Dietary supplement stakeholders slam FDA on Capitol Hill

On the morning of June 7, government institutions funded by Congress—including the Food and Drug Administration—were top of mind for a group of dietary supplement industry professionals as they prepared to meet with lawmakers and their staff on Capitol Hill.

“We’ve had a couple of administrative agencies that have taken some real liberties in the last little while,” said Matt Warnock, second-generation owner of RidgeCrest Herbals, a Salt Lake City-based developer and manufacturer of botanical formulas, whose flagship product targets lung and respiratory health. “FDA has been asking Congress … for a mandatory listing requirement, and they’re saying that this is a tightly tailored regulation that applies to the entire industry. So that should tell you that it’s not a very tightly tailored regulation.”

Warnock spoke to a reporter while walking to the offices of the U.S. Senate during fly-in day, an annual lobby event hosted by the Natural Products Association (NPA).

Asked about his concern with FDA’s legislative proposal to require that all dietary supplement products be listed with FDA, Warnock responded, “Our concern in principle is that FDA thinks they need to know everything that happens in the industry. They have that kind of control over the drug industry, and it’s been a bloody disaster. That last thing we want to see is our industry fall into that model.”

Related:Natural Products Association hosts lobby day for first time in four years

FTC guidance

FDA wasn’t the only federal agency on the mind of Warnock as he prepared to meet with legislative offices. He is among those concerned with “Health Products Compliance Guidance” published in December by the Federal Trade Commission.

He interprets the guidance as FTC requiring two clinical trials to substantiate advertising for every product sold to consumers. The guidance doesn’t explicitly say that, though it encourages multiple trials.

“Randomized, controlled human clinical trials (RCTs) are the most reliable form of evidence and are generally the type of substantiation that experts would require for health benefit claims,” FTC stated in the guidance, which supplanted a dietary supplement advertising guide issued in 1998. “Although there is no requirement for a specific number of RCTs, the replication of research in an independently conducted study adds to the weight of the evidence. Replication in a second study by independent researchers reduces the chance that the results of a single RCT may be influenced by unanticipated, undetected, systematic biases that may occur despite the best intentions of sponsors and investigators.”

A product-specific requirement for two clinical trials “is not good science,” Warnock said. “It’s just a regulatory tick box and imposes probably half a million dollars of increased costs on every product on the market.”

This week, the Alliance for Natural Health USA (ANH-USA) announced filing a documentation request with FTC due to concerns with its guidance. In a news release announcing the Freedom of Information Act (FOIA) request, Robert Verkerk, Ph.D., executive director of ANH-USA, characterized the updated FTC guidance as “a backdoor ban on supplement health claims.”

“Clinical trials are incredibly expensive, but pharma companies can afford them because drugs are patentable and the costs can be recouped after the drug is licensed and sold for exorbitant prices,” Verkerk added. An FTC spokesman said the agency has a policy of not commenting on FOIA requests.

Asked whether he believes FDA and FTC are engaging in over-reach of their authorities, Warnock commented, “Absolutely. No question about it.”

DSHEA education

Warnock also discussed the message he wanted to convey to legislative offices.

“I think we just need to help them to understand that this is an industry that has been tremendously successful precisely because it has not been regulated to death,” Warnock said. “When DSHEA [the Dietary Supplement Health and Education Act] was passed in 1994, it was passed on a different model” than drugs.

“Things were OK unless they proved themselves to be not OK,” he continued, commenting on the regulatory framework governing dietary supplements. “That’s the opposite of what FDA has been doing with drugs for the last 100 years, and [DSHEA] has proven itself remarkably successful for the last 30 years.”

Others who attended fly-in day also expressed concerns about FDA. NPA Chairman Mark LeDoux, for example, said he would like FDA, especially the Office of Dietary Supplement Programs (ODSP), “to actually enforce DSHEA as it’s written.”

He acknowledged the need to educate lawmakers on DSHEA since many of them weren’t in Congress when the law was passed.

“You’re talking about 1994,” said LeDoux, who also is founder, chairman and CEO of Natural Alternatives International Inc. (NAI), a manufacturer of nutritional supplements headquartered in Carlsbad, California. “So, it’s a whole new generation of lawmakers.”

NMN, CBD

Matthew Anania, product manager of CellMark Ingredients, was on Capitol Hill to discuss FDA’s determination that healthy aging ingredient NMN cannot be marketed in supplements. FDA has concluded NMN was authorized for investigation as a new drug before it was lawfully marketed in supplements, consequently precluding its use in natural products under DSHEA.

In March, NPA and ANH-USA filed a citizen petition with FDA, requesting the agency reverse its position that NMN is excluded from dietary supplements.

“We want to talk to our representatives to get some answers, and as of right now, there hasn’t really been much progress,” Anania said the morning of fly-in day, before he and a colleague from CellMark Ingredients headed off to House and Senate offices to discuss his concerns. “Maybe there could be progress through government interaction.”

Sibyl Swift, Ph.D., is chief science officer and VP of regulatory affairs with cbdMD Inc., a company operating in an industry (hemp CBD) that has long mourned the absence of a federal regulatory framework.

FDA has expressed many safety concerns about CBD and has asserted the current regulatory frameworks for conventional food and dietary supplements aren’t appropriate for the ingredient. An FDA official recently outlined a “harm-reduction” model for CBD, though he acknowledged a new regulatory framework “is really in Congress’s hands.”

Swift, a former FDA official in ODSP, asserted FDA is not effectively using its current authorities and doesn’t need additional powers to oversee the CBD market.

“Why is this ingredient special?” she asked. “It’s naturally derived.”

FDA enforcement

Joe Weiss is an NPA board member and president of Nutrition21 LLC, a developer and supplier of nutritional ingredients based in Saddle Brook, New Jersey.

On the morning of fly-in day, he identified a list of items he wanted to discuss with legislative offices, including expanding consumer access to dietary supplement products through flexible spending and health savings accounts reimbursements; strengthening patent eligibility for natural products; and combatting counterfeit products that present risks to consumers or defraud them.

Asked about enforcement, he responded FDA officials are “not enforcing existing laws anywhere near where they should be.”

“In fact, we’re here to tell Congress that that’s the case,” Weiss said. “We want to reinforce [to] Congress that they need to push FDA to start doing their job and enforcing the laws and protect consumers.”

New York-based industry lawyer Marc Ullman also met with legislative offices on Capitol Hill during NPA’s fly-in day.

“We discussed general issues with FDA lack of effectiveness as a regulator and that the issue stems not from anything wrong with the law, but with an agency lack of will and interest in making use of the tools that’s been given in DSHEA,” said Ullman, of counsel with Rivkin Radler LLP. “In particular, we addressed the notion that a mandatory product listing would be a panacea that would cure all of the ills and make FDA’s job so much easier, which is nonsense.”

ODSP Director Cara Welch, Ph.D., has said her agency faces “an information gap about the marketplace,” and mandatory product listing “would go a long way to address that data gap.” Greater visibility into the market via a listing regime would enable FDA “to quickly identify illegal products” and “promote a risk-based regulation,” she told Natural Products Insider in an interview last year.

Nutrabolt VP of Global Regulatory and Government Affairs Diana Morgan was interviewed at the Capitol Hill Club—a social club for Republicans—following a day of lobbying. The company’s sports nutrition brands include C4 Energy, Cellucor and Xtend.

While on Capitol Hill, Morgan shared, she and others had “a lot to say about FDA’s lack of enforcement [of] the regulatory framework … and I’d like to hear from FDA firsthand why they’re not enforcing … their own laws.”

Among the topics Morgan and others discussed with legislative offices was the need for FDA to crack down against “bad actors.”

FDA had no comment for this story on criticism of the agency's enforcement. 

Morgan welcomed an opportunity to have interactions with FDA officials that resemble industry stakeholders’ meetings with legislative offices during lobby day. She said she didn’t know anyone else from the agency other than ODSP’s Welch.

“It would be really great for people [who] work at the FDA to also put a face to the name of a lot of these brands that they see on the shelves,” she said.

NPA Director of Government Affairs Kyle Turk addressed the criticisms of FDA communicated during lobby day.

Many industry professionals “are frustrated with inconsistent and often times neglectful enforcement [by] the agency, and they want to have a seat at the table and work with legislators to address FDA’s deficiencies—whether it’s on NMN, import alerts [or] counterfeit products,” he said in an interview. “You name it. The list goes on and on.”

Turk added, “A lot of people came to meet with their U.S. House member [and] U.S. senator to develop relationships that could ultimately help move the agency and the industry forward in a way that is beneficial to both industry stakeholders and consumers.”