinations that an ingredient is precluded from the definition of a dietary supplement due to its investigation or approval as a drug. In some cases, FDA has made such determinations after ingredients have been marketed in dietary supplements for many years, or even decades—as was the case with N-acetyl-L-cysteine (NAC).
“That’s not fair to the companies that are investing [and] trying to do the job right, and we really feel that is an area that must be addressed,” Israelsen said.
Another issue the UNPA president raised was related to FDA investigators providing conflicting opinions on cGMP (current good manufacturing practices) issues during inspections.
Israelsen recalled telling FDA officials, “Not a week goes by we don’t hear from a company that says, ‘FDA was just in here and told us that we’re doing this all wrong. The prior inspector told us that’s the way we should be doing it.’”
When a company asks the FDA inspector for guidance, Israelsen continued, they respond, “We’re not here to tell you how to do it. We’re just here to tell you you’re doing it wrong.”
Such a response from FDA, he concluded, isn’t helpful to industry.
AHPA’s McGuffin presses for more opportunity to ‘engage’
American Herbal Products Association (AHPA) President Michael McGuffin also had the chance to speak during the meeting with FDA officials. He said FDA has inadequate funds earmarked for its dietary supplements team.
“I simply reiterated we and other trade groups consistently ask for more money” from Congress, he said in an interview. “We’ll continue to do so.”
McGuffin referenced the Reagan-Udall Foundation report. It noted 83% of the budget for the Center for Food Safety and Applied Nutrition is for food safety, 7% for nutrition and just 10% for other activities, including cosmetics and dietary supplements.
During the meeting with FDA officials, McGuffin recalled, he also expressed his support for a recommendation in the Reagan-Udall Foundation report that FDA create a new foods advisory committee. In 2017, CFSAN’s foods advisory committee was disbanded.
That was an “inopportune time to cease the input of industry expertise,” considering that FDA was busy implementing regulations under the Food Safety Modernization Act (FSMA), McGuffin said. He said he served on FDA’s food advisory committee on two different occasions and “found it very useful and a meaningful opportunity to engage.”
McGuffin further noted during the meeting that the Reagan-Udall Foundation report doesn’t address how dietary supplements would be affected under various options to reorganize the FDA structure of the human foods program.
“My plea was once they choose one of these options or a different option to not leave dietary supplements unaddressed,” he said. “As [FDA officials] look at restructuring their management of the human foods program, don’t forget that we’re foods and don’t leave us unaddressed just because Reagan-Udall did not address dietary supplements.”
NPA’s Fabricant makes the case for enforcement action
Natural Products Association (NPA) President and CEO Dan Fabricant was the first trade association executive to address FDA officials during the meeting. He said he began by asking why the Reagan-Udall Foundation report excluded dietary supplements.
FDA’s answer to that question, several people who attended the meeting said, didn’t offer clarity or make a lot of sense.
Fabricant supports the U.S. government issuing a new report on FDA oversight of dietary supplement products before there is any reorganization affecting the commodity. In an interview, he said supplements are far down on the priority list of the commissioner’s office, and he described the attention devoted to the commodity at the highest rungs of the agency as “the step-sister of a step-sister.”
During the meeting with FDA officials, Fabricant recalled, he referenced FDA views on purported impediments to using its food authorities to target tainted products marketed as dietary supplement products. Fabricant said he mentioned a letter in 2015 from Sen. Hatch, which urged the U.S. Department of Justice to increase investigations and enforcement actions against adulterated products sold as dietary supplements.
“The agency has for whatever reason refused to attempt to use mandatory recall or [administrative] detention for spiked products masquerading as supplements,” Fabricant said in a follow-up email.
He questioned why the intended use of a product isn’t a food if it’s being labeled as a dietary supplement or contains a food additive or GRAS ingredient. And he suggested FDA has discretion to use its food authorities to target spiked products masquerading as supplements.
“If you look at violative food products with disease claims, it’s not like the agency does a drug GMP [good manufacturing practices] inspection once they see a disease claim,” said Fabricant, who oversaw FDA’s Division of Dietary Supplement Programs from 2011 until 2014.
FDA inspects the products based on food or supplement GMPs, “so clearly there’s room to interpret things by the agency on what authorities to use,” he maintained.