FDA’s willingness to explore reform of DSHEA draws mixed reactions

Consumer advocates, some Democratic lawmakers and industry trade organizations reacted differently to FDA’s willingness to examine possible reform of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

The divergent reactions reflect stark differences of opinion over the reputation of the dietary supplement industry and its 25-year-old regulatory regime.

Peter Lurie, M.D., a former FDA associate commissioner who leads the nonprofit Center for Science in the Public Interest (CSPI), described DSHEA in a statement as a “deeply flawed law that has long handcuffed the FDA’s regulatory efforts and has produced the sprawling, largely unregulated and often reckless industry we have today.”

Industry trade groups weighed in with a radically different perspective. DSHEA offered consumers wide access to supplements while protecting the safety of the public, according to Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).

“We are intrigued and enthusiastic to hear what FDA has in mind, but we will be very careful to protect that balance between access and safety,” Mister said in an interview.

FDA’s top official supported the notion that most companies in the industry are responsible. The remarks by FDA Commissioner Scott Gottlieb, M.D., also underscored the need for FDA to rigorously enforce its authority to target “bad actors” who spike products with undeclared prescription drugs or otherwise endanger the public health.

“We know that most of players in this industry act responsibly,” Gottlieb said in a statement, revealing his plans to strengthen regulation of dietary supplements. “But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk. As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.”

Gottlieb expressed a willingness to open talks with stakeholders concerning whether it’s necessary to modernize DSHEA. The law’s principal champions—including Sen. Orrin Hatch, the Republican from Utah—are now retired from Congress.

“While the FDA is committed to leveraging its existing resources and authorities to the fullest extent possible, we believe there may be value in a broader public conversation about whether certain changes to the law might be helpful,” Gottlieb said. “We believe there may be opportunities to modernize DSHEA for the future, while preserving the law’s essential balance.”

Michael McGuffin, president of the American Herbal Products Association (AHPA), refuted the perception that the legal framework governing dietary supplements hasn’t been touched in a quarter century. He pointed out Congress amended the law in 2006 when it added adverse event reporting requirements for supplements— a move the industry supported.

“That was not in DSHEA, so we have reformed the regulation of supplements on our own,” he said in an interview.

McGuffin added he is open to a discussion about possible reforms, including whether the law should clarify the new dietary ingredient (NDI) provisions in DSHEA and make clear that synthetic products are allowed to be sold in supplements, among other issues.

He asked whether the laws could be “improved so that consumers have unfettered access and excellent and truthful information about a broad range of dietary supplements” that they use to promote their health.

Some consumer groups have argued reform is sorely needed, including mandatory registration of dietary supplements products. Sandra Eskin, project director of food safety with The Pew Charitable Trusts, a global research and public policy organization, commended Gottlieb for his plans to strengthen oversight of dietary supplements.

“Clearly, more must be done to ensure that unsafe products are not marketed,” she said in an email. “FDA needs to know what supplement products each company makes, as well as the ingredients and copies of the product labels. This information is absolutely essential to effective oversight.”

Daniel Fabricant, Ph.D., leads the Natural Products Association (NPA) and is a former FDA official who oversaw what was formerly known as the Division of Dietary Supplement Programs. In a statement, Fabricant said dietary supplements are safe, and he encouraged “FDA to use the current tools it has at its disposal to protect consumers from companies selling illegal products masquerading as nutritional supplements.”

Crediting collaboration between the supplement industry and federal regulators, Fabricant proclaimed the United States “has the safest nutritional supplements in the world.”

Critics of the supplement industry have pushed for additional safeguards, yet Gottlieb’s announcement drew a variety of reactions.

Commenting via Twitter, Sen. Dick Durbin (D-Illinois) said Gottlieb’s announcement “holds promise to be the first real dietary supplement safety improvement in 25 years.”

“Under this new plan, consumers will be informed quicker when there’s a problem with a product, and FDA can enforce new strategies and take action against bad actors,” the senator added.

Pieter Cohen, M.D., is an associate professor of medicine at Harvard Medical School who has studied potentially dangerous ingredients in products marketed as dietary supplements, and his research has been published in prominent peer-reviewed journals.

He described Gottlieb’s statement as a “non-announcement.” The only specific action taken by FDA, the physician noted, was the issuance of warning letters and online advisory letters to companies for marketing products for Alzheimer’s and other diseases.

“That’s business as usual,” he said in an interview. “That’s just doing your most basic work over there.”

He added, “If you’re serious about making changes, then already say, ‘I’m going over to talk to Congress tomorrow. We’re going to convene this [committee] tomorrow.'"

Cohen said he understands FDA wants to solicit input from stakeholders before making certain plans, “but to have absolutely nothing concrete other than warning letters to companies selling Alzheimer’s cures … that seems to me like maybe this is going to be it.”

He asserted two measures are necessary to ensure the safety of dietary supplements: FDA enforcement of the current laws and reform of DSHEA.

Gottlieb’s announcement coincides with DSHEA’s 25-year anniversary, said Loren Israelsen, president of the United Natural Products Alliance (UNPA).

“We recognize that the world has changed,” he wrote in a memo to his members.

Israelsen said UNPA planned to work closely with FDA on its stated objectives and any of its proposed ideas.

“The prospects of amendments to DSHEA has long been discussed as a non-starter,” Israelsen added. “We, of course, will listen closely to FDA’s ideas regarding DSHEA amendments and will work in close consultation with our members to that end.”

Sen. Richard Blumenthal (D-Connecticut), a renowned critic of the industry, suggested reform is long overdue.

“The dietary supplement industry has skirted scrutiny [and] hidden behind loopholes, allowing bad actors to deceive [and] even harm consumers,” Blumenthal said via Twitter, commenting on the warning letters and Gottlieb’s announcement. “Today's FDA action is an important step, one I’ve long called for, to begin reforming this mostly unregulated industry.”

Industry insiders have maintained supplements are amply regulated, but they largely expressed support for Gottlieb’s moves to strengthen oversight.

Attorney Scott Bass, a partner with Sidley Austin LLP, concluded in an interview, “I consider the statement …. from FDA to be a big positive for industry.”