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DSHEA 2.0 proposals leave room for finding common ground

TAGS: Ingredients
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Several consumer groups and industry trade organizations are in favor of a new requirement that dietary supplements be listed with FDA, highlighting an area where diverse stakeholders can find common ground related to modernization of DSHEA. Yet even within the dietary supplement industry, there remain divisions over the benefits of a mandatory product listing.

Editor’s note: This is the second article in a series on proposed reforms to DSHEA by several consumer groups in a recent letter to Congress.

Recent proposals by consumer groups to modernize the regulation of dietary supplements have drawn mixed reactions from industry trade organizations.

In a March 10 letter to lawmakers on Capitol Hill, four consumer groups and a prominent physician recommended 11 reforms to how supplements are regulated.

The groups also urged Congress to reject legislation introduced this year in the House of Representatives that would legalize CBD in dietary supplements.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) “has served us extremely well for 27 years,” said David Spangler, senior vice president of legal, government affairs and policy with the Consumer Healthcare Products Association (CHPA), in an interview. “But the industry has grown and “there are some things that ought to be fixed.”

The Council for Responsible Nutrition (CRN) and CHPA both support the consumer groups’ proposal to require dietary supplement products be listed with FDA. The agency itself floated the idea in two consecutive budget requests by the Trump administration and publicly reiterated its support for a mandatory product listing.

“FDA should require mandatory product listing and registration so that it can track dangerous products and repeat offenders, identify hazards in dietary supplements and anticipate safety issues,” the consumer groups wrote to Congress.

The letter was signed by Dr. Pieter Cohen of Harvard Medical School, as well as representatives of the Center for Science in the Public Interest (CSPI), Consumer Federation of America, Consumer Reports and National Consumers League.

Industry trade groups are not all supportive of mandatory product listing. Dan Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), questioned what industry would get in return for a proposal that would impose additional obligations on companies.

“Are we going to preempt the states once and for all?” he asked in an interview. “Is there anything that benefits the industry? Because if that’s not where the conversation starts, then the so-called advocates for the industry really aren’t advocating.”

The American Herbal Products Association (AHPA) also doesn’t support mandatory product listing.

“Our position is we have yet to hear how that [proposal] would help consumers, the industry or FDA,” said Michael McGuffin, AHPA president, in an interview. “What we’ve heard is that it would, but we haven’t been presented with any cogent rationale or narrative as to how it would actually protect consumers, the industry or FDA.”

Consumer groups and industry representatives who agree manufacturers should list their dietary supplement products with FDA may not see eye to eye on the particulars of the proposal.

“I think a number of trade associations have said that they’re for product listing or this or that reform without actually putting any muscle behind it,” said CSPI Policy Director Laura MacCleery, who signed the recent letter to Congress.

In an interview, MacCleery suggested she is open to meeting with industry representatives to find common ground regarding CBD. The ingredient is commonly found in hemp extracts labeled as “dietary supplements”—despite FDA’s long-standing position that CBD was first studied as a drug and cannot be legally marketed as a supplement.

“I would really like to see a bona-fide effort to come to the table and negotiate a legislative solution to this problem,” MacCleery said, commenting on CBD. “We’re certainly interested in that. We will be happy to meet with whomever has a genuine interest.”

There also seems to be room for stakeholders to negotiate reforms to DSHEA. Steve Mister, president and CEO of CRN, said in an interview that his organization agrees with more than half of the consumer groups’ proposed reforms for dietary supplements outlined in the March 10 letter to Congress.

For instance, Mister said he supports increasing FDA’s resources, strengthening its enforcement and specifying in the law that FDA has power to enforce its dietary supplement authorities against products marketed as supplements but adulterated with drugs.

FDA has proclaimed it cannot enforce the dietary supplement provisions in the law against firms selling adulterated products if they don’t technically meet the definition of a dietary supplement.

Several industry representatives believe FDA already has authority to treat such products as “supplements.”

“Congress could change the laws, but that’s not really what needs to be done,” according to Fabricant, a former FDA official who led the Division of Dietary Supplement Programs.

FDA’s Office of Chief Counsel should write a legal opinion that a product labeled as a dietary supplement reflects its intended use, and even if it contains a drug, the agency can use its supplement authority to protect public health, Fabricant said.

“Our view is … if a product looks like a duck and quacks like a duck, it’s a duck,” Mister said. “If you’re holding your product out in the marketplace with a dietary supplement label, then you ought to be subject to those requirements.”

He’s nonetheless supportive of clarifying through legislation—including a CBD bill—that FDA can leverage its dietary supplement authorities to enforce against such products. On the other hand, CRN is opposed to some of the consumer groups’ proposals to change how supplements are regulated, and “we will fight on those,” Mister said.

“But it’s interesting to me how much common ground there could be,” he commented, “if CSPI would come to the table and talk to the industry rather than using us as a punching bag.”

 

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